New Delhi: Over eight months after it found adulterated polio vaccines affecting close to 30 lakh children in two states, the Modi government has launched prosecution against Ghaziabad-based vaccine maker Bio-Med Pvt. Ltd for causing a major health scare, ThePrint has learnt.
The Central Drugs Standard Control Organisation (CDSCO) — the country’s apex drug regulation body under the Ministry of Health and Family Welfare — is prosecuting the company under severe provisions of the Drugs and Cosmetics Act, 1940, said a senior CDSCO official.
Using the same provisions — which provide for imprisonment for three to five years for non-compliance — the CDSCO is also prosecuting Bio-Med’s octogenarian founder and managing director Sarayu Garg, added the official who didn’t wish to be identified.
The latest move to chargesheet the company came after a Ghaziabad court granted bail to 81-year-old Garg, who had been remanded to 14 days of judicial custody in October in the contamination case.
“We have already launched the prosecution and the matter will soon come up for hearing,” the official said. “The company is still not aware that we have proceeded but they are aware through media reports that we are planning strict action. Presuming that we will take a harsh stand, they have requested us to soften our approach.”
The case first came to light in September last year when the government found several batches of the company’s oral polio vaccines contaminated with traces of the Type-2 virus — a kind which was declared eliminated around the world in 2016.
The adulterated polio vials had made as many as 30 lakh children vulnerable against polio infection in Uttar Pradesh and Telangana as part of the government’s immunisation programme, triggering an alarm.
The government later said there was no need to panic, adding that an inactivated polio vaccine (IPV) booster shot may be taken for precaution.
The company had initially challenged the government probe, but after re-testing of samples in November, the initial report was confirmed. The company was then barred from selling any of its products.
ThePrint reached Garg for comment but there was no response until the time of publishing this report. This report will be updated when he responds.
What the prosecution means
Under the Drugs and Cosmetics Act, section 27(B) — the provision under which Bio-Med is being prosecuted — provides for the company’s top management to be punished with imprisonment for a term not less than three years extending up to five years.
Moreover, the company will be “liable to pay a fine which shall not be less than Rs 1 lakh, or three times the value of the drugs confiscated, whichever is more”.
Speaking to ThePrint, the CDSCO official said Garg has requested the regulatory body to prosecute them under softer sections of the Act.
“Last week, the founder had visited the CDSCO premises to meet the drug controller general of India, Dr. S. Eswara Reddy. The company has requested to consider section 27(d) which reduces the span of imprisonment and amount of fine,” said the official.
According to section 27(d), the accused is punishable with an imprisonment term not less than a year but extending up to two years.
It also provides for a fine not less than Rs 20,000.
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