In India, the brouhaha surrounding Baltimore-based Emergent BioSolutions has garnered only passing attention. The company was one of the Trump administration’s favourite vaccine
contract manufacturers. In 2020, the US government had given Emergent $626 million to stockpile vaccines for a possible Anthrax attack. It also got contracts to manufacture the Johnson & Johnson
(J&J) and AstraZeneca vaccines.
In April this year, news broke that the US government had to destroy millions of doses of J&J vaccines produced by Emergent. The US Food and Drugs Administration (FDA) during an inspection found that Emergent had contaminated the J&J drugs with AstraZeneca ingredients.
Though the US had hedged its bets by placing orders for four separate vaccines — Pfizer, Moderna, AstraZeneca and J&J — and far in excess of what was needed to vaccinate its population, it was still a loss of valuable doses and ingredients.
Manufacturing quality and practices of drug makers do not get much attention in the Indian media except when a big Indian generic drugs exporter gets pulled up by the US FDA
for not meeting its prescribed manufacturing standards. But globally, vaccine
manufacturing hiccups have again turned the spotlight on quality control issues.
So far, according to reports, the US FDA
has forced Emergent to destroy 60 million doses while other countries like South Africa have also had to destroy contaminated J&J doses. AstraZeneca, which relies heavily on contract manufacturers spread across the world, has also faced problems. Apart from the problems at the US-based Emergent, it initially faced issues in its Belgium facility and also with its contract manufacturing partner in Thailand.
Questions have also been raised by the World Health Organization about the testing and data integrity of Sputnik V ’s manufacturing plants in Russia, though the company insists that all those issues have been sorted out.
India’s homegrown vaccine, Covaxin by Bharat Biotech, was initially rejected by Brazil’s drug regulator Anvisa for not meeting the Good Manufacturing Practices. (It subsequently won a contract for supply to Brazil
with fresh data, but now the contract has been temporarily suspended over irregularities).
In India, the Central Drugs Standard and Control Organisation (CDSCO) is a part of the Union Ministry of Health and Family Welfare. It prescribes the standards and measures for the safety, efficacy and quality of drugs and vaccines. It also approves the licences for manufacturing the drugs and vaccines.
Unfortunately, while it does have the authority, it lacks the resources to strictly monitor the production of drugs and vaccines. That is mostly left to state regulatory authorities, which are supposed to ensure that the drug manufacturers in the state adhere to the quality and other standards prescribed by the CDSCO. The Central Drugs Laboratory (CDL) in Kasauli does a check of each batch of vaccines being released in the market.
The problem is that, given the complexity of the manufacturing processes; the lack of resources that these state authorities suffer from; and manufacturing standards and quality concerns, data is not very strictly monitored. India has thousands of big and small contract manufacturers and their standards vary widely.
The biggest manufacturers, which export to the US and the EU, get monitored strictly by the drug regulatory authorities of their countries Indeed, FDA certification for a plant is what can make or break an Indian firm’s reputation and fortune.
Vaccines are more complex than normal drugs to produce and so far, the CDL, Kasauli, has done a good job of monitoring the quality of samples headed for the market. Also, India has a long history of vaccine
production and exports.
But because of the sheer requirement of Covid vaccines, the CDL Kasauli’s workload has increased exponentially. Recently, The Print reported that because of the Covid vaccine volumes, parallel testing procedures had been implemented — with some vaccine batches being tested in CDL labs while others tested in the manufacturers own quality control labs. CDL compares the test results of the two batches before approving their release. The government is trying to get other vaccine testing facilities ready — the Noida-based National Institute of Biologicals is already notified and the Pune-based National Centre for Cell Science is being prepared to help with testing. But even that might not be enough to handle the flood of new vaccines.
Indian production of Covid vaccines is being scaled up and more homegrown vaccines are being approved to meet the government’s target of vaccinating as many adults as possible by December. Doses of Sputnik V are already being imported and imports of J&J and Moderna vaccines are also expected. Testing facilities will also need to be scaled-up to handle that deluge.
All the vaccines approved by the regulator may be highly effective but even a small error for a single batch can dramatically alter the safety and efficacy profiles. That is why monitoring of manufacturing facilities becomes crucial as does enhancing the capabilities of the testing laboratories. Hopefully, the government realises this and will take it more seriously than it had the vaccine procurement process.
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