Clinical Trials in the Country

Clinical trial is an essential component of drug discovery research. In order to generate adequate evidence to establish safety and efficacy of any new drug for any specific indication, it is necessary that over and above in vitro studies and in vivo studies in animals, the product is also administered to human subjects (healthy human subjects and/or patients) and clinically studied under a well-defined protocol, to establish its safety and efficacy. As per the Clinical Trial Registry (www.clinicaltrials.gov) maintained by the National Institute of Health, USA, as against 1,30,302 clinical trials reported from various parts of the world as on 3.8.2012, only 2010 clinical trials were conducted in India as compared to 63,036 in USA, 34,616 in Europe, 3,091 in China and 3,551 in South Korea. As per the Clinical Trial Registry (CTRI) maintained by the ICMR, New Delhi, the number of clinical trials approved by Central Drugs Standard Control Organization (CDSCO) during the last few years is as under:

Year	Number of approved clinical trials registered at CTRI
2007	3
2008	65
2009	391
2010	500
2011	321
2012	262
Total	1542

However, certain cases of irregularities in the conduct of clinical trials have been reported in the country.

Recently, several new regulatory initiatives and legislative measures have been taken by the Government, especially for the safety and well-being of the clinical trial participants and compensations have been paid to the clinical trial participants. The Drugs and Cosmetics Rules, 1945 have been amended by the notifications G.S.R. 53(E) dated 30.1.2013, G.S.R. 63(E) dated 1.2.2013 and G.S.R No. 72(E) Dated 8.2.2013 for strengthening of regulatory mechanism for the conduct of clinical trials, which inter alia include:-

Provision for compensation in case of injury or death due to clinical trials and free medical management as long as required.

Expansion of responsibilities of Sponsor, Investigator and Ethics Committees to ensure that the reports of Serious Adverse Events (SAEs) including deaths are reported, analyzed as per the prescribed timelines and in case of clinical trial related injury or death, compensation is paid as per the prescribed procedures. 

Revised and more elaborate informed consent documents.

Time-bound reporting of injury or death to the DCG(I).

 Constitution of independent Expert Committee by DCG (I) to examine the cases of deaths and give recommendations to DCG (I).

Registration of clinical trials at Clinical Trials Registry of India before enrolling the first patient for the study.

Registration of Ethics Committee, valid for a period of three years and suspension or cancellation of the registration in case of non-compliance to the provisions.

Authorization to CDSCO to inspect, search and seize any records, documents, drugs, etc.

Provision for suspension or cancellation or debarment from conduct of clinical trials in case of non-compliance to the provisions.

The above information was given by the Union Minister for Health & Family Welfare, Shri Ghulam Nabi Azad in a written reply to a question in the Rajya Sabha on February 26, 2013.