Regualtor to seek WHO inputs to bolster charge sheet against firm which supplied contaminated polio vaccine

NEW DELHI: The drug regulatory authority will seek inputs from the World Health Organisation (WHO) to corroborate and reinforce allegations in the charge sheet it plans to file against Ghaziabad-based firm BioMed for supplying polio vaccine contaminated with type 2 virus.

The UN agency had also drawn samples following the contamination and tested them separately. The findings of the laboratory tests will be part of the government's charge sheet to start prosecution against the company, senior official sources said.

"Our investigation team is collecting information from various sources. Since WHO also procures vaccines from India as well as does surveillance, it had also drawn batches to probe the contamination. We are seeking a report from them to substantiate our findings and allegations in the charge sheet to be filed against BioMed," a senior official told TOI.

In September 2018, TOI was the first to report that several batches of polio vaccines have been found contaminated with type 2 polio virus which was already withdrawn worldwide including in India. The contamination had put several children born after April 2016 at risk, prompting the health ministry, WHO and other international health agencies to step up surveillance and take immediate preventive measures to contain the impact, particularly in Uttar Pradesh, Maharashtra and Telangana - where the contaminated batches were supplied under government immunisation programme.

The contaminated vaccine was found to be manufactured by BioMed and the drugs controller general of India (DCGI) had filed an FIR against the company.

BioMed challenged the findings of the initial tests by the government laboratory in Kasauli. However, on retesting of the samples, the contamination was confirmed again.

The health ministry had also set up a three-member committee to probe the contamination. The team also visited the Indonesia-based raw material supplier to BioMed for the vaccine. The team also found violations of good manufacturing practices at the company's factory during a recent inspection, the official said.

"The chargesheet will have various facts and witnesses to substantiate and validate our allegations. The contamination is serious and could have caused a serious threat to public health," he said.

Polio drops contain live polio viruses that are shed by vaccinated children in their stools. The contamination triggered fears that if type 2 virus passes into the sewage or water system, it may regain neuro-virulence and spread polio. Another major concern was of virus mutation.

Earlier, trivalent polio vaccines containing type 1, 2 and 3 were in use but after the type 2 polio virus was eradicated worldwide, governments switched to bivalent vaccines, containing only type 1 and 3 strains. In 2016, India, in line with WHO guidance, had ordered withdrawal and destruction of all trivalent OPV stocks by April 2016.