http://journalofsopi.com/index.php/sopi/issue/feed Journal of Pharmacovigilance and Drug Safety 2020-06-29T03:32:58+00:00 Prof. (Dr.) Farhan Ahmad Khan editorjournalsopi@gmail.com Open Journal Systems <p style="text-align: justify;">In the modern era of clinical application of knowledge of pharmacology, it is a big dilemma in hoosing between the good and the best drug. In making a decision for treatment planning clinician must consider the additional features of local and systemic issues, patient's economic status as well as potential adverse effect of the drug.</p> <p style="text-align: justify;">There are large number of drug trial going on world wide to observe the effect of a particular drug or a molecule. However, the scenario has changed drastically in last 20 years. What it was with the western/ developed world is now shifting over to developing world.</p> <p style="text-align: justify;">India is set to grab clinical trial business, making the subcontinent world's preferred destination for clinical trials. The big reason being low cost of trial along with friendly drug control system with&nbsp;competent work force and patient availability. Indian investigators and clinical trial research professionals have already demonstrated their medical and scientific skills in various global clinical trials. It is time now to capitalize on this opportunity. Indian investigators and research professionals can prove their ability and show to the world and register their presence now as well as for future.</p> <p>&nbsp;</p> http://journalofsopi.com/index.php/sopi/article/view/18 “DOOR MAN” (Documentation of Objectionable advertisement and Reporting under Magic and Remedies Act Notification) Android Mobile App for AYUSH Magical Remedial Act Programmes: An Efficient and Easy Way of Assessing Magic Remedies Act 2020-02-09T08:15:25+00:00 MS Shree Devi editorjournalsopi@gmail.com P Sathiyarajeswaran editorjournalsopi@gmail.com <div class="page" title="Page 1"> <div class="section"> <div class="layoutArea"> <div class="column"> <p>Background: “DOOR MAN” (Documentation Of Objectionable advertisement and Reporting under Magic and Remedies Act Notification) Android Mobile App is a pioneer app of its kind in AYUSH which helps in documenting, reporting and improve the communication of safety issues related to false claims, magic and misleading advertisements. Siddha Central Research Institute, Chennai is a Peripheral Pharmacovigilance Centre developed “DOOR MAN”, a free smartphone app which will be available on Android stores, after beta version deployment. In recent times, the incidence of false claims, magic and misleading advertisements with embellished claims on efficacy has increased by multiple folds. These Indian legislations govern the ‘Schedule J of Drugs and Cosmetics Rules’ and ‘Drugs and Magic Remedies Act’ advertisement related to drugs, treatments and procedures. As per the statement from Honourable Minister, Ministry of AYUSH has come across 804 instances of misleading advertisements/claims allegedly of herbal/AYUSH products &amp; services including Ayurvedic medicines during the period of last two years and current year from April, 2015 to January, 2018 as reported from the Advertising Standards Council of India (ASCI) and the Grievances Against Misleading Advertisements (GAMA) portal maintained by the Department of Consumer Affairs.</p> <p>Aim: This Android Application helps to enforce Drugs and Magic Remedies Act, in AYUSH, which will attempt to capture the advertisements, videos, Tv shows, Pamphlets related to drugs, treatments and procedures appearing irrespective their rationality, truthfulness and violation of Indian Legislations specific to Magic Remedies Act.</p> <p>Methods: 15 single questionnaires in the report form were combined in the App. Algorithms were written and mobile app was designed using Android Studio with Eclipse plug-in along with SDK tools and manager. The app runs on android based Operating System of version 2.1 or higher.</p> <p>Results: This Android app helps in capturing real time Misleading advertisements, tele- marketing, multi-level marketing, direct selling which promotes various products by making unrealistic claims. It will lessen the time consumption and promotes the habit of being vigilant in Drugs and Magic Remedies Act. This App enhance the AUSH Physician, Pharmacist, Health Worker, Nurse, Social Worker, NGO, Others (Including Public) to report. This app would be a boon to the AYUSH community which has responsibility to preserve legacy and ensure its credibility which should not compromised for cheap publicity or short-term economic gains.</p> <p>Conclusion: “DOOR MAN” android mobile app can be an effective method to capture Misleading Advertisements and can become an important tool in strengthening the AYUSH Community.</p> </div> </div> </div> </div> 2020-02-09T07:09:28+00:00 Copyright (c) 2019 MS Shree Devi, P Sathiyarajeswaran http://journalofsopi.com/index.php/sopi/article/view/19 SiddAR (Siddha Initiative for Documentation of Drug Adverse Reaction): Android Mobile App for AYUSH Pharmacovigilance Programmes: An Efficient and Easy Way of Assessing ADR 2020-02-09T08:15:26+00:00 P Sathiyarajeswaran editorjournalsopi@gmail.com MS Shree Devi editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Mobile phones have become integral part of human life. A mobile application helps in Delivering food and also helps to conduct Delivery. Apart from connectivity android and iPhone make ease of all activities.&nbsp; One area of those applications is healthcare applications. “SiddAR” (<strong><u>S</u></strong>iddha <strong><u>I</u></strong>nitiative for <strong><u>D</u></strong>ocumentation of <strong><u>D</u></strong>rug <strong><u>A</u></strong>dverse <strong><u>R</u></strong>eaction) Android Mobile App is a pioneer app of its kind in AYUSH which helps in documenting, reporting and improve the communication of safety issues related to adverse drug reaction. Siddha Central Research Institute, Chennai is a Peripheral Pharmacovigilance Centre developed “SiddAR”, a free smartphone app available on Android stores, for reporting adverse drug reactions and requesting drug safety information instantaneously.</em></p> <p><strong><em>Aim: </em></strong><em>In AYUSH pharmacovigilance, contemporary documentation process involves in submission of reports through filled in physical forms / online forms. Rapidity in Reporting would be lifesaving and also helps to prevent mortality and Morbidity.</em></p> <p><strong><em>Methods: </em></strong><em>25 single questionnaires in the report form were combined in the App. Algorithms were written and mobile app was designed using Android Studio with Eclipse plug-in along with SDK tools and manager. The app runs on android based Operating System of version 2.1 or higher. </em></p> <p><strong><em>Results: </em></strong><em>This Android app helps in real time documentation, lessening the time consumption and promotes the habit of being vigilant with drugs in market and their defects in manufacturing process. This App enhance the Researcher to document ADR in Clinical trials. This app would be a boon to the AYUSH health professionals and support team like nurses, AYUSH pharmacy persons and allied AYUSH persons to report the adverse events caused by drugs and to stream line the process of ADR reporting and analysis.</em></p> <p><strong><em>Conclusion: </em></strong><em>“SiddAR”</em><em> ADR android mobile app can be an effective alternative method to manual ADR analysis and can become an important tool in strengthening the AYUSH Pharmacovigilance programmes.</em></p> 2020-02-09T07:15:23+00:00 Copyright (c) 2019 P Sathiyarajeswaran , MS Shree Devi http://journalofsopi.com/index.php/sopi/article/view/20 Anti-retroviral therapy (ART) regimens and associated adverse events: A prospective observational study in a Tertiary Care Hospital of South Odisha 2020-02-09T08:15:26+00:00 Chinmaya SopiMahapatra editorjournalsopi@gmail.com Jai Prakash editorjournalsopi@gmail.com Y Roja Ramani editorjournalsopi@gmail.com Prasanna Kumar Kar editorjournalsopi@gmail.com Supriya Sahoo editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>HIV prevalence in Odisha has reduced to 0.13% from 0.31 % (2010) since the advent of antiretroviral therapy (ART).&nbsp; It has been proven to be efficacious and also lifesaving in patients living with HIV (PLHIV). However their associated adverse events [AEs] are a matter of serious concern. Therefore the present study was conducted to evaluate the AEs following various ART regimens.</em></p> <p><strong><em>Methods: </em></strong><em>This was a prospective observational study (September 2018 - August 2019) among PLHIV and receiving ART from the outpatient setting of ART centre of M.K.C.G. Medical College &amp; Hospital, Berhampur, Odisha. Data were collected and analyzed to find out the demographic characteristics, causality and severity of </em><em>adverse </em><em>events (AEs) with different ART regimens.</em></p> <p><strong><em>Results:</em></strong> <em>The study showed that, 317 patients were identified to be suffering from one or more adverse events. Female gender, 40-49 years age group were more prone to adverse events. Among them, Eight (8) cases were labeled as </em><em>‘</em><em>serious</em><em>’</em><em> category and were hospitalized. 97.5% patients were graded as </em><em>‘</em><em>possible</em><em>’ [</em><em>WHO-UMC causality assessment scale]. Patients were administered 10 types of ART regimen of which most AEs (217) were observed with Tenofovir + Lamivudine + Efavirenz (TLE). Most commonly observed adverse events were acid peptic disease (89), myalgia (85), acute respiratory tract infection (18), anemia (15), neuritis (15). </em></p> <p><strong><em>Conclusion: </em></strong><em>ART regimen has considerably reduced the morbidity and mortality of PLHIV, but increased numbers of AEs, demands intensive monitoring and timely intervention for tackling the associated AEs to improve patient compliance and quality of life.</em></p> 2020-02-09T07:17:55+00:00 Copyright (c) 2019 Chinmaya SopiMahapatra, Jai Prakash, Y Roja Ramani, Prasanna Kumar Kar, Supriya Sahoo http://journalofsopi.com/index.php/sopi/article/view/21 Patient Knowledge and Awareness Regarding Prescribed Medications 2020-06-29T03:32:58+00:00 Hetul Patel editorjournalsopi@gmail.com Minaxi Shah editorjournalsopi@gmail.com Sumit Patel editorjournalsopi@gmail.com Akanksha Prajapati editorjournalsopi@gmail.com R K Dikshit editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Patient’s medication knowledge is important for a better outcome, compliance and adherence.</em><em> Improper information may affect the treatment outcome. Therefore, this work was carried out to evaluate the knowledge in patients regarding their prescribed medications.</em></p> <p><strong><em>Methods: </em></strong><em>A cross sectional </em><em>study</em><em> was </em><em>carried out in out-patient pharmacy </em><em>at GCS Hospital, Ahmedabad </em><em>from January to May 2019</em><em>. </em><em>Adult patients (251) were interviewed as per questionnaire and categorised according to their information status regarding disease condition and prescribed medication.</em></p> <p><strong><em>Results</em></strong><em>: Males and females were 139 (55.4%) and 112 (44.6%) respectively with mean age of 42 years. Patients with no education, primary education, higher education and graduation were 10%, 28%, 45%, 17% respectively. All patients were informed about medication by doctor and pharmacist. Additional source of information were family members and internet. About 45% recalled the appropriate name of drug and 86% graduate patients cross checked their symptoms and/or diagnosis on internet [p&lt;0.05]. Only 24% with higher education discontinued the treatment without guidance. [p&gt;0.05].Tendency to reuse the old prescription was more in higher education and graduate group [p&lt;0.05]. All knew route, frequency and total duration of treatment. None of them were aware about side effects of drugs. Knowledge about indication(s) differed as per education. </em></p> <p><strong><em>Conclusion: </em></strong><em>Patient’s interest, education, clear instructions from doctors as well as pharmacist are major factors associated with improved awareness regarding use of medicines.</em></p> 2020-02-09T07:20:25+00:00 Copyright (c) 2019 Hetul Patel, Minaxi Shah, Sumit Patel, Akanksha Prajapati, R K Dikshit http://journalofsopi.com/index.php/sopi/article/view/22 Pharmacovigilance for safer use of drugs in Ayurveda through Experimental study 2020-02-09T08:15:27+00:00 Nilima Narayanrao Wadnerwar editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Heavy metals are used in Ayurvedic medicine since ancient period. Case reports published in national and international journals and news papers regarding heavy metals poisoning after the use of drugs in Ayurveda has created a negative impact on public towards the use of Ayurvedic medicine. On the ground where formulations of Ayurved are targeted to contain high levels of heavy metals, there is urgent need to have pharmacovigilance for these drugs regarding their safety in the treatment. Hence, an experimental study was conducted to assess the toxicity and to identify the factor responsible for the toxicity of the arsenical compounds Rasamanikya which is a very popular medicine used for various ailments. </em></p> <p><strong><em>Methods:</em></strong><em> Physical and physico-chemical properties of three different market preparations of Rasamanikya were studied by using advance methods (ICP-AES and XRD) and the sample containing highest level of Arsenic was subjected to chronic toxicity study in rats. Hematological and biochemical parameters were assessed at 30, 60 and 90 days and histopathological study was conducted at the end of the study. </em></p> <p><strong><em>Result:</em></strong><em> All the three samples showed variation in concentration of arsenic and its crystal size. Traces of nineteen other metal compounds were found in all samples other than Arsenic and Sulphur. There were no significant differences observed most of hematological and biochemical parameters up to 60 days in Wistar rats. No significant differences in body weight and relative organ weight were observed. Minimal to mild changes were observed in liver and kidney which were pathologically insignificant. </em></p> <p><strong><em>Conclusion:</em></strong><em> LD 50 of Rasamanikya may be more than 2000 mg/kg and Rasamanikya is safe for 15 days duration in the therapeutic dose in human beings. Chronic Arsenic toxicity due to Rasamanikya is not possible if it is consumed in therapeutic dose for 10- 15 days. But there is an urgent need of standardization of method of preparation and standardization of contents to prepare Rasamanikya and its use for therapeutic purposes. </em></p> 2020-02-09T07:26:43+00:00 Copyright (c) 2019 Nilima Narayanrao Wadnerwar http://journalofsopi.com/index.php/sopi/article/view/23 Drug Genuinity and its Role in Ayurvedic Pharmacovigilance W.S.R.T Pippali (Piper Longum) 2020-02-09T08:15:28+00:00 Princy Xavier editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Herbal preparations constitute the primary therapeutic interventions in Ayurveda. In Kerala more than 200 medicinal plants are taken on large scale for the preparation of medicinal products. Pippali is one among the drug which is used in almost all formulations. The genuinity, purity and quality of the drugs have direct impact on the quality of medicinal formulations. In the present study an attempt has made to ascertain the genuineness of fruit of Pippali in Kerala market, in concern with pharmacovigilance.&nbsp; </em></p> <p><strong><em>Methods: </em></strong><em>Samples were collected randomly from different markets of Kerala. Genuiness of samples were analysed formacroscopic, microscopic and physicochemical parameters like total ash, water soluble extractives, TLC and HPTLC. </em></p> <p><strong><em>Results: </em></strong><em>Marked variations are noted in both macroscopic and microscopic characters. Instead of Piper longum, Piper retrofractum is using in many parts of Kerala. HPTLC was performed between the samples which showed marked differences in quantity of Piperine, which is a major chemical constituent of Pippali. Some of the samples does not matches with the parameter mentioned in API. </em></p> <p><strong><em>Conclusion: </em></strong><em>Standardisation of finished products can achieved only by the usage of genuine drugs. . The need of the hour is to take caution right from the collection of raw drug so as to avoid adulteration and substitution, which in turn prove that the AYUSH drugs are safe and scientific in global market.</em></p> 2020-02-09T07:29:43+00:00 Copyright (c) 2019 Princy Xavier http://journalofsopi.com/index.php/sopi/article/view/24 Standardisation & investigation of preliminary phytoconstituents at three stages of fruiting of figs of Udumbar (Fius racemosa Linn.) 2020-02-09T08:15:28+00:00 Rajanee Vijay Jadhav editorjournalsopi@gmail.com Sambhaji Tike editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Udumber</em><em> (Ficus racemosa Linn.) is a plant seen mostly all over India. It’s every part i.e. root, stem, leaves, fruits, ksheer are used in treatment of various diseases Diabetes, Diarrhoea, Cancer by its pharmaceutical &amp; nutritional properties. Though having medicinal property abundant amount of its fruits are wasted. It green fruit is eaten as vegetable in villages &amp; ripened fruits are eaten. Udumber trees are seen in so often Udumber fruiting is in clusters &amp; 2-4 times in year. Feasibility of fruits are good. They can be eaten directly or with honey/sugar/jaggery/ghee. Therefore it will be cheapest, easily available nutrition to children, in pregnant woman, malnourished patients of cancer, diabetes, HIV, Koch’s etc as compared to available costly nutritious, pharmaceutical drugs.<strong> Materials and Materials and Methods: </strong>Samples were collected 5 seasons of its fruiting throughout year from Kharghar –Navi Mumbai &amp; are authenticated. Collection of equal amount of samples each at three stages of figs of Udumber (Ficus racemosa Linn.) i.e Unriped figs (Bright green), Middle stage between Unriped &amp; ripened (Reddish orange), Ripened Figs (Red) from different clusters of same plants randomly. Standardization were done according to Ayurvedic Pharmacopia of India. Study were done in 3 stages i.e Pharmacognostic study,&nbsp; preliminary phytoconstituents study and analysis of collected data by ANOVA method done.<strong> Result and Discussion:</strong> Ficus racemosa is with ripened fig- LOD-0.11%,ASH-8.05%,AIA-0.746%,ASE-8.896%,WSE,- 28.304%,pH-5.2.Proteins-9.34,Carbohydrates-22.88,Fixed oils : 2.736<strong>, </strong>Unripened Fig- LOD-0.11%,ASH-9.842%,AIA-1.26%,ASE-9.764%,WSE,-16.264%,pH-5.2. Proteins-9.07%, Carbohydrates-21.64%, Fixed oils: 5.12% Primary metabolites present as Carbohydrates, Proteins &amp; fats. Presence of secondary metabolites like Tannin, Glycosides, Steroids, Caumarins, Flavonoids in all stages of ripened &amp; unripened figs. Alkaloids &amp; saponins are not traceful. Calcium, Phosphorus, Iron, Silica, Potassium etc. are present in all stages. </em></p> <p><strong><em>Conclusion: </em></strong><em>ANOVA test done for statistical evaluation.There are no significant difference in view of Physicochemical &amp; phytoconstituents evaluation at three stages of figs of Udumbar.</em></p> 2020-02-09T07:33:53+00:00 Copyright (c) 2019 Rajanee Vijay Jadhav, Sambhaji Tike http://journalofsopi.com/index.php/sopi/article/view/25 A cross sectional survey on the knowledge and attitude of Ayurvedic practitioners of Kerala towards Pharmacovigilance 2020-02-09T08:15:28+00:00 Indu M Menon editorjournalsopi@gmail.com MS Deepa editorjournalsopi@gmail.com <p><strong><em>Background:</em></strong><em> The popular perception of Ayurvedic medicines of being devoid of any adverse drug reaction is at stake. Owing to the increased industrialization in this field, there is an alarming increase in the rate of adverse drug reactions. To tackle these issues, National Pharmacovigilance Programme for AYUSH drugs was introduced. An in-depth research was conducted to assess the knowledge and attitude of Ayurvedic Practitioners of Kerala towards Pharmacovigilance and the extent to which they report adverse drug reactions (ADRs) to the higher centres. </em></p> <p><strong><em>Methods:</em></strong><em> A validated web based questionnaire was designed and a cross sectional survey was conducted among 100 Ayurvedic clinical practitioners in different districts of Kerala (n=100). Inclusion criteria were Clinical practitioners and excluded Teaching faculties and PG Scholars. Statistical method employed was Descriptive statistics. </em></p> <p><strong><em>Results:</em></strong><em> Statistical analysis revealed that only 58% physicians are aware of the existence of National Pharmacovigilance Programme. 56% does not have the idea of the higher reporting centres. 80% are unaware of the existence of Peripheral Pharmacovigilance centre in Kerala. 