JOIN USCovishield, Covaxin get conditional market approval for use in adult population
India’s drug regulator on Thursday granted a conditional market authorisation for Covishield and Covaxin asking the manufacturers to submit safety data for the two Covid-19 vaccines after every six months, but retained the existing vaccination rules for the recipients at the moment.
“The Central Drug Standards and Control Organisation has upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions,” Union Health Minister Mansukh Mandaviya said in a tweet.
The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis.
While there is no official word on the relaxation of existing rules allowing a common man to buy the vaccines from the market, PTI soon after the approval reported quoting sources that the two jabs would be available in private clinics at pre-decided MRP so that people could buy them. But the shots would be administered as per the prevailing government guidelines only.
Gradually, the vaccine will be available in the market at a price lower than at what it was being sold earlier at private hospitals.
"The idea is that those who are keen to get a booster dose can now avail it through private clinics as the vaccine available in private clinics can be used for any purpose, whether it's first dose, second dose or a booster as one wishes, provided that all guidelines including for eligibility of beneficiaries are followed," sources said.
A regular license would allow the two manufacturers Serum Institute of India (Covishield) and Bharat Biotech (Covaxin) to bring their products to the commercial market for better availability.
"The programme setting would continue, which means application of the vaccines is to be done only through Co-WIN. There would also be monitoring of adverse events following immunisation,” explained Lav Agarwal, a joint secretary in the Health Ministry.
A key difference is currently such safety data is submitted every 15 days but with the upgraded licensing, the companies would have to share the data with the Drugs Controller General of India every six month.
About ten days ago, an expert panel recommended granting regular new drug licenses for the two vaccines instead of the emergency use authorisation after more than a year of their use in India's Covid-19 vaccination programme.
India’s cumulative vaccination coverage crossed 164 crore doses on Thursday, of which 141 crore was Covishield and 23 crore was Covaxin.
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