The subject expert panel on Covid-19 vaccines on Wednesday recommended to the Central Drugs Standard Control Organisation that Covishield and Covaxin be granted regular market approval. Currently, the vaccines have clearance for restricted use in emergency situations.
The regulatory authority also said that it has recommended certain conditions for granting of the new drug permission. However, it did not specify the conditions. The final decision on the matter will be taken by the Drugs Controller General of India, the Central Drugs Standard Control Organisation said in a tweet.
At a press conference on Thursday evening, Union Health Secretary Rajesh Bhushan also said if the market approval is granted to Covaxin and Covishield, certain conditions will be imposed.
Covishield and Covaxin have been available in India since January last year under an emergency use authorisation from the drug regulator. An emergency use authorisation is granted during public health emergencies, based on results of clinical trials.
The lifting of the emergency use authorisation label would effectively make availability of vaccines easier and provide an opportunity for its entry into the distribution channel.
Once the Drugs Controller General of India approves the vaccine panel’s recommendation, the Covishield and Covaxin shots may soon be available in smaller private clinics unless the government decides to continue with the existing system of immunisation. However, it is still expected to take some time before consumers could buy the vaccines from retail outlets.
The upgradation would also mean that manufacturers of the two vaccines, Serum Institute of India and Bharat Biotech, will no longer be required to submit adverse event reports every fortnight. Currently, they are mandated to do so under the Drugs and Cosmetics Act, 1940.
Last month, the Serum Institute of India, which manufactures Covishield shots, had applied for a full market authorisation of the vaccine. The company’s Chief Executive Officer Adar Poonawalla had said that supplies of Covishield in India have crossed 1.25 billion doses, and that the government has enough data for granting full market authorisation.