How many clinical trials are there in India?

The total number of clinical trials registered during the study period was 67,448 across seven study nations.

How are clinical trials performed in India?

Prerequisites of conducting a clinical trial in India Permission from the Drugs Controller General, India (DCGI). Approval from respective Ethics Committee where the study is planned. Mandatory registration on the ICMR maintained website www.ctri.in.

Why do clinical trials in India?

An attractive destination for conducting clinical trials in recent years is India. India offers rapid completion and reduced cost to the sponsors from Canada, Europe and US. Our standards to conduct trials have already risen to the International requirements and made India ready to participate in more global trials.

Who controls clinical trials in India?

The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.

When did clinical research started in India?

The Indian clinical trial market had started flourishing after the amendment of the patent law and Schedule Y of Drug and Cosmetic Rules in 2005. Foreign pharmaceutical companies had turned to India as a drug research opportunity by taking advantage of the vast population and loose regulatory system.

What is NDA filing?

NDA Filing means a New Drug Application filed as a result of activities under this Agreement with the FDA, or the equivalent application to the equivalent agency in any other country of the Territory, the filing of which is necessary to market and sell a Product, including all amendments and supplements to any of the …

How much does a clinical trial cost in India?

For example, the application fees for a Phase III Clinical Trials have increased to INR 200,000 from INR 25,000. While previously there were no fees for a Phase IV study, the applicant must now pay INR 200,000 for a Phase IV study. There are also some new categories for which fees have been included.

How can I get drug approval in India?

The manufacturer / sponsor have to submit application on Form 44 for permission of New Drugs Approval under the provisions of Drugs and Cosmetic Act 1940 and Rules 1945. The document design is as per the International submission requirements of Common Technical Document (CTD) and has five Modules.

Who regulates drugs in India?

The Central Drugs Standard Control Organisation(CDSCO)under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India.