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Vaccine Regulation in India

2024 MAY 7

Mains   > Social justice   >   Health   >   Miscellaneous


GS 2 >> Public health


AstraZeneca, a global pharmaceutical manufacturer, has recently acknowledged that its COVID-19 vaccine can lead to a rare side effect -Thrombotic Thrombocytopenia Syndrome (TTS) involving blood clotting and low platelet count following immunization. In India, 1.75 billion doses of the same vaccine have been administered under the brand name Covishield, produced by the Serum Institute based in Pune. This revelation has drawn attention to vaccine regulations in India.


In India, regulations governing the approval of new drugs, including vaccines, are outlined in the New Drugs and Clinical Trial Rules established in March 2019.

The process for vaccine approval in India includes several key steps:

  1. Identification and development of a safe and immunogenic vaccine strain.
  2. Full characterization of the vaccine strain through in-vitro experiments.
  3. Pre-clinical studies in small animals (e.g., mice, rabbits, guinea pigs) to assess safety and dosage.
  4. Preclinical studies in larger animals to evaluate safety, efficacy, and formulation.
  5. Phase-I human clinical trials involving fewer than 100 individuals to establish safety.
  6. Phase-II human clinical trials involving usually fewer than 1,000 individuals to assess immunogenicity and immune protection.
  7. Phase-III human clinical trials involving several thousand individuals to determine vaccine efficacy. Regulatory approval is granted after successful completion of these trials.
  8. Phase-IV human clinical trials, or post-marketing surveillance studies, analyze long-term data for decision-making.

Approval for vaccines or drugs in India requires that clinical trials be conducted within the country, from phase-I to phase-III.


  1. The Indian Council of Medical Research (ICMR), which sets guidelines for ethical conduct during clinical trials.
  2. The Central Drugs Standard Control Organisation (CDSCO), which grants licenses and permissions for vaccine manufacture under the Drugs and Cosmetics Act, 1940.
  3. Market authorization applications are filed with the CDSCO after successful completion of all three phases of trials.

During the pandemic, special provisions such as Emergency Use Authorizations (EUA) were implemented to expedite approval for vaccines showing promising efficacy in Phase-II trials.


  • Issues with Clinical Trials: There have been reports of mistrust, arbitrary decrees, opacity, and lax regulations in clinical trials in India. Instances of animal cruelty in trials have also been reported.
  • Delays in Approval: The process of regulatory approval in India can be time-consuming, leading to delays, especially during urgent situations such as epidemics or emergencies.
  • Focus on Foreign Approval: India's regulatory framework has often focused on analyzing formulations that have already received foreign regulatory approval, using mechanisms like Emergency Use Authorizations (EUA) based on foreign approvals.
  • Inadequate Regulation: Poor regulation can result in the flooding of the market with poor-quality or counterfeit medications. This lack of oversight can compromise the efficiency, safety, and potency standards of vaccines.
  • Inadequate Monitoring: Insufficient monitoring of adverse drug reactions and a lack of robust post-market surveillance can hinder the timely detection and mitigation of potential dangers from vaccine adverse reactions. The controversy surrounding the Covishield vaccine is an example of this issue.


  1. Enhanced Resources and Capacity Building: Increase resources and capacity building efforts for regulatory agencies like the Central Drugs Standard Control Organisation (CDSCO) and the Drug Controller General of India. This would enable them to conduct more thorough regulatory scrutiny.
  2. Clear Guidelines for Emergencies: Develop clear guidelines for the approval process of vaccines during emergencies and epidemics, as outlined in the New Drugs and Clinical Trials Rules.
  3. Single Regulatory Agency: Consider establishing a single regulatory body to streamline oversight and expedite the approval process for medications.
  4. Improved Post-Market Surveillance: Implement systems for robust post-market surveillance, similar to the Vaccine Adverse Event Reporting System (VAERS) in the United States. This would help in detecting rare adverse events and responding promptly to emerging safety concerns.
  5. Effective Pharmacovigilance Programs: Create effective pharmacovigilance programs to address current gaps in the regulatory landscape. Encourage transparency and accountability within these programs.


Q: Discuss the regulatory framework and challenges associated with vaccine approvals in India. How can regulatory oversight be strengthened to ensure the safety and efficacy of vaccines?(15M, 250W)