Abstracts

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Abstract

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Abstract Title: Medical Vigilance Programmes

Author Name: Dr Anupama Sukhlecha

Author’s affiliation: M P Shah Govt. Medical College, Jamnagar

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:

Pharmacovigilance of herbal medicines:

The use of herbs as 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.

Hemovigilance Program of India (HvPI):

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.

Vaccine vigilance:

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:

  • Vaccine Adverse Event Safety Reporting forms (VAERS)
  • CIOMS form for vaccine reporting-Vaccine XML for submissions to VigiFlow-Global database (as per CDSCO office order of May 2015)

Materio-vigilance Programme of India (MvPI):

This modern concept of monitoring and safety of medical devices is known materiovigilance. Medical devices could range from simple devices such as tongue depressors and thermometers to advanced devices such as 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.

Cosmetovigilance:

It is the ongoing and systematic monitoring of the safety of cosmetics 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.

Ecopharmacovigilance (EPV):

Introduced in 2006 by Dr S Z Rahman (as Pharmacoenvironmentology)

Activities of EPV include:

  • Increasing the availability of environmental data on medicinal products
  • Tracking emerging data on environmental exposure, effects and risks after product launch
  • Using environmental risk management plans to manage risk throughout a drug's life cycle
  • Following risk identification, promoting further research and environmental monitoring

Promoting a global perspective on EPV issues

 

 

Abstract Title: Indonesian Traditional Herbal Medicine (Jamu) for High Cholesterol Problems

Author Name: Swandari Paramita*1,2

Author’s affiliation: 1Department of Community Medicine, Faculty of Medicine, Mulawarman University, Samarinda, East Kalimantan, 75119, Indonesia

2Research Center for Medicine and Cosmetic from Tropical Rainforest Resources, Mulawarman University, Samarinda, East Kalimantan, 75119, Indonesia

Background: 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 jamu. Scientific jamu 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.

Methods: The ingredients consist of main and additional components.

Results: 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 jamu for hypercholesterolemia are Chinese teak leaves (Senna alexandrina Mill.); Dutch teak leaves (Guazuma ulmifolia Lam.);

tempuyung herbs (Sonchus arvensis L.); and green tea herbs (Camellia sinensis (L.) Kuntze). Medicinal plants in the additional components of scientific jamu for hypercholesterolemia are temulawak (Curcuma xanthorrhiza Roxb.); turmeric (Curcuma longa L.); and meniran herbs (Phyllanthus niruri L.).

Conclusions:

Keywords: Indonesian traditional medicine, high cholesterol, jamu

 

Abstract Title: Traditional Medicines and Off-label Usage in Elderly: Can We Really be Pharmacovigilant Enough?

Author Name: Ashok Kumar Dubey

Author’s affiliation:

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.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.  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.

ORAL PRESNTATION

Abstract No.  AO-01

Abstract Title: Moringa oleifera lam. enriched biscuits induced adverse drug reaction- a case report

Author’s Name: Meena Shamrao Deogade1, Vishakha Kumbhare2, Anita Wanjari3, Shilpa Gaidhane4

Author’s affiliation: 1Professor & Head of Dravyaguna vigyan, 3Professor & Head of Rasashastra-Bhaishjya Kalpana, 4Professor Medicine, Mahatma Gandhi Ayurved College Hospital and Research Centre, Wardha (M.S.)

2Scientist- E, Forest Research centre for skill development Chhindawada (M.P.)

4Jawaharlal Neharu Medical College, sawangi (M), Wardha (M.S.)

Background: Moringa oleifera 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.

Methods: 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.  Moringa oleifera enriched biscuits were given in a dose two biscuits twice daily since 7 September 2019.  She has reported after 5 days i.e. on 12 September 2019 with the complaint of red rash over back and arm.  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

Results: After Ayurveda medication within 12 hours she got relief from itching and red rash disappeared gradually.

