Reports Of Delay In Licensing For Covaxin ”Factually Incorrect”: Centre

Reports Of Delay In Licensing For Covaxin ''Factually Incorrect'': Centre

Covaxin is manufactured by the Hyderabad-based Bharat Biotech. (File)

New Delhi:

The government on Thursday dismissed as “completely baseless and factually incorrect” reports in a section of media followed by some tweets alleging delay in licensing for Covaxin and delayed approval for technology transfer for manufacturing the vaccine in the country.

The Union government is consistently and pro-actively working to secure and enhance the availability of vaccines, the Health Ministry said, adding that Government of India is pro-actively engaging with foreign vaccine manufacturers like Moderna, Pfizer to apply for emergency use authorisation in India so that these vaccines can be easily imported and made available in the country.

Simultaneously, Government of India, along with other like-minded countries, is also stressing on IPR waiver for COVID-19 vaccines. These two interventions, taken in conjunction, will ensure easy availability of vaccines not only in India but globally too, the ministry said in its statement.

“There have been reports in a section of the media followed by some uninformed tweets alleging delay in licensing for Covaxin and delayed approval for technology transfer for manufacturing Covaxin vaccine in the country.

“These news reports and the content mentioned in the tweet are completely baseless and factually incorrect,” the ministry said in its statement.

Government of India, in its new liberalised strategy, has made specific provisions that vaccines 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 statement said.

It also provides for post-approval parallel bridging clinical trial in place of conduct of prior local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs and Clinical Trials Rules 2019.

“This is a radical departure from past allowing rapid and simplified authorisation of foreign vaccines by the Drugs Controller General of India (DCGI),” the ministry stated.

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 liberalised vaccine pricing and scaling up of vaccine coverage to incentivise 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, the statement said.

Government of India, as part of its policy to augment the domestic production of COVID-19 vaccine, has pro-actively encouraged Public Sector Undertakings (PSUs) as well as private companies to enter into technology transfer agreements with Indian vaccine manufacturers.

Two central government PSUs, namely, 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, the statement said.

All these technology transfer agreements have been actively promoted and assisted by Government of India. The Union government has also extended substantial financial assistance to all the above three undertakings.

As a result of this pro-active intervention of the central government, Indian Immunologicals Limited 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 statement said.

Government of India presently is also engaged in pro-active 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.

Under the new policy, 100 per cent doses of imported and ready to use foreign vaccine will be available for other than Government of India channel comprising state governments, private hospitals and hospitals of industrial establishments. The ”Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy” also incentivises in terms of prices to attract private manufacturers including offshore vaccine manufacturers to enter the country, the statement added.

(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)


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