The approval paves the way for the roll out of at least two vaccines in India in the coming days.
In announcing the emergency use, VG Somani, DCGI chief, said the vaccines were "110% safe", according to The Times of India.
It is indeed a red-letter day for India today as two vaccines for COVID-19 produced by Pune-based Serum Institute's Covishield and Bharat Biotech's Covaxin, received emergency approval from the country's drug regulator this morning. "This is particularly important given the lack of adequate information regarding the UK MHRA's review of the AstraZeneca/Oxford vaccine and the fact that interim data for safety and immunogenicity from the Serum Institute/ICMR Phase 2/3 study have not been made publicy available", it said.
"After detailed deliberations SEC has recommended for grant of permission for restricted use in emergency situation subject to certain regulatory conditions".
The other vaccine, known as COVAXIN, has been developed locally by Bharat Biotech and the government-run Indian Council of Medical Research.
Both vaccines will be administered in two doses and stored at two to eight degrees Celsius, he said. This vaccine is developed on Vero cell platform, which has well-established track record of safety and efficacy in the country and globally.
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Weddings, funerals and places of worship will also be reduced to 100 people and will be subject to the four-square-metre rule. Children under 12 and those with specific health disorders are exempt but encouraged to wear masks where possible.
Nov 16 - Bharat Biotech says it is starting phase III trials.
The news of the sign-off on COVAXIN came after lawmaker Subramanian Swamy, a member of Prime Minister Narendra Modi's nationalist party, complained on Twitter that a foreign-developed shot had been approved while a local one tested on thousands of people at home was "in the ditch".
"The DCGI statement is puzzling and the government must reveal the final data of global efficacy trials and the final trials in United Kingdom which has been shared officially by UK's MHRA following a government to government agreement signed between the two countries which should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine", Anand Sharma added. The results have demonstrated that the vaccine is "safe and provides a robust immune response", the DCGI said.
AESI, the World Health Organization says, is a relatively new AEFI classification that started with pandemic vaccine development. Phase 3 trials for Bharat's drug, Covaxin, are underway with about 20,000 volunteers in 26 hospitals, said Suchitra Ella, Bharat's joint managing director, in a televised interview with Rajya Sabha TV on Friday.
Regarding India's capabilities to transport and store the COVID-19 vaccines at the appropriate temperatures, he said that the programme mechanisms are being strengthened and geared up to cater to the county's population.
Randeep Guleria, director of AIIMS and member of the National Covid-19 task force, told The Indian Express that the approval to Covaxin was given to ensure that in case there was a sudden surge in cases, and the availability of Oxford University vaccine was insufficient, it could be deployed "in clinical trial mode".