1/n In my column in Business Standard today, I look at the quality control and testing of vaccines, which are still a weak link in our vaccination efforts business-standard.com/article/opinio…
2/n Quality control and testing rarely gets much media attention in India except when some big generic drug maker's production facilities get pulled up by the US FDA -- but it is crucial in ensuring that the quality of the drugs and vaccines we take are good
3/n In April, the US FDA realised to its horror that Emergent BioSolutons, the Baltimore-based contract manufacturer of vaccines that was going to produce a lot of J&J and AstraZeneca vacciness had managed to contaminate entire batches..
4/n Over 60 million J&J doses produced in the Baltimore facility has been destroyed in the US alone -- other countries have also destroyed many million doses as welll
5/n The Brazil regulator refused to clear India's Covaxin, made by Bharat Biotech, because of its concerns that the company was not following Good Manufacturing Practices (GMP) stringently...
6/n In India, the Central Drugs Standards and Control Organisation (CDSCO) lays down the GMP and gives licenses for manufacturing of drugs and vaccines. Unfortunately, it has little resources to check the facilities and depends a lot on state bodies
7/n State regulatory bodies also face resource and manpower constraints and with the thousands of small units manufacturing drugs, the quality control of smaller units cannot always be checked
8/n Vaccines have a more rigorous system. All vaccines batches go to the Central Drugs Laboratory (CDL) Kasauli for testing before they can be released in themarket
9/n However, with vaccine procurement picking up sharply, domestic producers are upping capacity while plenty of doses of Sputnik V and J&J etc are also being imported ... and CDL Kasauli lacks the manpower and facilities to test all these
10/ and n/n While the government is trying to get two other labs up to speed to handle the increased volumes, some testing is now being done at vaccine manufacturer's own facilities with data being then sent to CDL Kasauli...so our testing has not kept up with procurement volumes
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