The Drugs Controller General of India (DCGI) has granted full market authorisation to Covid-19 vaccines Covaxin and Covishield under certain conditions, Union health minister Mansukh Mandaviya said on Thursday. The decision comes almost a week after the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) recommended for upgradation of Covishield and Covaxin status from restricted use in emergency situations to grant of new drug permission with conditions in the adult population.
“The @CDSCO_INDIA_INF has now 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,” Mandaviya tweeted. “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,” Mandaviya added.
According to the government officials, the drug controller granted the approval under the New Drugs and Clinical Trials Rules, 2019. The SEC on January 19 had recommended full market authorisation for Covaxin and Covishield under certain conditions. SII and Bharat Biotech, the manufacturers of Covishield and Covaxin-- both being administered under the national Covid-19 immunisation programme under emergency use authorisation -- had separately applied for full market authorisation.
“Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission,” Adar Poonawalla, CEO of SII recently tweeted.
What is full market authorisation and what does it mean?
The granting of full market authorisation from the CDSCO means that vaccines are fit to meet the prescribed standards of safety, effectiveness and manufacturing quality under the Drugs and Cosmetic Act, 1940, for a new vaccine. Senior officials in the union health ministry said that the panel granted the authorisation after long-term follow-up of clinical trial data of the vaccines in terms of safety and their efficacy in preventing severe Covid-19. Government decides to grant a full market authorisation after it finds the vaccine safe and effective for majority of people who have received them. The authorities also review full data of quality, safety and effectiveness from phase 1, 2 and 3 trials before granting a full market approval.
The development would mean that Hyderabad-based Bharat Biotech’s Covaxin and Covishield, developed by Oxford-AstraZeneca and manufactured by Pune-based Serum Institute of India’s (SII) under a licence, would now be available in the retail market for sale. The emergency use authorisation was an interim approval after considering sufficient evidence suggesting the vaccines were safe and effective. The EUA allowed the vaccines to be used in the general public in government’s supervision.
So far, the sale of both the vaccines was regulated by the government and could only be administered under the government’s Covid-19 immunisation drive, with all the doses manufactured sold and tracked via government. Basically, the manufacturers cannot sell their vaccines in the retail market with an EUA status.
After full market authorisation, the vaccines will be available across medical distribution channels. The clinics and hospitals registered with CoWin platform may also have the vaccines in near future for a price. There may also be a possibility of availing the booster shots, which is now only available for only above 60 years of age with comorbidities and healthcare and frontline workers.
What are the conditions for full market authorisation?
The government would continue post-marketing surveillance. The government said the vaccine manufacturers will, however, have to continue documenting the data from clinical trials and submit it along with the real-world usage data to the regulator on a regular basis. Government also won't allow over the counter sales of these vaccines because of the documentation of each and every Covid-19 vaccine dose being administered in the country.
Will it impact pricing of the vaccines?
The government officials have said that to control pricing of these vaccines, which are the drivers of country’s Covis-19 immunisation program, it has decided to cap the prices even after granting full market authorisation.
The National Pharmaceutical Pricing Authority (NPPA) is working towards capping their prices so that they can still be affordable to people in the retail market.
While Covaxin is currently priced at Rs 1,200 per shot, Covishield is charged at Rs 780 in private vaccination centres, including Rs 150 as service charge. Sources in the union health ministry have indicated that the prices may be capped at Rs 275 per dose of both the vaccines, the centres may be allowed to charge a service charge of Rs 150 as in current scenario.
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