Amid being the second worst affected COVID-19 country in the world, India has now taken a big leap towards ending the pandemic and responding to the unprecedented health crisis after the government has given its final approval for the emergency-use of two COVID-19 vaccines. The approval was given on Sunday and it has been expected that India would roll out the vaccination drive soon. 

India's drugs regulator - Drugs Controller General of India (DCGI) has given final approval for two vaccines - one developed by AstraZeneca and Oxford University and the other one being India's indigenous vaccine developed by Bharat Biotech, a state-run institute. Through the final approval, India marks a significant development in treating the global pandemic. 

India has become one of the first-line countries to approve the vaccination and according to Reuters, the country is expected to begin a massive vaccination drive and immunization programme in a week. The second worst affected country is hoping to infuse 300 million of its 1.35 billion people and the government has already announced that the vaccination would be free of charge and the government has targeted to vaccinate these 300 million people in the first six to eight months of 2021. 

The development was commended by Prime Minister Narendra Modi and several ministers. Union Health Minister Harsh Vardhan said, "It's now time to reap the benefits of the robust supply chain infrastructure we have put in place for quick and equitable distribution of the vaccine". Vardhan had urged all citizens to entrust the stringent protocols followed for ensuring the safety, efficacy, and immunogenicity of the approved vaccines. 

DCGI VG Somani said that the overall efficacy of the AstraZeneca/ Oxford vaccine was 70.42%, while Bharat Biotech's Covaxin was safe and provides a robust immune response. Somani further stated that the vaccines are approved for restricted use in emergency situations. The British-developed AstraZeneca/Oxford shot is being made locally by the Serum Institute of India and will be branded as COVISHIELD while Bharat Biotech has collaborated with the Indian Council of Medical Research and developed a vaccine called COVAXIN. 

Somani added that the vaccine developed by Bharat Biotech has been approved in the public interest as an abundant precaution, in clinical trial mode, and to have more options for vaccinations, especially in case of infection by the mutant strains. Prime Minister Narendra Modi had hailed the development and welcomed the approvals. Taking to Twitter, the Prime Minister said, "It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India". 

Narendra Modi had pressed the development as a sign of a self-reliant country. As the vaccination drive is on the verge of getting rolled out, the approvals had stirred major expectations from across the country on combating the invisible enemy that had claimed more than 1.8 million lives globally. Indian company Bharat Biotech had earlier said they could produce up to 300 million doses a year and according to Reuters, the efficacy of the Indian vaccine could go up much more than 60% after two doses are infected. 

Bharat Biotech's chairman Krishna Ella said, "While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most". However, on the other hand, the approvals had drawn flak and a series of questions on the efficacy and transparency of the vaccines. Besides the approval, the Central government has been surfaced with questions over giving the approval without publishing efficacy data for the indigenous COVID-19 vaccine. 

The government has been surfaced with the question of whether it is giving a push to 'Aatma Nirbhar'- self-reliant India without issuing the efficacy and transparency data of the vaccines. Activist Saket Gokhale asked the government that on what basis was this approval given when Bharat Biotech hasn't provided enough data proving safety and efficacy. Gokhale had moved his petition to the RTI demanding the government to issue the data concerning the safety and efficacy of the two vaccines. Along with the activist, former Union ministers and opposition lawmakers had questioned the lack of transparency in approving the vaccines. 

Senior Congress leader Shashi Tharoor asked said that the approval for the vaccines was premature and could be dangerous and Tharoor urged the Union Health Minister to furnish the explanation. Another senior Congress leader Jairam Ramesh said, "Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally accepted protocols relating to phase 3 trials are being modified for Covaxin".