Context: The government has decided to fast track approvals for COVID-19 vaccines that have been developed outside India and have been granted the emergency use authorisation (EUA) by other drug regulatory agencies.
- The decision was taken based on the recommendation made by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC).
- India has already approved three vaccines — Covishield, Covaxin and Sputnik V — for restricted use.
- The Subject Expert Committee cleared Sputnik V vaccine on April 12 and the Indian drug regulator’s nod came on Tuesday.
Eligibility: The vaccines that would be eligible for the fast-track approval will include those that have been granted an EUA by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), UK Medicines and Healthcare products Regulatory Agency (MHRA) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or those that have been prequalified by the WHO for emergency use.
- I.e. Pfizer, Moderna and Johnson and Johnson vaccines would be eligible for fast-track approval.
Process of approvals:
- Under the fast-track approval process, the bridging studies will take place in parallel to mass vaccination.
- So far, clinical trials conducted in India were needed before the Indian regulator could approve the vaccine.
- But before mass roll out of the vaccines, the vaccines will be first given to 100 beneficiaries and these individuals will be assessed for seven days for safety outcomes.
- It aims to “expand the basket of vaccines for domestic use and hasten the pace and coverage”.
- The decision will facilitate quicker access to such foreign vaccines by India.
- It would encourage imports including import of bulk drug material, optimal utilisation of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability for domestic.
- The decision finally complies with the WHO’s recommendation of regulatory reliance.
- The World Health Organisation (WHO) defines regulatory reliance as “The act whereby the regulatory authority in one jurisdiction may give significant weight to evaluations performed by another regulatory authority or trusted institution in reaching its own decision.
- The relying authority remains responsible and accountable for decisions taken, even when it relies on the decisions and information of others.
Clinical Trials: A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile or adverse effects of a new drug on humans.
- It is the only way of establishing the safety and efficacy of any drug before its introduction in the market for human use and is preceded by animal trials.
Phases of Clinical Trials: Clinical trials are carried out in four phases. Clinical trials of drugs developed in India have to undergo all four phases of trials in India.
- Phase I or clinical pharmacology trials or “first in man” study, where the new drug is administered to a small number.
- Phase II or exploratory trials, during which the medicine is administered to a group of approximately 10-12 informed patients to determine its effect and also to check for any unacceptable side effects.
- Phase III or confirmatory trials, to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients.
- Phase IV or post-marketing phase or phase of surveillance after the medicine is made available to doctors, who start prescribing it.