Conclusion: 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.

Keywords: Moringa oliefera, Shigru, Adverse drug reaction, Pharmacovigilance, Shatadhauta Ghruta, Laghusutashekhara Rasa, Avipattikara churna

Abstract No. AO-02

Abstract Title: Analytical study of Brahmi (Bacopa monnieri Linn.) accession with special reference to its quality control pertaining to pharmacovigilance

Author’s Name: Dr. Priyanka Wate*1, Dr. Pramod Khobragade2

Author’s affiliation: *1Assistant Professor, Dept. of Dravyaguna vigyana, M S Ayurvedic Medical College, Gondia, 2 Professor & Head of department, Dept. of Dravyaguna vigyana, DMAMCH & RC, Nagpur

Background: Brahmi (Bacopa monnieri Linn.) is a renowned medicinal plant globally used for enhancing memory and intellect. Due to unorganized harvesting & trading, lack of Good Agricultural & Collection Practices, its substitute drug Mandukaparni is routinely used though it has different action. Due to sub-standard raw material, finished products exhibit ADR issues. Hence, study on Brahmi accessions in three seasons of year, planted at different locations was carried out with emphasis on quality control & pharmacovigilance. The aim of this analytical study was to evaluate Brahmi accession with special reference to quality control.

Methods: Methanolic extract of wild and cultivated accession of Brahmi collected in summer, rainy & winter season of year 2016 was subjected to HPLC. Quantification of Bacoside A was done using standard marker compound.

Results: Minimum percentage of Bacoside A was seen in winter, moderate in summer & maximum in rainy season. Quantity of Bacoside A was higher in cultivated sample as compared to wild sample. Moderate humidity, high temperature & average rain fall in rainy season are suitable for production of quality raw material of Brahmi. 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.

Conclusion: Sub-standard herbal products due to spurious raw material can affect clinical outcome along with ADR issues.  Above analytical research work on Brahmi would help to enlighten about Good Agricultural & Collection Practices with minimum ADR issues.

Keywords: Brahmi, Pharmacovigilance, Quality control

Abstract No. AO-03

Abstract Title: Safety study of Shodhita (Processed) Bhanga (Cannabis sativa L.) leaves in established animal experimental models

Author’s Name: Swagata Tavhare1, Mukesh Nariya2, Rabinarayan Acharya3

Author’s affiliation: 1 Assistant professor, Department of Dravyaguna, GJP-IASR, New VV Nagar, Anand, Gujarat, 2. Professor & Head, Pharmacology lab, 3. Department of Dravyaguna, IPGT & RA, Gujarat Ayurved University, Jamnagar

Background: ‘Safety’ is one of the prime fundamental principle and critical component of quality control. Bhanga (Cannabis) is known for its wide ranging pharmacological actions. Ayurveda, to reduce intoxicant (Madakari) effect, recommends its use after certain processing known as Shodhana. To evaluate the safety of Jalaprakshalana Shodhita Bhanga (Water-wash processed Cannabis) through acute toxicity and gross behaviour study.

Methods: Acute toxicity and gross behaviour study was conducted following OECD guideline 425 (modified, adopted 23rd March 2006) in female wistar strain albino rats weighing 160 ± 20 g. Test drug (Fine powder water-wash processed Cannabis sativa 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.

Results: At various studied dose levels significant gross behavioral changes were found with mortality of 33.33% at limit dose i.e. 2000 mg/kg.

Conclusion: Jalaprakshalana Shodhita Bhanga leaves powder administered orally is found safe from 22.5mg/kg to 400mg/kg animal dose in studied animal experimental model.

Keywords: Bhanga, Cannabis, Shodhana, Acute toxicity, Gross behaviour, Safety

Abstract No. AO-05

Abstract Title: Pharmacovigilance for safer use of drugs in Ayurveda through experimental study

Author’s Name: Dr. Nilima Narayan Rao Wadnerwa

Author’s affiliation:  Asso. Prof., MGACH & RC, Salod, Wardha, Maharashtra

Background: 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 Rasamanikya which is a very popular medicine used for various ailments.

