PT Bio Farma Gets Cleanchit In Polio Vaccine Contamination Case

New Delhi, 26 Nov 2018: Drug inspectors working to unearth the mystery behind the contamination of polio vaccines have found nothing amiss at the Indonesian bulk-manufacturer, said two people aware of the matter, bringing the spotlight back to the Indian firm that supplied the final vaccine to an official immunization programme.

In September, traces of polio type-2 virus, believed to be long eradicated, were discovered in vaccines made by Ghaziabad-based Bio-Med Pvt. Ltd for the national vaccination programme. As part of investigations to identify its source, a four-member team was despatched to Indonesia’s PT Bio Farma Pvt. Ltd which supplies the bulk vaccine called key starting material (KSM).

According to the two 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.

The contamination of 1.5 lakh vials of oral polio vaccine by type-2 polio virus believed to be long gone, has put India’s polio-free status at risk. PT Bio Farma said it has “proactively investigated” the matter, comprising among others, batch review, facility assessment and testing of retain samples of all bulks shipped to Bio-Med using validated test method. 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 23 November remained unanswered till press time. The government may now move the Supreme Court (SC) challenging the bail given to Bio-Med’s 81-year-old managing director (MD) Sarayu Garg, said the second person cited above. The Ghaziabad district court had released the Bio-Med executive on bail after 14 days in judicial custody. The health ministry has now sought the law ministry’s opinion on cancelling the bail and prosecution, this person added.

“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 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. In October, Mint had carried a detailed report on the testing mechanism followed at the government’s central drug laboratory at Kasauli and the tendering procedure to choose the company for supplying vaccines. Livemint