The Central Drugs Standard Control Organisation (CDSCO) needs to handle the re-emergence of a polio-virus strain long believed to have been eradicated with a much larger degree of deftness than it is known for if India is to keep its polio-free tag.
The Central Drugs Standard Control Organisation (CDSCO) needs to handle the re-emergence of a polio-virus strain long believed to have been eradicated with a much larger degree of deftness than it is known for if India is to keep its polio-free tag. To be sure, the Indian drug standards regulator has moved fast ever since the presence of Polio Type 2 (P2) in oral polio vaccine samples was detected in September; even the WHO has lauded it for this. Orally-administered polio vaccines were found to be containing P2 specimen (vaccines carry weakened viral strains to induce an immune system response), and batches of the vaccine that are feared to have gotten contaminated have already been used in Uttar Pradesh and Telangana. The viral strain, believed to have been eradicated and thus taken out of polio vaccination across the world, was detected in vaccines made by Ghaziabad-based Bio-Med Pvt Ltd. Public health experts believe, given the contamination, there are chances of children contracting vaccine-derived polio if the P2 strain mutates into a virulent form.
There are obvious gaps in the drug-testing protocol, which could have contributed to this particular episode—for instance, as per testing standards set by the Indian Pharmacopoeia Commission, the government laboratory for drug-standards testing examines drugs/vaccines for only what is mentioned on the label. Thus, if Bio-Med missed detecting P2 contamination and its vaccine’s label only mentions P1 and P3, the government laboratory will not test for P2. There is, of course, a need to review protocol for gaps and even strengthen the drug testing ecosystem—at the Central Drugs Laboratory in Kasauli, Mint reports, there were over 4,000 vacancies in July. But the fact is the problem also has roots in India’s public procurement policy that, thanks to misplaced zealousness over transparency and minimising cost to the exchequer, suffers from L1-itis. CDSCO has found Bio-Med guilty of not adhering to Good Manufacturing Practices not just in this particular case, but also in an earlier case, too. And yet, Bio-Med won the government contract for OPV because it was the L1-bidder. Outbidding competitors is easier if a company doesn’t spend as much on, say, rigorous quality testing.