The Bio-Med MD was arrested after traces of polio strain 2 virus were found in polio vaccines produced at the company in September, but he received bail 14 days later
New Delhi: The government is considering filing a special leave petition (SLP) in the Supreme Court against the Ghaziabad district court’s decision to grant bail to managing director of pharma company Bio-Med Pvt. Ltd. The 81-year-old executive was arrested after traces of polio strain 2 were found in polio vaccines produced at the Ghaziabad-based company in September. He was released on bail after 14 days of judicial custody.
The health ministry’s plan comes in the backdrop of experts from India continuing their probe at Indonesia’s pharmaceutical company PT Bio Farma with the aim of solving the mystery behind the contamination of some batches of a polio vaccine. The health ministry has written to the law ministry, seeking their opinion on cancellation of bail and further prosecution in the case.
“The MD was charged under certain section 37 A, C, section 17 (a), section 27 (a) under the Drugs and Cosmetics (D&C)Act. As per the act, it is a non-bailable offence. To be released on bail, his lawyer referred to a decision by Allahabad High Court as per which drug inspectors do not have a power to file a police complaint. We have now asked the law ministry for their opinion so that we can file SLP in the SC stating to quash the order of Allahabad High court and Ghaziabad’s district court order of granting bail so that further action on the firm and its officials can be taken," said two people aware of the matter.
Meanwhile, a four-member expert team left for Indonesia last week as Indonesian company PT Bio farma supplies the key starting material (KSM), the active raw materials used in a vaccine that give it a therapeutic effect, to Indian manufacturers that make polio vaccines in oral forms.
While the mystery behind the contamination threatens to change India’s polio-free status, the health ministry and the Central Drugs Standard Control Organisation (CDSCO) have been on their toes since the news of contamination surfaced. The government has been investigating how the type 2 strain of polio, believed to be long gone, found its way into vaccines made by Bio-Med.
The polio drops, which carry weakened polio viruses, are given to children below the age of five under a government programme designed to build their immunity against the crippling disease. The type 2 strain is thought to have been eradicated so long ago that the current polio vaccine no longer protects against it, and vaccine makers have been asked to remove it from the vaccine and destroy their stocks of the strain.
However, this September, experts at the World Health Organization (WHO) found type 2 polio virus in sewage and stool samples. The batches belonged to Bio-Med, which was supplying polio vaccines for the government-run universal immunization programme. Around 50,000 vials—one vial has 20 doses—of contaminated vaccine are believed to have been used in Uttar Pradesh and Telangana. In October, Mint had also carried a detailed investigation on the testing mechanism followed at government’s central drug laboratory at Kasauli and the tender procedure that is followed to choose the company for supplying vaccines.
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