Govt. checks vaccine production capacity

NEW DELHI : The central government is assessing the domestic industry’s capacity to mass-produce successful vaccine candidates, as the world’s second-most populous country readies to meet the challenge of producing enough doses for its more than billion people.

The government is trying to understand the regulatory, technical and market-related challenges that are likely to crop up in getting a manufacturer to produce a vaccine developed elsewhere, according to two people directly aware of the development.

While India is among the world’s largest vaccine producers, preparing a facility to manufacture a certain type of vaccine from scratch requires months of effort, including repeat phase 3 clinical trials, dozens of tests and millions of dollars in investments.

Two executives at two covid vaccine developers said it is relatively easier for companies to just fill and package finished vaccines produced by the original manufacturer than manufacture it.

“Even if the processes are the same, contract manufacturing would require a separate phase 3 trial like the one Serum Institute is currently doing for University of Oxford’s vaccine candidate ‘Covishield’," said a senior government official on condition of anonymity. 

“The phase 3 trial will be necessary as changes in machinery, temperature, people, etc., can change the vaccine efficacy."

On the other hand, if the company were to just fill-and-finish another manufacturer’s vaccine, then only a few tests will need to



be conducted at the Central Drugs Laboratory in Kasauli, the official said.

India is home to some of the largest vaccine firms, including Pune-based Serum Institute of India, the largest vaccine maker.

“Vaccine firms have been asked whether they can potentially contract manufacture vaccines developed by someone else," said a senior executive at a vaccine maker. These talks have been held under the aegis of the National Expert Committee on Vaccine Administration as well as Biotechnology Industry Research Assistance Council, a non-profit under the Department of Biotechnology.

“At the meetings, companies are asked if they can contract manufacture another company’s vaccine or if they have spare bottling capacity for fill-and-finish of other bulk vaccines. India might require at least 500 million doses to begin with, and finding enough vials will also be a big constraint," said a second executive at a vaccine maker.

Multiple calls made to V.K. Paul, Niti Aayog member and chairman of the panel on vaccine administration, remained unanswered, while Indian Council of Medical Research director-general Balram Bhargava, another member of the committee, declined to comment on the discussions.

Although stability tests for drugs and vaccines need six months to determine the shelf life, the Drug Controller General of India can, in an emergency, allow firms to commercialise the product with a shorter shelf life after examining a month’s data while continuing tests to determine its shelf life, a government official said.