(a) whether the some multinational companies have been conducting clinical trials in
India in view of stringent law in many European countries;
(b) if so, the details thereof and the reasons therefor;
(c) whether the Government proposes to enact a law with regard to clinical trials in
the country;
(d) if so, the details thereof; and
(e) if not, the reasons therefor?
MINISTER OF THE STATE IN THE MINISTRY OF HEALTH & FAMILY WELFARE
(SMT. PANABAKA LAKSHMI)
(a) & (b) It is not a fact that stringent laws in Europe and other countries have driven
these multinational companies to India for clinical trials.
India has some inherent and natural advantages in clinical research. India’s highly
skilled medical fraternity, many world class medical institutions, a large treatment
naïve population, and the cost competitive of Indian research institutions gives India
a definite advantage over other countries in the matter of Clinical Research.
(c) to (e) Regulation for conducting Clinical Trials in the country are prescribed
under Rules 122 DA-122 E and Schedule Y of Drugs & Cosmetics Rules which was amended
in the year 2005.
Good Clinical Practices (GCP) Guidelines were introduced by the Ministry in the year
2001 and Ethical Guidelines for Biomedical Research were issued by Indian Council of
Medical Research (ICMR) in the year 2000.