60% are ignorant that ADRs should be reported and 77% are not familiar with the standard form for ADR reporting of Ayurvedic medicines. </em></p> <p><strong><em>Conclusion:</em></strong><em> The present study brought into light the lack of knowledge of National Pharmacovigilance Programme and ADR reporting of Ayurvedic medicines. This study has unveiled the urgent need for a regular training and reinforcement for the ADR reporting among the Ayurvedic Practitioners.&nbsp;&nbsp;&nbsp; </em></p> 2020-02-09T07:37:24+00:00 Copyright (c) 2019 Indu M Menon, MS Deepa http://journalofsopi.com/index.php/sopi/article/view/26 Moringa oleifera Lam. Enriched Biscuits Induced Adverse Drug Reaction- a Case Report 2020-02-09T08:15:29+00:00 Meena Shamrao Deogade editorjournalsopi@gmail.com Vishakha Kumbhare editorjournalsopi@gmail.com Anita Wanjari editorjournalsopi@gmail.com Shilpa Gaidhane editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Moringa oliefera Lam. (Shigru/Moringa) is used as day to day edible product and as well as medicinal purpose for its enriched nutrients and medicinal values. Thus the biscuits of Shigru leaves were prepared to carry out a clinical trial to correct Iron deficiency anaemia in females. Out of 51 recruited participants during the clinical trial, one case of adverse drug reaction was reported. </em></p> <p><strong><em>Materials and Methods:</em></strong><em> An 18 year female participant with 39 kg weight included in research trial as her Hb% was 10.2 and serum ferritin was 3.85.&nbsp; Moringa oliefera enriched biscuits were given in a dose two biscuits twice daily since 7 September 2019.&nbsp; She has reported after 5 days i.e. on 12 September 2019 with the complaint of red rash over back and arm.&nbsp; She was advised to withdraw the biscuits immediately got relief within 24 hours. After restarting the biscuits, she reported again rash with itching, then a case of ADR recorded and Ayurveda treatment has been initiated.&nbsp; <strong>Result:</strong> After Ayurveda medication within 12 hours she got relief from itching and red rash disappeared gradually. </em></p> <p><strong><em>Discussion and Conclusion:</em></strong><em> Moringa is even though commonly used as in many edible forms; the Moringa enriched biscuit reported 1 ADR out of 51 recruited participants. This is important and helpful for pharmacovigilance to record and control adversity that affects the issues of consumers and regularization of Ayurveda health care system. </em></p> 2020-02-09T07:39:49+00:00 Copyright (c) 2019 Meena Shamrao Deogade, Vishakha Kumbhare, Anita Wanjari, Shilpa Gaidhane http://journalofsopi.com/index.php/sopi/article/view/27 Serankottai induced contact dermatitis during suthi process in Siddha -A case report 2020-02-09T08:15:29+00:00 L Juliet editorjournalsopi@gmail.com SR Karthik Raja editorjournalsopi@gmail.com VL Reena editorjournalsopi@gmail.com V Aarthi editorjournalsopi@gmail.com P Rajeshwaran Sathiya editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>In Siddha, the famous quote ‘Chukkuku pura nanju ,Kadukaiku aga nanju’, reveals that most of the plants are adjoined with the toxic part /chemical which has to be removed by the Suthi process before its medicinal uses. Any untoward medical occurrence during treatment is the ADR (Adverse Drug Reaction). Contact dermatitis is one of the common toxic symptoms/known ADR of most of the poisonous drugs. Serankottai (Semecarpus anacardium nuts- SA nuts) is enormously used in Siddha medicine for various challenging diseases like Rheumatoid arthritis, Cancer, Psoriasis, etc. This drug comes under poisonous herbs Schedule-E drugs and the expected adverse events are allergic contact dermatitis, redness, severe itching, burning sensation, facial edema, anasarca and anaphylactic reaction in extreme conditions. This study reports about the toxic signs developed by Serankottai and its management through Siddha medicines. </em></p> <p><strong><em>Methods: </em></strong><em>Reporting of a different case, presented with Contact dermatitis during Siddha purification method in Siddha manufacturing unit and the negative rechallenge of the symptoms by Siddha antidotes were discussed. </em></p> <p><strong><em>Results: </em></strong><em>It is to report that, Serankottai induced contact dermatitis has been successfully managed by proper Siddha antidotes like Puli ilai kudineer (Tamarind leaf decoction) and Sengal podi ottradam (Brick powder Fomentation) as mentioned in Gunapadam Mooligai Vagupu and Sattam Saarndha Maruthuvamum Nanju Maruthuvamum.</em></p> <p><em>&nbsp;<strong>Discussion:</strong> Proper purification of Toxic plants reduces toxicity to end user. Siddhars have documented step by step SOP in Purification of Toxic Plants. They have also prescribed remediation helping in Negative rechallenge. Here a case has been reported with Clinical manifestations like Blisters and boils after getting consent as per the CARE Guidelines to reveal the Negative rechallenge in pharmacovigilance.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </em></p> 2020-02-09T00:00:00+00:00 Copyright (c) 2019 L Juliet, SR Karthik Raja, VL Reena, V Aarthi, P Rajeshwaran Sathiya http://journalofsopi.com/index.php/sopi/article/view/28 Pellagroid Dermatitis due to Phenytoin Medication Error in an adult woman with Generalized Epilepsy 2020-02-09T08:15:30+00:00 HJ Dholakia editorjournalsopi@gmail.com AP Singh editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Phenytoin is a drug commonly used for treatment of generalized tonic clonic seizures and partial seizures. It has very narrow therapeutic index. Its therapeutic range is 10-20 mcg/dL above which signs of toxicities appear. Pellagroid Dermatitis is a rare adverse drug reaction of phenytoin with incidence of 23 cases among 57,792 cases of ADR due to Phenytoin in VIGIacess.</em></p> <p><strong><em>Case report: </em></strong><em>A 25 years female, having epilepsy since 1 month was prescribed phenytoin 100mg thrice a day. She, due to misunderstanding; took 3 tablets of 100mg, together at bed time and plasma level of phenytoin was elevated to 33.44mcg/dL along with Pellagroid Dermatitis, Diarrhea and Giddiness. Rashes were distributed bilaterally, on the exposed areas of back of hands up to rim of sleeves (Pellagra Gloves). Area involved in legs is up to the edge of trousers or skirt. As Tab. Phenytoin was withdrawn, diarrhea and giddiness improved. She was given Tab. Niacinamide 250mg twice a day. Patient was shifted to tab. Valproate 200mg thrice a day orally</em></p> <p><strong><em>Discussion: </em></strong><em>Phenytoin elimination is dose dependent. At low blood levels 10-15mcg/dl, it follows first order kinetics; as the blood level rises above 20mcg/dl, liver enzymes get saturated and plasma level rises rapidly. Peak plasma level reaches within 3-12 hours of oral administration. Plasma levels in individual’s shows emergence of dose-related side effects. </em><strong><em>Conclusion: </em></strong><em>Phenytoin may contribute to niacin deficiency at higher concentration that can manifest as pellagra. As the drug has narrow therapeutic index, therapeutic drug monitoring along with counseling of patient for proper use of medicine must be done. </em></p> 2020-02-09T07:44:44+00:00 Copyright (c) 2019 HJ Dholakia, AP Singh http://journalofsopi.com/index.php/sopi/article/view/29 A case of Digoxin toxicity due to renal insufficiency and drug-drug interaction 2020-02-09T08:15:30+00:00 RB Kotadia editorjournalsopi@gmail.com AR Kubavat editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Digoxin is a cardiac glycoside indicated for the control of resting ventricular rate in patients with chronic atrial fibrillation in adults. The drug has a narrow therapeutic range (0.5 – 2 ng/ml) that leads to toxicity. However, we report a case of serious digoxin toxicity. </em></p> <p><strong><em>Methods: </em></strong><em>A K/C/O AF with CVA, 57 year old male patient presented with c/o vomiting, chest pain, ghabaraman, dizziness and generalized-weakness. The patient was also having renal calculi with on and off hydro-nephrosis. He was prescribed with Digoxin (0.125 mg) 5 day in a weak along with Tab Atorvastatin 40 mg, Tab Aspirin 150 mg and Tab Clopidogrel 75 mg OD since 1 year.&nbsp; The physician observed ECG changes indicating Bradycardia and A-V block as a suspected ADR of Digoxin and was confirmed by Laboratory investigation and causality assessment, immediately Digoxin was stopped. The symptoms improved significantly after withdrawal of the drug and Injection Atropine 0.5 mg intravenously stat.</em></p> <p><strong><em>Discussion</em></strong><em>: The most frequent causes of toxicity are renal insufficiency and overdosing. Digoxin is primarily excreted by the kidneys; therefore, patients with impaired renal function require smaller than usual maintenance doses of digoxin. Atorvastatin can lead to increase Digoxin plasma concentration by 22% requiring reduction in dosage.</em></p> <p><strong><em>Conclusion: </em></strong><em>Dosage of Digoxin should be decided only obtaining results of Renal and Liver function test and checking drug-drug interaction with drugs prescribed simultaneously. TDM should be done regularly &amp; periodically in patients with Digoxin Therapy.</em></p> 2020-02-09T07:46:13+00:00 Copyright (c) 2019 RB Kotadia, AR Kubavat http://journalofsopi.com/index.php/sopi/article/view/30 Environmental Pharmacovigilance (EPV): An emerging branch of Science- A review 2020-02-09T08:15:30+00:00 K Vyas editorjournalsopi@gmail.com V Sharma editorjournalsopi@gmail.com <p><strong><em>Introduction:</em></strong><em> Environmental Pharmacovigilance (EPV) is a developing branch of science relating to the detection, assessment, understanding and prevention of Adverse Environmental Impacts (AEI) of Pharmaceutical products. It identifies risk levels of pharmaceutical residues mainly in water &amp; soil for Environmental Risk Assessment (ERA) and its effective management. These spotting activities are necessary not only after launch of a new pharmaceutical product but also through its whole Life cycle. </em></p> <p><strong><em>Aims &amp; Objectives:</em></strong><em> The branch is aimed to find out significant environmental issues related to Pharmaceuticals in Environment (PIE). </em></p> <p><strong><em>Review &amp; Discussion:</em></strong><em> The main components of Environmental Pharmacovigilance (EPV) are- Environment, Pharmaceutical Product, Product user (Human/ animal)/ dealer and Victims of the risks developed. The victims may be non-targeted human population, wild life species or aquatic inhabitants etc. The documentation of this vigilance search is completely limited as it is quite difficult to differentiate the relative impact of pharmaceuticals and other Environmental stimuli. Moreover, management plans require deep knowledge of Physico-chemistry, pharmacokinetics, toxicology and other sciences, which make it very specific. Though Environmental Risk Assessment is already included in regulatory approval process for new drugs, its implementation is poor in Developing countries. </em></p> <p><strong><em>Conclusion:</em></strong><em>&nbsp; there is great need to focus on this branch of vigilance in order to save the world from fatal hazards.</em></p> 2020-02-09T07:49:12+00:00 Copyright (c) 2019 K Vyas, V Sharma http://journalofsopi.com/index.php/sopi/article/view/31 Challenges in implementing Pharmacovigilance Programme for ASU & H drugs 2020-02-09T08:15:31+00:00 K Haseena editorjournalsopi@gmail.com N Manojkumar editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>Pharmacovigilance deals with the Adverse Drug Reaction or any Drug related issues. Identification and reporting of Adverse Drug Reaction/ Adverse events and analysis of its consequences have a positive impact on the public health. Implementation of Pharmacovigilance programme for ASU &amp; H drugs is not an easy task; it has come across with many challenges and barriers. This article highlights the challenges faced during the implementation of Pharmacovigilance Program for ASU &amp; H drugs at Peripheral center.</em></p> <p><strong><em>Methods: </em></strong><em>It is an explorative study, wherein personal interviews of health care professionals and peer reviewed journals were collected and evaluated. Already published articles and books were also referred for compilation and interpretation of results. </em></p> <p><strong><em>Results: </em></strong><em>With the span of one year, the centre identifies certain obstacles like signal detection and reporting, collection of the details of the suspected drug, drug regulation etc </em></p> <p><strong><em>Discussion:</em></strong><em> Lack of awareness of ADR reporting among the healthcare professionals is considered as the major problem in implementing the programme. Hence certain considerations are made like Improvement in knowledge of Pharmacovigilance, communication with all sectors of health care system, patient education etc which will definitely help in implementing Pharmacovigilance programme.</em></p> 2020-02-09T07:52:05+00:00 Copyright (c) 2019 K Haseena, N Manojkumar http://journalofsopi.com/index.php/sopi/article/view/32 Mercury toxicity and its earlier footprints in Siddha system of medicine– Analogous to Pharmacovigilance 2020-02-09T08:15:31+00:00 P Kamalasoundaram editorjournalsopi@gmail.com M Kannan editorjournalsopi@gmail.com P Sathiyarajeswaran editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>According to Siddhars,</em> <em>Mercury is the chief of all elements and ubiquitous. Due to the life-threatening toxicity of mercury, it is considered by WHO as one of the top 10 chemicals of major public health concern [1]. Siddhars</em> <em>believe and prove that Mercury can cure most of the incurable diseases, protect</em> <em>the body from the disease, gives good health and facilitate to attain eight folds of Siddhi (Attama Siddhigal)[2].Siddhars practiced Pharmacovigilance</em> <em>successfully in all the areas of drug profile such as collection and selection of raw drugs, purification, SOP’s of formulations, medicinal dosage, duration of the treatment, vehicle, and precaution. Because, the occurrence of ADR is mostly due to error in the above steps. The symptoms and the treatment of ADR caused by mercury and its toxicity is well explained in Siddha literature. In mercury, the collection is made by the removal of impurities from the mercurial ore itself, the literature describes impurities and its toxicity (Thodam &amp;Sattai) [2].The purification (ore dressing) of mercury is the process to detoxify the toxin by chelation and increase the efficacy. The science behind the detoxification of mercury needs to be explored for the betterment of health. Insisting upon the ban on mercury, monitoring, and reporting of the adverse reaction and adverse event for the mercurial product should be registered and documented for the successive current Pharmacovigilance practice. Implementation of Pharmacovigilance practice will throw the renaissance to the Siddha system of medicine. </em></p> 2020-02-09T07:56:46+00:00 Copyright (c) 2019 P Kamalasoundaram, M Kannan, P Sathiyarajeswaran http://journalofsopi.com/index.php/sopi/article/view/33 A review on need of Vatsanabha (Aconitum ferox) Shodhana and its Pharmacovigilance concern 2020-02-09T08:15:31+00:00 VS Nithya editorjournalsopi@gmail.com <p><strong><em>Introduction: </em></strong><em>Practice of Indian system of medicine is considered to be the safest form of therapy, however incidence of ADR owing to the consumption of traditional drug necessitates the introduction of Pharmacovigilance of ASU drugs. Vatsanabha is one such drug mentioned in various Ayurvedic formulation, on which many reports have been publishing regarding its ADR. </em></p> <p><strong><em>Methodology</em></strong><em>: A thorough literary review was carried out through various classical text books like Bhaishajyaratnavali, Bhavapraksha, Rasatarangini etc and various databases like Pubmed, science direct, Google scholar, Dhara using the key word Vatsanabha, ADR, Aconitum ferox, A total of 6 papers was found to be relevant and selected for the literary review. </em></p> <p><strong><em>Result:</em></strong><em>Reports are published regarding the ADR, like Hypotension, Bradycardia due to consumption of aconite based Ayurvedic medicine. Studies proved that the impact of Shodhana process in the classic method using cow’s urine is found to be more safe than any other purification methods. TLC studies shown that pseudoaconitine and aconitine were converted into less toxic substance like veratroyl pseudoaconine benzoylaconine respectively only through traditional Ayurvedic Shodhana. </em></p> <p><strong><em>Discussion: </em></strong><em>Vatsanabha is a toxic plant with Gunas like vikasi, vyavayi, sookshma etc in prominence. Purification method should be proper and in suitable medium so as to modify these Gunas and mitigate its noxious effect. </em></p> 2020-02-09T07:59:54+00:00 Copyright (c) 2019 VS Nithya http://journalofsopi.com/index.php/sopi/article/view/34 Review on Adulteration of Ayurvedic raw drugs 2020-02-09T08:15:31+00:00 R Sreelekshmi editorjournalsopi@gmail.com <p><strong><em>Background: </em></strong><em>The genuiness, purity, and quality of the drugs have direct impact on the medicinal preparation. Now days most of the drugs got from raw materials were adulterated. Destructive harvesting, deforestation, lack of adequate cultivation, high price and demand, in contrast to the smaller population size of the plant, have motivated adulteration. Deliberate adulteration rather than by mistake is a serious offense and is the most important reason for adverse drug effects these days. This paper intends to disclose three of such adulteration on market samples (trivrith, sariba, tila taila) by reviewing dissertation works done at Govt ayurveda college Thiruvanthapuram, Dravyaguna dept viz. </em></p> <p><strong><em>Methodology: </em></strong><em>Review of Physico chemical evaluation of the samples and comparing it with API standards of the drug. </em></p> <p><strong><em>Result: </em></strong><em>From the review it is revealed that other species of periplocaceae used instead of Hemidesmus indicus, trivrith shoot is used instead of root, mineral oil present in thila taila<strong>. </strong></em></p> <p><strong><em>Discussion: </em></strong><em>From the above results, it is evident that these drugs were not in compliance with their phytochemical standards. Either deliberately or accidently drugs were adulterated. This can cause mild to severe consequences even in its judicial administration with respect to dose etc. Illiberal rules and their mandatory executions are needed to get rid of these disagreeable acts. Without those, all the efforts to globalize this science of living will be pointless. The genuiness, purity, and quality of the drugs have direct impact on the medicinal preparation. Now days most of the drugs got from raw materials were adulterated. Destructive harvesting, deforestation, lack of adequate cultivation, high price and demand, in contrast to the smaller population size of the plant, have motivated adulteration. Deliberate adulteration rather than by mistake is a serious offense and is the most important reason for adverse drug effects these days.</em></p> 2020-02-09T08:05:55+00:00 Copyright (c) 2019 R Sreelekshmi http://journalofsopi.com/index.php/sopi/article/view/35 Abstracts 2020-02-09T08:15:31+00:00 SoPi Editor editorjournalsopi@gmail.com <p><strong>Invited speakers</strong></p> <p><strong>Abstract Title: </strong><strong>Medical Vigilance Programmes</strong></p> <p><strong>Author Name: </strong>Dr Anupama Sukhlecha</p> <p><strong>Author’s affiliation: </strong>M P Shah Govt. Medical College, Jamnagar</p> <p>Pharmacovigilance Programme of India (PvPI) is running successfully all over India since 2010. Vigilance programmes have also been started in allied medical fields, some of which are:</p> <p><strong>Pharmacovigilance of herbal medicines:</strong></p> <p>The use of herbs as&nbsp;traditional medicines is expanding rapidly across the world. It could be difficult to identify the causes of herbal medicine-associated adverse events since the amount of data on each event is generally less. Ayurveda, Siddha, Unani and various traditional systems come under this category. Ayush suraksha has taken a lead in reporting adverse reactions due to herbal medicines.</p> <p><strong>Hemovigilance Program of India (HvPI):</strong></p> <p>This was implemented to monitor adverse events and incidences associated with blood donations and transfusions. It was launched under PvPI on Dec 10, 2012 in collaboration with National Institute of Biologicals, NOIDA. There are transfusion reaction reporting forms and software Hemovigil through which information reactions is uploaded. The data is collated to identify trends, recommend best practices and interventions required to improve patient care and safety.