Lakhs of children were said to have been administered oral polio vaccines from a batch tainted with the type 2 polio virus, which was eradicated years ago.
New Delhi: A team of Indian drug regulators is all set to fly to Indonesia to trace the source of the eradicated polio strain that found its way to vaccination batches in Uttar Pradesh and Telangana last month.
As many as 30 lakh children are believed to have received oral polio vaccine (OPV) contaminated with the type 2 polio virus, though the government has assured that there is no need to panic.
The strain, which has been eradicated worldwide, was found in vaccines manufactured by a Ghaziabad-based company named Biomed during the last week of September.
The investigation conducted by the Central Drugs Standard Control Organisation (CDSDO), a regulatory body under the ministry of health and family welfare, on the premises of Biomed failed to yield the source of the virus.
While the investigation report mentions loopholes in the manufacturing practices of the company, it rules out the chances of the adulteration happening at the Biomed facility.
“We have not found anything suspicious during the thorough investigation on the premises of Biomed,” said a senior ministry of health official.
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“They can, however, be charged with non-compliance as we have observed problems in sterilisation and deviation of standards in manufacturing,” the official added.
The report suggests the source of the contamination could be the imported raw material, called ‘bulk vaccine’.
“There is a high possibility that the bulk vaccine, which is imported through an Indonesian manufacturing company, Bio Farma, could be contaminated,” said a senior bureaucrat at the ministry of health.
“However, we cannot establish the claim unless we inspect their facilities,” the bureaucrat added.
Asked if Bio Farma supplies bulk vaccine to Biomed, a spokesperson for the Indonesian firm said, “We will check and coordinate internally.”
According to the World Health Organisation (WHO), there are only a few approved OPV players – Bio Farma, GlaxoSmithKline (UK); Serum Institute of India and Bharat Biotech (India); and Sanofi Pasteur (France).
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According to the UNICEF’s supply agreement, prices of the polio vaccine have already been negotiated with Bio Farma till 2020.
The big scare
The government banned Biomed from supplying and manufacturing polio vaccines after last month’s scare, pending an investigation.
The Drugs Controller General of India had filed an FIR and issued notice to the company to bar manufacture and supply, while the Biomed managing director, S.P. Garg, was arrested.
Earlier, the government was concerned that Biomed may have tried to contaminate their vaccines to keep the disease alive and their revenues healthy.
“Criminality or culpability in the matter has not yet been established,” said Ghaziabad superintendent of police (city) Shlok Kumar.
“There was an order from the court that asked us to investigate the matter, conduct a thorough inquiry and then register a case. We are still investigating the matter,” he added.
(Inputs from Ananya Bhardwaj)