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Govt to frame guidelines for cos to set up pharmacovigilance system

Shardul Nautiyal, Mumbai
Tuesday, March 10, 2015, 08:00 Hrs  [IST]

In order to strengthen the pharmacovigilance system for collection, processing and forwarding of Adverse Drug Reaction reports (ADRs), Government has formed a high level committee to prepare guidelines for manufacturers on the same to effectively monitor drug safety.

Setting up of a pharmacovigilance system was recommended in a recent meeting with officials from the Pharmacy Council of India (PCI) and Indian Council of Medical Research (ICMR). It was suggested that the manufacturer or applicant should have a pharmacovigilance system in place for collection, processing and forwarding of the ADR report.

This, according to official sources, has been done in consideration of the proposal to amend provisions relating to post marketing surveillance under Schedule Y. The said amendment relating to post marketing surveillance will make it mandatory for the applicant to have a pharmacovigilance system for collection of reports of ADRs on the use of the drug.

Schedule Y under para (3) and sub para (4) pertaining to post- marketing surveillance requires that the applicant is to furnish Periodic Safety Update Reports (PSUR) to the Central Drugs Standard Control Organization (CDSCO). However, it does not specify that the applicant should have a pharmacovigilance system in place to monitor the clinical safety of new drugs after it is introduced for marketing in the country. In many countries, it is mandatory for the pharmaceutical company to have such a system in place to monitor drug safety.

The issue was earlier also considered by the Drug Technical Advisory Board (DTAB) in its 60th meeting held on October 10, 2011. It recommended the following clause to be introduced in the para relating to post marketing surveillance which states -"The applicant should have have a pharmacovigilance system in place for collection, processing and forwarding of the ADR report of the licencing authority for information on ADR emerging from the use of the drug manufactured and marketed by the applicant in the country. The system should be managed by qualified and trained personnel. The officer-in-charge of collection and processing of data shall be a medical officer trained in analysis of ADRs."

DTAB after deliberations recommended that the person-in-charge should be a medical officer or a pharmacist trained in collection and analysis of ADRs. Drugs Technical Advisory Board is the highest decision making body under the Union health ministry on technical matters.

CDSCO is vested with the powers to approve new drugs and clinical trials in the country. It also lays down the standards for drugs, controls the quality of imported drugs, coordinates with state drug control organisations and provides expert advice to bring  about uniformity in the enforcement of the Drugs and Cosmetics Act, 1940 and Rules 1945.


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