The Central Drug Standard Control Organisation (CDSCO) has recently received applications from three vaccine developers seeking emergency use approval for their candidate Covid-19 vaccines. These vaccines are still currently under trial.
Vaccine Candidates Awaiting Approval
Awaiting emergency use approval are three vaccines: COVISHIELD, COVAXIN, and BNT162b2. COVISHIELD is by the Pune-based Serum Institute of India, and it is currently in its Phase-III trials. COVAXIN, developed by Bharat Biotech, a company based in Hyderabad, is also in its Phase-III trials. The third candidate, BNT162b2, was developed in collaboration between US pharmaceutical giant Pfizer and BioNTech, although no trials have taken place in India up to this point.
Regulations for Vaccine Approval in India
In India, clinical trials and the subsequent approvals of new drugs and vaccines are governed by the Drugs and Clinical Trials Rules, 2019. According to these rules, there isn’t any provision for emergency use approval. However, an “Accelerated Approval Process” caters for specific situations, which could include a pandemic such as the one at present.
This means a drug that’s still in clinical trials could be given approval if it can demonstrate therapeutic benefit. If it is designed to treat a serious disease or condition with high relevance to the country, and meets unmet medical needs, it may also qualify for accelerated approval. If the drug shows remarkable effectiveness during phase-II trials, it may be considered for approval, subject to additional post-licensure studies. Any approval given to drugs or vaccines still undergoing trials is temporary and only valid for a year.
The Clinical Trial Explained
Clinical trials are systematic studies aimed at generating data that helps discover or verify the clinical and pharmacological profile of a new drug, including its potential adverse effects on humans. These trials are carried out in four phases.
Phase I or clinical pharmacology trials involve administering the new drug to a small number of healthy volunteers. Phase II or exploratory trials assess the drug’s effects on a group of approximately 10-12 patients. The purpose of Phase III or confirmatory trials is to gather sufficient evidence about the drug’s efficacy and safety on a larger patient population. Lastly, during Phase IV trials or post-marketing phase, the effects of the medicine are monitored on thousands of patients to identify any unforeseen side effects.
Regulatory Mechanisms in India
Clinical trials in India are regulated by several acts, including the Drugs and Cosmetics Act, 1940, the Medical Council of India Act, 1956, and the Central Council for Indian Medicine Act, 1970. Conducting a clinical trial in India requires permission from the Drugs Controller General, India (DCGI), approval from the respective Ethics Committee where the study is planned, and mandatory registration on the website maintained by The Indian Council of Medical Research (ICMR).
About the Central Drugs Standard Control Organisation (CDSCO)
The CDSCO is the National Regulatory Authority (NRA) of India, operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. Various responsibilities related to the regulation of drugs and cosmetics have been entrusted to central and state regulators by The Drugs & Cosmetics Act, 1940 and Rules 1945. CDSCO plays a crucial role in approving drugs and conducting clinical trials. CDSCO, along with state regulators, grants licenses of certain specialized categories of critical Drugs such as blood and blood products, I.V. Fluids, Vaccines, etc.