</p> <p><strong>Vaccine vigilance:</strong></p> <p>Vaccines are a miraculous invention of the mankind. But they may also cause adverse reactions. Regulatory authorities have defined guidance and formats for reporting vaccine-related events. Vaccine reporting formats in Pvdge for report submissions are:</p> <ul> <li>Vaccine Adverse Event Safety Reporting forms (VAERS)</li> <li>CIOMS form for vaccine reporting-Vaccine XML for submissions to VigiFlow-Global database (as per CDSCO office order of May 2015)</li> </ul> <p><strong>Materio-vigilance Programme of India (MvPI):</strong></p> <p>This modern concept of monitoring and safety of medical devices is known materiovigilance. Medical devices could range from simple devices such as&nbsp;tongue depressors and thermometers to advanced devices such as&nbsp;medical robots and cardiac pacemakers. The manufacturers, importers, and device user facilities need to report certain device-related adverse events and product problems. It is also meant to generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders. The biotechnology wing of the Sree Chitra Thirunal Institute of Medical Sciences and Technology in Thiruvananthapuram has been designated as the national collaborating center for the program which would be under CDSCO.</p> <p><strong>Cosmetovigilance:</strong></p> <p>It is the ongoing and systematic monitoring of the safety of&nbsp;cosmetics&nbsp;in terms of human health. The aim is to detect adverse effects of cosmetic products, and to prevent adverse effects by taking appropriate measures. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed and then to collect reports of adverse reactions. The practical consequence of cosmetics legislation is a requirement for continuous observation of cosmetic products after marketing.</p> <p><strong>Ecopharmacovigilance (EPV):</strong></p> <p>Introduced in 2006 by Dr S Z Rahman (as Pharmacoenvironmentology)</p> <p>Activities of EPV include:</p> <ul> <li>Increasing the availability of environmental data on medicinal products</li> <li>Tracking emerging data on environmental exposure, effects and risks after product launch</li> <li>Using environmental risk management plans to manage risk throughout a drug's life cycle</li> <li>Following risk identification, promoting further research and environmental monitoring</li> </ul> <p>Promoting a global perspective on EPV issues</p> <p>&nbsp;</p> <p><strong>&nbsp;</strong></p> <p>Abstract Title: Indonesian Traditional Herbal Medicine (<em>Jamu</em>) for High Cholesterol Problems</p> <p>Author Name: Swandari Paramita*<sup>1,2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Department of Community Medicine, Faculty of Medicine, Mulawarman University, Samarinda, East Kalimantan, 75119, Indonesia</p> <p><sup>2</sup>Research Center for Medicine and Cosmetic from Tropical Rainforest Resources, Mulawarman University, Samarinda, East Kalimantan, 75119, Indonesia</p> <p><strong>Background:</strong> High cholesterol levels (hypercholesterolemia) has been recognized to cause various disease, most notably the cardiovascular disease. Unfortunately, most anti-hypercholesterolemic drugs deliver several side effects for patients, by which medicinal plants have begun to attract attention for treating hypercholesterolemia. Traditional medicine using medicinal plants in Indonesia is called <em>jamu</em>. Scientific <em>jamu</em> for hypercholesterolemia is the result of traditional medicinal plants research conducted by the Ministry of Health Republic of Indonesia, based on empirical composition that has been carried out by literature studies so that they are suitable for use in the community.</p> <p><strong>Methods:</strong> The ingredients consist of main and additional components.</p> <p><strong>Results:</strong> The main composition consists of medicinal plants which have a direct effect in reducing blood cholesterol levels. Additional compositions are medicinal plants intended to improve the quality of life and fitness of patients. Medicinal plants in the main components of the scientific <em>jamu</em> for hypercholesterolemia are Chinese teak leaves (<em>Senna alexandrina</em> Mill.); Dutch teak leaves (<em>Guazuma ulmifolia</em> Lam.);</p> <p><em>tempuyung</em> herbs (<em>Sonchus arvensis</em> L.); and green tea herbs (<em>Camellia sinensis</em> (L.) Kuntze). Medicinal plants in the additional components of scientific <em>jamu</em> for hypercholesterolemia are <em>temulawak</em> (<em>Curcuma xanthorrhiza</em> Roxb.); turmeric (<em>Curcuma longa</em> L.); and <em>meniran</em> herbs (<em>Phyllanthus niruri</em> L.).</p> <p><strong>Conclusions: </strong></p> <p><strong>Keywords: </strong>Indonesian traditional medicine, high cholesterol, <em>jamu</em></p> <p><strong>&nbsp;</strong></p> <p><strong>Abstract Title: </strong>Traditional Medicines and Off-label Usage in Elderly: Can We Really be Pharmacovigilant Enough?</p> <p><strong>Author Name: </strong>Ashok Kumar Dubey</p> <p><strong>Author’s affiliation: </strong></p> <p>Elderly population all over the world has increased to a total of about 900 million, contributing to more than sixty percent of the total population. Indian elderly population has tripled in the last fifty years and it is projected to increase to more than one thirty million by the 2021 census. This age-group is the most heterogenous with prevalence of multi-morbidity and practice of poly-pharmacy. There is altered pharmacokinetic and pharmacodynamic profile due to ageing. Evidence-based practice is also compromised in the elderly due to their under-representation in the clinical trials. Usage of traditional medicines and off-label drugs is particularly common in this age group. More than 60 percent of elderly patients today use traditional medicines.</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>&nbsp;</p> <p>Most of these patients practice self-prescribing of traditional medicines and are ignorant about possible drug-drug interactions with drugs from other systems of practice. Similarly, off label prescribing, which refers to the use of a drug in conditions other than those for which it is officially approved, is quite a common medical practice, especially in elderly patients, because many drugs used in this population are approved after clinical trials on adult participants. Off label drug usage is associated with significantly higher risk of adverse drug reactions (relative risk 1.67, with a 25 % increase in risk for every additional off label drug used). There has to be a multipronged approach for better healthcare of the elderly patients including judicious prescribing, evaluating and generating supportive evidence along with regulatory support to create a robust pharmacovigilance system.&nbsp; The complexities of physiology, diseases, practiced therapies and the response to the drugs in the elderly need us to be even more pharmacovigilant for this age group.<strong><br></strong></p> <p><strong>ORAL PRESNTATION</strong></p> <p><strong>Abstract No.&nbsp; AO-01</strong></p> <p><strong>Abstract Title: </strong><em>Moringa oleifera</em> lam. enriched biscuits induced adverse drug reaction- a case report</p> <p><strong>Author’s Name: </strong>Meena Shamrao Deogade<sup>1</sup>, Vishakha Kumbhare<sup>2</sup>, Anita Wanjari<sup>3</sup>, Shilpa Gaidhane<sup>4</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Professor &amp; Head of Dravyaguna vigyan, <sup>3</sup>Professor &amp; Head of Rasashastra-Bhaishjya Kalpana, <sup>4</sup>Professor Medicine, Mahatma Gandhi Ayurved College Hospital and Research Centre, Wardha (M.S.)</p> <p><sup>2</sup>Scientist- E, Forest Research centre for skill development Chhindawada (M.P.)</p> <p><sup>4</sup>Jawaharlal Neharu Medical College, sawangi (M), Wardha (M.S.)</p> <p><strong>Background: </strong><em>Moringa oleifera Lam. </em>(<em>Shigru/Moringa</em>) is used as day to day edible product and as well as medicinal purpose for its enriched nutrients and medicinal values. Thus the biscuits of <em>Shigru</em> leaves were prepared to carry out a clinical trial to correct Iron deficiency anaemia in females. Out of 51 recruited participants during the clinical trial, one case of adverse drug reaction was reported.</p> <p><strong>Methods: </strong>An 18 year female participant with 39 kg weight included in research trial as her Hb% was 10.2 and serum ferritin was 3.85.&nbsp; <em>Moringa oleifera</em> enriched biscuits were given in a dose two biscuits twice daily since 7 September 2019.&nbsp; She has reported after 5 days i.e. on 12 September 2019 with the complaint of red rash over back and arm.&nbsp; She was advised to withdraw the biscuits immediately got relief within 24 hours. After restarting the biscuits, she reported again rash with itching, then a case of ADR recorded and Ayurveda treatment has been initiated</p> <p><strong>Results:</strong> After Ayurveda medication within 12 hours she got relief from itching and red rash disappeared gradually.</p> <p><strong>Conclusion: </strong><em>Moringa</em> is even though commonly used as in many edible forms; the <em>Moringa</em> enriched biscuit reported 1 ADR out of 51 recruited participants. This is important and helpful for pharmacovigilance to record and control adversity that affects the issues of consumers and regularization of Ayurveda health care system.</p> <p><strong>Keywords: </strong><em>Moringa oliefera,</em> <em>Shigru</em>, Adverse drug reaction, Pharmacovigilance, <em>Shatadhauta Ghruta, Laghusutashekhara Rasa, Avipattikara churna</em></p> <p><strong>Abstract No. AO-02</strong></p> <p><strong>Abstract Title:</strong> Analytical study of <em>Brahmi</em> (<em>Bacopa monnieri</em> Linn.) accession with special reference to its quality control pertaining to pharmacovigilance</p> <p><strong>Author’s Name: </strong>Dr. Priyanka Wate*<sup>1</sup><strong>, </strong>Dr. Pramod Khobragade<sup>2</sup></p> <p><strong>Author’s affiliation: </strong>*<sup>1</sup>Assistant Professor, Dept. of Dravyaguna vigyana, M S Ayurvedic Medical College, Gondia, <sup>2 </sup>Professor &amp; Head of department, Dept. of Dravyaguna vigyana, DMAMCH &amp; RC, Nagpur</p> <p><strong>Background:</strong> <em>Brahmi</em> (<em>Bacopa monnieri</em> Linn.) is a renowned medicinal plant globally used for enhancing memory and intellect. Due to unorganized harvesting &amp; trading, lack of Good Agricultural &amp; Collection Practices, its substitute drug <em>Mandukaparni</em> is routinely used though it has different action. Due to sub-standard raw material, finished products exhibit ADR issues. Hence, study on <em>Brahmi</em> accessions in three seasons of year, planted at different locations was carried out with emphasis on quality control &amp; pharmacovigilance. The aim of this analytical study was to evaluate <em>Brahmi</em> accession with special reference to quality control.</p> <p><strong>Methods:</strong> Methanolic extract of wild and cultivated accession of <em>Brahmi</em> collected in summer, rainy &amp; winter season of year 2016 was subjected to HPLC. Quantification of Bacoside A was done using standard marker compound.</p> <p><strong>Results:</strong> Minimum percentage of Bacoside A was seen in winter, moderate in summer &amp; maximum in rainy season. Quantity of Bacoside A was higher in cultivated sample as compared to wild sample. Moderate humidity, high temperature &amp; average rain fall in rainy season are suitable for production of quality raw material of <em>Brahmi</em>. It is advisable for herbal industries to track raw material as per these quality standards to obtain maximum efficacy as well as safety of finished products.</p> <p><strong>Conclusion:</strong> Sub-standard herbal products due to spurious raw material can affect clinical outcome along with ADR issues.&nbsp; Above analytical research work on Brahmi would help to enlighten about Good Agricultural &amp; Collection Practices with minimum ADR issues.</p> <p><strong>Keywords:</strong> <em>Brahmi</em>, Pharmacovigilance, Quality control</p> <p><strong>Abstract No. AO-03</strong></p> <p><strong>Abstract Title:</strong> Safety study of <em>Shodhita</em> (Processed) <em>Bhanga</em> (<em>Cannabis sativa</em> L.) leaves in established animal experimental models</p> <p><strong>Author’s Name: </strong>Swagata Tavhare<sup>1</sup>, Mukesh Nariya<sup>2</sup>, Rabinarayan Acharya<sup>3</sup></p> <p><strong>Author’s affiliation: </strong>1 Assistant professor, Department of Dravyaguna, GJP-IASR, New VV Nagar, Anand, Gujarat, 2. Professor &amp; Head, Pharmacology lab, 3. Department of Dravyaguna, IPGT &amp; RA, Gujarat Ayurved University, Jamnagar</p> <p><strong>Background:</strong> ‘Safety’ is one of the prime fundamental principle and critical component of quality control. <em>Bhanga</em> (<em>Cannabis</em>) is known for its wide ranging pharmacological actions. Ayurveda, to reduce intoxicant (<em>Madakari</em>) effect, recommends its use after certain processing known as <em>Shodhana</em>. To evaluate the safety of <em>Jalaprakshalana Shodhita Bhanga</em> (Water-wash processed <em>Cannabis</em>) through acute toxicity and gross behaviour study.</p> <p><strong>Methods:</strong> Acute toxicity and gross behaviour study was conducted following OECD guideline 425 (modified, adopted 23<sup>rd</sup> March 2006) in female wistar strain albino rats weighing 160 ± 20 g. Test drug (Fine powder water-wash processed <em>Cannabis sativa</em> L. leaves) in the dose 2000 mg/kg (Limit test), 400, 175, 100, 55 and 22.5 mg/kg was orally administered in selected animal along with cow milk (50 ml) mixed with sugar (4 g), as an adjuvant. Observations were made at ½, 1, 2, 3, 4, 5, 6, 24 hours after dose administration and thereafter daily once for mortality during entire period of the study (14 days). Gross behavioural changes like circling, grooming, licking, rearing, sniffing, hyperactivity, straub’s tail were assessed by assigning scores on 0-3 point scale.</p> <p><strong>Results:</strong> At various studied dose levels significant gross behavioral changes were found with mortality of 33.33% at limit dose i.e. 2000 mg/kg.</p> <p><strong>Conclusion: </strong><em>Jalaprakshalana Shodhita Bhanga</em> leaves powder administered orally is found safe from 22.5mg/kg to 400mg/kg animal dose in studied animal experimental model.</p> <p><strong>Keywords:</strong> <em>Bhanga</em>, <em>Cannabis</em>, <em>Shodhana</em>, Acute toxicity, Gross behaviour, Safety</p> <p><strong>Abstract No. AO-05</strong></p> <p><strong>Abstract Title:</strong> Pharmacovigilance for safer use of drugs in Ayurveda through experimental study</p> <p><strong>Author’s Name: </strong>Dr. Nilima Narayan Rao Wadnerwa</p> <p><strong>Author’s affiliation: &nbsp;</strong>Asso. Prof., MGACH &amp; RC, Salod, Wardha, Maharashtra</p> <p><strong>Background:</strong> Heavy metals are used in Ayurvedic medicine since ancient period. Case reports published in national and international journals and newspapers regarding heavy metals poisoning after the use of drugs in Ayurveda has created a negative impact on public towards the use of Ayurvedic medicine. On the ground where formulations of Ayurved are targeted to contain high levels of heavy metals, there is urgent need to have pharmacovigilance for these drugs regarding their safety in the treatment. Hence, an experimental study was conducted to assess the toxicity and to identify the factor responsible for the toxicity of the arsenical compounds <em>Rasamanikya</em> which is a very popular medicine used for various ailments.</p> <p><strong>Methods:</strong> Physical and physico-chemical properties of three different market preparations of <em>Rasamanikya</em> were studied by using advance methods (ICP-AES and XRD) and the sample containing highest level of Arsenic was subjected to chronic toxicity study in rats. Hematological and biochemical parameters were assessed at 30, 60 and 90 days and histopathological study was conducted at the end of the study.</p> <p><strong>Results:</strong> All the three samples showed variation in concentration of arsenic and its crystal size. Traces of nineteen other metal compounds were found in all samples other than Arsenic and Sulphur. There were no significant differences observed in most of hematological and biochemical parameters up to 60 days in Wistar rats. No significant differences in body weight and relative organ weight were observed. Minimal to mild changes were observed in liver and kidney which were pathologically insignificant.</p> <p><strong>Conclusion: </strong>LD 50 of <em>Rasamanikya</em> may be more than 2000 mg/kg and <em>Rasamanikya</em> is safe for 15 days duration in the therapeutic dose in human beings. Chronic Arsenic toxicity due to <em>Rasamanikya</em> is not possible if it is consumed in therapeutic dose for 10- 15 days. But there is an urgent need of standardization of method of preparation and standardization of contents to prepare <em>Rasamanikya</em> and its use for therapeutic purposes.</p> <p><strong>Keywords:</strong> Pharmacovigilance, Heavy metal toxicity, <em>Rasamanikya</em>, Chronic Arsenic toxicity</p> <p><strong>Abstract No. AO-06</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance in Ayurveda – Where are we and way to go ahead</p> <p><strong>Author’s Name: </strong>Dr. Shubhashree M.N.<sup>1</sup>, Dr. Raghavendra Naik<sup>2</sup>, Dr. Sunona George<sup>3</sup>, Dr.B.K. Bharali<sup>4</sup></p> <p><strong>Author’s affiliation: </strong>1. Research Officer (S-2), 2. Research Officer (Ayu), 3. Programme Assistant, National Pharmacovigilance&nbsp;&nbsp; Programme, Asst. Director Incharge, Regional Ayurveda Research Institute for Metabolic disorders (RARIMD), Bangalore.</p> <p><strong>Background:</strong> Due to the widespread publicity, there is a raising demand for Ayurvedic medicine not just in India, in other countries also. However, safety is still a major concern from western viewpoint. Thalidomide disaster was a wakeup call to initiate steps regarding Pharmacovigilance in conventional medicine. Ayushsuraksha web portal is a major initiative taken up for recording the Adverse drug event (ADE)/Adverse drug reaction (ADR) for AYUSH Drugs.</p> <p><strong>Methods:</strong> This paper intends to take stock of all the activities initiated so far, to spread the concept of Pharmacovigilance and intends to throw light on the possible measures which can be taken up in future at different levels . For instance –Conducting periodic CME’s, making the drug information easily accessible in a portal or website with possible side effects/ADR, methods to avoid or combat the ADR will be useful to educate physicians. Hospitals and teaching institutions should conduct periodic audits for assessment and reporting of ADE, in different departments. It is equally essential to educate all stakeholders of health like pharmacist, nurses/matrons, medicos, doctors about the reporting of ADE/ADR to Peripheral Pharmacovigilance centres (PPvC) / Ayushsuraksha</p> <p><strong>Results:</strong> Real world evidence goes a long way in capturing data pertaining to medicine consumption e.g AHMIS (AYUSH Hospital Information Management Systems). Just as the world is waking up to the overusage of&nbsp; antibiotics, survey has to be conducted all over the country to assess whether Guggulu is overprescribed and has any long term effects as patients continue to consume for months together, assuming all herbal drugs are safe. The paper discusses at length the measures which can be taken up in future in this regard.</p> <p><strong>Conclusion:</strong></p> <p><strong>Keywords:</strong> Pharmacovigilance, AYUSH, Ayushsuraksha</p> <p><strong>Abstract No. AO- 07</strong></p> <p><strong>Abstract Title: </strong>Preclinical safety studies of <em>Rasamanikya</em>, an Ayurvedic Arsenical Formulation in Rats</p> <p><strong>Author’s Name: </strong>Vikas Kumar<sup>1</sup>, Shivanand Biradar<sup>2</sup>, Galib R<sup>3</sup>, B. J. Patgiri<sup>4</sup></p> <p><strong>Author’s affiliation: </strong>1. Ph.D Scholar, Dept. of RSBK, IPGT &amp; RA, GAU, Jamnagar; 2. Lecturer, Dept. of RSBK, Sai Ayurvedic college, Sholapur; 3. Associate Professor, Dept. of RSBK, AIIA, New Delhi; 4. Professor, Dept. of RSBK, IPGT &amp; RA, GAU, Jamnagar</p> <p><strong>Background:</strong> In Ayurveda, use of metals and minerals is being major concern on heavy metal contents by scientific fraternity of conventional system though they are used in Ayurvedic therapeutics without any noticeable side effects since ages. So it is need of hour to evaluate the safety profile of such medicines. To evaluate the safety of <em>Rasamanikya </em>through acute and chronic toxicity studies.</p> <p><strong>Methods:</strong> <em>Rasamanikya</em> was administered at a maximal dose of 2000 mg/kg to overnight fasted rats and observed closely for behavioral changes, signs of toxicity and mortality if any, continuously for the first six hours and thereafter periodically up to 14 days. In the chronic toxicity, the drug was administered daily at the doses of 22.5, 112.5 and 225 mg/kg along with honey and ghee as an adjuvant to rats for 90 days followed by a 30 days recovery period.