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A change in the country’s regulatory process for fast-tracking emergency approval of Covid-19 vaccines, approved by regulators in the US, UK, EU, Japan or by WHO, will compress the timeline to launch vaccines in India. This is a liberal regulatory step to improve access to vaccines, V K Paul, member (health), Niti Aayog said. This was being done under special circumstances and because of the sense of urgency caused by the pandemic, so a pre-condition for prior clinical trial will not be applicable, Paul said. However, a bridging study will continue even after the vaccine is rolled out.
This decision was taken up on the recommendation of the National Expert Group on Vaccine Administration (NEGVAC), Paul said at a media briefing on Tuesday. Paul chaired the NEGVAC meeting that recommended this change in regulation. The first 100 beneficiaries of the foreign vaccines to be allowed in India will be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country.
Union health secretary, Rajesh Bhushan said this was an enabling regulatory provision to enable Covid-19 vaccines, approved by credible foreign regulators, to launch in the country and it denoted fastracking and streamlining of the regulatory approval system. The availability of the vaccine becomes faster and it also opens up doors for import of bulk or import of finished vaccines in vials or import leading to fill and finish in India so it has a far reaching impact in the country, Bhushan said.
At present, Covaxin by Bharat Biotech and Covishield by Serum Institute of India have received Emergency Use Authorisation (EUA) from the national regulator, Drugs Controller General of India (DCGI). The regulator, on Tuesday, approved EUA for the Russian vaccine Sputnik and this was a significant step in the country’s vaccination drive, Paul said. Six companies have tied up for manufacturing and technology tie-up for making the Sputnik vaccine in India.
This decision will facilitate quicker access to foreign vaccines such as those by Moderna and Pfizer, but whether it would be applicable for the Serum Institute’s Novovax vaccines is not clear as it is currently undergoing trials in India.
This decision was expected to encourage imports, including import of bulk drug material, optimal utilisation of domestic fill and finish capacity to provide a fillip to vaccine manufacturing capacity and total vaccine availability in the country.