Union health secretary Rajesh Bhushan has said it was an enabling regulatory provision to enable those 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 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 Authorization (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.
Six companies have tied up for manufacturing and technology for making the Sputnik vaccine in India. The details regarding capacity, pricing, production and timeline for roll out in the national immunisation programme will get crystallised.
This decision will facilitate quicker access to foreign vaccines such as those of 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.