</p> <p><strong>Results:</strong> In acute toxicity, <em>Rasamanikya </em>at the dose of 2000 mg/kg did not produce any observable toxic effects or mortality. Safety of <em>Rasamanikya </em>at therapeutic and five-fold therapeutic dose level has been revealed in the chronic toxicity study. Mild to moderate pathological changes on different haematological, serum biochemical and cytoarchitecture of different organs were observed at ten-fold therapeutic dose level.</p> <p><strong>Conclusion: </strong>Based on these observations, it can be concluded that <em>Rasamanikya </em>is safe at therapeutic dose levels when used judiciously along with specified adjuvants.</p> <p><strong>Keywords:</strong> Arsenic, <em>Haratala</em>, <em>Rasamanikya</em>, safety, <em>Shodhana</em>, toxicity</p> <p><strong>Abstract No. AO- 08</strong></p> <p><strong>Abstract Title: </strong>The role of adjuvant as bio-enhancer in Ayurveda drug safety and its Pharmacovigilance overview.</p> <p><strong>Author’s Name: </strong>Aniket Kamble<sup>1*</sup>, <sup>2</sup>Shraddha Dhundi, <sup>3</sup>Swapnil Chowdhary, <sup>4</sup>B. J. Patgiri</p> <p><strong>Author’s affiliation: </strong>1.* MD scholar, 2 Ayurvedic Physician 3. Assistant professor, 4. Pofessor, Department of Rasa Shastra and bhaishajya kalpana, IPGT &amp; RA, Jamnagar.</p> <p><strong>Background:</strong> Pharmacovigilance (PV) plays vital role in healthcare system. It is a science related to detection, assessment, analyzing and prevention of adverse drug effect. There is raising demand of Ayurveda medicine over worldwide and hence it is a matter of concern related safety of drug. Drugs carry a number of risks and understanding the science behind adverse drug reactions can help increase the safety of new medicines through pre-clinical studies. <em>Anupana/sahapana</em> are the adjuvants that increases the drug absorption thus enhancing the bioavailability of drug. The bio-enhancement leads to reduction in therapeutic dose of principal drug, thus reducing the possibilities of toxicity and side effects of drug.</p> <p><strong>Methods:</strong> In-vivo acute and chronic toxicity study was carried out on test drug <em>Makardhwaja </em>and attempt was made to study its effect on ponderal and different bio-chemical parameter with and without adjuvant.</p> <p><strong>Results:</strong> Insignificant changes were observed in body weight, Haematological and biochemical parameters in all treated group even at 10 times TED (therapeutically equivalent dose) level in a drug with adjuvant group. Analysis of the data related to biochemical parameters indicated consistent increase in serum urea level all the three dose levels and elevation in serum creatinine at TED level in without adjuvant group.</p> <p><strong>Conclusion: </strong>This study provide sufficient data for establishing the safety when used along with <em>Sahapana/Anupana</em>. Hence, it can be taken in practices for improving the understanding drug safety issues during the drug development and it’s post-approval.</p> <p><strong>Abstract No. AO-09</strong></p> <p><strong>Abstract Title: </strong>Acute and Chronic Toxicity of <em>Rasa Parpati</em> in Charles Foster Albino Rats</p> <p><strong>Author’s Name: </strong>Jigisha patel<sup>1</sup>, Ankesh Agrawal<sup>2</sup>, Galib<sup>3</sup>, B. J. Patgiri<sup>4</sup></p> <p><strong>Author’s affiliation: </strong>1. PhD Scholar, 4. HOD, RSBK Dept, IPGT &amp; RA, Jamnagar, 2. Medical Officer, 3. Associate Professor, RSBK Dept, AIIA, Delhi</p> <p><strong>Background:</strong> <em>Rasa parpati</em> is an unique Ayurvedic mercurial formulation extensively prescribed by Ayurvedic physicians to treat different ailments. Considering toxicity concerns of traditional formulations for containing heavy metals like Mercury, Arsenic, Lead etc.; it becomes, imperative to evaluate safety aspects of such formulations. In Ayurveda, metals and minerals are advocated to be processed through the specified guidelines before their therapeutic application. An attempt has been made to evaluate the impact of <em>Shodhana</em> on safety aspects of <em>Rasa parpati</em> through acute and chronic toxicity of <em>Rasa</em> <em>parpati</em> that was prepared by two different samples of raw materials. One by using <em>Hingulottha</em> <em>parada</em> and <em>Shuddha</em> <em>gandhaka</em> (HRP) while, another with <em>Ashuddha</em> <em>parada</em> and <em>Ashuddha</em> <em>gandhaka </em>(ARP).</p> <p><strong>Methods:</strong> Oral acute toxicity of test drugs was carried out at limit dose of 2000 mg/kg orally along with adjuvant in Charles foster female rats. In chronic toxicity, both ARP and HRP were orally administered at therapeutically equivalent dose (22.5 mg / kg), TEDx5 (112.5 mg/kg), TEDx10 (225 mg/kg) levels along with adjuvant for 90 days. Two recovery groups were also studied in the experiment.</p> <p><strong>Results:</strong> Acute toxicity revealed that, both the test drugs did not produce any signs and symptoms of toxicity and mortality up to oral dose of 2000 mg/kg in rats. Chronic administration of HRP for 90 days revealed that, the drug at TED X10 dosese has potential to produce liver and kidney toxicity however, can be relatively safe at therapeutic dose level. ARP has potential for liver, kidney and GI tract toxicity with deposition in other organs. The recovery study suggests that, after discontinuation of HRP the observed changes are reversible in nature while, in ARP some of the observed changes are irreversible in nature.</p> <p><strong>Conclusion: </strong>It is concluded that HRP was found to be safer than ARP at different dose levels suggesting safely use at therapeutic dose level.</p> <p><strong>Keywords:</strong> Ayurveda<strong>, </strong>Mercury<strong>, </strong><em>Parada</em>, <em>Rasa Parpati</em>, Safety, Toxicity</p> <p><strong>Abstract No. AO-10</strong></p> <p><strong>Abstract Title: </strong>Acute and subchronic toxicity study of <em>Gomutra </em>(Cow urine) <em>Shodhita </em>(processed) <em>Bakuchi </em>&nbsp;(<em>Psoralea corylifolia </em>Linn.) seeds powder</p> <p><strong>Author’s Name: </strong>Jigyasa Pathak1*, Mukesh B.Nariya2<sup>*</sup>, Rabinarayan Acharya3*</p> <p><strong>Author’s affiliation: </strong>*Ph.D Scholar, Dept. of Dravyaguna, **Head, Dept of Pharmacology, ***Professor &amp; Head, Dept. of Dravyaguna, I.P.G.T. &amp; R.A., Gujarat Ayurved University, Jamnagar, Gujarat, India.</p> <p><strong>Background:</strong> <em>Bakuchi</em> is frequently administered, for a long duration, in the treatment of <em>Switra</em>. Present study has been designed to ascertain the role of <em>Shodhana </em>on safety profile of <em>Gomutra </em>(cow urine) <em>Shodhita </em>(processed) <em>Bakuchi </em>seed powder, through acute oral toxicity and sub-chronic toxicity in rats.</p> <p><strong>Methods:</strong> <em>Bakuchi</em>, a known corrosive drug, was processed with <em>Gomutra </em>(cow urine) and administered to rats at dose of 2000 mg/kg, in powder form, in acute toxicity study. For subchronic toxicity study, it was administered for 60 consecutive days at the dose of 270 mg/kg (TED), 1350mg/kg (TED 5) and 2700mg/kg (TED 10). The effect of drug was assessed on ponderal changes, haematological, serum biochemical, and histopathology of various organs.</p> <p><strong>Results:</strong> In acute toxicity study, no signs of toxicity and mortality were observed during 14 days of observation. Sub chronic toxicity study, at therapeutic equivalent dose level (TED) and five times the therapeutic equivalent dose (TED 5) levels no significant sign and symptoms of toxicity were observed. Significant decrease in Hb was observed in TED and TED 10 group. Significant decrease in MCH and MCHC was observed in TED 5 and TED 10 groups. Degenerative changes were observed in the kidney, liver and stomach at therapeutic equivalent dose (TED) X 10 dose levels.</p> <p><strong>Conclusion: </strong>The observed effect of the <em>Bakuchi</em> in acute toxicity study at the dose of 2000 mg/kg suggest that drug is devoid of any serious toxic effect or adverse effect in rats. In sub-chronic toxicity, specific degenerative organ changes were observed at highest dose which suggest that the drug may produce toxic changes depending upon the dose administered.</p> <p><strong>Keywords: </strong>Acute toxicity, <em>Bakuchi, Psoralea corylifolia </em>L., <em>Shodhana, </em>Subchronic toxicity</p> <p><strong>Abstract No. AO- 11</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance concerns of <em>Tamra Bhasma</em> (Incinerated Copper) and its formulations –Facts</p> <p><strong>Author’s Name: </strong>Swapnil Chaudhari* BJ Patgiri**</p> <p><strong>Author’s affiliation: </strong>* Assistant Professor, ** Professor&nbsp; &amp; Head, Dept of RS&amp;BK, IPGT&amp;RA, Jamnagar</p> <p><strong>Background:</strong> <em>Tamra Bhasma</em> (TB) is one among herbo-metallic mercurial preparations extensively used in routine ayurvedic practice. It is reported as poison as or more than that if not processed or purified properly as per classical methods. In current scenario, <em>Bhasma</em> preparations used in ayurveda are always under stern observations for containing heavy metals like mercury (Hg) which may raise the question of their safety. Recent articles pertaining to the alarming level of heavy metals, especially Hg in ayurvedic formulations have created a lot of controversy regarding the safety and efficacy of these formulations. Aim of the present study is to screen and compile such available published reports on safety of <em>Tamra Bhasma</em> and its formulations from different databases and provide brief information on their safety and toxicity aspects.</p> <p><strong>Methods:</strong> Available published reports on safety of <em>Tamra Bhasma</em> and its formulations from different databases are screened and compiled to provide brief information on their safety and toxicity aspects.</p> <p><strong>Results:</strong> Published reports on <em>Tamra Bhasma, Hridayrnava Rasa, Arogyavardhini Rasa</em> and <em>Garbha Chintamani Rasa </em>revealed that these formulations are found to be safe at therapeutic doses with suitable adjuvant when accessed through acute, sub chronic, chronic and genotoxicity studies in experimental animals.</p> <p><strong>Conclusion: </strong><em>Tamra Bhasma</em> and its formulations are found to be safe at therapeutic doses when administered with suitable adjuvant in experimental models. Mere presence of metallic fractions doesn’t have any relation with the toxicity of metallic preparations. Different manufacturing techniques to which the metals subjected ensures safety of these formulations. Pharmacovigilance concern for these formulations may not arise if compliance of code of conduct during pharmaceutical procedures.</p> <p><strong>Keywords: </strong>Heavy Metal, Pharmacovigilance, Safety, Tamra Bhasma and Toxicity</p> <p><strong>Abstract No. AO-12</strong></p> <p><strong>Abstract Title: </strong>Assessment of safety of <em>Tankanodaka</em> <em>Shodhita</em> (borax water processed) <em>Vatsanabha</em> (<em>Aconitum</em> <em>ferox</em> Wall.) through acute toxicity study.</p> <p><strong>Author’s Name: </strong><strong>:&nbsp; </strong>Mital Buha*, Mukesh Nariya**, Rabinarayan Acharya***</p> <p><strong>Author’s affiliation: </strong>*Ph.D. scholar, **Professor &amp; Head Department of pharmacology *** Professor &amp; Head Department of Dravyaguna, IPGT&amp;RA, Jamnagar, Gujarat, India</p> <p><strong>Background:</strong> <em>Vatsanabha</em> (<em>Aconitum</em> <em>ferox </em>Wall<em>.</em>), a schedule E1 drug of Drugs and cosmetic Act 1946, root is extremely lethal and contains highly toxic alkaloids like aconitine, pseudaconitine, indaconitine, etc. Ayurveda pharmacopoeia recommends its internal administration for treating many a disease conditions after proper&nbsp;&nbsp; <em>Shodhana</em> (processing) with media like <em>Gomutra</em>, <em>Triphala</em> <em>kwatha</em>, <em>Godugdha</em> and <em>Tankanodaka</em> etc. Present study reports the effect of <em>Tankanodaka</em> <em>Shodhita</em> <em>vatsanabha</em> through acute toxicity city in experimental animals.</p> <p><strong>Methods:</strong> Acute toxicity (14 days) of <em>Shuddha</em> <em>Vatsanabha</em> was assessed by administering 140, 70 and 14 mg/kg of drug suspension in sequential manner. Single dose of drug suspension <em>Tankanodaka Shodhita</em> <em>Vatsanabha</em> root powder was administered once orally to overnight fasted rats.</p> <p><strong>Results:</strong> The test drug showed mortality at dose of 140 mg/kg and 70 mg/kg and abdominal writhing syndrome, convulsion like symptoms at all time in comparison to initial reading were also observed while at dose level of 14mg/kg showed no mortality but hyperactivity along with other adverse changes such as CNS depression (hypoactivity, passivity, etc), ANS stimulation in acute oral toxicity.</p> <p><strong>Conclusion: </strong>The drug produced adverse changes even at very low oral dose of 14 mg/kg on single administration which suggest that drug is highly potent hence; suggest for classification as GHS category I when processed with <em>Tankanodaka</em>.</p> <p><strong>Keywords:</strong><em> Aconitum ferox </em>Wall., Acute toxicity, <em>Shodhana</em></p> <p><strong>Abstract No. AO-13</strong></p> <p><strong>Abstract Title: </strong>Concerns of Pharmacovigilance and Drug safety in Ayurveda- A Review</p> <p><strong>Author’s Name: </strong>Raghavendra Naik<sup>1</sup>, Shubhashree M N<sup>2</sup>, Sunona George<sup>3</sup>, B K Bharali<sup>4</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Research Officer (Ayu), <sup>2</sup> Research Officer (S-2), <sup>3</sup>Programme Assistant, <sup>4</sup>Asst. Director Incharge, Regional Ayurveda Research Institute for Metabolic Disorders, CCRAS, Ministry of AYUSH, Bengaluru-560109</p> <p><strong>Background:</strong> Ayurveda is a science which has been serving mankind since time immemorial, currently practiced in India and many countries. &nbsp;This science not only provides medical cures for disease, but its holistic approaches use distinctive principles of diet, lifestyle etc to uphold the healthy life. Since the decision making regarding choice of drugs and their doses with reference to an individual's needs relies upon the skills (<em>Yukti</em>) of the physician, ancient texts clearly mentioned that, if a drug is used without the knowledge of its action, it would certainly act as the poison. To avoid such consequences, classical texts of Ayurveda describes all the possible adverse reactions to medicines when they are prepared or used inappropriately in clinical practice.&nbsp;</p> <p><strong>Methods:</strong> In the current review, concepts related to Pharmacovigilance in Ayurveda were reviewed from different available classical texts and presented in a systematic manner.</p> <p><strong>Results:</strong> Though the word pharmacovigilance is not mentioned in Ayurvedic literature, the concepts and safety issues are presented throughout texts of Ayurveda. Classical texts of Ayurveda have given utmost importance to improvement of patient care and safety in every step of treatment. The concept of pharmacovigilance in Ayurveda includes selection of raw drugs, proper collection guidelines, different processing techniques, and their proper administration in appropriately diagnosed patient. Different classical texts have mentioned various causes for adverse drug reactions like overdose (<em>Atimatra</em>), drug-diet interaction, drug intolerance, use of unwholesome drugs (<em>Asatmya</em>), idiosyncrasy (<em>Vaidyakrita</em>) etc.</p> <p><strong>Conclusion: </strong>The physician who prescribes the medicine should be vigilant enough to assess all the possible adverse effects and their management in clinical practice.</p> <p><strong>Keywords: </strong>Adverse drug reactions, Ayurveda, Pharmacovigilance, <em>Yukti</em></p> <p><strong>Abstract No. AO-14</strong></p> <p><strong>Abstract Title: </strong>Assessment of dermal toxicity of mustard oil based formulation of <em>Nerium indicum</em></p> <p><strong>Author’s Name: </strong>Vivek Kumar Patel<sup>1</sup>, R. N. Acharya<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Ph.D. scholar, <sup>2</sup>Professor &amp; Head, Department of Dravyaguna, IPGT&amp;RA, Jamnagar, Gujarat, India</p> <p><strong>Background:</strong> <em>Nerium indicum</em> (family <em>Apocynaceae)</em> botanical source of <em>Rakta</em> <em>Karavira</em> from the <em>Upavisha</em> (semi-poisonous) category, has been mentioned for various therapeutic indications in the form of internal and external administration.</p> <p><strong>Methods:</strong> <em>Rakta Karavira Taila</em> prepared from the root bark of <em>Rakta</em> <em>Karavira</em> and mustard oil was used for local application. Acute dermal toxicity study was assessed in wistar albino rats at a single dermal dose of 2000 mg/kg body weight while sub-acute dermal toxicity was assessed at repeated dermal dose of 1000 mg/kg body weight, for 28 days.</p> <p><strong>Results:</strong> No mortality and toxicity were observed at single dermal dose level of 2000 mg/kg. At repeated dermal dose of 1000 mg/kg of body weight, statistically significant decrease in weight of testes, significant increase in W.B.C and platelet count while rest of hematological and biochemical parameters showed non-significant changes. Histopathological study showed sinusoidal inflammation in liver, fatty degenerative changes in liver and kidney. Severe degenerative changes in seminiferous tubules and decrease in spermatogenesis were observed in comparison to normal control group.</p> <p><strong>Conclusion: </strong><em>Rakta Karavira Taila</em> containing toxic drug <em>Karavira</em> which have potential to produce adverse changes particularly male reproductive system therefore, should not be used for longer duration at higher dose.</p> <p><strong>Keywords: </strong>Acute dermal toxicity, <em>Karavira, Nerium indicum,</em> <em>Rakta Karavira Taila, </em>Sub-acute dermal toxicity.</p> <p><strong>Abstract No. AO-15</strong></p> <p><strong>Abstract Title: </strong>Acute and Chronic Toxicity studies of <em>Rasasindura</em>, an Ayurvedic Formulation</p> <p><strong>Author’s Name: </strong>Satish Solanki<sup>1</sup>, Rohit Gokarn<sup>2</sup>, Swapnil Chaudhari<sup>3</sup>, Prashant Bedarkar<sup>4</sup>, BJ Patgiri<sup>5</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>PG Scholar, <sup>3</sup>Asst Professor, <sup>4 </sup>Associate Professor, <sup>5</sup> Professor &amp;Head, Dept of RS&amp;BK, IPGT&amp;RA, Jamnagar, <sup>2</sup> Associate Professor, Swaminarayana College, Kalol, Gujarat</p> <p><strong>Background:</strong> <em>Rasasindura</em> is a unique, Ayurvedic mercurial preparation widely used by practitioners. This work is an attempt to perform acute and chronic oral toxicity evaluation of <em>Rasasindura</em> along with an adjuvant <em>Guduchi</em> <em>Ghana</em> (solidified aqueous extract of <em>Tinospora</em> <em>cordifolia</em> Will.) in rats.</p> <p><strong>Methods:</strong> Oral acute toxicity study of test drug was carried at the limit dose of 2000 mg/kg orally in rats. For chronic toxicity, <em>Rasasindura</em> with adjuvant was administered at therapeutic equivalent dose (45 mg/kg, orally), therapeutic equivalent dose×5 (225 mg/kg, orally), therapeutic equivalent dose×10 (450 mg/kg, orally) for 90 days and an additional recovery group of therapeutic equivalent dose×10 for 30-day observation after the treatment period.</p> <p><strong>Results:</strong> Acute toxicity result showed that drug did not produce any signs and symptoms of toxicity or mortality up to an oral dose of 2000 mg/kg in rats. Chronic toxicity results showed that <em>Rasasindura</em>, even at a level as high as therapeutic equivalent dose×10 level, had no significant effect whatsoever on the ponderal and hematological parameters. Although the drug produced mild to moderate adverse changes (in kidney, liver, intestine, and stomach) at therapeutic equivalent dose×10 dose level, equivalent of which are unlikely to be ever employed in a clinical trial. The observed changes were not seen at the lower dose levels as well as in the recovery study.</p> <p><strong>Conclusion:</strong> Hence, it is suggested that the <em>Rasasindura</em>, along with the adjuvant prepared as per the customary method, is safe for consumption at the therapeutic dose level.</p> <p><strong>Keywords: </strong>Ayurveda, <em>Guduchi</em> <em>Ghana</em>, <em>Rasasindura</em>, Safety, Toxicity</p> <p><strong>Abstract No. AO-16</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance for non-metallic, non-poisonous herbal drug</p> <p><strong>Author’s Name: </strong>Dr Sunitha M P</p> <p><strong>Author’s affiliation: </strong>Associate Professor,</p> <p>Dept Of Dravyaguna Vignana, SAMC &amp; H, Bangalore</p> <p><strong>Background:</strong> An increased importance for the pharmacovigilance of herbal medicines is seen in current times because of the growing demand for the herbal products and herbal medicines globally. The study was aimed to analyse, factors related to herbal raw materials which may become the cause for Adverse Drug Reactions (ADRs) of the herbal drugs, which is presumed to be safe drug. To review the traditional classical references to avoid factors which may be the cause for adverse drug reactions.