Govt. to allow 100% doses of imported and ready to use foreign vaccine
Chemical

Govt. to allow 100% doses of imported and ready to use foreign vaccine

Proactively engaging with foreign vaccine manufacturers like Moderna, Pfizer etc., to apply for Emergency Use Authorization in India so that these vaccines can be easily imported and made available in India

  • By ICN Bureau | May 14, 2021

The Union Government is consistently and proactively working to secure and enhance the availability of vaccines in the country by allowing 100% doses of imported and ready to use foreign vaccines. 

Under the new policy, 100% doses of imported and ready to use foreign vaccines will be available for other than the government of India channel comprising state governments, private hospitals and hospitals of industrial establishments. The new policy also incentivizes in terms of prices to attract private manufacturers including offshore vaccine manufacturers to enter the country. 

Government of India is also proactively engaging with foreign vaccine manufacturers like Moderna, Pfizer etc., to apply for Emergency Use Authorization in India so that these vaccines can be easily imported and made available in India. Simultaneously, Government of India along with other like-minded countries is also stressing on IPR waiver for the COVID-19 vaccines. These two interventions, taken in conjunction, will ensure easy availability of COVID-19 vaccines not only in India but globally too. 

In its new liberalized strategy, the government has made specific provisions that vaccines for COVID-19 which have been developed and are being manufactured in foreign countries and which have been granted emergency use authorization by National Regulators of United States, European Medicine Agency (EU), United kingdom, Japan or which are listed in WHO (Emergency Use Listing) will be granted emergency use approval in India.

 The strategy also provides for post-approval parallel bridging clinical trials in place of conduct of prior local clinical trials as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019. This is a radical departure from the past allowing rapid and simplified authorization of foreign vaccines by the Drugs Controller General of India (DCGI). This will ease and facilitate the import of COVID-19 vaccines and ensure increased availability of COVID-19 vaccines in India.

The New “Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy” aims at liberalized vaccine pricing and scaling up of vaccine coverage to incentivize vaccine manufacturers to rapidly augment their production and to attract new vaccine manufacturers. It would make pricing, procurement and administration of vaccines more flexible and ensure increased vaccine production as well as wider availability of vaccines in the country. 

Government of India, as part of its policy to augment the domestic production of COVID-19 vaccine, has proactively encouraged PSUs as well as private companies to enter into technology transfer agreements with Indian vaccine manufacturers. Indian Immunologicals Ltd. (IIL) and BIBCOL have entered into a technology transfer agreement with Bharat Biotech. 

In addition, one state government undertaking, namely, Haffkine Institute, has also entered into a technology transfer agreement with Bharat Biotech. All these technology transfer agreements have been actively promoted and assisted by the government of India. The union government has also extended substantial financial assistance to all the above three undertakings. 

As a result of this proactive intervention of the government, IIL will be in a position to start production of Covaxin from September 2021, while Haffkine Institute and BIBCOL will start production of Covaxin from November 2021.

The government of India is also engaged in proactive dialogue with Bharat Biotech and some other PSUs, as well as private companies to execute technology transfer agreements. This would further enhance and augment the production of Covaxin in the country.

Register Now to Attend E-Conference on Digital Transformation: The Catalyst for Agile and Smarter Process R&D on June 4 at 3:00 - 4:30 PM IST

Register Now to Attend NextGen Chemicals & Petrochemicals Summit 2025 on June 18-19th 2025, The Leela Mumbai

Other Related stories

Startups

Petrochemical

Energy

Digitization