REGULATORY APPROVAL OF VACCINES

Subject: Governance

Context: Covid-19 second surge: Centre clears way for foreign vaccines, fast-tracks approval.

Concept:

Government announced it would not enforce the pre-condition of conducting phase 2 and 3 clinical trials in India for those vaccines that have been granted emergency approvals by the US, EU, UK and Japanese regulators, including those listed by the WHO.
The Centre said that the decision to ease regulatory approvals was taken on the recommendation of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC).
The Union Ministry of Health and Family Welfare said the foreign manufactures have to comply with one condition: the first 100 beneficiaries would be assessed for seven days for safety outcomes before the vaccines are rolled out for the immunisation programme.
Companies will also have to conduct a “post-approval parallel bridging clinical trial”.

Regulatory Provisions for Approval of Vaccines in India:

Clinical trials of new drugs and vaccines, and their approvals, are governed by the Drugs and Clinical Trials Rules, 2019.
There is nothing such as emergency use approval in Indian rules, however the 2019 rules provide for “Accelerated Approval Process” in several situations that would include the one like the current pandemic.
In such situations, there is a provision for granting approval to a drug that is still in clinical trials provided the product is of meaningful therapeutic benefit.
Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs.
A new drug, or a vaccine, can be considered for approval if remarkable effectiveness is reported even from phase-II trials.
In such cases, additional post licensure studies may be required.
The approval granted to drugs or vaccines that are still in clinical trials is temporary, and valid only for one year.