Drug regulator stalls approval for sale of Biological E’s pneumococcal vaccine

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India’s drug regulator has withheld approval for Biological E to sell its Pneumococcal Conjugate Vaccine (PCV) in the country after two batches failed during testing, officials said.

“Two batches of PCV manufactured by Biological E were reported to have failed as they couldn’t meet the testing parameters,” an official told Moneycontrol.

Another official said the Hyderabad-based company has sent an over 500-page document in response to queries raised by the Drug Controller General of India.

“The DCGI raised the matter during the review of the market authorisation application of Biological E for PCV after approval of the Subject Expert Committee (SEC),” one of the officials said.

Pneumococcal disease is caused by the streptococcus pneumoniae bacteria. Infection can result in diseases such as meningitis, septicaemia and pneumonia, apart from sinusitis and otitis media. The vaccine is generally given to children under the age of 5.

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The DGCI grants permission for a drug or vaccine to be sold in the country after reviewing data from all phases of the clinical trials and assessing the results and recommendations of the expert group.

Setback for company

Pharmaceutical companies seeking to sell new drugs are required to submit the data of three consecutive batches of the medicines to the DCGI and the Central Drugs Laboratory in Kasauli, Himachal Pradesh. The CDL tests immunobiologicals (vaccines and antisera) meant for human use in India.

The regulator grants full market authorisation only after it finds a vaccine safe and effective for the majority of people who have received them.

The Central Drugs Standard Control Organisation’s SEC approved the market authorisation application of Biological E’s PCV on August 29.

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The DCGI’s red flag is a setback for Biological E’s vaccine candidate at this stage.

A Biological E official told Moneycontrol the company follows established international standards in manufacturing of drugs, but declined to comment on the PCV batches that are said to have failed the tests.

“As a company policy, we do not comment on matters of regulatory approvals while the review is ongoing by the authorities,” said Laxmi Narayan Neti, COO of Biological E.

The health ministry floated a tender in April for the procurement of 78 million doses of PCV for the Government e Marketplace (GeM), an online platform for sale and procurement of goods and services.

The Serum Institute of India won the contract and will supply 78 million doses of PCV to the health ministry.

Prior to the development of Serum Institute's indigenous vaccine, global pharma giant Pfizer was the biggest supplier of pneumococcal vaccines for the country’s immunisation programme.