India¡¯s Central Drugs Standards Control Organisation has cleared the way for foreign vaccines to come to India and released a set of new guidelines for the same.?
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Reported first by ET, with the new guidelines, any private entity can now import the COVID-19 vaccine if that has been approved by the drug regulatory authority and has received an import license for the vaccine.?
In case a vaccine hasn¡¯t really been approved, the importer or authorized agent of the vaccine will be required to obtain permission licence from the aforementioned regulatory authority which will permit the drug under the New Drugs and Clinical Trials Rules, 2019, import registration under Drugs Rules, 1945 and import license under Drug Rules 1945.?
As of now, both the Serum Institute (which makes AstraZeneca-Oxford¡¯s Covishield) and Bharat Biotech (which make Covaxin) are cumulatively able to provide around 75 million doses.?
Adar Poonawal in previous statements has claimed that he aims to push the manufacturing to 100 million doses by July and around 2.3 billion doses annually. Bharat Biotech on the other hand Covaxin has announced that it has ramped up its production to reach 700 million doses per anum.?
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The first vaccine to be permitted with the refreshed set of guidelines will be Russia¡¯s Sputnik V, in collaboration with Dr Reddy¡¯s Laboratories as the company has announced the launch to commence this quarter.?
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It has already received 150,000 doses at the start of this month and is expected to receive another batch of 150,000 doses over the weekend.?
Johnson & Johnson, has teamed up with Hyderbad based vaccine maker Bio E in India. In the US, it is aiming at manufacturing 1 billion doses and has promised to deliver 100 million doses to the US by the end of June. For its facilities in India, however, J&J had aimed at a goal of making 500 to 600 doses every year at Genome Valley facility of Biological E.
Now let¡¯s talk about vaccine makers that don¡¯t have manufacturing tie-ups in India -- Pfizer and Moderna.?
Pfizer has set a goal for manufacturing and shipping 2.5 billion doses of its vaccine globally by the end of this year. They also recently announced that they¡¯d supply a total of 600 million doses to the European Union member states and around 300 million doses to the US by July this year.?
Moderna, on the other hand, has also announced that it plans on boosting its capacity to 700 million to 1 billion doses in 2021 -- 3 billion doses in 2022 and is working to ship up to 1 billion doses in this fiscal year. As of now, it has shipped over 132 million doses globally. It has a target to deliver 100 million doses by the end of May and another 100 million doses by the end of June.?
After eliminating the commitments made by both these companies, and looking at the manufacturing targets laid out by the companies, India could still get enough doses to vaccinate a larger chunk of our population if it does decide to import these vaccines to India.