Sunday, October 17, 2021

Government exploring possibility of Covaxin production outside India – ET HealthWorld

To address the shortage of Covid-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.

The government also intends to take up the matter with the World Health Organisation (WHO) to step up Covaxin production.

It will also take up with Moderna, Johnson and Johnson and other vaccine makers the issue of granting voluntary licence to third-party manufacturers in India on transfer of technology basis.

These issues were discussed in an inter-ministerial meeting on May 18 to deliberate upon the options, including voluntary licence, compulsory licence and government use authorisation under the Patents Act, 1970, available to increase the availability of drugs and vaccines used for treatment of Covid-19.

The Ministry of External Affairs has also been asked to take up the matter with AstraZeneca, the maker of Covishield, to encourage them to grant more voluntary licences in India.

The MEA and the Department of Biotechnology (DBT) will also prepare a roadmap to address raw material supply constraints for Covishield and identify the sources of raw material, sources said.

As for Pfizer vaccine, the Department for Promotion of Industry and Internal Trade (DPIIT) to take up the matter with MEA, Niti Aayog and Law Secretary to prepare a status report on the issue of indemnity and liability agreement being proposed by vaccine manufacturer, they added.

Many states have complained about the shortage of vaccines. To address the issue, the government has been taking measures to ramp up the production of Covaxin.

Last week, V K Paul, Member (Health) in the Niti Aayog said Covaxin requires a Biosafety Laboratory-3, a facility which is not available with all.

The DBT and the Drug Controller General of India (DCGI) have been asked to identify manufacturers having BSL-3 facility as well as those who can establish such a facility to increase manufacturing sites in India, sources said.

“The MEA (has been asked) to take up the exercise of identification of Covaxin manufacturing sites globally in consultation with DBT. DoHFW (Department of Health and Family Welfare) may take up the matter with WHO to boost manufacturing of Covaxin,” a source said.

The DBT has been asked to inform about incentives including royalty being given to Bharat Biotech for grant of licence to manufacture Covaxin on transfer of technology basis.

Last month, the DBT announced a plan to significantly ramp up the production of Covaxin.

This included roping in three public sector companies — Haffkine Biopharmaceutical Corporation Ltd, Mumbai, a PSU under the Maharashtra government; Indian Immunologicals Limited (IIL), Hyderabad, a facility under National Dairy; and Bharat Immunologicals and Biologicals Limited (BIBCOL), Bulandshahr, a PSU under the DBT.

Paul had said 7.5 crore doses are expected to be produced by August and 10 crore by September.

The DBT last week also said Gujarat Biotechnology Research Centre, Department of Science and Technology of the Gujarat government, along with Hester Biosciences and OmniBRx, has also firmed up its discussions with Bharat Biotech to scale up the Covaxin technology and to produce minimum 20 million doses per month.

Technology transfer agreements have been finalised with all manufacturers.

Separately, plans are on to manufacture the vaccine in Maharashtra and Karnataka.

Last week, the government estimated that by December, the country will have 216 crore vaccines, including 75 crore doses of Covishield and 55 crore doses of Covaxin.

Further, Biological E is expected to produce 30 crore doses, Zydus Cadila 5 crore, Serum Institute of India 20 crore doses of Novavax, and Bharat Biotech 10 crore doses of its nasal vaccine, while Gennova will make available 6 crore doses and Sputnik V 15.6 crore doses, he said.

The vaccine candidates of Biological E, Zydus Cadila, Gennova, Bharat Biotech’s nasal vaccine are in various stages of clinical trials.

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