India’s drug regulator drafts norms to report adverse effects of vaccines

Given the growing concerns over the covid vaccine and the associated lawsuits, India’s Central Drugs Standard Control Organization (CDSCO) has framed a compulsory guidance note outlining the vaccine's pharmacovigilance requirements.

In a draft note reviewed by Mint, the country’s apex drug regulatory body has directed that all manufacturers and importers of vaccines must report Serious Adverse Events (SAEs) in India and distributing countries within 15 days to the CDSCO.

Post Market Surveillance (PMS) is a process under which the Marketing Authorization Holders (MAH) need a pharmacovigilance system. This system is used to collect, process, and forward reports on Adverse Event Following Immunization (AEFI) in the country due to the company’s vaccine, to the licensing authorities, so that action can be taken whenever there are safety concerns.

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The manufacturers will have to submit a detailed pharmacovigilance plan which will include spelling out the method of pharmacovigilance, individual case safety reports, passive and active surveillance, and simulated reporting (e.g. in hospitals).

Strengthening safety surveillance

The draft note also talks about strengthening safety surveillance for introducing new vaccines in the market or pandemic preparedness as in the case of Covid-19 vaccines.

“One of the major challenges faced when a new vaccine is introduced is the non-availability of a complete safety profile of the vaccine. Safety data available at the time of introduction is usually limited to clinical trial data,” it said.

The fresh directives say that after a vaccine is approved, stringent follow up is essential to monitor vaccine safety in routine use through phase IV-post marketing trials, PMS, observational or non-interventional study for active surveillance, including assessment of AEFI and Adverse Events of Special Interest (AESI).

Besides, manufacturers must conduct a post-authorization safety study and submit its final results to the top drug regulatory body.

“After Covid-19 vaccination, we learnt that post marketing surveillance was available as a part of compliance. But now, the system is being made more robust, strict, and stronger,” said a person aware of the matter, requesting anonymity.

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The Drugs Controller General of India (DCGI), will take action as per the Drugs & Cosmetics Act and Rules, based on the recommendations of the Periodic Surveillance Update Report committee, the document said.

Furthermore, adverse events after using vaccines, whether in the Universal Immunization Programme (UIP) or private sector, paediatric vaccines or vaccines used in adults or for international travel, etc. should be reported to the AEFI surveillance system and CDSCO within 15 days.

This is the second round of consultations on the draft note to align with New Drugs and Clinical Trials Rules, 2019 and the regulator has sought comments from pharmaceutical companies within 15 days to finalise the document.

Queries sent to the health ministry spokesperson remained unanswered.