Domestic vaccine maker Bio-Med is under the scanner after failing government quality tests for its meningitis vaccine.
The drug controller general of India has launched a probe into Bio-Med’s facility after samples of meningitis vaccine failed the sterility test at government labs in Kasauli, Himachal Pradesh.
While the company has been barred from manufacturing and supplying these vaccines, drug inspectors on Wednesday visited the facility in Ghaziabad to seize stocks and further investigate the source of contamination.
A report by the Central Drug Laboratory (CDL), Kasauli, which is the national control laboratory for testing of immunibiologicals meant for human use in India, reveals that all three batches of meningitis vaccines manufactured by Bio-Med failed quality tests. Three batches of 90,000 doses each were sent for testing in June. The vaccination is mandatory for those going on Haj pilgrimage, held in August.
Ghaziabad-based Bio-Med is the same company that came under lens for supplying tainted polio vaccines in September when it was barred from manufacturing and supplying vaccines. However, the company was given a one-time permit in June to produce meningitis vaccines for Haj pilgrims. With these samples too failing tests, drug inspectors are on their toes once again.
“Bio-Med will only be allowed to supply vaccines once we see consistency in their quality. Drug inspectors who visited the facility on Wednesday have seized stocks and will now investigate the source of contamination,” said a senior official at the health ministry. According to information available on Bio-Med’s website, the company manufactures vaccines for polio, typhoid, meningococcal meningitis, and Hib and is one of the main suppliers for government-run vaccine programmes.
The zonal drug regulator’s office at Ghaziabad has already filed a complaint at a Ghaziabad court seeking to prosecute senior officials at Bio-Med Pvt. Ltd for supplying “adulterated” and “substandard” polio vaccine in the government-run polio eradication programme.
The complaint has been filed against five directors, the in-charge of its laboratory, and the company.
“Six people of the company and the company itself have been made accused in the complaint for committing the offence of supplying adulterated vaccines in the government-run programme. The test reports have confirmed the offence and hence a complaint has been filed for further prosecution,” added another official at the ministry of health. An email sent to Bio-Med’s director did not elicit any response till press time.
The complaint has been filed under section 27 of the Drugs and Cosmetics Act, which provides for imprisonment for 3-5 years. The court is yet to take up the matter.
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 firm was then barred from making and supplying vaccines.
Bio-Med challenged the results of the initial tests by the Kasauli lab. However, when the samples were tested again, contamination was re-confirmed. The report on the retest was submitted by CDL at the Ghaziabad district court on March 15. “Besides, recent inspections of the Bio-Med facility found violations of good manufacturing practices, prompting authorities to file a complaint,” said one of the two people cited above.
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