DCGI clears SII, Bharat Biotech's COVID-19 vaccines: Explaining what emergency use authorisation means and why it is essential
In India, drug regulations do not have provisions for emergency use approval and the procedure for receiving one is not clearly defined
Editor's note: This explainer is being republished in light of the DCGI's approval for restricted emergency use of the COVID-19 vaccines developed by Bharat Biotech and the Serum Institute of India.
The Drugs Controller General of India (DCGI) on Sunday approved the COVID-19 vaccines developed by Bharat Biotech, and Serum Institute of India (SII) for restricted emergency use.
In December 2020, as many as three pharmaceutical firms had applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for COVID-19 vaccines that they are developing.
The Indian arm of US pharmaceutical giant Pfizer had on 4 December sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Pune-based Serum Institute of India sought the nod for the Oxford COVID-19 vaccine, Covishield, on 6 December. Bharat Biotech has sought emergency approval for its indigeneously-developed vaccine Covaxin.
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) December 7, 2020
In this context, it comes important to understand what emergency use approval for a vaccine means.
What is emergency use approval?
Manufacturers of vaccines, medicines, diagnostic tests and medical devices have to obtain approval from regulatory authorities before these can be used on the general public.
These approvals depend on an assessment of the safety and effectiveness of these vaccines, medicines, etc., based on data from trials. Each phase of the trials also has to be approved by the regulators.
In India, drug regulations do not have provisions for emergency use approval and the process for receiving one is not clearly defined or consistent, an article in Hindustan Times notes. However, the unprecedented crisis in the form of the COVID-19 pandemic has led authorities to issue such approvals in recent months. The CDSCO has granted emergency or restricted emergency approvals to remdesivir and favipiravir for COVID-19 treatment in June and itolizumab in July.
However, the exact process by which such emergency use approvals are granted is not clear. An article in The Indian Express quotes Murali Neelakantan, lawyer and former global general counsel for Cipla and Glenmark Pharmaceuticals, as saying, "We still don't know the story behind these approvals — we haven't seen the clinical trial data published anywhere and we haven't seen the protocols that were followed for each drug."
The article quoted a senior government official as saying that any company seeking to launch a vaccine approved elsewhere will have to conduct local trials to show that it is safe and effective on the Indian population.
While there is no specific policy on emergency use approval in India, a look at such a policy in the United States gives us an idea of what it could entail. The US' Food and Drug Administration Commissioner can allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases. Such approval can also be granted in situations of chemical or biological warfare.
However, the emergency use approval can only be granted if the "known and potential benefits outweigh the known and potential risks" of the vaccine. Also, such an application can only be considered if sufficient efficacy data from phase 3 trials are known.
A PTI report quoted a source as saying, “DCGI has already started processing the applications. The subject expert committee (SEC) on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9.”
After evaluation, the SEC will give its recommendations to the DCGI on whether emergency use approval for the vaccine candidates should be granted or not, the source said.
At an all-party meeting on 4 December, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks.
With inputs from PTI
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