</p> <p><strong>Methods:</strong> This study was carried out after searching various databases like Pubmed, Google scholar, websites etc and classical texts like Charaka Samhita, Sushrutha Samhita etc. Texts books related to Dravya Guna Vignana.</p> <p><strong>Results:</strong> Knowledge of Aushadha dravya with respect to its <em>Nama</em> (Nomenclature, Identification), <em>Rupa</em> (Morphology), <em>Guna</em> (Properties – Physicochemical and Phytochemical), this covers the most of the guidelines to avoid adverse drug reaction which is similar to the HATC classification. If raw materials are not collected as per the <em>Dravya Sangraha</em> explained in <em>Dravyaguna</em> <em>Shastra</em> it will become the root cause for anthropogenic contamination, thus leading to ADRs. The <em>Dravya – Pareeksha vidhi</em> explained by Acharya Charaka in <em>Vimanasthana</em> 8<sup>th</sup> chapter If all these ten factors are stringently considered while administering the drug ADRs due to Drug related factors, Disease related factors and Patient related factors can be avoided. &nbsp;Application of <em>Paradi Gunas</em> in treatment helps in avoiding the ADRs.&nbsp;</p> <p><strong>Conclusion: </strong>: Basic philosophy behind the data management of herbal products and traditional medicines is to achieve a system that is capable of handling all levels of information related to herbal drugs including its ADRs. These ADRs are explained in detail under <em>Dravya Pareeksha Vidhi</em>, <em>Dravya Sangrahana</em>, and Application of <em>Paradi Guna</em> in <em>Chikitsa</em>. Hence, by the integration of classical methods of safety assessment tools and modern technical methodologies together if it is adopted, the myth of common people i.e., herbal drugs are safe can be made Truth. Thus, even a poisonous drug can be used in therapeutics just like ambrosia for that condition without any adverse effect as told in Ayurveda.</p> <p><strong>Abstract No. AO-17</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance – Patient Safety in Integrative Cancer Management</p> <p><strong>Author’s Name: </strong>Dr. Harish Babu H</p> <p><strong>Author’s affiliation: </strong>Assistant Professor<strong>, </strong>Dept of Agada Tantra Evam Vidhi Vaidyaka</p> <p>Sushrutha Ayurvedic Medical College and Hospital</p> <p>Prashanti Kuteeram; Jodi Bingipura; Jigani Hobli; Bengaluru</p> <p><strong>Background:</strong> Cancer rates are increasing day by day globally and are main cause for morbidity and mortality too. 12.7 million Cancer cases are recorded by WHO and is said to increase to 21 million by 2030. Ayurveda is recognised for its therapeutic potential in cancer Management as well as cancer Complications. Patients approach to Ayurveda during chemo or Radiation for second opinion and take Ayurveda medicines along with chemo therapy drugs which has increased the concern of Herb-Drug interactions. To identify the potential herb drug interactions in cancer practice. To understand the synergistic or antagonistic actions of Herb-Drug.</p> <p><strong>Methods:</strong> This study was carried out based on databases like Pubmed, Google scholar, websites etc. and classical texts like Charaka Samhita, Sushrutha Samhita etc. Texts books related to pharmacovigilance.</p> <p><strong>Results:</strong> Cancer Medicines in Ayurveda are available by over the counter without any supervision with a belief that “All drugs are safe and can be used by anyone’’. This has increased the chances of Drug-herb interactions which is not yet understood completely and requires proper guidelines to monitor the preparation, quality standards and Efficacy.</p> <p><strong>Conclusion: </strong>Integration of different systems is now inevitable in cancer management and has led to multi drug approach. Many Herbal or herbo- mineral formulations in Ayurveda are efficacious in treating cancer or cancer complications or Therapy complications but Their use along with chemotherapy drugs yet unknown, Pharmacovigilance helps in detection, assessment, understanding and prevention of adverse effects or any other drug related problem</p> <p><strong>Keywords: </strong>Integrative oncology; Ayurveda; cancer; Pharmacovigilance.</p> <p><strong>Abstract No. AO-18</strong></p> <p><strong>Abstract Title: </strong>Critical review on various Basic principles to prevent ADR in children w.s.r. to <em>Kashyapa</em> <em>Samhita.</em></p> <p><strong>Author’s Name: </strong>Dr. Sagar M. Bhinde</p> <p><strong>Author’s affiliation: </strong>Asst. Prof., Department of Kaumarbhritya, IPGT&amp;RA, Jamnagar, Gujarat</p> <p><strong>Background:</strong> The World Health Organization defines adverse reactions as harmful and unintended responses to a drug and which occur with doses normally used in humans for prophylaxis, diagnosis or treatment of a disease or modifying a physiological function. In 2001, according to a U.S. surveillance study, ADRs were the cause of 244 outpatient visits of children under 15 years of age. Hence the practice of pharmacovigilance for paediatric use medicines requires special attention. But in Ayurveda, the chances of ADR in pediatric patients are even more, if one do not follow the basic principles given in <em>Kashyapa Samhita</em>, because there is very little description of pediatric specific management in <em>Brihatrayi</em> (three prime <em>Samhitas</em> of Ayurveda i.e. <em>Charaka, Sushruta</em> and <em>Ashtanaga Hridaya</em>) and <em>Laghhutrayi </em>(three authentic compiled books of Ayurveda i.e. <em>Sharangdhara, Madhav Nidana</em> and <em>Bhava Prakasha</em>).</p> <p><strong>Methods:</strong> Scattered references of mode of drug administration, drug dosage and basic principles for pediatric management are critically analyzed and scientific bases are searched from resent researches and from contemporary science.</p> <p><strong>Results:</strong> Pediatric specific drug dosage is given in <em>Lehadhyaya</em> and <em>Bhaishjopkramaniya</em>. Various basic principles of management are mentioned in <em>Aushadhbheshajendriyadhyaya</em>, <em>Dhupa Kalpadhyaya</em>, <em>Bhaishjopkramaniya</em>, <em>Yush Nirdeshniya</em> and many other chapters, which are unique and most important for prevention of ADR.</p> <p><strong>Conclusion: </strong>Ghee is mentioned as a vehicle for infants younger than 8 month, which is not practiced by majority of <em>Vaidyas</em> and hence could cause harm to the child. Many such basic principles are covered in <em>Kashyapa Samhita</em> to prevent ADR in children. Still if any ADR occurs in children by any means, it is utmost duty of Kaumarbhritya physician to report it to prevent further ADR to any child.</p> <p><strong>Keywords: </strong>ADR in children, Kashyapa Samhita, Kaumarbhritya, Prevention of ADR in Children</p> <p><strong>Abstract No. AO-19</strong></p> <p><strong>Abstract Title: </strong>The pharmacovigilance concern as mentioned in various chapters of <em>priya nighantu</em></p> <p><strong>Author’s Name: </strong>Tarun Sharma<sup>1</sup>*, Rabinarayan Acharya<sup>2</sup></p> <p><strong>Author’s affiliation: </strong>Assistant Professor, PG Dept. of Dravyaguna Vigyana, J. S. Ayurveda Mahavidyalaya, Nadiad, Gujarat, India, 2 Professor, PG Dept. of Dravyaguna Vigyana, IPGT &amp; RA, GAU, Jamnagar, Gujarat, India</p> <p><strong>Background:</strong> Pharmacovigilance plays a crucial role in optimizing drug safety and improving treatment outcomes. There is a necessity to upsurge the pharmaco-vigilant views of prophets who have already mentioned the attainable adverse effects of medicinal plants, minerals, animal products if not administered judiciously. The best illustrations in these lines are evident in <em>Nighantus </em>(lexicons) of <em>Dravyaguna</em>.<em> Priya Nighantu, </em>one among them postulates varied undesirable actions of drugs and even food items once consumed wrong or against regular protocol. The present paper is an attempt to focus on the pharmacovigilant aspects of certain medicinal plants documented in <em>Priya Nighantu</em>.</p> <p><strong>Methods:</strong> The present review is about the possible adverse effects caused by inappropriate administration of some medicinal plants that have been documented by author of <em>Priya Nighantu</em>. The observations have been given in a tabular form consisting of the name of the plant, part used, botanical name, its effect on <em>dosha, dhatu, mala </em>and others.</p> <p><strong>Results:</strong> It is observed that out of total 13 Vargas (classified group), near about 474 drugs of herbal origin were reviewed critically with regards to provocation of <em>dosha, dhatu, mala</em> and other possible adverse effects.</p> <p><strong>Conclusion: </strong>After a critical analysis, it is observed that <em>Priya Nighantu </em>has a well-developed idea about adverse effects of drug and diets if not consumed according to classical recommendations.</p> <p><strong>Keywords: </strong><em>Ayurveda</em><strong>, </strong><em>Dravyaguna</em><strong>, </strong>Drug safety, pharmacovigilance, <em>Priya Nighantu</em></p> <p><strong>Abstract No. AO-20</strong></p> <p><strong>Abstract Title:</strong> Perspective of Ayurveda on use of medicinal plants to avoid possible risk in <em>Garbhini</em> <strong>&nbsp;</strong></p> <p>Author’s Name: Rasika Kolhe<sup>1</sup>*, Vishnu Bavne<sup>2</sup>Author’s Affiliation: 1.* Research Officer (Ayurveda) -Regional Ayurveda Institute for Fundamental Research (RAIFR), Kothrud, Pune, 2. Associate professor (Dept. of Stree Roga and Prasuti tantra)- D. Y. Patil School of Ayurveda, Nerul, Navi Mumbai</p> <p><strong>Background:</strong> <em>Garbhini Avastha</em> is one of the precious stages of any woman’s life and utmost importance has been given to the safety of pregnant woman and healthy progeny. Ayurveda advise code of conduct to be followed right from the <em>Rajaswala</em> to <em>Sutika. </em>&nbsp;Do’s and don’ts are mentioned directly or through fundamental principle. But nowadays many cases of ADR due to Ayurvedic products and medicinal plants have been reported in the journals and news. Prevalence of herbal medicine in pregnant woman is very common. But data on their safety among women and neonates&nbsp;is not available. To compile and critical analysis the information and data regarding use of herbal medicine and their safety in pregnancy.</p> <p><strong>Methods:</strong> Classical references of medicinal plants contraindicated in <em>Garbhini</em>, and certain fundamental principle from <em>Samhita</em> elucidating the safety aspect of <em>Garbhini</em> and <em>Sutika</em> have been compiled.&nbsp; Reported data on ADR in pregnancy have been critically analysed and presented systematically.</p> <p><strong>Results:</strong> <em>Aardrka</em>(&nbsp;<em>Zingiber officinale</em>&nbsp;Roscoe.), <em>Methika</em> (<em>Trigonella foenum greacum L.</em>)<em>, Markandika</em> <em>&nbsp;(Cassia&nbsp;angustifolia Vahl.), Erand </em>(<em>Ricinus communis</em>&nbsp;L.) have been reported with ADR in pregnant woman. In the classical text <em>Haritaki, Rasona, Palandu, Suran</em> etc. are clearly contraindicated, whereas use of hot, spicy, heavy to digest food, <em>Kshara </em>(Alkali preparation), Pulses, <em>Panchakarma</em> regime, etc. are also contraindicated.</p> <p><strong>Conclusion</strong>: Understanding of&nbsp; fundamental principle of Ayurveda, do’s and don’ts for the use of medicinal plants, Code of conduct and <em>Garbhopaghatakar Bhav</em> depicted in classical text will definitely help to create awareness about prevention of possible adverse effects during pregnancy or the postnatal period.</p> <p><strong>Keywords:</strong> Ayurveda, <em>Garbhini</em>, Safety, Pharmacovigilance</p> <p><strong>Abstract No. AO-21</strong></p> <p><strong>Abstract Title:</strong> Cytotoxicity evaluation of seed oil of <em>Terminalia bellerica Roxb.</em>using tetrazolium (MTT) assay</p> <p><strong>Author’s Name:</strong> Dr. Neha Gaonkar</p> <p><strong>Author’s affiliation:</strong> final year, YMT Ayurved Medical College, Kharghar, Navi Mumbai, Maharashtra</p> <p><strong>Background:</strong> Various assays are used to evaluate the cytotoxic effect of drugs on cultured cells. The MTT(dimethylthiazol diphenyltetrazolium bromide) assay is a colorimetric assay based on mitochondrial uptake and succinct dehydrogenase reduction of soluble, yellow, MTT tetrazolium salt to an insoluble blue MTT formazen product. The aim of this study was to evaluate the cytotoxicity of seed oil of <em>Terminalia bellerica Roxb</em> using MTT assay.</p> <p><strong>Methods:</strong> Mouse fibroblast cells were seeded into a 96 well plate and incubated for 24 hours. After 24 hours investigational samples were added into respective wells in triplicates and incubated for 24 hours.After an exposure, MTT reagent was added to each well and plates were incubated for 4 hours. MTT medium was discarded carefully and the formazen crystals were eluted in SDS reagent. Plate was kept at room temperature for 30 minutes and then was read at 570 nm. Total 4 set of concentrations from 0.1 mg/ml to 1 mg/ml were done, and percent viability was calculated.</p> <p><strong>Results &amp; Conclusion:</strong> Concentrations of 0.1 mg/ml, 0.3 mg/ml,0.5 mg/ml and 1 mg/ml showed percent viability of 97.3%,95.8%,67.1%,45.8% respectively, indicating toxicity above 1 mg/ml.Seed oil of <em>Terminalia bellerica Roxb </em>has been described for premature hair graying in the form of <em>Pratimarsha nasya</em> which consists of 1-2 drops which justifies the toxicity levels above the concentration of 1 mg/ml.</p> <p><strong>Keywords:</strong> MTT assay, seed oil of <em>Terminalia bellerica Roxb</em>.</p> <p><strong>Abstract No. SO-01</strong></p> <p><strong>Abstract Title: </strong><em>Sidd</em>AR (Siddha Initiative for Documentation of Drug Adverse Reaction): Android Mobile App for AYUSH Pharmacovigilance Programmes: An efficient and easy way of assessing ADR.</p> <p><strong>Author’s Name: </strong>Sathiyarajeswaran P<sup>*1</sup>, Shree Devi MS<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>*</sup>1. Director in-charge, Siddha Central Research Institute, CCRS, Chennai., 2. Research Officer(S), Dept of Pharmacy, Siddha Central Research Institute, CCRS, Chennai.</p> <p><strong>Background:</strong> Mobile phones have become integral part of human life. A mobile application helps in delivering food and also helps to conduct delivery. Apart from connectivity, android and iPhone make ease of all activities.&nbsp; One area of those applications is healthcare applications. <em>“SiddAR”</em> (<strong><u>S</u></strong>iddha <strong><u>I</u></strong>nitiative for <strong><u>D</u></strong>ocumentation of <strong><u>D</u></strong>rug <strong><u>A</u></strong>dverse <strong><u>R</u></strong>eaction) Android Mobile App is a pioneer app of its kind in AYUSH which helps in documenting, reporting and improve the communication of safety issues related to adverse drug reaction. Siddha Central Research Institute, Chennai is a Peripheral Pharmacovigilance Centre developed <em>“SiddAR”</em>, a free smartphone app available on Android stores, for reporting adverse drug reactions and requesting drug safety information instantaneously. In AYUSH, pharmacovigilance contemporary documentation process involves in submission of reports through filled in physical forms or online forms. Rapidity in reporting would be lifesaving and also helps to prevent mortality and morbidity</p> <p>Methods: A questionnaire comprising of 25 questions in the report form were combined in the App. Algorithms were written and mobile app was designed using Android studio with eclipse plug-in along with SDK tools and manager. The app runs on android based Operating system of version 2.1 or higher.</p> <p><strong>Results:</strong> This Android app helps in real time documentation, lessening the time consumption and promotes the habit of being vigilant with drugs in market and their defects in manufacturing process. This App facilitates the Researcher to document ADR in clinical trials. This app would be a boon to the AYUSH health professionals and support team like nurses, AYUSH pharmacy persons and allied AYUSH persons to report the adverse events caused by or possibly by drugs and to stream line the process of ADR reporting and analysis.</p> <p><strong>Conclusion:</strong> <em>“SiddAR”</em> ADR android mobile app can be an effective alternative method to manual ADR analysis and can become an important tool in strengthening the AYUSH Pharmacovigilance programmes.</p> <p><strong>Keywords:</strong> <em>“SiddAR”, </em>Android mobile APP, ADR, Siddha, AYUSH, pharmacovigilance.</p> <p><strong>Abstract No. SO-02</strong></p> <p><strong>Abstract Title: </strong><em>Serankottai</em> induced contact dermatitis during <em>Suthi</em> process in Siddha - A case report</p> <p><strong>Author’s Name: </strong>Juliet. L <sup>*1&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </sup>Karthikraja.S.R<sup>2&nbsp;&nbsp;&nbsp; </sup>Reena.V.L<sup>3</sup>, Aarthi.V <sup>4 &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </sup>Sathiya, Rajeshwaran. P<sup>5</sup></p> <p><strong>Author’s affiliation: </strong><em><sup>*1</sup></em><em>Resea</em><em>rch Officer (Siddha), Siddha Central Research Institute, Chennai, Tamilnadu, India. <sup>2</sup>Research Associate, Siddha Central Research Institute, Chennai, Tamilnadu, India, <sup>3</sup>Assistant Research Officer (Chemistry), Siddha Central Research Institute, Chennai, Tamilnadu, India, 4 Research Officer (Siddha), Central Council for Research in Siddha, Chennai, Tamilnadu, India, 5 Director i/c, Siddha Central Research Institute, Chennai, Tamilnadu, India.</em></p> <p><strong>Background:</strong> In Siddha, the famous quote ‘Chukkuku pura nanju ,Kadukaiku aga nanju’, reveals that most of the plants are adjoined with the toxic part /chemical which has to be removed by the Suthi process before its medicinal uses. Any untoward medical occurance during treatment is the ADR (Adverse drug reaction). <em>Serankottai </em>(<em>Semecarpus anacardium</em> nuts- SA nuts) is enormously used in Siddha medicine for various challenging diseases like Rheumatoid arthritis, Cancer, Psoriasis, etc. It comes under poisonous herbs of Siddha, Schedule-E (1) drugs in Drugs and cosmetics rule. This study reports about the toxic signs developed by unprocessed <em>Serankottai</em> and its management through Siddha medicines.</p> <p><strong>Methods:</strong> Reporting of a single case, presented with contact dermatitis- 2 days after the exposure of unprocessed <em>Serankottai</em> during Siddha purification method in Siddha manufacturing unit and the negative rechallenge of the symptoms by Siddha antidotes were discussed.</p> <p><strong>Results:</strong> It is to report that, unprocessed <em>Serankottai </em>induced contact dermatitis has been successfully managed by proper <em>Siddha</em> antidotes like <em>Puli ilai kudineer</em> (Tamarind leaf decoction)-120 ml thrice a day and <em>Sengal podi ottradam</em> (Brick powder Fomentation) twice a day for 1 week as mentioned in <em>Gunapadam mooligai vagupu and Sattam saarndha maruthuvamum nanju maruthuvamum.</em></p> <p><strong>Conclusion: </strong>Proper purification of Toxic plants reduce toxicity to end user. Siddhars have documented step by step SOP in purification of toxic plants. They have also prescribed remediation helping in negative rechallenge. Here a case has been reported with clinical manifestations like blisters and boils after getting consent as per the CARE Guidelines to reveal the negative rechallenge in pharmacovigilance.</p> <p><strong>Keywords: </strong><em>ADR,</em> <em>Pharmacovigilance</em>, <em>Semecarpus anacardium-nut, Suthimuraigal</em></p> <p><strong>Abstract No. SO-03</strong></p> <p><strong>Abstract Title: </strong>Siddha traditional testing methods to ensure the quality, safe 2020-02-09T08:10:34+00:00 Copyright (c) 2019 SoPi Editor http://journalofsopi.com/index.php/sopi/article/view/36 Abstracts 2020-02-09T08:15:37+00:00 SoPi Editor editorjournalsopi@gmail.com <p><strong>POSTER PRESENTATION</strong></p> <p><strong>Abstract No. AP-01</strong></p> <p><strong>Abstract Title: </strong>A review on need of <em>Vatsanabha </em>(<em>Aconitum ferox</em>) <em>S</em><em>hodhana</em> and its Pharmacovigilance concern</p> <p><strong>Author’s name: </strong>Dr. Nithya V S</p> <p><strong>Author’s affiliation: </strong>IIMD Scholar Dept of Dravyaguna Vijnan, Govt. Ayurveda College Thiruvananthapuram</p> <p><strong>Background: </strong>Practice of Indian system of medicine is considered to be the safest form of therapy, however incidence of ADR owing to the consumption of traditional drug necessitates the introduction of Pharmacovigilance of ASU drugs. <em>Vatsanabha</em> is one such drug mentioned in various Ayurvedic formulation, on which many reports have been publishing regarding its ADR.</p> <p><strong>Methods: </strong>A thorough literary review was carried out through various classical text books like <em>Bhaishajyaratnavali, Bhavapraksha, Rasatarangini</em> etc and various databases like Pubmed, science direct, Google scholar, Dhara using the key word <em>Vatsanabha</em>, ADR, <em>Aconitum</em> <em>ferox</em>, A total of 6 papers was found to be relevant and selected for the literary review.