Methods: 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.

Results: 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.

Conclusion: 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.

Keywords: Pharmacovigilance, Heavy metal toxicity, Rasamanikya, Chronic Arsenic toxicity

Abstract No. AO-06

Abstract Title: Pharmacovigilance in Ayurveda – Where are we and way to go ahead

Author’s Name: Dr. Shubhashree M.N.1, Dr. Raghavendra Naik2, Dr. Sunona George3, Dr.B.K. Bharali4

Author’s affiliation: 1. Research Officer (S-2), 2. Research Officer (Ayu), 3. Programme Assistant, National Pharmacovigilance   Programme, Asst. Director Incharge, Regional Ayurveda Research Institute for Metabolic disorders (RARIMD), Bangalore.

Background: 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.

Methods: 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

Results: 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  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.

Conclusion:

Keywords: Pharmacovigilance, AYUSH, Ayushsuraksha

Abstract No. AO- 07

Abstract Title: Preclinical safety studies of Rasamanikya, an Ayurvedic Arsenical Formulation in Rats

Author’s Name: Vikas Kumar1, Shivanand Biradar2, Galib R3, B. J. Patgiri4

Author’s affiliation: 1. Ph.D Scholar, Dept. of RSBK, IPGT & 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 & RA, GAU, Jamnagar

Background: 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 Rasamanikya through acute and chronic toxicity studies.

Methods: Rasamanikya 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.

Results: In acute toxicity, Rasamanikya at the dose of 2000 mg/kg did not produce any observable toxic effects or mortality. Safety of Rasamanikya 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.

Conclusion: Based on these observations, it can be concluded that Rasamanikya is safe at therapeutic dose levels when used judiciously along with specified adjuvants.

Keywords: Arsenic, Haratala, Rasamanikya, safety, Shodhana, toxicity

Abstract No. AO- 08

Abstract Title: The role of adjuvant as bio-enhancer in Ayurveda drug safety and its Pharmacovigilance overview.

Author’s Name: Aniket Kamble1*, 2Shraddha Dhundi, 3Swapnil Chowdhary, 4B. J. Patgiri

Author’s affiliation: 1.* MD scholar, 2 Ayurvedic Physician 3. Assistant professor, 4. Pofessor, Department of Rasa Shastra and bhaishajya kalpana, IPGT & RA, Jamnagar.

Background: 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. Anupana/sahapana 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.

Methods: In-vivo acute and chronic toxicity study was carried out on test drug Makardhwaja and attempt was made to study its effect on ponderal and different bio-chemical parameter with and without adjuvant.

Results: 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.

Conclusion: This study provide sufficient data for establishing the safety when used along with Sahapana/Anupana. Hence, it can be taken in practices for improving the understanding drug safety issues during the drug development and it’s post-approval.

Abstract No. AO-09

Abstract Title: Acute and Chronic Toxicity of Rasa Parpati in Charles Foster Albino Rats

Author’s Name: Jigisha patel1, Ankesh Agrawal2, Galib3, B. J. Patgiri4

Author’s affiliation: 1. PhD Scholar, 4. HOD, RSBK Dept, IPGT & RA, Jamnagar, 2. Medical Officer, 3. Associate Professor, RSBK Dept, AIIA, Delhi

Background: Rasa parpati 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 Shodhana on safety aspects of Rasa parpati through acute and chronic toxicity of Rasa parpati that was prepared by two different samples of raw materials. One by using Hingulottha parada and Shuddha gandhaka (HRP) while, another with Ashuddha parada and Ashuddha gandhaka (ARP).

Methods: 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.

Results: 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.

Conclusion: It is concluded that HRP was found to be safer than ARP at different dose levels suggesting safely use at therapeutic dose level.

