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Post Marketing Surveillance of Drugs

Post marketing surveillance is performed after market approval/clinical trials of drugs in India. The regulatory framework for conducting clinical trials of drugs is provided under the Drugs and Cosmetics Act, 1940 (“Act”) and the Drugs and Cosmetics Rules, 1945 (“Rules”). Further, Part X-A and Schedule Y of the Rules specifically deal with the statutory provisions applicable for clinical trial of drugs in India. Schedule Y divides Clinical trial of drugs into 4 Phases, namely, Human Pharmacology (Phase-I), Therapeutic exploratory trials (Phase-II), Therapeutic confirmatory trials (Phase III) and Post Marketing Trials (Phase-IV).

As per Schedule Y of the Rules, Post Marketing Trials are studies (other than routine surveillance) performed after drug approval and related to the approved indication(s). These trials go beyond the prior demonstration of the drug’s safety, efficacy and dose definition. These trials may not be considered necessary at the time of new drug approval but may be required by the Licensing Authority for optimizing the drug’s use. They may be of any type but should have valid scientific objectives. Phase IV trials include additional drug-drug interaction(s), dose-response or safety studies and trials designed to support use under the approved indication(s), e.g. mortality/morbidity studies, epidemiological studies etc.

The Central Government (Department of Health and Family Welfare) vide its Notification (G.S.R. 287 (E)) dated 8th March, 2016 (“Notification”) in exercise of the powers conferred under section 12 and section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and after consultation with the Drugs Technical Advisory Board, amended the Drugs and Cosmetics Rules, 1945, whereby the term “Post Marketing Surveillance” as appeared in Schedule Y of the Drugs and Cosmetics Rules, 1945 is substituted as follows:

4.      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 drug 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 the product.”

The term Pharmacovigilance may be defined as a continuous post-marketing monitoring system relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. As per the Rules, if it is found by the drugs licensing authority that any part of any batch of the drug is not in conformity to the standards of strength, quality or purity specified in the Rules, the concerned authority may direct the manufacturer to withdraw the remainder of the batch from sale.

Now in order to effect the pharmacovigilance of drugs in India, it is obligatory on the part of applicants (e.g. manufacturers and marketing companies) that they put in place pharmacovigilance system for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant (who applied for market approval of drugs) in India. Further, pharmacovigilance system is required to 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.

Conclusion:

Prior to the Notification, it was obligatory on the part of the applicants that subsequent to approval of the product, new drugs should be closely monitored for their clinical safety once they are marketed. For this purpose, the applicants were required to furnish Periodic Safety Update Reports (PSURs) for a period of four years. However, the Notification has extended the limited scope of post marketing surveillance by including requirements of pharmacovigilance system and appointment of a medical officer to manage the said system.

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