Pharmacovigilance System Mandate for Drug Manufacturers

in Ayush July 14, 2019

Periodic Safety Update Report (PSUR) and Post Marketing Surveillance (4th phase of clinical trial) is described in schedule Y of Drugs & Cosmetic Act 1940 and its rules 1945. Now Government of India, Ministry of Health & Family Welfare on 8th March 2016 published a Gazette Notification under Drugs & Cosmetics Act 1940 and rules 1945 there under included Pharmacovigilance system as a mandate for drugs approved by drug regulatory authorities. The details included in the Gazette Notification G.S.R. 287 (E) are as under:-

Post Marketing Surveillance.-

I) The applicant shall have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drugs manufactured or marketed by the applicant in the country. Ia) The system shall be managed by qualified and trained personnel and the officer in-charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.

Ib) Subsequent to approval of the product, new drug shall be closely monitored for its clinical safety once it is marketed.

Ic) The applicant shall furnish Periodic Safety Update Reports (PSURs) in order to-

(a) Report all relevant new information from appropriate sources;

(b) Relate the data to patient exposure;

(c) Summarise the market authorisation status in different countries and any significant variations related to safety; and

(d) Indicate whether changes shall be made to product information in order to optimise the use of product.”


IPC Symposium on PV for Herbal Medicine

Dr Sunita Vohra makes a presentation on SONAR, giving an insight into need for PV in natural health products

An informative symposium-cum-lecture session on pharmacovigilance for herbal medicines was conducted by NCC-PvPI, IPC, Ghaziabad on November 20, 2017. The programme featured Dr Sunita Vohra, Professor, Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Canada, who made a presentation on “Study of Natural Health Product Adverse Reactions (SONAR)”. She emphasized the need for pharmacovigilance in herbal products which are essentially natural health products, saying pharmacists must be encouraged to report adverse reactions. She also gave an overview of regulations on natural health products in Canada. The symposium was attended by nearly 30 participants, comprising the licensing and regulatory authority, policy-makers, pharma industry, medical practitioners and academia. Dr Rubina Bose, DDC (I), CDSCO, Dr Naresh Sharma, ADC (I), CDSCO, were invited as distinguished speakers. Dr Jai Prakash, Senior PSO, IPC, made a presentation on the role of IPC in promoting quality and safety of herbal drugs. 

The challenges and opportunities in causality assessment of AYUSH drugs were deliberated upon and debated threadbare. The most challenging aspect was reported to be the causality assessment visa-vis the Indian systems of medicine. It was unanimously agreed upon that AYUSH medical colleges be enrolled as Adverse drug reaction Monitoring Centres (AMCs) in a systemic manner so that ADRs from herbal medicines and other traditional Indian systems of medicine can be reported and analysed.