Indonesian firm gets clean chit in polio vaccine contamination case
NEWDELHI: Drug inspectors working to unearth the mystery behind the contamination of polio vaccines have found nothing amiss at the Indonesian bulkmanufacturer, 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 Ghaziabadbased Bio-Med Pvt. Ltd for the national vaccination programme. As part of investigations to identify its source, a fourmember 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 peo- ple 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 poliofree 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.