New Delhi: Over the last few days, three states — Uttar Pradesh, Maharashtra and Odisha — have floated global tenders for the procurement of Covid-19 vaccines. Delhi Tuesday announced similar plans.
While this has raised hopes of international behemoths such as Pfizer and Moderna stepping in to ease the pressure on Serum Institute of India (SII) and Bharat Biotech — the two domestic manufacturers currently driving vaccinations in India — this may still be some time away.
The reason: Any vaccine requires the nod of the Drug Controller General of India before it can be imported. Currently, only three vaccines are approved for use in India — Covishield of SII, Covaxin of Bharat Biotech, and Russia’s Sputnik V.
The last of these, while developed abroad, is currently being manufactured by five companies in India. Covishield was also developed abroad, but is being made in India by the SII. Covaxin is indigenous.
“The current guidelines for phase 3 of the Covid-19 vaccination programme allow private hospitals, state governments or industrial establishments with hospitals to procure vaccines from abroad. However, such vaccines can be used in India only when the relevant licences have been obtained from the drug controller. A vaccine that is not approved cannot be used,” said a senior official in the Union health ministry.
The central government is in talks with foreign vaccine manufacturers to get their products into India.
“It is submitted that efforts in the direction of procurement of other vaccines from other countries is essentially a responsibility of the central government. For such procurement, significant efforts are being made at several levels, including through diplomatic channels, both within and outside the country,” the central government said in a 9 May affidavit filed in the Supreme Court, which has suo motu taken up the matter of essential supplies’ distribution during the pandemic.
The affidavit also says: “It is submitted that the central government is in active discussions with Pfizer, Moderna, J&J (Johnson & Johnson) and other vaccine developers/manufacturers outside India to facilitate their imports.
“It is submitted that if these efforts are successful, it will make more quantity of vaccines available for the country and thereby lead to increased pace of vaccination.”
Among the companies India is in discussions with, Pfizer is the only one that expressed interest in seeking licensure in the country. The American giant, better known pre-Covid for its erectile dysfunction drug Viagra, had applied to the Central Drugs and Standards Control Organisation for approval last year. However, the company withdrew the application later on.
Sources in the government say the company wants indemnity against lawsuits before it makes any move to enter India. The only company from which states can import currently is AstraZeneca as its vaccine Covishield is already approved in India.
Clinical trial requirement waived but approval still needed
Both Pfizer (US) and Moderna (US) have mRNA vaccines that are currently in use in many countries across the world. Like the ones currently in use in India, both require two doses to realise their full immunogenic potential. However, what makes J&J (US) attractive for India, which is struggling to meet the vaccine requirement for its population, is the fact that it is a single-dose vaccine.
India has made significant relaxations in the approval process for foreign vaccines, especially those that have already received regulatory clearance in some specific geographies. However, that does not waive the requirement for the approval process to be followed.
On 13 April, the Government of India, while accepting the recommendations of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), announced that foreign-made vaccines that have been granted emergency approval for restricted use by global regulatory bodies — such as USFDA, EMA (Europe), UK MHRA, PMDA Japan — or which are named in the WHO’s Emergency Use Listing, may be granted emergency-use approval in India.
However, after approval, they will need to conduct “parallel bridging clinical trial in place of conduct of local clinical trial as per the provisions prescribed under Second Schedule of the New Drugs & Clinical Trials Rules 2019”, it added. A parallel bridging trial would mean one that is conducted even as the vaccine is rolled out.
Pfizer, Moderna and J&J have received emergency-use authorisation in many countries, including some of those mentioned in the Government of India’s statement. But before they can respond to global tenders from Indian states and union territories, they will need to apply for licensure in the country.
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