Tuesday, December 4, 2012

Tightening of Norms of Clinical Trials

04-December-2012 12:56 IST
Courtesy Photo
Rules are made or amended by the Central Government in consultation with the Drug Technical Advisory Board (DTAB) as per the provisions of the Drugs & Cosmetics  Act, 1940 and the Drugs & Cosmetics Rules, 1945.  A Statement containing various steps taken / being taken for strengthening of the provisions for conduct of clinical trials in the country is annexed.

Central Drugs Standard Control Organization (CDSCO) headed by the Drug Controller General (India) [DCG(I)] has six zonal offices and four sub-zonal offices in  different parts of the country for undertaking various activities as per the provisions of Drugs and Cosmetics Act and Rules made thereunder, including overseeing clinical trials of new drugs conducted by the drug companies.
           The following measures have so far been taken by the Government for strengthening the regulatory provisions for clinical trials in the country:
Ø  12 New Drug Advisory Committees (NDAC) consisting of experts from the government medical colleges, institutes from all over the country have been constituted. Fresh applications of clinical trial proposals of new drug substances excluding Investigation New Drugs (INDs) are being evaluated by these Committees.
Ø  All IND applications are evaluated by the IND committees.  
Ø  Registration of clinical trial in ICMR registry has been made mandatory since 15.6.2009.
Ø  Every approval / permission for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation for the injury or death and statement to this effect should be incorporated in the informed consent form. Further in case of such injury or death, the details of compensation provided should be intimated to the office of DCG (I).
Ø  Guidelines for conducting Clinical Trial inspection of site and sponsor / Clinical Research Organisations (CRO) have been prepared and posted on the website of the Central Drugs Standard Control Organisation (CDSCO).
1.      Draft Rule and guidelines and requirement for registration of CRO have already been notified.  
2.      Draft rules for incorporation / amendments of following proposals in Drugs and Cosmetics Rules related to clinical trials have been notified.:
Ø  To incorporate a new rule for provisions for payment of compensation in case of clinical trial related injury or death
Ø  To incorporate New Appendix in Schedule-Y mentioning the procedures and methods of providing compensation.
·         Compensation will be borne by the sponsor or his representative.
·         Sponsor or his representative shall prove before the Ethics Committee that the injury or death is not due to clinical trial within 30 days; failing which they shall be liable to provide the compensation within 60 days as decided by the Ethics Committee.
·         Claims made by the subject shall be settled within 90 days.
Ø  To amend the informed consent format to capture the details of address, qualification and occupation, and annual income of the subject.
Ø  To amend patient information sheet to mention that the applicant will provide compensation in case of trial related injury or death.
Ø  To expand responsibilities of investigators to ensure that:
·         The investigator informs the trial subject about his / her rights to claim compensation in case of in trial related injuries on death. 
·         Information is provided about the contact details of representatives of Sponsors / CRO and Ethics Committee.
Ø  To expand the responsibilities of Sponsor:
·         Sponsor shall make payment for treatment and also provide compensation.
·         The details of compensation provided shall be submitted to the DCG (I) within 90 days.
3.      Following proposals to amend the provisions of Drugs and Cosmetics Rules related to clinical trials have been considered and approved by DTAB.:
Ø  To incorporate Rule
·         To have authority for clinical trial inspection by CDSCO assisted by concerned state authority.
·         To take administrative actions like suspension / cancellation of clinical trial permission, restriction of investigator, sponsor / CRO to conduct future clinical trial in case of non-compliance.
Ø  Registration of Ethics Committee
·         To incorporate Rules and Schedule  Y- 2 for registration of Ethics Committee –
·         Quantity of compensation in case of trial related injury or death to be decided by Ethics Committee as per prescribed Guidelines.
Ø  To incorporate amendment in Schedule-Y specifying that clinical trials are required to be conducted at sites which have their own Ethics Committee. However, for conduct of Bio-availability & Bio-equivalence study of drug approved in the country and / or elsewhere (for new drug approval purpose), Ethics Committee approval may be obtained from Independent Ethics Committee of same areas where the site is located.
This information was given by Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a  question in the Rajya Sabha today. (PIB)


No comments:

Post a Comment