Keywords: Ayurveda, Mercury, Parada, Rasa Parpati, Safety, Toxicity

Abstract No. AO-10

Abstract Title: Acute and subchronic toxicity study of Gomutra (Cow urine) Shodhita (processed) Bakuchi  (Psoralea corylifolia Linn.) seeds powder

Author’s Name: Jigyasa Pathak1*, Mukesh B.Nariya2*, Rabinarayan Acharya3*

Author’s affiliation: *Ph.D Scholar, Dept. of Dravyaguna, **Head, Dept of Pharmacology, ***Professor & Head, Dept. of Dravyaguna, I.P.G.T. & R.A., Gujarat Ayurved University, Jamnagar, Gujarat, India.

Background: Bakuchi is frequently administered, for a long duration, in the treatment of Switra. Present study has been designed to ascertain the role of Shodhana on safety profile of Gomutra (cow urine) Shodhita (processed) Bakuchi seed powder, through acute oral toxicity and sub-chronic toxicity in rats.

Methods: Bakuchi, a known corrosive drug, was processed with Gomutra (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.

Results: 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.

Conclusion: The observed effect of the Bakuchi 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.

Keywords: Acute toxicity, Bakuchi, Psoralea corylifolia L., Shodhana, Subchronic toxicity

Abstract No. AO- 11

Abstract Title: Pharmacovigilance concerns of Tamra Bhasma (Incinerated Copper) and its formulations –Facts

Author’s Name: Swapnil Chaudhari* BJ Patgiri**

Author’s affiliation: * Assistant Professor, ** Professor  & Head, Dept of RS&BK, IPGT&RA, Jamnagar

Background: Tamra Bhasma (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, Bhasma 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 Tamra Bhasma and its formulations from different databases and provide brief information on their safety and toxicity aspects.

Methods: Available published reports on safety of Tamra Bhasma and its formulations from different databases are screened and compiled to provide brief information on their safety and toxicity aspects.

Results: Published reports on Tamra Bhasma, Hridayrnava Rasa, Arogyavardhini Rasa and Garbha Chintamani Rasa 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.

Conclusion: Tamra Bhasma 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.

Keywords: Heavy Metal, Pharmacovigilance, Safety, Tamra Bhasma and Toxicity

Abstract No. AO-12

Abstract Title: Assessment of safety of Tankanodaka Shodhita (borax water processed) Vatsanabha (Aconitum ferox Wall.) through acute toxicity study.

Author’s Name: Mital Buha*, Mukesh Nariya**, Rabinarayan Acharya***

Author’s affiliation: *Ph.D. scholar, **Professor & Head Department of pharmacology *** Professor & Head Department of Dravyaguna, IPGT&RA, Jamnagar, Gujarat, India

Background: Vatsanabha (Aconitum ferox Wall.), 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   Shodhana (processing) with media like Gomutra, Triphala kwatha, Godugdha and Tankanodaka etc. Present study reports the effect of Tankanodaka Shodhita vatsanabha through acute toxicity city in experimental animals.

Methods: Acute toxicity (14 days) of Shuddha Vatsanabha was assessed by administering 140, 70 and 14 mg/kg of drug suspension in sequential manner. Single dose of drug suspension Tankanodaka Shodhita Vatsanabha root powder was administered once orally to overnight fasted rats.

Results: 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.

Conclusion: 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 Tankanodaka.

Keywords: Aconitum ferox Wall., Acute toxicity, Shodhana

Abstract No. AO-13

Abstract Title: Concerns of Pharmacovigilance and Drug safety in Ayurveda- A Review

Author’s Name: Raghavendra Naik1, Shubhashree M N2, Sunona George3, B K Bharali4

Author’s affiliation: 1Research Officer (Ayu), 2 Research Officer (S-2), 3Programme Assistant, 4Asst. Director Incharge, Regional Ayurveda Research Institute for Metabolic Disorders, CCRAS, Ministry of AYUSH, Bengaluru-560109

Background: Ayurveda is a science which has been serving mankind since time immemorial, currently practiced in India and many countries.  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 (Yukti) 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. 

