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Friday, June 14, 2024

Indian drug regulator’s draft guidelines for reporting vaccine side effects.

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In Short:

India’s CDSCO has issued guidelines requiring vaccine manufacturers to report adverse events within 15 days. Post Market Surveillance (PMS) will monitor vaccine safety post-approval. Stringent follow-up will include phase IV trials and active surveillance for adverse events. Manufacturers must conduct safety studies and report findings to the DCGI. The new rules aim to strengthen safety surveillance for vaccines.


India’s CDSCO Issues Vaccine Pharmacovigilance Guidelines Amidst Growing Concerns

Hey there, folks! So, with all the chatter going around about the covid vaccine and the lawsuits popping up left and right, India’s Central Drugs Standard Control Organization (CDSCO) has decided to step in and lay down some ground rules.

Pharmacovigilance Requirements

In a nutshell, the CDSCO has put together a compulsory guidance note that tells all manufacturers and importers of vaccines to keep an eye out for any Serious Adverse Events (SAEs). They’ve got to report these incidents in India and distributing countries within 15 days straight to the CDSCO.

Post Market Surveillance

Now, let’s talk about Post Market Surveillance (PMS). It’s basically a process where the Marketing Authorization Holders (MAH) have to set up a system to keep track of any Adverse Event Following Immunization (AEFI) caused by their vaccines. This data will be passed on to the authorities to ensure everyone’s safety.

Strengthening safety surveillance

The CDSCO is also keen on strengthening safety surveillance, especially when it comes to introducing new vaccines or dealing with emergencies like Covid-19. They wanna make sure that there’s a complete safety profile of the vaccine before it hits the market.

Remember, it’s not just about getting the vaccine approved, but also keeping a close eye on its safety through post-marketing trials, surveillance studies, and reporting systems.

Robust System Implementation

According to insiders, the post-marketing surveillance system is getting a major makeover to become more robust, strict, and effective. So, no more cutting corners when it comes to vaccine safety!

Don’t forget, any adverse events post-vaccination should be reported within 15 days, whether it’s from the Universal Immunization Programme, private sector vaccines, or even those used for international travel.

Finalizing the Guidelines

And lastly, the CDSCO is currently in talks with pharmaceutical companies to get their feedback on these guidelines. The goal is to align everything with the New Drugs and Clinical Trials Rules, 2019 for a more streamlined process.

Well, that’s the scoop for now, folks! Let’s all do our part to ensure vaccine safety for everyone.

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