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PUNE: Biovet Pvt Ltd, an associate firm of Bharat Biotech, is confident of making a plant at Manjari in Pune “fully functional” for vaccine production by August- end, a senior administrative official has said.
Hyderabad-based Bharat Biotech is the manufacturer of Covaxin, one of the two vaccines being used in the nationwide COVID-19 inoculation drive.
Pune divisional commissioner Saurabh Rao and district collector Rajesh Deshmukh visited the plant on Wednesday.
The Bombay High Court recently permitted Biovet to take possession of a ready-to-use vaccine manufacturing plant, built on a 12-hectare plot at Manjari in Pune, to produce Covaxin.
“The plant has a ready infrastructure. Another strength of the company is that it is very competent and has a dedicated team. I do not think there is any need to create any infrastructure to start production. Everything is in place,” Rao told PTI on Thursday.
Biovet officials, however, are still assessing the infrastructure available at the plant, he said.
“Since vaccine manufacturing is a very sophisticated and sensitive subject and the process is absolutely scientific, they can not take any chance.
“So they are assessing the entire manufacturing line and other machinery,” the commissioner added.
Biovet officials have promised that within a week, they would be able to complete assessment of the facility, he said.
“With the kind of encouragement and support the firm is getting from the Centre and the Maharashtra government about licencing, permissions, regulatory decisions, etc, they are confident of making the plant fully functional by the end of August and roll out the first batch of the vaccine,” Rao said.
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Recently, the High Court permitted Biovet to take possession of the vaccine manufacturing plant.
The HC gave the nod while hearing an application filed by Karnataka-based Biovet, seeking direction to the Maharashtra government to hand over possession of the unit.
The HC had said that considering the COVID-19 situation, the authorities concerned should hand over the facility to Biovet.
The plant was earlier used by Intervet India Pvt Ltd, a subsidiary of Merck & Co, a US-based multinational pharma company, after land was granted to it in 1973 to manufacture vaccine for foot and mouth disease.
Intervet is exiting business operations in India and entered into an agreement with Biovet to transfer the land and manufacturing unit to the latter.
the central government on Thursday said it will provide all possible assistance to all companies willing to manufacture the vaccine to ramp up the supply.
It, however, flagged the non-availability of a sophisticated laboratory with most vaccine makers that is necessary to produce the indigenously developed Covaxin jab.
The Centre also rejected Delhi government’s claim that Covaxin maker Bharat Biotech has refused to provide “additional” vaccine doses to the Delhi government, saying the national capital has received over 15 lakh doses of the vaccine and its role is to facilitate the states.
On Tuesday, Deputy Chief Minister Manish Sisodia had alleged the Covaxin manufacturer in a letter said it cannot provide the Delhi government vaccines due to unavailability, under instruction of government officials concerned.
“It means that the central government is controlling supply of the vaccine,” Sisodia, who is a senior Aam Aadmi Party (AAP) leader, had said.
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Addressing a briefing of the Union Health Ministry, Niti Aayog Member (Health), V K Paul said Government of India’s role is to facilitate.
“We refute (the charge) that there is any pressure on anybody not to supply to any particular state,” he said, adding that such charges affect the morale of vaccine manufacturers.
“It is because of them that we are in the position of not asking others (countries for vaccines),” Paul said.
He said Bharat Biotech is also ramping up its capacity and has already roped in three public sector undertakings.
Earlier, Delhi Chief Minister and AAP national convenor Arvind Kejriwal had written to Prime Minister Narendra Modi, saying the Centre should share the vaccine formula of Covaxin and Covishield with other capable pharmaceutical companies to scale up production in the country.
On increasing production of Covaxin, Paul said Bharat Biotech has already welcomed the move of ramping up production of doses by involving other players.
“They also reached out and under this initiative, our PSUs have been connected to this process,” he said.
Last month, the Department of Biotechnology (DBT), under Mission COVID Suraksha, spelt out a plan to ramp up production of Covaxin and double it by May-June by roping in three public sector companies (PSUs).
The PSUs are Haffkine Biopharmaceutical Corporation Ltd, Mumbai, a PSU under the Maharashtra government; Indian Immunologicals Limited (IIL), Hyderabad, a facility under National Dairy Development Board; and Bharat Immunologicals and Biologicals Limited, Bulandshahr, a PSU of the Department of Biotechnology, to increase the capacity of vaccine production.
“The current production capacity of indigenously developed Covaxin will be doubled by May-June 2021 and then increased nearly 6-7 fold by July-August 2021, i.e.increasing the production from 1 crore vaccine doses in April 2021 to 6-7 crore vaccine dose/month in July-August.
It is expected to reach nearly 10 crore doses per month by September 2021,” the DBT had said.
Reacting to this, Kejriwal on Thursday tweeted, “A very welcome step by central government. It will help in ramping up production.”
“I also urge the Centre to directly procure vaccines from foreign companies rather than each state bidding against each other in international market,” he tweeted.
Giving details about Covaxin, Paul said that it is made by inactivating a live virus.
“This happens only in the BSL3 (Biosafety Laboratory-3) laboratory which is very sophisticated. Such laboratories are mostly not there in other companies. It is not something that every company has. Those companies who want to do this, we give an open invitation and we have already reached out from our side to make it together,” he said.
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“Still our request is, those who want to make this vaccine, the government will provide full assistance to ramp up the capacity,” Paul said.
During the briefing, Paul said that 75,000 Covaxin doses have been given to Delhi in May.
“In January-May, 13,91,000 Covaxin doses were received by Delhi. The state has procured 1 lakh doses, while private (institutions) have got 20,000 doses,” he said.
According to the vaccine bulletin issued by the Delhi government, the Centre has provided 13,91,000 doses of vaccine to the Delhi government and it has procured 1,50,000 doses from Bharat Biotech.
So far, it has received 43,20,490 doses of Covishield and Covaxin.
Following the allegations levelled by the Delhi government, Joint Secretary in the Union Health Ministry Lav Agarwal had denied that the Centre had any role to play in the purchase of vaccines by states.
Bharat Biotech on Wednesday had said it is quite disheartening to listen to some states complaining about the company’s intentions regarding supply of Covaxin.
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.
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“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.
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