Explore new drug approval process in India, it is crucial for pharmaceutical companies seeking to introduce new drugs to the Indian market.
New Drug Approval Process in India
In India, the Drug and Cosmetic Act of 1940 and Rules 1945 were announced by the Indian Parliament to regulate the import, manufacture, supply and sale of drugs and cosmetics. This process is overseen by the Central Drugs Standard Control Organization (CDSCO), led by the Drugs Controller General of India (DCGI).
Schedule Y
Indian government included Schedule Y to the Drug and Cosmetics Rules 1945 in 1988. Schedule Y offers the guidelines and requirements for clinical trials, which were revised in 2005 to make it equivalent to the procedure recognized across the world. An Indian company if wishes to manufacture/import a new drug should apply for approval from the licensing authority (DCGI) by filling in Form 44 and also submitting data as provided in Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945.
Clinical Trials in India
To validate the efficiency and safety of the new drug in Indian population, clinical trials should be conducted as per the requirements and guidelines specified by Schedule Y. These guidelines for clinical trials were revised in 2005 to make it equivalent to the procedure recognized across the world. According to the Rule-122A of the Drugs and Cosmetics Act, it is not necessary to conduct clinical trials for new drugs that are approved and being used for many years in other countries.
- Section 2.4 (a) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 states that drugs discovered in India should undergo all phases of clinical trials.
- Section 2.4(b) of Schedule Y of Drugs and Cosmetics Act 1940 and Rules 1945 states that for drugs discovered outside India, the applicant should submit the data presented by other countries and the licensing authority may replicate all the studies or allow the applicant to start from Phase III clinical trials.
In 2006, the Drugs and Cosmetics Act was established to introduce definitions for Phase I-IV trials and outline the responsibilities of investigators and sponsors.
Application Process of clinical trials
- To initiate clinical trials in India, an application, along with data on manufacturing, chemistry, control and animal studies, must be submitted to the DCGI.
- Trial protocol, investigator brochures and approval documents should also be included.
- Additionally, a copy of the application must be submitted to the ethical committee.
- Clinical trials can commence only after receiving approval from both the DCGI and the ethical committee.
Phases of Clinical Trials
- Phase I: Performed for controlling the adverse reactions and maximum tolerated dose in healthy human volunteers.
- Phase II: Performed for determining the therapeutic uses and effective dose ranges in 10-12 patients at each dose level.
- Phase III: For generating data related to the efficacy and safety of the drug in about 100 patients from 3 -4 centers, Phase III trials should perform on at least 500 patients from 10-15 centers.
- Phase IV Trials: After New Drug Application (NDA) approval, Phase IV trials are ongoing, where new drug applied in different populations to study long-term effects and more.
You may also like to read Regulatory Requirements for Drug Approval.