Question : Research and Development of Medicine

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether India is far behind in research and development of medicine and if so, the reaction of the Government thereto;

(b) whether India needs to increase the pace of research in regenerative medicine to come up to the global level, especially in the area of clinical trials and regulatory requirement and if so, the details thereof;

(c) whether the Government has prepared any plan of action in this regard with fixed targets and if so, the details thereof;

(d) the funds allocated for the purpose during the last three years and the current year; and

(e) the extent to which the Government has achieved the target and goals so far in this regard?

ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SMT. ANUPRIYA PATEL)
(a): No. India is at par with global developments in the field of research and development of medicine.

(b) to (e): Yes. Regenerative Medicine/Stem Cell Research is such a fast growing field with possible solutions to many disease conditions. Indian Council of Medical Research (ICMR) has updated set of document in 2017, containing guidance for scientists & clinicians to address the ethical, social and scientific issues, in this innovative technology, in harmonization with existing rules/regulations and Acts.

The Central Drug Control and Standard Organisation (CDSCO), M/o H & FW has published draft rules vide GSR 334 dated 04.04.2018 for inclusion of Stem Cell and Cell based Products in the definition of new drug under Drugs and Cosmetics Rules,1945.

There is no earmarked funding for regenerative medicine or Stem Cell Research. However, ICMR has spent Rs. 6.5 crores on research activities in this subject area, during the past three years.