Methods: In the current review, concepts related to Pharmacovigilance in Ayurveda were reviewed from different available classical texts and presented in a systematic manner.

Results: 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 (Atimatra), drug-diet interaction, drug intolerance, use of unwholesome drugs (Asatmya), idiosyncrasy (Vaidyakrita) etc.

Conclusion: The physician who prescribes the medicine should be vigilant enough to assess all the possible adverse effects and their management in clinical practice.

Keywords: Adverse drug reactions, Ayurveda, Pharmacovigilance, Yukti

Abstract No. AO-14

Abstract Title: Assessment of dermal toxicity of mustard oil based formulation of Nerium indicum

Author’s Name: Vivek Kumar Patel1, R. N. Acharya2

Author’s affiliation: 1Ph.D. scholar, 2Professor & Head, Department of Dravyaguna, IPGT&RA, Jamnagar, Gujarat, India

Background: Nerium indicum (family Apocynaceae) botanical source of Rakta Karavira from the Upavisha (semi-poisonous) category, has been mentioned for various therapeutic indications in the form of internal and external administration.

Methods: Rakta Karavira Taila prepared from the root bark of Rakta Karavira 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.

Results: 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.

Conclusion: Rakta Karavira Taila containing toxic drug Karavira which have potential to produce adverse changes particularly male reproductive system therefore, should not be used for longer duration at higher dose.

Keywords: Acute dermal toxicity, Karavira, Nerium indicum, Rakta Karavira Taila, Sub-acute dermal toxicity.

Abstract No. AO-15

Abstract Title: Acute and Chronic Toxicity studies of Rasasindura, an Ayurvedic Formulation

Author’s Name: Satish Solanki1, Rohit Gokarn2, Swapnil Chaudhari3, Prashant Bedarkar4, BJ Patgiri5

Author’s affiliation: 1PG Scholar, 3Asst Professor, 4 Associate Professor, 5 Professor &Head, Dept of RS&BK, IPGT&RA, Jamnagar, 2 Associate Professor, Swaminarayana College, Kalol, Gujarat

Background: Rasasindura is a unique, Ayurvedic mercurial preparation widely used by practitioners. This work is an attempt to perform acute and chronic oral toxicity evaluation of Rasasindura along with an adjuvant Guduchi Ghana (solidified aqueous extract of Tinospora cordifolia Will.) in rats.

Methods: Oral acute toxicity study of test drug was carried at the limit dose of 2000 mg/kg orally in rats. For chronic toxicity, Rasasindura 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.

Results: 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 Rasasindura, 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.

Conclusion: Hence, it is suggested that the Rasasindura, along with the adjuvant prepared as per the customary method, is safe for consumption at the therapeutic dose level.

Keywords: Ayurveda, Guduchi Ghana, Rasasindura, Safety, Toxicity

Abstract No. AO-16

Abstract Title: Pharmacovigilance for non-metallic, non-poisonous herbal drug

Author’s Name: Dr Sunitha M P

Author’s affiliation: Associate Professor,

Dept Of Dravyaguna Vignana, SAMC & H, Bangalore

Background: 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.

Methods: 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.

Results: Knowledge of Aushadha dravya with respect to its Nama (Nomenclature, Identification), Rupa (Morphology), Guna (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 Dravya Sangraha explained in Dravyaguna Shastra it will become the root cause for anthropogenic contamination, thus leading to ADRs. The Dravya – Pareeksha vidhi explained by Acharya Charaka in Vimanasthana 8th 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.  Application of Paradi Gunas in treatment helps in avoiding the ADRs. 

Conclusion: : 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 Dravya Pareeksha Vidhi, Dravya Sangrahana, and Application of Paradi Guna in Chikitsa. 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.

