A complaint has been filed at a Ghaziabad court seeking to prosecute senior officials at Ghaziabad-based Bio-Med Pvt. Ltd for supplying “adulterated" and “substandard" polio vaccine in the government-run polio programme.
The complaint was filed on Monday against Bio-Med’s five directors, the in-charge of its laboratory, and the company by the zonal drug regulator’s office at Ghaziabad, a senior government official confirmed.
“Six people of the company and the company itself have been made accused in the complaint for committing offence of supplying adulterated vaccines in the government-run programme. The tests reports have confirmed the offence and hence a complaint has been filed for further prosecution," added another official at the ministry of health.
The complaint has been filed under section 27 of the Drugs and Cosmetics Act, which provides imprisonment of 3-5 years for non-compliance.
In September, an analysis of some sewage and stool samples showed traces of polio-2 strain, a variant believed to have been long eradicated. New vaccines no longer offer protection against the variant. The contaminated vaccine was found to be manufactured by Bio-Med.
Around 50,000 vials—one vial has 20 doses—of contaminated vaccines were believed to have been used in Uttar Pradesh and Telangana. The company was then barred from manufacturing and supplying vaccines.
Bio-Med challenged the results of the initial tests by the Central Drugs Laboratory (CDL) in Kasauli. However, when the samples were tested again, contamination was re-confirmed. The report of re-testing the samples was submitted by CDL to the Ghaziabad district court on 15 March.
“Besides, recent inspections of the Bio-Med facility found various violations of good manufacturing practices (GMP), prompting authorities to file a complaint," said one of the two people cited above.
“Bio-Med’s facility was also inspected and the inspectors found serious GMP violations in the facility. The report has been submitted to the DCGI (Drug Controller General of India), following which the Ghaziabad drug inspectors were told to initiate action," one of the two people cited above said on condition of anonymity.
An email sent to Bio-Med and text messages sent to managing director Sarayu Garg went unanswered till press time.
Polio drops, which carry weakened polio viruses, are given to children below five years under a government-run programme. 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 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.
The government’s polio eradication programme has been under stress since September.
There are five major manufacturers of the bivalent vaccine in India—Bio-Med, Bharat Biotech International, Panacea Biotec, and Bibcol and Mumbai-based Haffkine Bio Pharmaceutical Corp. Ltd. Significantly, the CDL, which conducts quality tests, in April declared 16 batches manufactured by Bharat Immunological and Biologicals Corp. Ltd (Bibcol) as “substandard" after they failed sterility tests. The public sector undertaking also supplies vaccines to the government’s polio eradication programme.