**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 the requirement for filing applications to market New Chemical Entities (NCEs) in India. This decision follows the Ministry's finalization of actions proposed based on the recommendations of 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.
Specifically, the order stipulates that if India participates in global clinical trials of NCEs intended for diseases prevalent in the Indian population, sponsors and clinical trial applicants must provide an undertaking to CDSCO. This undertaking must state that, upon marketing approval in the innovator country or well-regulated developed country markets, an application will be filed with CDSCO to seek marketing approval for the NCE in India. The intent is to ensure that, after CDSCO approval, these NCEs are marketed in India expeditiously, preferably through domestic production. The order is addressed to NDAC Members, IDMA/IPA, OPPI/ISCR/ACRO, and copied to the US (Under Secretary), Ministry of Health and Family Welfare. Dr. G.N. Singh, Drugs Controller General of India, is the issuing authority. The file number for this order is 120114DC Pt.47.
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 in India.
Ministry of Health Family Welfare: The government ministry responsible for health policy in India.
New Chemical Entities: New Chemical Entities (NCEs) are new drugs that have not been previously approved for marketing.
Prof. Ranjit Roy Chaudhury: Chair of the Expert Committee constituted by the Ministry of Health Family Welfare to formulate policy and guidelines for approval of new drugs, clinical trials and banning of drugs.
CDSCO: Abbreviation for Central Drugs Standard Control Organization, the drug regulatory authority in India.
India: The country where the policy is applicable.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India. The current office holder is Dr. G. N. Singh.
New Delhi: City in Delhi, India. Location of FDA Bhawan and the Central Drugs Standard Control Organization.
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
Date: 03.07.2014
ORDER
SUBJECT: Requirement for filing of application to market New Chemical Entities -
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.
Pursuant to above, it has been decided that if Indian participates in global clinical
trials of NCE(s) to be used for diseases that are prevalent in our population, after approval
for marketing in the innovator country or in well-regulated developed country markets,
approval should be sought from CDSCO for marketing these NCEs in India. After approval
from CDSCO, these NCEs should be marketed in India speedily, preferably by production
within the country.
All the sponsors / clinical trial applicants are hereby directed to provide an
undertaking to CDSCO alongwith the application for approval of clinical trials of such New
Chemical / Biological Entity that after approval for marketing of such entity in the innovator
country or in well-regulated developed country, they will file application to CDSCO seeking
approval for marketing such drugs in the country.
(Dr. G. N. Singh)
Drugs Controller General (India)
To
1. NDAC Members
2. IDMA/IPA/ OPPI/1ISCR/ACRO
CC to:
US (D), Ministry of Health and Family Welfare