Abstract No. AO-17

Abstract Title: Pharmacovigilance – Patient Safety in Integrative Cancer Management

Author’s Name: Dr. Harish Babu H

Author’s affiliation: Assistant Professor, Dept of Agada Tantra Evam Vidhi Vaidyaka

Sushrutha Ayurvedic Medical College and Hospital

Prashanti Kuteeram; Jodi Bingipura; Jigani Hobli; Bengaluru

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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

Keywords: Integrative oncology; Ayurveda; cancer; Pharmacovigilance.

Abstract No. AO-18

Abstract Title: Critical review on various Basic principles to prevent ADR in children w.s.r. to Kashyapa Samhita.

Author’s Name: Dr. Sagar M. Bhinde

Author’s affiliation: Asst. Prof., Department of Kaumarbhritya, IPGT&RA, Jamnagar, Gujarat

Background: 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 Kashyapa Samhita, because there is very little description of pediatric specific management in Brihatrayi (three prime Samhitas of Ayurveda i.e. Charaka, Sushruta and Ashtanaga Hridaya) and Laghhutrayi (three authentic compiled books of Ayurveda i.e. Sharangdhara, Madhav Nidana and Bhava Prakasha).

Methods: 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.

Results: Pediatric specific drug dosage is given in Lehadhyaya and Bhaishjopkramaniya. Various basic principles of management are mentioned in Aushadhbheshajendriyadhyaya, Dhupa Kalpadhyaya, Bhaishjopkramaniya, Yush Nirdeshniya and many other chapters, which are unique and most important for prevention of ADR.

Conclusion: Ghee is mentioned as a vehicle for infants younger than 8 month, which is not practiced by majority of Vaidyas and hence could cause harm to the child. Many such basic principles are covered in Kashyapa Samhita 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.

Keywords: ADR in children, Kashyapa Samhita, Kaumarbhritya, Prevention of ADR in Children

Abstract No. AO-19

Abstract Title: The pharmacovigilance concern as mentioned in various chapters of priya nighantu

Author’s Name: Tarun Sharma1*, Rabinarayan Acharya2

Author’s affiliation: Assistant Professor, PG Dept. of Dravyaguna Vigyana, J. S. Ayurveda Mahavidyalaya, Nadiad, Gujarat, India, 2 Professor, PG Dept. of Dravyaguna Vigyana, IPGT & RA, GAU, Jamnagar, Gujarat, India

Background: 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 Nighantus (lexicons) of Dravyaguna. Priya Nighantu, 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 Priya Nighantu.

Methods: The present review is about the possible adverse effects caused by inappropriate administration of some medicinal plants that have been documented by author of Priya Nighantu. The observations have been given in a tabular form consisting of the name of the plant, part used, botanical name, its effect on dosha, dhatu, mala and others.

Results: 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 dosha, dhatu, mala and other possible adverse effects.

Conclusion: After a critical analysis, it is observed that Priya Nighantu has a well-developed idea about adverse effects of drug and diets if not consumed according to classical recommendations.

Keywords: Ayurveda, Dravyaguna, Drug safety, pharmacovigilance, Priya Nighantu

Abstract No. AO-20

Abstract Title: Perspective of Ayurveda on use of medicinal plants to avoid possible risk in Garbhini  

Author’s Name: Rasika Kolhe1*, Vishnu Bavne2Author’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

Background: Garbhini Avastha 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 Rajaswala to Sutika.  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 is not available. To compile and critical analysis the information and data regarding use of herbal medicine and their safety in pregnancy.

Methods: Classical references of medicinal plants contraindicated in Garbhini, and certain fundamental principle from Samhita elucidating the safety aspect of Garbhini and Sutika have been compiled.  Reported data on ADR in pregnancy have been critically analysed and presented systematically.

