Biomed writes to Health Ministry saying it can supply vaccines for Haj pilgrims

Biomed Pvt Ltd was directed to stop the manufacture, sale and distribution of all human vaccines, including the Quadrivalent Meningococcal Meningitis vaccine after type-2 poliovirus was found in the sewage and stool samples in Maharashtra, Telangana and Uttar Pradesh in September last year.

New Delhi: A pharmaceutical company, which was the only firm to manufacture meningitis vaccines before being banned from production, has written to the Health Ministry, saying it can supply the doses needed for Haj pilgrims before they embark on their journey.

The ministry is concerned about the arrangement of 1.9 lakh vaccines for the pilgrims as the firm, Biomed Pvt Ltd, was asked to stop production of all human vaccines in September last year after type-2 poliovirus contamination was detected in oral polio vaccines.

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The Ghaziabad-based company was the only firm which manufactured the vaccines and provided it to the government.

"The Biomed Pvt Ltd has written to the Health Ministry saying they have a bulk of the vaccine in stock and can manufacture more doses for this year's Haj pilgrims," the source said.

During inspections in March, a team of officers from CDSCO and state licensing authority Uttar Pradesh found major non-compliances with the Current Good Manufacturing Practice (CGMP) standards, including qualifications and validations of major equipment and utility systems.

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"In light of major non-compliances with the CGMP observed by joint inspecting team, the firm should be required to comply satisfactorily and submit compliance report that the same could be verified by the joint inspection team for further consideration of their proposal to manufacture and supply quadrivalent Meningococcal Meningitis Polysaccharide Vaccine," the source said.

"The firm has submitted its compliance report to the observations mentioned in the inspection report on April 15 and it is being reviewed by Health Ministry," the source said.

Around 1.27 lakh people are expected to go for the annual Haj pilgrimage in July for which the ministry will have to arrange at least 1.9 lakh doses. Extra vaccines are kept as some are rendered ineffective in the process of delivery to the states.

The Health Ministry is also learnt to be in talks with two firms already which import the vaccines.

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Those going to Saudi Arabia for the purpose of Umra or pilgrimage are required to submit a certificate of vaccination with the quadrivalent (ACYW 135) vaccine against meningitis, proving the vaccine was administered no more than three years ago and no less than 10 days before arrival in the country.

Biomed Pvt Ltd was a licensed indigenous manufacturer for Meningococcal Polysaccharide vaccine, while two firms M/s Sanofi Pasteur India Pvt Lt, Mumbai and M/s GlaxoSmithKline Pharmaceuticals Ltd, Mumbai are importers for quadrivalent Meningococcal Meningitis Conjugate vaccine in the country.

"Earlier, with Biomed Pvt Ltd providing the vaccines, the government spent Rs 250 for each vaccine but now if they have to buy from companies which import the vaccines, they may have to shell out around Rs 1500 per dose. The Health Ministry is already in talks with the two firms which import the vaccines," the sources said.

Biomed Pvt Ltd was directed to stop the manufacture, sale and distribution of all human vaccines, including the Quadrivalent Meningococcal Meningitis vaccine after type-2 poliovirus was found in the sewage and stool samples in Maharashtra, Telangana and Uttar Pradesh in September last year.

The polio drops were sent for testing which confirmed that some of them were contaminated with the type-2 virus, a strain believed to have been eradicated in 2016.

The managing director of Biomed Pvt Ltd., which was supplying polio vaccines for only government-run immunisation programmes, was arrested after the central drug regulator filed a complaint and an FIR was registered.

The destruction of traces of type-2 poliovirus was ordered by the central drug regulator to all manufacturers in 2016.