Regulator may chargesheet Bio-Med over supply of adulterated polio drug2 min read . Updated: 19 Apr 2019, 01:30 AM IST
- An analysis of some sewage and stool samples showed traces of polio-2 strain, a variant believed long gone
- Bio-Med challenged the results of the initial tests by the government laboratory in Kasauli
Authorities are set to file a charge sheet against the people responsible for running the affairs of Ghaziabad-based Bio-Med Pvt. Ltd for supplying “adulterated" polio vaccines, two people aware of the matter said.
In September, an analysis of some sewage and stool samples showed traces of polio-2 strain, a variant believed long gone so that new vaccines no longer protect against them. The contaminated vaccine was found to be manufactured by Bio-Med.
The Drug Controller General of India (DCGI) has given permission to the Central Drugs Standard Control Organization (CDSCO) at Ghaziabad to file a charge sheet so that prosecution proceedings can begin, according to the people mentioned above.
Bio-Med challenged the results of the initial tests by the government laboratory in Kasauli. However, when the samples were tested again, they re-confirmed the contamination. Besides, recent inspections of the Bio-Med facility found various violations of good manufacturing practices (GMP), prompting authorities to file a charge sheet.
“Bio-Med’s facility was inspected recently and the inspectors found serious GMP violations in the facility. The report has been submitted to the DCGI, following which the Ghaziabad drug inspectors have been told to initiate action, which is filing a charge sheet," one of the two persons mentioned above said on condition of anonymity.
The report was submitted by Central Drugs Laboratory (CDL) Kasauli to the Ghaziabad district court on 15 March. “The samples that were sent for testing following the court order were found to be positive again, which means that the batches had type 2 virus in it," the second person said, requesting anonymity.
An email sent to Bio-Med and messages sent to managing director Sarayu Garg remained unanswered till press time.
Polio drops, which carry weakened polio viruses, are given to children below five years of age under a government-run programme. On 27 September, the DCGI asked Bio-Med to explain how the eradicated polio-2 strain found its way into vaccine vials. Around 50,000 vials—one vial has 20 doses—of contaminated vaccine were believed to have been used in Uttar Pradesh and Telangana. The company was then barred from manufacturing and supplying vaccines.
Confident that the polio-2 strain had been wiped out, vaccine makers were asked to destroy their stocks of type 2 virus strain by April 2016, an order that Bio-Med has allegedly violated. Drug inspectors working to unearth the mystery behind the contamination of polio vaccines had in October also travelled to Indonesia’s PT Bio Farma Pvt. Ltd, the company that supplies the bulk vaccine called key starting material. However, they did not find anything amiss there. That brought the spotlight back on Bio-Med.
PT Bio Farma said it had “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 firm said in an emailed response.