Weekly blog: More questions, no definitive answers on source of polio vaccine contamination

The company came under the lens of CDSCO inspectors as it supplied bulk vaccine or key starting material (KSM) to Ghaziabad-based Bio-Med.

Bio-Med supplied around 1.5 lakh vials of oral polio vaccine contaminated with long-eradicated type 2 polio virus putting India's polio-free-country status at risk and has left millions worried about their children's health.

Source of contamination

The investigation of CDSCO is yet to find the source of contamination. The investigation conducted by CDSCO team on the premises of Bio-Med facility failed to reveal the source of the virus.

There were reports in the media quoting an unnamed health ministry official as saying they have not found anything suspicious during the investigation on Bio-Med's premises, except for some deviations in sterilisation and manufacturing standards.

The CDSCO which is part of health ministry is yet to make an official statement on its findings at Bio-Med.

If the Bio Farma version is to be believed, then the needle once again point towards Biomed. Or if Biomed is not the source of type 2 polio virus contamination, as some media reports indicate, then there could be a possibility of foul play in the transit. That is an extremely serious matter for the government.

Lack of oversight

Many were baffled by the existence of type-2 polio virus which ought to have been destroyed in 2016 itself by all companies and laboratories, with exception of government’s National Institute of Virology in Pune.

This is no simple voluntary destruction, the companies will have to give an undertaking on the destroyed stocks and CDSCO will have to verify them.

Bio-Med was said to have complied with the government order.

There were also gaps in the procedures followed by government’s Central Research Institute at Kasauli, Himachal Pradesh responsible of testing vaccines for any contamination.

The last, but not the least -- the manufacturing practices at Bio-Med.

Vaccine manufacturers’ world over are subjected to stringent regulatory standards, as they deal with biologic products, that are prone for contamination and instability.

The manufacturing facilities of vaccine companies are inspected routinely, and sometimes unannounced to review conformance with current good manufacturing practices (cGMP), maintenance of facilities, manufacturing and quality systems and performance of the process. Vaccines out on market are also constantly monitored to see any adverse events.

This is not the first case for Bio-Med. In March, this year CDSCO ordered a national recall of Bio-Med typhoid conjugate vaccine that was found to be substandard. This incident should have alarmed CDSCO.

There is also growing a demand for the government to make World Health Organisation (WHO) Good Manufacturing Practices (GMP) as pre-requisite to participate in government tenders. WHO GMP is already a prerequisite for most international tenders. In India, it is not mandatory to have WHO GMP or pre-qualification to participate in government tenders.