**Summary:**
On July 3, 2014, the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare issued an order (File No. 120114DC Pt.47) regarding the waiver of clinical trials in the Indian population for the approval of new drugs. This decision follows the submission of a report by an Expert Committee, chaired by Prof. Ranjit Roy Chaudhury, which was tasked with formulating policy and guidelines for new drug approvals, clinical trials, and drug banning. The Ministry of Health & Family Welfare finalized actions based on the Expert Committee's recommendations. The order specifies that waivers for clinical trials in the Indian population for new drugs already approved outside India will currently only be considered in cases of national emergency, extreme urgency, epidemic, orphan drugs for rare diseases, and drugs indicated for conditions/diseases where no therapy exists. The Drugs Controller General of India, Dr. G.N. Singh, is the contact person. The order was disseminated to industry associations including IDMA, IPA, OPPI, and ISCRACRO, as well as NDAC and MDAC members. A copy was also sent to the US D, Ministry of Health and Family Welfare.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices in India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
New Delhi, Delhi: The location of FDA Bhawan, where the order was issued.
Clinical Trial: A research study conducted to evaluate the safety and efficacy of new drugs or medical treatments.
Indian population: Refers to the population of India, in the context of clinical trials for drug approval.
Prof. Ranjit Roy Chaudhury: Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
IDMA IPA OPPI ISCRACRO: List of Pharmaceutical Associations
File No. 12-01/14-DC Pt.47
Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
FDA Bhawan, Kotla Road, New Delhi-110002
Dated: 03.07.2014
ORDER
SUBJECT: Waiver of Clinical Trial in Indian population for approval of New Drugs-
regarding
The Ministry of Health & Family Welfare had constituted an Expert Committee
under the Chairmanship of Prof. Ranjit Roy Chaudhury to formulate policy and guidelines
for approval of new drugs, clinical trials and banning of drugs. The Expert Committee
submitted its report to the Ministry of Health & Family Welfare. The actions proposed to be
taken on the recommendations of the Expert Committee were finalised by the Ministry of
Health & Family Welfare.
In pursuance to above, it has been decided that waiver of Clinical Trial in Indian
population for approval of new drugs, which have already been approved outside India,
can presently be considered only in cases of national emergency, extreme urgency, and
epidemic and for orphan drugs for rare diseases and drugs indicated for
conditions/diseases for which there is no therapy.
(Dr. Gj N. Singh)
Drugs Controller Gengral (India)
To:
1. IDMA /IPA/ OPPI/ISCR/ACRO
2. NDAC / MDAC Members
CC to:
US (D), Ministry of Health and Family Welfare