Vaccine Regulations In India- Explained Pointwise

Recently, the Global pharmaceutical manufacturer, AstraZeneca has admitted that its Covid-19 vaccine, can cause a rare side effect of blood clotting and low platelet count after immunisation. 175 crore doses of the same vaccine have been administered in India under the brand name of Covishield, which has been manufactured by the Pune-based Serum Institute. This development has put the spotlight on Vaccine regulations in India.

What is the Vaccine Regulation in India?

In India, the regulations for the approval of new drugs, which include vaccines, are governed by the New Drugs and Clinical Trial Rules that were notified in March 2019.

A key aspect of granting approval to a vaccine or a drug in India is the requirement of clinical trials conducted within the country- from phase-I to phase-III.

Regulatory Bodies Involved in Vaccine Regulations in India- The manufacture of vaccines in India is strictly controlled by a hierarchy of regulatory bodies.

1. Guidelines provided by the Indian Council of Medical Research (ICMR) set the rules of conduct for clinical trials. These guidelines address ethical issues that arise during Phases I-IV of every vaccine study.

2. The licences and permissions required for the manufacture of any vaccine are obtained under the Drugs and Cosmetics Act, 1940. Clinical study reports after the completion of each phase of the trial (Phase I, Phase II, Phase III, Phase IV) are furnished to the Central Drugs Standard Control Organisation (CDSCO).

3. Upon successful completion of all three phases of the trials (Phase I, II, III), a market authorization application is filed by the manufacturer, as per Rule 122B of Drugs and Cosmetics Rules 1945 (Rules).

Relaxation provided during Pandemic

Emergency use authorizations (EUA) were provided to the vaccines for early remedy of the growing malaise of COVID-19. Special provisions for accelerated approval for a vaccine were employed, for the vaccines which showed ‘Remarkable efficacy’ during Phase-II trails.

What are the challenges associated with the Vaccine regulatory approvals in India?

1. Challenges with Clinical Trials- The clinical trials in India have been plagued by the problems of Mistrust, arbitrary decree, opacity and lax regulations. For ex- Reports of animal cruelty in clinical trials.

2. Delays in approval- In India, the procedure for receiving regulatory approval have been found to be time-consuming. The regulatory and bureaucratic delays have been a sore point in urgent situations like epidemics or emergencies.

3. Primarily focussed on foreign approval- India’s regulatory framework has been primarily focused on analyzing formulations that have received foreign regulatory approval and determining their appropriateness for India.  For ex-  ‘Emergency use authorizations (EUA)’ uses the foreign regulatory approval.

4. Inadequate regulation- Poor regulation of vaccine floods the market with poor-quality and fake medications. The lack of efficiency, safety, and potency standards endangers the life of patients.

5. Inadequate monitoring- The inadequate monitoring of adverse drug reactions and lack of proper post-market surveillance hampers the proper detection and reduction of possible dangers from the adverse reactions of vaccines. For ex- The controversy around Covishield Vaccine.

What should India do to streamline its vaccine regulation?

1. Strengthening of regulatory oversight- We must augment the resources and capacity building of regulatory agencies like CDSCO and the Drug Controller General of India like FDA in the United States or the EMA in the European Union. This will help in proper regulatory scrutiny.

2. New Drugs and Clinical Trials Rules during pandemic- There should be clear guidelines on the process to be followed  for vaccine approval during exigencies and epidemics.

3. Single regulatory agency- The establishment of a single regulatory body will enhance oversight and quicken the approval process for medications.

4. Post-Market Surveillance- Systems for post-market surveillance like VAERS in the United States, will enable us to detect cases of rare adverse events and ensure timely responses to emerging safety concerns.

5. Pharmacovigilance- The current gaps in the regulatory landscape can be filled by creating effective pharmacovigilance programs and encouraging transparency and accountability.