New Delhi: The subject of the drug regulator (SEC) expert committee on the Covid vaccine on Wednesday recommended full authorization for two used Jabs – Covishield and Covaxin.
However, the vaccine will continue to be available and managed only in the centers listed under the Government Cowin platform, the official source said.
After the drug controller General India gives final approval, which is expected in one or two days, the manufacturer – Serum Institute of India and Bharat Biotech – no need to submit safety data and data related to side effects every 15 days for doses given under the immunization program, said source.
Instead, they must do it once in six months as determined for other new drugs under the drug law and cosmetics.
“The SEC CDSCO has recommended an increase in Covishield and Covaxin status from limited use in emergency situations to provide new drug permits with conditions in the adult population.
DCGI will evaluate recommendations and give a decision,” said an official.
Asked whether individuals will now be able to buy jabs from chemists, the official said to the Toi: “It would not be possible because the vaccine came in the 10 dosage vial.
In addition, every managed dose needs to be tracked under the Cowin system.
Every center that manages the vaccine It must be registered under the Government Cowin platform.
“Allowing retail sales will create many challenges in monitoring production, availability and vaccine administration.
Cowin registration also allows the government to issue a vaccination certificate.
Toi has reported on January 15 that Covid-Vaccines will not be available in the retail market in the near future even though the regulator expert committee can rule out certain conditions which are part of the current regulatory agreement.
Conditions are imposed because vaccines are given accelerated approval based on limited clinical trial data in the emergency pandemic situation.