Emergency Use Approval: Covid-19 Vaccines
- 09 Dec 2020
- 6 min read
Why in News
Recently, three vaccine developers have made applications to the Central Drug Standard Control Organisation (CDSCO), seeking emergency use approval for their candidate Covid-19 vaccines.
- The vaccine for which the developers are seeking approval are still under trial.
- Candidates for Covid-19 vaccines:
- 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.
- Emergency Provisions:
- 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.
- A clinical trial is a systematic study to generate data for discovering or verifying the clinical and pharmacological profile (including pharmacodynamic and pharmacokinetic) or adverse effects of a new drug on humans.
- Phases of Clinical Trials:
- Clinical trials are carried out in four phases.
- Phase I or clinical pharmacology trials or “first in man” study: This is the first time where the new drug is administered to a small number, a minimum of 2 healthy, informed volunteers for each dose under the close supervision of a doctor.
- The purpose is to determine whether the new compound is tolerated by the patient's body and behaves in the predicted way.
- Phase II or exploratory trials: During this phase, the medicine is administered to a group of approximately 10-12 informed patients in 3 to 4 centers to determine its effect and also to check for any unacceptable side effects.
- Phase III or confirmatory trials: Purpose is to obtain sufficient evidence about the efficacy and safety of the drug in a larger number of patients, generally in comparison with a standard drug and/or a placebo as appropriate. In this phase, the group is between 1000-3000 subjects.
- Phase IV trials or post-marketing phase: Phase of surveillance after the medicine is made available to doctors, who start prescribing it. The effects are monitored on thousands of patients to help identify any unforeseen side effects.
- Regulatory Mechanism in India:
- Clinical trials in India are governed by the following acts: Drugs and Cosmetics Act, 1940, Medical Council of India Act, 1956 and Central Council for Indian Medicine Act, 1970.
- Prerequisites of conducting a clinical trial in India are:
Central Drugs Standard Control Organisation (CDSCO)
- CDSCO is under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India.
- The Drugs & Cosmetics Act, 1940 and Rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics.
- Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials.
- Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine etc.