</p> <p><strong>Results: </strong>Reports are published regarding the ADR, like Hypotension, Bradycardia due to consumption of aconite based Ayurvedic medicine. Studies proved that the impact of <em>Shodhana</em> process in the classic method using cow’s urine is found to be more safe than any other purification methods. TLC studies shown that pseudoaconitine and aconitine were converted into less toxic substance like veratroyl pseudoaconine benzoylaconine respectively only through traditional <em>Ayurvedic Shodhana</em>.</p> <p><strong>Conclusion: </strong><em>Vatsanabha</em> is a toxic plant with <em>Gunas</em> like <em>vikasi, vyavayi, sookshma &nbsp;</em>in prominence. Purification method should be proper and in suitable medium so as to modify these <em>G</em><em>unas</em> and mitigate its noxious effect.</p> <p><strong>Keywords: </strong>ADR, <em>Shodhana</em>, <em>Vatsanabha</em>, <em>Aconitum ferox</em></p> <p><strong>Abstract No. AP-02</strong></p> <p><strong>Abstract Title: </strong>Standardisation &amp; investigation of preliminary phytoconstituents at three stages of fruiting of figs of<em> Udumbar</em> (<em>Fius racemosa Linn.)</em></p> <p><strong>Author’s name: </strong>Dr. Rajanee Vijay Jadhav<sup>1</sup>, Dr.Sambhaji Tike<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>PG Scholar, Dravyaguna Department, YMT Ayurvedic Medical College &amp; PG Institute, Kharghar, Navi Mumbai, <sup>2</sup> HOD Dravyaguna Department, YMT Ayurvedic Medical College &amp; PG Institute, Kharghar, Navi Mumbai</p> <p><strong>Background: </strong><em>Udumbar</em> (<em>Ficus racemosa</em> Linn.) is a plant seen mostly all over India. It’s every part i.e. root, stem, leaves, fruits, <em>ksheer</em> are used in treatment of various diseases Diabetes, Diarrhoea, Cancer by its pharmaceutical &amp; nutritional properties. Though having medicinal property abundant amount of its fruits are wasted. It green fruit is eaten as vegetable in villages &amp; ripened fruits are eaten. <em>Udumbar</em> trees are seen in so often <em>Udumbar</em> fruiting is in clusters &amp; 2-4 times in year. Feasibility of fruits are good. They can be eaten directly or with honey/sugar/jaggery/ghee. Therefore it will be cheapest, easily available nutrition to children, in pregnant woman, malnourished patients of cancer, diabetes, HIV, Koch’s etc as compared to available costly nutritious, pharmaceutical drugs.</p> <p><strong>Methods: </strong>Samples were collected in 5 seasons of its fruiting throughout year from Kharghar –Navi Mumbai &amp; are authenticated. Collection of equal amount of samples each at three stages of figs of <em>Udumbar (Ficus racemosa Linn</em>.) i.e Unriped figs (Bright green), Middle stage between Unriped &amp; ripened (Reddish orange), Ripened Figs (Red) from different clusters of same plants randomly. Standardization were done according to Ayurvedic Pharmacopia of India. Study were done in 3 stages i.e Pharmacognostic study, preliminary phytoconstituents study and analysis of collected data by ANOVA method done.</p> <p><strong>Results: </strong><em>Ficus racemosa</em> is with ripened fig showed - LOD-0.11%, ASH-8.05%, AIA-0.746%, ASE-8.896%, WSE,-28.304%, pH-5.2. Proteins-9.34, Carbohydrates-22.88, Fixed oils: 2.736<strong>, </strong>Unripened fig- LOD-0.11%, ASH-9.842%, AIA-1.26%, ASE-9.764%, WSE-16.264%, pH-5.2. Proteins-9.07%, Carbohydrates-21.64%, Fixed oils: 5.12% Primary metabolites present as Carbohydrates, Proteins &amp; fats. Presence of secondary metabolites like Tannin, Glycosides, Steroids, Caumarins, Flavonoids in all stages of ripened &amp; unripened figs. Alkaloids &amp; saponins are not traceful. Calcium, Phosphorus, Iron, Silica, Potassium etc.are present in all stages.</p> <p><strong>Conclusion: </strong>ANOVA test done for statistical evaluation.There are no significant difference in view of Physicochemical &amp; phytoconstituents evaluation at three stages of figs of <em>Udumbar</em>.</p> <p><strong>Keywords: </strong>ANOVA, Phytoconstituents, Primary &amp; secondary metabolites, <em>Udumbar</em>.</p> <p><strong>Abstract No. AP-03</strong></p> <p><strong>Abstract Title: </strong>Good cultivation, collection practice and pharmacovigilance</p> <p><strong>Author’s name: </strong>Dr Murukaraj V.</p> <p><strong>Author’s affiliation: </strong>PG scholar, Dept. of Dravya guna vijnana, Govt. Ayurveda College Thiruvanathapuram</p> <p><strong>Background: </strong>Over several decades of Indian medicinal history, Ayurvedic drugs are marked as safe to administer than they are effective. Even in the absence of sophisticated testing methodologies then, these drugs seldom caused any adverse effects. This is due to nothing but the ingenious rules and ethical principles this science followed right from the selection of sowing ground to the manufacturing of dosage forms. According to WHO, the number of reports of adverse effect owing to herbal drug usage has been increasing exponentially, Analysis revealed amongst its several reasons “Quality compromise of the herbal medicine” is the second leading one. Mandatory execution of the GACP guidelines will be the early remedy for the situation. This paper illustrates some of the issues of improper cultivation and collection practice and to provide some suggestion for its correction.</p> <p><strong>Methods: </strong>Collecting information from different journals, databases and by interrogating herbal cultivators of Kerala and enlisting all the issues concerning the subject to find out suitable solution.</p> <p><strong>Results: </strong>It is revealed that amongst several issues concerning cultivation and collection practice, improper execution of GACP guideline has the prior importance. Adequate remedial measures are equipped&nbsp;&nbsp; after discussion with subject scholars.</p> <p><strong>Conclusion: </strong>Field of herbal cultivation is facing the most dangerous situation in the last few decades. 70% of the issues are avoidable by proper correction and implementation of stringent rules. Hence it is imperative to follow the GACP guidelines through every steps of herbal drug development</p> <p><strong>Keywords: </strong>Good cultivation, collection Practices, Pharmacovigilance, adverse drug reaction</p> <p><strong>&nbsp;</strong></p> <p><strong>&nbsp;</strong></p> <p><strong>Abstract No. AP-04</strong></p> <p><strong>Abstract Title: </strong>A cross sectional survey on the knowledge and attitude of ayurvedic practitioners of Kerala towards pharmacovigilance</p> <p><strong>Author’s name: </strong>*Indu. M. Menon, **Dr. M. S. Deepa</p> <p><strong>Author’s affiliation: </strong>*2<sup>nd</sup> year PG Scholar, **Associate professor, Dept. of Dravyaguna Vijnana, Govt. Ayurveda College, Thiruvananthapuram</p> <p><strong>Background: </strong>The popular perception of Ayurvedic medicines of being devoid of any adverse drug reaction is at stake. Owing to the increased industrialization in this field, there is an alarming increase in the rate of adverse drug reactions. To tackle these issues, National Pharmacovigilance Programme for AYUSH drugs was introduced. An indepth research was conducted to assess the knowledge and attitude of Ayurvedic Practitioners of Kerala towards Pharmacovigilance and the extent to which they report adverse drug reactions (ADRs) to the higher centres.</p> <p><strong>Methods: </strong>A validated web based questionnaire was designed and a cross sectional survey was conducted among 100 Ayurvedic clinical practitioners in different districts of Kerala (n=100). Inclusion criteria were Clinical practitioners and excluded Teaching faculties and PG Scholars. Statistical method employed was Descriptive statistics.</p> <p><strong>Results: </strong>Statistical analysis revealed that only 58% physicians are aware of the existence of National Pharmacovigilance Programme. 56% does not have the idea of the higher reporting centres. 80% are unaware of the existence of Peripheral Pharmacovigilance centre in Kerala. 60% are ignorant that ADRs should be reported and 77% are not familiar with the standard form for ADR reporting of Ayurvedic medicines.</p> <p><strong>Conclusion: </strong>The present study brought into light the lack of knowledge of National Pharmacovigilance Programme and ADR reporting of Ayurvedic medicines. This study has unveiled the urgent need for a regular training and reinforcement for the ADR reporting among the Ayurvedic Practitioners.&nbsp;&nbsp;&nbsp;</p> <p><strong>Keywords: </strong>Cross sectional survey, Pharmacovigilance for Ayurvedic medicines, ADR</p> <p><strong>Abstract No. AP-05</strong></p> <p><strong>Abstract Title: </strong>Environmental Pharmacovigilance (EPV): An emerging branch of Science- A review.</p> <p><strong>Author’s name: </strong>Vyas K<sup>1</sup><strong>, </strong>Sharma V<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1 </sup>Research Officer (Ayu), RARIND, CCRAS, Jaral Pandoh, District Mandi, H.P., <sup>2 </sup>HOD of QA, Torque Pharma, Baddi, District Mandi, H.P.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</p> <p><strong>Background: </strong>Environmental Pharmacovigilance (EPV) is a developing branch of science relating to the detection, assessment, understanding and prevention of Adverse Environmental Impacts (AEI) of Pharmaceutical products. It identifies risk levels of pharmaceutical residues mainly in water &amp; soil for Environmental Risk Assessment (ERA) and its effective management. These spotting activities are necessary not only after launch of a new pharmaceutical product but also through its whole Life cycle. The branch is aimed to find out significant environmental issues related to Pharmaceuticals in Environment (PIE).</p> <p><strong>Results: </strong>The main components of Environmental Pharmacovigilance (EPV) are- Environment, Pharmaceutical Product, Product user (Human/ animal)/ dealer and Victims of the risks developed. The victims may be non-targeted human population, wild life species or aquatic inhabitants etc. The documentation of this vigilance search is completely limited as it is quite difficult to differentiate the relative impact of pharmaceuticals and other Environmental stimuli. Moreover, management plans require deep knowledge of Physico-chemistry, pharmacokinetics, toxicology and other sciences, which make it very specific. Though Environmental Risk Assessment is already included in regulatory approval process for new drugs, its implementation is poor in Developing countries.</p> <p><strong>Conclusion: </strong>There is great need to focus on this branch of vigilance in order to save the world from fatal hazards.</p> <p><strong>Keywords: </strong>Environmental Risk Assessment, Pharmaceuticals, Adverse Environmental Impact, Regulatory approval process</p> <p><strong>Abstract No. AP-06</strong></p> <p><strong>Abstract Title: </strong>Review on Adulteration of Ayurvedic raw drugs</p> <p><strong>Author’s name: </strong>Sreelekshmi R</p> <p><strong>Author’s affiliation: </strong>PG Scholar, Govt Ayurveda College Thiruvananthapuram.</p> <p><strong>Background: </strong>The genuiness, purity and quality of the drugs have direct impact on the medicinal preparation. Now a days most of the drugs obtained from raw materials are adulterated. Destructive harvesting, deforestation, lack of adequate cultivation, high price and demand, in contrast to the smaller population size of the plant, have motivated adulteration. Deliberate adulteration rather than by mistake is a serious offense and is the most important reason for adverse drug effects these days. This paper intends to disclose three of such adulteration on market samples(<em>trivrith</em>, <em>sariba, tila taila</em>) by reviewing dissertation works done at Govt ayurveda college Thiruvanthapuram, Dravyaguna dept viz.</p> <p><strong>Methods: </strong>Review of Physico chemical evaluation of the samples and comparing it with API standards of the drug.</p> <p><strong>Results: </strong>From the review it is revealed that other species of periplocaceae used instead of <em>Hemidesmus indicus</em>, <em>trivrith</em> shoot is used instead of root, mineral oil present in <em>thila taila</em><strong>. </strong></p> <p><strong>Conclusion:</strong> From the above results, it is evident that these drugs were not in compliance with their phytochemical standards. Either deliberately or accidently drugs were adulterated. This can cause mild to severe consequences even in its judicial administration with respect to dose etc. Illiberal rules and their mandatory executions are needed to get rid of these disagreeable acts. Without those, all the efforts to globalize this science of living will be pointless.</p> <p><strong>Abstract No. AP-08</strong></p> <p><strong>Abstract Title: </strong>Analytical study of <em>Hinguleshwar Rasa</em></p> <p><strong>Author’s name: </strong>Dr. Ajay B. Sonawane,<sup>1</sup> Dr. Archana P. Gharote<sup>2</sup></p> <p><strong>Author’s affiliation:<sup> 1</sup></strong>M.D Rasashastra, Ph.D Scholar, Rasashastra &amp; Bhaishajya kalpana, School of Ayurveda D Y Patil, Nerul, Navi Mumbai., <sup>2</sup>Professor &amp; HOD of Rasashastra &amp; Bhaishajya kalpana Department, School of Ayurveda D Y Patil, Nerul, Navi Mumbai.</p> <p><strong>Background: </strong>In <em>Rasashastra</em> each and every step mentioned in basic principles of formulation is very important. There is need to validate &amp; standardize the process by using different analytical technique for seeing what changes happen during the whole process.&nbsp;</p> <p><strong>Methods: </strong>In this study we have carried out <em>Hingula Shodhana, Vatsanabha</em> <em>Shodhana</em> &amp; then prepared <em>Hinguleshwara</em> <em>rasa</em> as per classical reference.</p> <p><strong>Results: </strong>In ICP AES test of purified <em>Hingula</em> we found elements like CR, NA, W. but these element were not present in sample of unpurified <em>Hingula</em>. In the sample of purified and unpurified <em>Vatsanabha</em> we did not find any different significant element in this test. In <em>Hinguleshwara rasa</em> we did not find elements which were present in purified <em>Hingula</em> &amp; purified <em>Vatsanabha</em> like CR, GA, NI, and W. In FEG-SEM we got images of given samples. In XRD, we did not find any structural changes in unpurified and purified Hingul &amp; purified <em>Hingula</em> used in <em>Hinguleshwara rasa</em>. HPTLC finger print analysis help to check quality of formulation as well as it was used for batch to batch consistency. Because of its reliability and simplicity it was used as a tool for quality control of formulation.</p> <p><strong>Conclusion: </strong>The Analytical tests done on <em>Hinguleshwara Rasa</em> like ICP AES, FEG SEM, XRD, HPTLC reveal presence of 19 elements ,reduce particle size, basic structure of <em>Hingula</em> (Cinnabar) is maintained and Phyto-constituence of <em>Pippali</em> were prominently seen in final product.</p> <p><strong>Keywords: </strong><em>Hinguleshwar Rasa, Hingul, Vatsanabh</em>, ICP AES, FEG SEM, XRD, HPTLC</p> <p><strong>Abstract No. AP-09</strong></p> <p><strong>Abstract Title: </strong>Glimpse of Pharmacovigilance in Sutrasthana of <em>Charaka Samhita</em></p> <p><strong>Author’s name: </strong>Samata Tomar*, Rabinarayan Acharya**</p> <p><strong>Author’s affiliation: </strong>* Professor and Head, Department of <em>Agadatantra</em>, SGAM, Gujarat Ayurved university, Jamnagar, Gujarat, India, **Professor and Head, Department of <em>dravyaguna</em>, IPGT &amp; RA, Gujarat Ayurved university, Jamnagar, Gujarat, India</p> <p><strong>Background: </strong><em>Charaka Samhita</em>(C.S.), one of the celebrated lexicon of Ayurvedic literature&nbsp; consists of 8 sections <em>(Sthana</em>) and contains total 120 (Adhyaya)chapters, 9035 <em>Sutras</em> (formula). Highly useful for therapeutic purpose. It covers the preventive and curative data of various disease conditions. In this article, an attempt has been made to collect the&nbsp; Pharmacovigilant(PhV) aspects described in different Sutras of C.S.</p> <p><strong>Methods: </strong>first <em>sthana- Sutrasthana</em> of C.S. has been reviewed and the relevant data is presented consicely.</p> <p><strong>Results: </strong>In Sutrassthana, Pharmacovigilant aspect of different food articles is described in 120 <em>sutras</em>. Ten <em>sutras</em> depicts the contraindications regarding the drugs and food use in different conditions, Materovigilance is mentioned in five sutras, ineligibility for treatment is portrayed in six <em>sutras</em>, complications caused by different drugs are shown in nine <em>sutras</em> and Basic principles governing the vigilant aspect of any drug, food, and regimen are described in thirty two sutras. Thus total 182 <em>shlokas</em> from <em>Sutrasthana</em> of <em>Charaka samhita</em> are related to PhV concept</p> <p><strong>Conclusion: </strong>Compiled data regarding safety issues and PhV can open new window for further researches in future for Ayurveda scholars</p> <p><strong>Keywords: </strong>Pharmacovigilance, safety issues, basic principles</p> <p><strong>Abstract No. AP-10</strong></p> <p><strong>Abstract Title: </strong>Medicinal plants to be critically analyzed before consumption, while planning a pregnancy: evidence based research data</p> <p><strong>Author’s name: </strong>Priyanka Galav*, Rabinarayan Acharya**</p> <p><strong>Author’s affiliation: </strong>M.D. Scholar*, Professor and Head** , Dravyaguna Department, IPGT &amp; RA, Gujarat Ayurved University, Jamnagar , Gujarat, India- 361 008.</p> <p><strong>Background: </strong>Since time immemorial, Ayurveda enlists both safe and unsafe medicinal plants to be taken during pregnancy. Herbs may contain substances that can cause uterine contractions causing miscarriage, premature birth, or injury to the fetus. In classical texts of Ayurveda, few plants are enlisted for their probable adverse effect but recent research reports certain plants for their teratogenic, embryotoxic and abortive effects in experimental animals. To provide the best available information on benefits and untoward effects of herbal medicine use during pregnancy.</p> <p><strong>Methods: </strong>Medicinal plants, which are commonly use in Ayurvedic Pharmacopoeia, either as a drug or used as diet, and reported for their anti-implantation, antifertility, teratogenic, embryotoxic and abortive effects were searched from web based engines&nbsp; and modern books.</p> <p><strong>Results: </strong>Present study reports that about 22 plants having reported for their adverse effects related to female reproductive system. Among these, 8 drugs (<em>Apamarga</em>, <em>karavellka</em> etc)&nbsp;&nbsp; are having abortifacient activity, 19 drugs (<em>Atibala</em>, <em>Bilwa</em> etc) having anti-implantation and anti-fertility activity.</p> <p><strong>Conclusion: </strong>Women who are planning for a pregnancy or having history of threatened abortion should avoid these plants either as a drug or diet and should take, if necessary, in consultation with a physician only.<strong>&nbsp; </strong>&nbsp;</p> <p><strong>Keywords: </strong>pregnancy, antifertility, Medicinal plants.</p> <p><strong>Abstract No. AP-11</strong></p> <p><strong>Abstract Title: </strong>Role of Eco-pharmacovigilance in the field of Ayurvedic Medicine manufacturing sector</p> <p><strong>Author’s name: </strong>Mahesh S<sup>1*</sup> , B.J.Patgiri<sup>2</sup></p> <p><strong>Author’s affiliation </strong>1.PhD scholar 2. Professor and HOD, Dept of Rasasastra and Bhaishajya kalpana, IPGT &amp;RA, Jamnagar</p> <p><strong>Background: </strong>Eco-pharmacovigilance is an emerging science in pharmacovigilance, deals with the adverse effect of pharmaceutical products on environmental entities. The world has witnessed a sudden decline in the vulture population across the Indian subcontinent due to ADR caused by diclofenac. So we must focus attention on the adverse effects of various pharmaceutical drugs on the environment and non-targeted species. Due to Industrialization, the Ayurvedic medicine manufacturing sector is now controlled by large scale industries.</p> <p><strong>Methods: </strong>The data regarding the details of waste management in Ayurvedic sector was collected from published works in electronic databases and through discussion with the personals in the R&amp;D section of various pharmacies.</p> <p><strong>Results: </strong>Due to increased demand for herbal medicines, the percentage of Ayurveda pharmacies were found to be increasing 0.5% per year in India. When there is an increase in the number of pharmacies, the amount of waste generated will also be increased proportionally. Herbo-mineral medicines were also produced in large scale, so there is always a concern of the presence of heavy metals in these wastes. Waste management became a herculean task for pharmacies and the effect of these various types of waste generated from Ayurvedic medicines on the environment is not properly studied and published yet.