Results: AardrkaZingiber officinale Roscoe.), Methika (Trigonella foenum greacum L.), Markandika  (Cassia angustifolia Vahl.), Erand (Ricinus communis L.) have been reported with ADR in pregnant woman. In the classical text Haritaki, Rasona, Palandu, Suran etc. are clearly contraindicated, whereas use of hot, spicy, heavy to digest food, Kshara (Alkali preparation), Pulses, Panchakarma regime, etc. are also contraindicated.

Conclusion: Understanding of  fundamental principle of Ayurveda, do’s and don’ts for the use of medicinal plants, Code of conduct and Garbhopaghatakar Bhav depicted in classical text will definitely help to create awareness about prevention of possible adverse effects during pregnancy or the postnatal period.

Keywords: Ayurveda, Garbhini, Safety, Pharmacovigilance

Abstract No. AO-21

Abstract Title: Cytotoxicity evaluation of seed oil of Terminalia bellerica Roxb.using tetrazolium (MTT) assay

Author’s Name: Dr. Neha Gaonkar

Author’s affiliation: final year, YMT Ayurved Medical College, Kharghar, Navi Mumbai, Maharashtra

Background: 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 Terminalia bellerica Roxb using MTT assay.

Methods: 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.

Results & Conclusion: 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 Terminalia bellerica Roxb has been described for premature hair graying in the form of Pratimarsha nasya which consists of 1-2 drops which justifies the toxicity levels above the concentration of 1 mg/ml.

Keywords: MTT assay, seed oil of Terminalia bellerica Roxb.

Abstract No. SO-01

Abstract Title: SiddAR (Siddha Initiative for Documentation of Drug Adverse Reaction): Android Mobile App for AYUSH Pharmacovigilance Programmes: An efficient and easy way of assessing ADR.

Author’s Name: Sathiyarajeswaran P*1, Shree Devi MS2

Author’s affiliation: *1. Director in-charge, Siddha Central Research Institute, CCRS, Chennai., 2. Research Officer(S), Dept of Pharmacy, Siddha Central Research Institute, CCRS, Chennai.

Background: 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.  One area of those applications is healthcare applications. “SiddAR” (Siddha Initiative for Documentation of Drug Adverse Reaction) 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. 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

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.

Results: 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.

Conclusion: “SiddAR” 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.

Keywords: “SiddAR”, Android mobile APP, ADR, Siddha, AYUSH, pharmacovigilance.

Abstract No. SO-02

Abstract Title: Serankottai induced contact dermatitis during Suthi process in Siddha - A case report

Author’s Name: Juliet. L *1         Karthikraja.S.R2    Reena.V.L3, Aarthi.V 4            Sathiya, Rajeshwaran. P5

Author’s affiliation: *1Research Officer (Siddha), Siddha Central Research Institute, Chennai, Tamilnadu, India. 2Research Associate, Siddha Central Research Institute, Chennai, Tamilnadu, India, 3Assistant 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.

Background: 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). Serankottai (Semecarpus anacardium 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 Serankottai and its management through Siddha medicines.

Methods: Reporting of a single case, presented with contact dermatitis- 2 days after the exposure of unprocessed Serankottai during Siddha purification method in Siddha manufacturing unit and the negative rechallenge of the symptoms by Siddha antidotes were discussed.

Results: It is to report that, unprocessed Serankottai induced contact dermatitis has been successfully managed by proper Siddha antidotes like Puli ilai kudineer (Tamarind leaf decoction)-120 ml thrice a day and Sengal podi ottradam (Brick powder Fomentation) twice a day for 1 week as mentioned in Gunapadam mooligai vagupu and Sattam saarndha maruthuvamum nanju maruthuvamum.

Conclusion: 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.

Keywords: ADR, Pharmacovigilance, Semecarpus anacardium-nut, Suthimuraigal

Abstract No. SO-03

Abstract Title: Siddha traditional testing methods to ensure the quality, safe

Published
2020-02-09