New Delhi: The Ghaziabad district court has asked the government to re-test samples of polio vaccines made by Ghaziabad-based Bio-Med Pvt. Ltd after the company contested results of a test that found contamination, two people aware of the matter said.

The retest will be done at the government-run Central Drugs Laboratory in Kasauli. In September, traces of polio type-2 virus, believed to be long eradicated, were discovered in the vaccines made by Bio-Med Pvt. Ltd, putting India’s polio-free status at risk.

“In their plea to the court, they (Bio-Med) have asked for retesting of samples, challenging the report which found its samples contaminated," said one of the persons aware of the matter.

“The company is doing everything to get the matter delayed. The samples will be sent for retesting to the Kasauli laboratory," added the second person.

Drug inspectors working to unearth the mystery behind the contamination of polio vaccines since September last year had in October also travelled to Indonesia’s PT Bio Farma Pvt Ltd, the company that supplies the bulk vaccine called key starting material (KSM). However, they did not find anything amiss there, bringing the spotlight back to the Indian firm that supplied the final vaccine to an official immunization programme.

According to the people cited above, who spoke on condition of anonymity, the 50-page report submitted by drug inspectors to the Drug Controller General of India (DCGI) did not find “any contamination" in the KSM supplied by PT Bio Farma. “They supply KSM to many other countries and the team has not found any contamination at their end. There are some minor good manufacturing practices (GMP) related issues which will be communicated to the firm, but as far as polio contamination is concerned, the team did not find any evidence of contamination at the Indonesia site," said the first person cited above.

PT Bio Farma said it has “proactively investigated" the matter, including batch review, facility assessment and testing of retain samples of all bulks shipped to Bio-Med using validated test methods. “Results have shown that there have not been any discrepancies in the manufacture of these bulks. Test results of retain samples do not indicate presence of type 2 polio virus," the company said in an e-mailed response.

“Polio bulks of the same batches have also been shipped to our other partners as well as utilized by Bio Farma with no complaints of the kind," it said.

An email sent to Bio-Med on Monday remained unanswered till press time. The company’s managing director, who was arrested in September after the test results came out, was released on bail after 14 days in judicial custody.

“The MD was charged under sections 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 a special leave petition 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 the second person.

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 came from 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.

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