Journal of Pharmacovigilance and Drug Safety

Indian Pharmacopoeia Commission in the Interest of Drugs Safety

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Indian Pharmacopoeia Commission (IPC) is an Autonomous Institution of the Ministry of Health and Family Welfare, Government of India. It is created to set the standards of drugs in the country. Its basic function is to regularly update the standards of drugs commonly used for the treatment of diseases. It publishes official documents for improving Quality of Medicines by way of adding new and updating existing monographs in the form of Indian Pharmacopoeia (IP). It further promotes rational use of generic medicines by publishing National Formulary of India. IP prescribes standards for identity, purity and strength of drugs essentially required from health care perspective of human beings and animals. IPC also provides IP Reference Substances (IPRS) which act as a fingerprint for identification of an article under test and its purity as prescribed in IP. In addition, IPC is the National Coordinating Centre (NCC) for Pharmacovigilance Programme of India (PvPI), Materiovigilance Programme of India (MvPI), Haemovigilance Programme of India (HvPI) and Adverse Events Following Immunization (AEFI). On 30th October 2017, IPC has also become the WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services.

A Study on Patients Drop-Out in Unani Pharmacopeial Validation of An Anti-obesity Drug

2021-08-17T09:34:45+00:00

Background: In the clinical research human subject is never in control of researcher, so the rate of dropout in clinical studies is always a major concern. In herbal clinical research the high rate of dropout is always foremost distress for researcher, prolongs the study duration and adds extra financial burden to the project.

Objective of the study: The objective of this study is to find out the possible reasons of dropout in a validation programme.

Materials and methods: All human subjects were informed in advance about the test drug, dosage form, time of administration, number of follow-up and laboratory investigations. The statements/ reasons of leaving of enrolled subjects in validation study on anti-obesity drug Jawarish Bisbasa were recorded in the case record form. At the end of the study all statements were analyzed.

Results: Total 49 patients were dropouts from the study due to various reasons e.g. indiscipline, social injustice, not effective and bad taste of drug, conception, domestic work etc.

Conclusion: Collectively, dropout rates are higher among middle-income group followed by lower middle-income group. The minimum dropout was observed among the socio-economical weak section. As per the occupation house makers are more dropout in comparison to other groups and on other hand, taste, palatability and slow action of formulation are also among them. It is an attempt to understand and explain the direction for future trial design.

Chymotrypsin (Chymoral Forte) Adverse Drug Event: Diarrhoea in Exclusively Breastfed Neonates

2021-08-17T09:34:46+00:00

A healthy full term newborn delivered by Caesarean Section was seen at two weeks of age with complaints of diarrhoea. He was on exclusive breastfeeding since birth. Mother was receiving enzymes Chymoral and Serratiopeptidase since caesarean ostensibly to ‘speed up ‘wound healing’ and to ‘reduce stitch edema’. The mother was advised to stop the enzymes, drink more water and breast feed more often to increase the breast milk output. Second case was similar. Such drugs should not be prescribed or prescribed only for three to five days, and, not for such a long time.

Pharmacovigilance: Opportunity and Future Career Prospects for Fresh Graduates – A Report

2021-08-17T09:34:46+00:00

In India, surveillance of adverse drug reactions developed when most of the developed and some of the not so developed countries had established monitoring programme. Many of these had formed National Centers and joined hands with WHO collaborating Centre for International Drug Monitoring, being governed through Uppsala Monitoring Centre, Sweden. In 1989, Indian Council of Medical Research (ICMR) for the first time came forward to finance a multicentric ADR monitoring programme involving six medical colleges located at Aligarh, Delhi, Jhansi, Meerut and Vellore. In a span of three years, ADR data from 58,194 patients was collected and reported to ICMR. This programme was later on converted into a task force, wherein the centers were increased from 6 to 12 located at Aligarh, Delhi, Jammu, Bhopal, Baroda, Hyderabad, Vellore, Bangalore, Chennai, Kolkata, Mumbai and Guwahati. Both these multicentric studies were coordinated by Prof. K. C. Singhal.

Drug Safety Alerts issued by Indian Pharmacopoeia Commission, National Coordination Centre-Pharmacovigilance Programme of India (PvPI) from January - June 2021

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The preliminary analysis of Adverse Drug Reactions (ADRs) from the PvPI database reveals that the following suspected drugs are associated with the ADRs reported by PvPI during January to June 2021

Medical Device Safety Alerts issued by Indian Pharmacopoeia Commission, National Coordination Centre-Materiovigilance Programme of India (MvPI) from January - July 2021

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MvPI, IPC sends details of medical device safety alerts to all Medical Device Monitoring Centre (MDMC).