**Summary:**
This order, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, on July 3, 2014, outlines a policy regarding the potential banning of marketed drugs in India. The policy stems from the recommendations of an Expert Committee, chaired by Prof. Ranjit Roy Chaudhury, which was formed to develop guidelines for drug approvals, clinical trials, and drug bans. The key provision of the policy states that if two or more countries remove a drug from their market due to concerns regarding its efficacy and/or safety, the continued marketing of that drug in India will be subject to examination and potential action. The order was issued by Dr. G.N. Singh, Drugs Controller General of India, and distributed to various industry associations (IDMA, IPA, OPPI, FOPE, CIPI) and the US FDA, as well as the Ministry of Health and Family Welfare. The file number for this order is 120114DC Pt.47. The CDSCO is located at FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body for pharmaceuticals and medical devices under the Ministry of Health and Family Welfare.
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.
Prof. Ranjit Roy Chaudhury: Chairman of the Expert Committee constituted by the Ministry of Health Family Welfare.
Expert Committee: A committee constituted to formulate policy and guidelines for approval of new drugs, clinical trials, and banning of drugs.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization in India, in this case Dr. G. N. Singh.
IDMA: Likely refers to the Indian Drug Manufacturers' Association, an organization representing pharmaceutical manufacturers.
OPPI: Likely refers to the Organisation of Pharmaceutical Producers of India.
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 Delthi-110002
Date: 03.07.2014
ORDER :
SUBJECT: Consideration of banning of a marketed drug - 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 finalized by the Ministry of
Health & Family Welfare. _
In pursuance to the above, it has been decided that If two or more countries
remove a drug from their market on grounds of efficacy and safety, then the continued
marketing of the drug in the country will be considered for examination and appropriate
action
_ (Dr. G. N. Singh)
Drugs Controller General (India)
To
IDMA/IPA/ OPPI/ FOPE / CIPI
CC to:
US (D), Ministry of Health and Family Welfare