</p> <p><strong>Keywords:&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </strong>Eco-pharmacovigilance, Herbominerals, waste management</p> <p><strong>Abstract No. AP-13</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance: issue Related to Pediatric and Adult Population</p> <p><strong>Author’s name: </strong>Dr. Kedar nath Upadhyaya</p> <p><strong>Author’s affiliation: </strong>Associate Prof. &amp; HOD</p> <p>Bundelkhand Govt. Ayurved College, Jhansi</p> <p>The developmental changes in physiology and consequently in pharmacology influence the efficacy, toxicity and dosing regimens of medicince used in children. It is therefore to review the relevant changes that take place from birth through to adolescence. It should be noted that specific diseases occur in the growing and maturing organism, which are not seen in adult, new born, infants have higher extra cellular fluid volume than any other paediatric population or adults on other hand fat content is lower in premature baby than in full term neonates and infants.</p> <p>Substantial changes in body proportions and composition accompany growth and development this dynamic process of maturation is one of the differences between the pediatric and adult population. Consequence of the lack of studies of medicines development in childrens and authorization of pediatrics medicine is of great concern like no information is available on effective and safe dosing regimens record in an ethical dilemma exists as to the choice between using off label medications when little or no information is available about their safety and efficacy. It may be necessary to deal with parents and guardians who after reading the prescribing information are apprehensive that a medicine not tested in children or not cleared for use in children is being used to treat their child, warning of possible ADRs and adverse events are insufficient or lacking.</p> <p><strong>Keywords: </strong>Pharmacovigilance, new born</p> <p><strong>Abstract No. AP-14</strong></p> <p><strong>Abstract Title: </strong>SUSAR Consolidation - New Procurement Approach in Pharmacovigilance</p> <p><strong>Author’s name: </strong><sup>1</sup>Abhay J Gandhi, <sup>2</sup>V. J. Shukla</p> <p><strong>Author’s affiliation: </strong>1. PhD Scholar, 2. Head of Pharmaceutical Chemistry, IPGT &amp; RA, Jamnagar</p> <p><strong>Background: </strong>Pharmaceutical companies outsource SUSARs under their PV services to various suppliers based upon their geography, product and service capabilities. The pharmaceutical companies maintain inhouse resources to ensure the quality of services for SUSAR reporting and maintenance. Suspected Unexpected Serious Adverse Reactions (SUSARs) have become a critical element in analysing the risk and benefit associated with the life cycle of a medicinal product, either in the market or undergoing clinical trial.</p> <p><strong>Results: </strong>Awareness about suspected unexpected serious adverse reactions reporting is still poor amongst contract research professionals in India. Incidence of suspected unexpected serious adverse reactions has to monitor carefully and has to report immediately. The bioethical considerations to be taken into account in determining and implementing health policy and specialties to harmonizing and strengthening drug safety surveillance measures. Average cost incurred for conducting clinical trial was higher.</p> <p><strong>Conclusion: </strong>It has been a dynamic and swiftly changing area of the pharmaceutical industry and has become one of the concerns as well.</p> <p><strong>Keywords: </strong>Suspected Unexpected Serious Adverse Reactions (SUSARS), Prospective Spontaneous reporting, Causality, Severity, Cost</p> <p><strong>Abstract No. AP-18</strong></p> <p><strong>Abstract Title: </strong>Pharmacovigilance concerns related to Opthalmic health; A critical review of Samhitha and Nigantu</p> <p><strong>Author’s name: </strong>Aswathi Mohan P*, Bhupesh R Patel**, Rabinarayan Acharya***</p> <p><strong>Author’s affiliation: </strong>*PhD Scholar, ** Associate Professor, *** Professor &amp; HOD, Department of Dravyaguna, IPGT &amp; RA, Gujarat Ayurveda University, Jamnagar, India</p> <p><strong>Background: </strong>Pharmacovigilance describes the possible side effects that can occur with different therapeutically useful drugs. It aims to prevent drug induced illness and improve patient safety by assessing drug risk benefits. Ayurveda explains its importance by stating that pure therapeutic procedure is one which pacifies a disease without provoking another. Ayurveda texts delineate pharmacovigilance aspects of various medicines, foods and treatment procedures. The pharmacovigilance concerns related to eye and vision explained in classics need special consideration as eye is the most vital sense organ among all sense organs. To identify and catagorise pharmaco-vigilant aspects of various <em>Aushadha</em> (medicine), <em>Ahara</em> (diet) and treatment procedures from the available literature giving emphasis on <em>Nethra</em> (eye and vision)</p> <p><strong>Methods: </strong>The present review has been undertaken to identify the above mentioned categories of substances which are <em>Achakshushya</em> (unwholesome for eyes) from Ayurveda Samhithas and various Nigantus.</p> <p><strong>Results: </strong>About 58 drugs were quoted to produce ocular disturbances when consumed wrongly or against regular protocol. About 34 food items were described to be unwholesome for eye. The regular and over use of <em>Amla</em> and <em>Lavana</em> rasa and the <em>Atiyoga</em> of treatment procedures like <em>Langhana</em>, <em>Vamana</em>, <em>Virechana</em> etc were also mentioned as bad for ophthalmic health.</p> <p><strong>Conclusion: </strong>The present review reports the possible adverse effects on eye and vision due to improper administration of certain drugs, food items and treatment procedures.</p> <p><strong>Keywords: </strong>Pharmacovigilance, Opthalmic health, <em>Achakshushya</em></p> <p><strong>Abstract No. AP-19</strong></p> <p><strong>Abstract Title: </strong>Possibility of Adverse event while preparing <em>Sanjivani vati</em> – A case Report</p> <p><strong>Author’s name: </strong>Kaushik S<sup>1*</sup>, Yadav P<sup>2</sup>, Galib<sup>3</sup>, Prajapati PK<sup>4</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>PG 2<sup>nd </sup>Year Scholar, <sup>2</sup>Assistant Professor, <sup>3</sup>Associate Professor, <sup>4</sup>Professor &amp; Head, Department of Rasashastra and Bhaishajya Kalpana, All India Institute of Ayurveda, SaritaVihar, New Delhi – 110076</p> <p><strong>Background: </strong>Using processed poisons in healthcare is an integral part of Ayurveda. <em>Bhallataka </em>(<em>Semecarpus anacardium</em> Linn.) is one important and commonly used ingredient in various Ayurvedic formulations<em>. </em>But<em>, </em>its injudicious contact may manifest contact dermatitis. <em>Sanjivani Vati</em>, which consists of <em>Bhallataka, </em>is one such most commonly used preparation being prescribed in the treatment of Indigestion, gastroenteritis with piercing pain and fever<em>. </em>This study aims at reporting a case of adverse event associated with preparation of <em>Sanjivani vati<strong>.</strong></em></p> <p><strong>Methods: </strong>Documentation of observed reactions and its management while preparing <em>Sanjivani vati</em> in Laboratory of <em>Rasashastra</em> and <em>Bhaishajya kalpana</em> at All India Institute of Ayurveda, New Delhi was done.</p> <p><strong>Results: </strong>It was found that the scholar developed itching, burning sensation, redness of skin and blisters after coming in contact with <em>Bhallataka </em>directly or indirectly during its <em>Shodhana</em> (processing) and preparation of <em>Sanjivani vati</em>. The symptoms resolved within 2 weeks on management, but left black scar marks over the area of blisters. The blisters kept on appearing &amp; resolving on exposure to heat, indicating its delayed hypersensitivity reaction.</p> <p><strong>Conclusion: </strong>Tarry oil present in the pericarp of <em>Bhallataka</em> fruit causes blisters on contact. Though the drug is herbal; one has to handle it cautiously to avoid adverse event. It is advisable to follow exclusive regulations in terms of diet and deeds before collection and during processing of <em>Bhallataka</em>. In this era of Pharmacovigilance, it is important to create awareness regarding precautions among workers involved in such pharmaceutical processes.</p> <p><strong>Keywords: </strong>Adverse events, <em>Bhallataka, </em>Pharmaceutical, <em>Sanjivani vati </em></p> <p><strong>Abstract No. AP-20</strong></p> <p><strong>Abstract Title: </strong>Safety and efficacy of <em>Ayurvedic</em> formulations containing <em>Bhallataka</em>; Schedule E (1) drug.</p> <p><strong>Author’s name: </strong>Dharmishtha Bopaliya <sup>1&nbsp; </sup>&nbsp;Dipali parekh<sup>2&nbsp; </sup>&nbsp;Dr. Prashant Bedarkara<sup>3</sup> Prof. B. J. Patgiri<sup>4</sup></p> <p><strong>Author’s affiliation: </strong>1. MD Scholar, 2. MD Scholar, 3. Associate Professor, 4. HOD of Dept. of Rasashastra and Bhaishajya Kalpana IPGT&amp;RA, Jamnagar.</p> <p><strong>Background: </strong><em>Bhallataka </em>(<em>Semecarpus anacardium </em>Linn) is the plant in the family Anacardiaceae. <em>Bhallataka</em> is mentioned in <em>UpavishaVarga </em>in Ayurvedic texts.&nbsp; The fruits are official part of <em>Bhallataka</em> and reported for containing Bilwanol, Anacardiolas the major chemical constituents. It is a common drug indicated therapeutically for the management of various disease like <em>Arsha</em>(Piles), <em>Kushtha</em>(Skin disease), <em>Udara</em>(Ascitis), <em>Jwara</em>(fever), <em>Krimi</em>(Worm infestation) etc. Number of Ayurvedic formulations includes this drug after its proper <em>Shodhana Samskara</em>(Purification process) as injudicious use of <em>Ashuddha</em>(impure) <em>Bhallataka </em>may results in toxic effects like burning sensation of skin, blister formation, ulcer and so on. Aim of the present review is to compile such available published report on safety and toxicity aspects of <em>Bhallataka</em> in Ayurveda<em>.</em></p> <p><strong>Methods: </strong>In present review, published articles on clinical trials of&nbsp; <em>Bhallataka </em>and its formulations containing were reviewed and relevant data of safety and efficacy, toxicity&nbsp; of <em>Bhallataka</em> in clinical were critically analyzed. Articles were searched through various search engines like google scholar, pubmed, and websites by searching the word- study on<em> Bhallataka</em>.</p> <p><strong>Results: </strong>Total 9 clinical studies showing safety and efficacy of <em>Bhallataka </em>and its formulations were found published. Side effects were noted in some cases after external and internal applications.&nbsp; Among them in 6 studies, ADR of&nbsp; <em>Bhallataka</em> were observed, in 2 studies, ADR were not&nbsp; mentioned and in one study&nbsp; no ADR were observed.</p> <p><strong>Conclusion: </strong><em>Bhallataka</em> and <em>Bhallataka</em> contiaing formulations did not show any serious adverse effect and effective in the clinical management in various diseased. There was no significant derangement in haematological and biochemical parameters in these studies.</p> <p><strong>Abstract No. AP-21</strong></p> <p><strong>Abstract Title: </strong>Drug genuinity and its role in Ayurvedic pharamcovigilance w.s.r.t <em>Pippali</em> (<em>Piper longum</em>)</p> <p><strong>Author’s name: </strong>*Princy Xavier</p> <p><strong>Author’s affiliation: </strong>PG Scholar, Department of Dravyaguna Vijnana, Government Ayurveda College, Thiruvananthapuram</p> <p><strong>Background: </strong>Herbal preparations constitute the primary therapeutic interventions in Ayurveda. In Kerala more than 200 medicinal plants are taken on large scale for the preparation of medicinal products. <em>Pippali</em> is one among the drug which is used in almost all formulations. The genuinity, purity and quality of the drugs have direct impact on the quality of medicinal formulations. In the present study an attempt has made to ascertain the genuineness of fruit of <em>Pippali</em> in Kerala market, in concern with pharmacovigilance.&nbsp;</p> <p><strong>Methods: </strong>Samples were collected randomly from different markets of Kerala. Genuiness of samples were analysed formacroscopic, microscopic and physicochemical parameters like total ash, water soluble extractives, TLC and HPTLC.</p> <p><strong>Results: </strong>Marked variations are noted in both macroscopic and microscopic characters. Instead of <em>Piper longum, Piper retrofractum</em> is using in many parts of Kerala. HPTLC was performed between the samples which showed marked differences in quantity of Piperine, which is a major chemical constituent of <em>Pippali</em>. Some of the samples does not matches with the parameter mentioned in API.</p> <p><strong>Conclusion: </strong>Standardisation of finished products can achieved only by the usage of genuine drugs. . The need of the hour is to take caution right from the collection of raw drug so as to avoid adulteration and substitution, which in turn prove that the AYUSH drugs are safe and scientific in global market.</p> <p><strong>Keywords: </strong>Genuineness, fruit of <em>Pippali</em>, physicochemical analysis, HPTLC</p> <p><strong>Abstract No. AP-22</strong></p> <p><strong>Abstract Title: </strong>Leech Application as a Source of Adverse Reaction – A Case Report</p> <p><strong>Author’s name: </strong>Singh R<sup>1*</sup>, Yadav P<sup>2</sup>, Galib R<sup>3</sup>,<sup>&nbsp; </sup>Prajapati PK<sup>4</sup></p> <p><strong>Author’s affiliation: </strong><sup>1*</sup>PG 2<sup>nd</sup> Year Scholar, <sup>2</sup>Assistant Professor, <sup>3</sup>Associate Professor, <sup>4</sup>Professor &amp; Head Department of Rasashastra and Bhaishajya Kalpana, AIIA, New Delhi.</p> <p><strong>Background: </strong>Leeches have been used for medical purposes especially for skin disorders since centuries in Ayurveda as well as in modern medical care. Among various <em>Shodhana</em> therapy,&nbsp;<em>Raktamokshana (</em>blood letting<em>)</em>&nbsp;is indicated in the management as <em>Rakta Dushti</em>&nbsp;is considered one of the prime causes of skin diseases<strong>. </strong><em>Jalaukaavacharna Karma</em> (Leech therapy) is considered as the ideal method to expel out the vitiated blood safely and effectively. In this study, we report a case of an irritant contact dermatitis in a patient who experienced severe redness, itching and painful oozing lesions after applying leeches for the relief of eczema.</p> <p><strong>Methods:</strong> A 21 years old female patient reported at OPD of All India Institute of Ayurveda, New Delhi for the treatment of swelling, painful and itchy lesions with vesicles oozing pus and blood intermittently on her feet and legs. She had taken medication and leech therapy on right foot for eczema 15 days ago. Within one day of leech therapy, she developed the symptoms mentioned above.</p> <p><strong>Results: </strong>Swelling, painful and itchy lesions aggravated in next three days and gradually affected whole body including face, eyes and both hands etc. Biochemical parameters were found normal and patient was treated at AIIA and got mild relief. But, gradually condition got worsened. Finally, she took conventional treatment.</p> <p><strong>Conclusion: </strong>Although, leech therapy has a lot of medical benefits but it can also lead to serious complications. So, Leech must be available in the centers for the therapy itself and should be provided by qualified person who can identify non-poisonous leeches. In house breeding of non-poisonous leeches can also be initiated. Some sensitivity test may be carried out.</p> <p><strong>Keywords:</strong> Adverse reactions, Leech therapy, Pharmacovigilance</p> <p><strong>Abstract No. AP-23</strong></p> <p><strong>Abstract Title: </strong>Concept of Pharmacovigilance in Ayurveda and measures to prevent ADR</p> <p><strong>Author’s name: </strong><em>Sunona George<sup>1</sup>, Shubhashree M.N<sup>2</sup>, Raghavendra Naik<sup>3</sup>, B.K.Bharali<sup>4</sup></em></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Programme Assistant, <sup>2</sup>Research Officer (S2), <sup>3</sup>Research Officer (Ayu), <sup>4</sup>Asst. Director Incharge, Regional Ayurveda Research Institute for Metabolic Disorders, CCRAS, Ministry of AYUSH, Bengaluru-560109</p> <p><strong>Background: </strong>Ayurveda is a major component of healthcare in India which is thoroughly time tested and presented in scientific manner thousands of years ago. The holistic approach of this ancient science mainly focused on preservation of normal health and curing the diseased one. Ayurvedic chikitsa primarily depends on <em>Bhisak</em> (Physician), <em>Dravya</em> (Drug), <em>Rogi</em> (Patient) and <em>Upasthata</em> (Attendant). &nbsp;Though Ayurveda is since centuries, there is a lacuna of systematic documentation related to the occurrence of adverse drug reactions and drug safety. Since the success of any pharmacovigilance system is in the ability to prevent possible adverse drug reactions successfully by understanding available concepts along with contemporary tools, the present review has been planned.</p> <p><strong>Methods: </strong>In the present study, concept of pharmacovigilance is compiled from Ayurvedic classics and presented in a systematic manner along with measures for its prevention.</p> <p><strong>Results: </strong>Though the word pharmacovigilance is not available in Ayurvedic classics, major goals of pharmacovigilance like of drug safety and rational use of medicines are highlighted by Acharyas. Different causes for adverse drug reactions like overdose (<em>Atimatra</em>), drug-diet interaction, drug intolerance, use of unwholesome drugs (<em>Asatmya</em>), Prakriti <em>virudda</em> <em>dravyaprayoga</em>), <em>Viruddaahara</em>, idiosyncrasy (<em>Vaidyakrita</em>) etc, are being emphasized repeatedly in all major texts. This risk of Adverse drug Reaction can be considerably reduced by following contemporary tools like blood investigations (LFT, RFT), Skin Tests (Scratch test, Patch test), Urine investigations etc.</p> <p><strong>Conclusion: </strong>Understanding the principles of drug safety mentioned in Ayurveda with the help of contemporary tools will help in developing various strategies for improving pharmacovigilance in Ayurveda.</p> <p><strong>Keywords:</strong> ADR, Ayurveda, Herbo-mineral drugs, Pharmacovigilance</p> <p><strong>Abstract No. AP-24</strong></p> <p><strong>Abstract Title: </strong>A review on the medicinal plants with adverse effects on <em>Shukradhatu</em></p> <p><strong>Author’s name: </strong>Niral Sojeetra<sup>1</sup>, R. N. Acharya<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Ph.D. scholar, <sup>2</sup>Professor &amp; Head, Department of Dravyaguna, IPGT&amp;RA, Jamnagar, Gujarat, India</p> <p><strong>Background: </strong>Among the eight branches of <em>Ayurveda, vajikarana deals with drugs&nbsp; </em>&nbsp;for obtaining a healthy progeny. Simultaneously one can trace the references about <em>Avrishya Dravyas </em>which interfere in the production of <em>shukra, in various classical texts. </em>&nbsp;A single hand information on these plants is lacking. To review adverse effect of certain drugs on <em>Shukradhatu </em>described in <em>Samhita</em> and <em>Nighantus</em></p> <p><strong>Methods: </strong>Possible adverse effects of medicinal plants on <em>Shukradhatu </em>documented in 4 <em>Samhita </em>and 7 <em>Nighantu </em>were critically analysed<em>. </em>Plants, which are commonly use in Ayurvedic Pharmacopoeia, either as a drug or used as diet, and reported for their antifertility activity in male were searched from various books and web based search engines. The reported information were analysed and possible correlation were made based upon the on concept of Pharmacovigilance of current science.</p> <p><strong>Results: </strong>Study reports, twenty two plants for their adverse effects related to male reproductive system. Among them, 6 drugs (<em>Dhanyaka, Shigru</em> etc.) are having <em>Avrishya</em> effect, 12 drugs (<em>Yavani, Shatapushpa</em> etc.) are <em>Shukrahrit, </em>2 drugs are<em> shukranashaka </em>and 2 drugs are<em> pumstvakaraka.</em></p> <p><strong>Conclusion: </strong>The observation of the present review may be helpful in preventing the possible adverse effect of these drugs on <em>Shukradhatu.</em></p> <p><strong>Keywords: </strong>Ayurveda, Dravyaguna, Drug safety, Medicinal plant, Male infertility</p> <p><strong>Abstract No. Ap-26</strong></p> <p><strong>Abstract Title: </strong>Contribution of Bhaishajya-ratnavali towards recommending four commonly used vegetable as <em>Apathya: </em>A review</p> <p><strong>Author’s name: </strong>Kajal Radadiya*, Rabinarayan Acharya**</p> <p><strong>Author’s affiliation: </strong>*MD Scholar, ** Professor and Head, Department of <em>dravyaguna</em>, IPGT &amp; RA, Gujarat Ayurved university, Jamnagar, Gujarat, India</p> <p><strong>Background: </strong>Diet plays an important role in the pathophysiology of many&nbsp; diseases. Ayurveda records these dietary items as <em>Apathya</em> and categorizes them into <em>Annavarga </em>(rice and cereals), <em>Phalavarga (fruits), Shakavarga (vegetable)</em>. Different classical texts recorded these plants under various group and highlighted theirs properties and actions. To review and analyze role of classical vegetables mentioned in <em>Bhaishajya-ratnavali</em> a compendium of 18<sup>th</sup> century<em>.