Regular market approval to Covishield, Covaxin expected soon after final price fixation: Sources

The regular market approval from Drugs Controller General of India (DCGI) to COVID-19 vaccine Covishield and Covaxin is expected soon, but only after price fixation which is still underway, official sources told ANI on Wednesday. Recently, the National Pharmaceutical Pricing Authority (NPPA), DCGI, Drug regulators and senior officials of the Union Health Ministry conducted a meeting regarding fixing the prices of Covishield and Covaxin, but no final decision has been taken yet. 

It is expected that the price of a vaccine will be fixed below Rs 275 per dose and additional service charges of 150 to make both the vaccines affordable for all. As per the earlier information given by the Central Drugs Standard Control Organisation (CDSCO), "Subject Expert Committee (SEC) of CDSCO has recommended for an upgrade of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population, DCGI will evaluate the recommendations and give its decision." The Serum Institute of India (SII) and Bharat Biotech both applied for market approval for the Covishield and Covaxin respectively in December 21. 

The subject expert committee during the meeting that was held last week asked both the vaccine manufacturing companies to submit more data before granting market approval. The market authorisation for vaccines means that they can be authorized for use without reservation and conditions.