</em></p> <p><strong>Methods: </strong>In the present review, plants described under <em>shaka-varga&nbsp; </em>indicated as <em>Apathya</em> in different disease condition were compiled from <em>Bhaishajyaratnavali</em>.</p> <p><strong>Results: </strong>Bhaishajya-ratnavali records 104 <em>aharadravya</em>, among them, 42 are vegetables. It is observed that four vegetables <em>Kalay</em>, <em>Sarsapa</em>, <em>Tumbi</em> and <em>Upodika</em> are commonly used.&nbsp; These drugs are mentioned as <em>Apathya</em> in 14 different diseases.</p> <p><strong>Conclusion: </strong>The observed results may be helpful in planning further scientific studies to establish a evidence based research on 4 vegetables are indicated as <em>Apathya</em> in 14 different diseases.&nbsp;</p> <p><strong>Keywords: </strong><em>Apathya</em>, <em>Shakavarga</em></p> <p><strong>Abstract No. AP-27</strong></p> <p><strong>Abstract Title: </strong>Contribution of <em>Bhaisajya Ratnavali</em> towards three commonly used pulses as <em>Apathya</em>:&nbsp; a review</p> <p><strong>Author’s name: </strong>Puspalata Panda* Rabinarayan Acharya**</p> <p><strong>Author’s affiliation: </strong>M.D.Scholar* Professor&amp;Head** Department of dravyaguna, IPGT&amp;RA, Jamnagar, GAU</p> <p><strong>Background: </strong>The goal of Ayurveda is to maintain health of healthy individual and prevent diseases of diseased person<em>. Pathya</em> <em>Ahar</em> a (wholesome diet) is considered as one of the important factor in maintaining the optimum health whereas <em>Apathya </em>(Unwholesome diet) causes of various diseases<em>.</em> Among the different dietary articles, Pulses have been described under the <em>Shimbidhanya</em> in Ayurveda. In classical texts of Ayurveda, different vegetables have been mentioned as <em>Apathya</em> (Unwholesome diet), which are the cause (<em>Nidana</em>) of various diseased condition. The present review focuses on the role of <em>Masha, Nishpava, kulatha</em> commonly used pulses (<em>Shimbidhanya</em>) as <em>Apathya</em> in causing of various disease. The present review focuses on the role of Three leafy Pulses i.e <em>Masha, Nispabha, Kulatha,</em> as <em>Apathya</em>&nbsp; in various diseases.</p> <p><strong>Methods: </strong>Pulses described under the group of <em>shimbidhanya varga</em>, Contraindicated as <em>pathya,</em> in various diseases were compiled from <em>Bhaisajya ratnavali</em>.</p> <p><strong>Results: </strong>Analysis of compiled results show that, among 104 <em>Shaka</em> (vegetables), 10 are categorised as Pulses, Contraindicated as <em>Pathya</em> in various diseases. Among these,<em> Masha, Nispabha, Kulatha</em> are frequently used and found contraindicated in more than 19 disease conditions. Majority of the Pulses contraindicated in 8&nbsp; <em>srotas</em> like <em>Pranavaha-hikka, Arnnavaha-grahani, Udakavaha- trishna, Rasavaha - Jwara, Raktavaha -kustha,&nbsp; Medavaha-medaroga, Mutravaha-mutraghata, Purishavaha-atisara</em></p> <p><strong>Conclusion: </strong>The observed results may be helpful in planning further scientific studies to establish an evidence based research on 10 Pulses (<em>Shimbidhanya</em>) contraindicated as pathya in 19 diseases related to 8 <em>Srotas</em>.</p> <p><strong>Keywords: </strong><em>Apthya</em>, Unwholesome diet, disease, <em>Shimbidhanya</em> <em>varga</em>.</p> <p><strong>Abstract No. Ap-28</strong></p> <p><strong>Abstract Title: </strong>Challenges in implementing Pharmacovigilance Programme for ASU &amp; H drugs</p> <p><strong>Author’s name: </strong>Haseena K <sup>1</sup>, N Manojkumar<sup>2</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup>Program Assistant, <sup>2</sup>Professor &amp; HOD Dravyaguna, Program Co-ordinator, Peripheral Pharmacovigilance Centre, VPSV Ayurveda College Kottakkal, Kerala</p> <p><strong>Background: </strong>Pharmacovigilance deals with the Adverse Drug Reaction or any Drug related issues. Identification and reporting of Adverse Drug Reaction/ Adverse events and analysis of its consequences have a positive impact on the public health. Implementation of Pharmacovigilance programme for ASU &amp; H drugs is not an easy task; it has come across with many challenges and barriers. This article highlights the challenges faced during the implementation of Pharmacovigilance Program for ASU &amp; H drugs at Peripheral center.</p> <p><strong>Methods: </strong>It is an explorative study, wherein personal interviews of health care professionals and peer reviewed journals were collected and evaluated. Already published articles and books were also referred for compilation and interpretation of results.</p> <p><strong>Results: </strong>With the span of one year, the centre identifies certain obstacles like signal detection and reporting, collection of the details of the suspected drug, drug regulation etc</p> <p><strong>Conclusion: </strong>Lack of awareness of ADR reporting among the healthcare professionals is considered as the major problem in implementing the programme. Hence certain considerations are made like Improvement in knowledge of Pharmacovigilance, communication with all sectors of health care system, patient education etc which will definitely help in implementing Pharmacovigilance programme.</p> <p><strong>Keywords: </strong>Adverse drug reaction, ASU &amp; H Drugs, challenges, considerations, implementation, Pharmacovigilance programme</p> <p><strong>Abstract No. AP-29</strong></p> <p><strong>Abstract Title: </strong>Exploring issues of Pharmacovigilance concerns in <em>Panchakarma</em></p> <p><strong>Author’s name: </strong>*Dr. Praveen Kumar K S, **Prof. Dr. Anup Thakar</p> <p><strong>Author’s affiliation: </strong>*PhD Scholar, Dept of Panchakarma, IPGT&amp;RA, Jamnagar, **Director and HOD, Dept of Panchakarma, IPGT&amp;RA, Jamnagar</p> <p><strong>Background: </strong>Ayurveda as treatment system have been in existence since centuries, and <em>Panchakarma</em> which is one of its main arsenals is often overlooked upon from the pharmacovigilance point of view. The procedure always goes parallel with drugs which is an area coming under Pharmacovigilance.</p> <p><strong>Methods: </strong>Classical text books having references related to Pharmacovigilance, published articles in peer-reviewed journals, published books and subject-related material available online have been thoroughly screened, compiled, organized and described in a systematic manner.</p> <p><strong>Results: </strong>The quality of drugs is a different aspect but when we consider that the drugs supplied for procedures are often not of good quality or are adulterated, then are chances of ADR being observed by the doctor. The body constitution of any patient can also make him react adversely to any particular drug like <em>vacha, yastimadhu</em> etc. Procedural safety is another issue where there are chances of adverse reactions. There are reports of duodenal ulcerations and rectal prolapse developed because of <em>asthapana basti</em>. A study in an Ayurvedic teaching hospital showed that Panchakarma produced the highest number of adverse reactions (44.23%) than other factors. Ecopharmacovigilance is also a new aspect which is very much applied here and need to be explored.</p> <p><strong>Conclusion: </strong>Panchakarma is a section where there are many chances of adverse reactions and are often disregarded upon due to the negligence or lack of expertise with the medical fraternity. Proper awareness and training for the same will help in its resolution.</p> <p><strong>Abstract No. AP-30</strong></p> <p><strong>Abstract Title: </strong>A review on toxicity studies carried on <em>Devasunda</em> (<em>Pittosporum floribundum</em> Wt. &amp; Arn.), A Promising Ethno medicinal Plant from Orissa.</p> <p><strong>Author’s name: </strong>Kishangiri Gunsai *, Rabinarayan Acharya**</p> <p><strong>Author’s affiliation: </strong>*Ph.D. scholar, ** Professor &amp; Head Department of Dravyaguna, IPGT&amp;RA, Jamnagar, Gujarat, India</p> <p><strong>Background: </strong><em>Pittosporum floribundum </em>Wt. &amp; Arn. (Pittosporaceae) is known as ‘<em>Devasunda’</em> in Orissa. In Ayurveda system high doses of bark acts as narcotic, used as antidote to snake poison and used in curing asthma, arthritis, inflammation. To review Acute and Subacute toxicity studies on plant <em>Devasunda</em> (<em>Pittosporum floribundum)</em> for Pharmacovigilance aspect.&nbsp;&nbsp;</p> <p><strong>Methods: </strong>Research papers published on acute and sub-acute toxicity and also on other aspects for pharmacovigilance aspects for the plant <em>Devasunda</em>, (<em>P.floribundum</em>) as on available public domains has been reviewed for this study.</p> <p><strong>Results: </strong>Acute Toxicity: The stem bark aqueous extracts showed high toxic effects showing LD 50 at 1337.5 mg/kg b.wt with at the log dose of 3.126 and the probit values 5.13.The ethanol and methanol extracts showed LD50 at 1843.6 mg/kg b.wt with log dose 3.265 mg/kg b.wt, the probit value 5.13. Toxicity was observed with aqueous extracts until the death of all (100%) animals at 1800 mg/kg b.wt and with the methanol and alcohol extracts at 2500mg/kg b.wt.</p> <p>Sub-Acute Toxicity: The drug <em>P.floribundum </em>bark extracts may be recommended at sub-acute doses between 10 mg to 75 mg/kg b.wt. The drug may be recommended as sub lethal dose with respect to the LD50 value of aqueous extracts as 134 mg/kg b.wt and 184 mg/kg b.wt as per the OECD guidelines of 1/10 dose to that of respective LD50 values.</p> <p><strong>Conclusion: </strong><em>P. floribundum</em> bark extracts also used as anti-inflammatory drug by the herbalist may also recommended at lower doses between 10 -75 mg/Kg. b.wt to reduce the inflammation, arthritis without causing damage to the organels. The <strong>anesthetic effect</strong> for about 30-45 minutes at lower doses also recommended as <strong>analgesic and sedative</strong> drug.</p> <p><strong>Keywords: </strong><em>Pittosporum</em> <em>Floribundum</em>, Devasunda, Acute Toxicity, Subacute toxicity, ethnomedicine</p> <p><strong>Acknowledgements: </strong>K. Naga Malleswari , N. Yasodamma and C. Alekhya, Department of Botany, Sri Venkateswara University, Tirupati.</p> <p><strong>Abstract No. AP-31</strong></p> <p><strong>Abstract Title: </strong>Impact of pharmaceuticals on various environmental entities</p> <p><strong>Author’s Name: </strong>Dr. Revati Bhat, Dr. Mayuri Dhok, Dr. Jayashree Changade, Dr. Nilima Ghangale, Dr. Abhijeet Shirkande</p> <p><strong>Author’s affiliation: </strong>Dravyaguna Department, Dr. D.Y. Patil College of Ayurveda and Research Centre, Pimpri.</p> <p>Conceptual study of the adverse effects of pharmaceuticals both on- the environment&nbsp;and on humans through indirect non-therapeutic exposure.</p> <p>Environmental pharmacovigilance is described as monitoring of the adverse effects of pharmaceuticals both on- the environment&nbsp;and on humans through indirect non-therapeutic exposure. Pharmaceuticals are described as potent group of chemical substances that bear biological effects at low concentrations</p> <p>According to Ayurveda, every living being is made from the five basic elements:&nbsp; Pruthvi, Agni Aap, Aakash and Vayu. Like the law “<em>Pindi te Brahmandi</em>”, these elements make up the environment too.&nbsp; As the various pharmaceuticals affect the human body, they affect these elements.&nbsp; Most of the times, the pharmaceuticals directly or through their process of preparation, cause pollution and contamination of these elements and which then affects the food and public health.</p> <p>Simple things like disposal of Ayurvedic medicines containing Mercury, Lead, Arsenic etc., disposal of industrial waste produced by pharmacies into air and sewage, pollute the air, water, and soil therefore directly affecting plants, marine life and thus human food.</p> <p>Hence, there is a need for preparation of a proper disposal channels for pharmaceuticals and their waste</p> <p><strong>Conclusion: </strong>The pharmacies and pharmaceuticals are therefore affecting the environment and human beings indirectly in addition to their direct therapeutic effects.</p> <p><strong>Abstract No. UP-01</strong></p> <p><strong>Abstract Title: </strong>Challenges in Monitoring the Safety of Unani Medicines</p> <p><strong>Author’s name: </strong>Dr Rabia Malik<sup>1*</sup>, Mohd Aleemuddin Quamri<sup>2</sup>, Muzaffar Din Ahmad Bhat<sup>3</sup></p> <p><strong>Author’s affiliation: </strong><sup>1</sup> Program Associate<strong>, </strong>Intermediary Pharmacovigilance Centre for Unani Drugs (IPvCC), National Institute of Unani Medicine, Bengaluru-91<strong>, </strong><sup>2</sup> Reader, Department of Moalajat National Institute of Unani Medicine, and Coordinator, Intermediary Pharmacovigilance Centre for Unani Drugs (IPvCC) National Institute of Unani Medicine, Bengaluru-91<strong>, </strong><sup>3</sup> Lecturer, Department of Moalajat, National Institute of Unani Medicine, Bengaluru-91</p> <p>Pharmacovigilance (PV) is related to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. &nbsp;WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Safety is a fundamental principle in the provision of herbal medicines and herbal products for health care, and a critical component of quality control. Unani medicine is an ancient system of medicine originated from Greece. It is more commonly practiced in Indian Subcontinent and has an age-old concept and principles of drug management.&nbsp;It has drugs from natural identity and source. Adverse drug reaction from Unani system of medicine are least reported. Many drugs are prepared and marketed without any safety requirements. Drugs like Habbe shifa have shown that Unani drugs may be associated with ADRs. The current challenges in Pharmacovigilance of Unani medicines includes drug safety problems, lack of quality control, lack of information about the mechanisms of action. Interactions between herbs and drugs may increase or decrease the pharmacological or toxicological effects of either component. Synergistic therapeutic effects may complicate the dosing of long-term medication. Monitoring the safety of Unani medicines have to go a long way so the common people may be advised to take the medicine with care. This paper will deliberate on the challenges in the safety of Unani medicine.</p> <p><strong>Keywords: </strong>Pharmacovigilance; Unani System of Medicine; Adverse drug reaction; Safety of Unani Medicine</p> <p><strong>Abstract No. SP-01</strong></p> <p><strong>Abstract Title: </strong>Implementation of pharmacovigilance in siddha medicine and practical challenges</p> <p><strong>Author’s name: </strong>Dhanalakshmi G<sup>1*</sup> Shankar S<sup>2*</sup></p> <p><strong>Author’s affiliation: </strong>Programme Assistant, Peripheral Pharmacovigilance centre, Govt. Siddha Medical College, Chennai-106, 2. Co-ordinator, Peripheral Pharmacovigilance centre, Govt. Siddha Medical College, Chennai-106</p> <p>Siddha system of medicine was practiced from pre Vedic era and time immemorial. According to Siddha principles, the nature that causes diseases and it is again nature that offers their cure. After thalidomide disaster the Western medical world aware about the importance of Pharmacovgilance while practicing modern medicines. Not only for modern medicine but Pharmacovigilance is important for any other system of medicines. World Health Organization recently widened its concerns in Pharmacovigilance to include Herbals and traditional medicines. While implementing Pharmacovigilance program in Siddha medicine, So many things has to include when recording Adverse Drug Reactions, the lacking of proper pharmacological studies, pharmacokinetic and dynamics also. The current models of Pharmacovigilance and its tools have been developing in relation to synthetic drugs, safety monitoring of Siddha medicine is improved by modifying existing methodology for safety profiles of Siddha drugs. In this article deals the briefs of challenges faced in Siddha Medicine while implementing Pharmacovigilance Programme.</p> <p><strong>Keywords: </strong>Pharmacovigilance, Siddha Medicine, challenges&nbsp;&nbsp;</p> <p><strong>Abstract No. SP-02</strong></p> <p><strong>Abstract Title: </strong>Effect of <em>Keezhanelli thylam</em> oil bath in the management of Kudiveri noi (chronic alcoholism)</p> <p><strong>Author’s name: </strong><em>A.Vasanth Milton raj <sup>1</sup></em>, S.Vanathi<sup>2</sup></p> <p><strong>Author’s affiliation: </strong>1. Assistant medical officer, Govt. Hospital,&nbsp; Bathlagundu. Tamil nadu.</p> <ol start="2"> <li>Project Assistant, PPvC, Govt. HQ Hospital, Dindigul. Tamil nadu.</li> </ol> <p><strong>Background: </strong>Siddha system is an ancient medical system on par with the Ayurvedic system and mainly practiced in south India. As per World health organization (ICD-10), Alcoholism is characterized by&nbsp;&nbsp; Intoxication, harmful use, alcoholic dependence, Withdrawal symptom&nbsp;&nbsp; and psychotic disorders.&nbsp; According to Siddha text, it can be correlated with Kudiveri noi. Despite great progress made in the past two decades, the development of low-toxicity and high efficiency medicines remains a challenging task for alcohol researchers. Ennai muzhuku is the non-invasive&nbsp;&nbsp; and safer mode of therapy used in <em>Pitham </em>related diseases.&nbsp; Keezhanelli thylam used for oil bath which is indicated to psychiatric diseases coated in <em>Theriyar thyla varuka churukam</em>.</p> <p><strong>Methods: </strong>Patients age between 18-60 yrs of age with classical features of Kudiveri noi from OPD of National Institute of Siddha, Chennai, India were selected for the present work, irrespective of their sex, religion, education, etc. Detailed research profoma was prepared incorporating all the signs and symptoms of disease. Alcohol use disorder identification test (AUDIT) performed before and after treatment.</p> <p><strong>Results: </strong>AUDIT score shows encouraging results of good improvement in 8patients (27%) moderate improvement in 14 patients (46%), mild improvement in 5 patient (17%) and poor improvement in 3 patients (10%) of cases.</p> <p><strong>Conclusion: </strong>From the above results, “Keezhanelli thylam oil bath” is improve the physical and mental and social improvement and also the safer therapy for kudiveri noi patients.</p> <p><strong>Keywords: </strong>Alcoholism, De-addiction, Kudiveri noi, Keezhanilli thylam, Siddha medicine.</p> <p><strong>Abstract No. SP-03</strong></p> <p><strong>Abstract Title: </strong>Mercury toxicity and its earlier footprints in Siddha system of medicine– Analogous to Pharmacovigilance</p> <p><strong>Author’s name: </strong>Kamalasoundaram.P*, Kannan.M,** Sathiyarajeswaran. P***</p> <p><strong>Author’s affiliation: </strong>*Prog Asst, Peripheral Pharmacovigilance Centre, Siddha Central Research Institute, Chennai-106, **Scientist-II,&nbsp;Research Officer (Siddha), Siddha Central Research Institute, Chennai-106, ***Scientist –II, AsstDirector I/c, Siddha Central Research Institute, Chennai-106</p> <p><strong>Background: </strong>According to Siddhas, Mercury is the chief of all elements and ubiquitous. Due to life-threatening toxicity of mercury, it is considered by WHO as one of the top 10 chemicals of major public health concern. Siddhas believe and proved that Mercury can cure most of the incurable diseases, protect the body from different diseases, maintains good health and facilitates to attain the eight folds of <em>Siddhi (Attama Siddhigal</em>). Siddhas take utmost care of Pharmacovigilance concern&nbsp;&nbsp; successfully in pharmaceutics and therapeutics&nbsp;&nbsp; such as collection and selection of raw drugs, purification, SOP’s of formulations, medicinal dosage form, duration of the treatment, choosing of suitable vehicle, and precautions to be taken. Occurrence of ADR is mostly due to errors in above steps. The symptoms and the treatment of ADR caused by mercury and its toxicity is well explained in Siddha literature.</p> <p><strong>Methods: </strong>In mercury, the collection is made by the removal of impurities from the mercurial ore itself, the literature describes impurities and its toxicity (<em>Thodam &amp; Sattai</em>).</p> <p><strong>Results: </strong>The purification (ore dressing) of mercury is the process to detoxify the toxin by chelation and increase the efficacy. The science behind the detoxification of mercury needs to be explored for the betterment of health. Insisting upon the ban on mercury, monitoring and reporting of the adverse reaction and adverse event for the mercurial product should be registered and documented for the successive 2020-02-09T08:15:00+00:00 Copyright (c) 2019 SoPi Editor