**Policy Summary:**
This notice, issued by the Drugs Controller General of India on January 17, 2017, announces a change in the review process for waiver requests related to clinical trials of new chemical entities. Effective immediately, the Central Licensing Authority (CLA) will be responsible for considering and disposing of waiver requests in accordance with the Drugs and Cosmetics Act, Rules, and relevant government guidelines. The Technical Committee will now serve as an appellate body to resolve disputes related to waiver decisions made by the CLA. This decision was made during the 32nd meeting of the Apex Committee, held on November 3, 2016, under the chairmanship of the Secretary, Ministry of Health & Family Welfare. The notice is addressed to all officers of the Central Drugs Standard Control Organisation (CDSCO), relevant stakeholders, and key personnel within the Ministry of Health & Family Welfare. The Drugs Controller General India is Dr. G.N. Singh.
Key Entities Referenced
Directorate General of Health Services: An organization under the Ministry of Health and Family Welfare, Government of India.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) in India.
New Drugs Division: A division within the Drugs Controller General India (DCGI) responsible for new drugs.
FDA Bhawan, Kotla Road New Delhi: Location of the Drugs Controller General India Office, New Delhi, Delhi
Ministry of Health Family Welfare: A ministry of the Government of India.
Apex Committee: A committee supervising clinical trials on new chemical entities.
Technical Committee: Acts as Appellate Committee in cases of disputes related to clinical trials
Drugs and Cosmetics Act: A law in India regulating the import, manufacture, distribution and sale of drugs and cosmetics.
File No. 12-01/17-DC (Pt-07)
Directorate General of Health Services
Office of the Drugs Controller General (India)
(New Drugs Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 17.01.2017
NOTICE
In 32" meeting of the Apex Committee held on 03.11.2016 under the
chairmanship of Secretary, Ministry of Health & Family Welfare for
supervising clinical trials on new chemical entities, it was decided that-
“In future, cases of waivers need not be brought to Technical Committee
and Apex Committee and these should be considered and disposed of
by the Central Licensing Authority as per provisions of Drugs and
Cosmetics Act, Rules and Guidelines issued by the Government from
time to time and Technical Committee will act as Appellate Committee in
cases of disputes”.
This is for information and necessary action.
(Dr.G.N. Singh)
Drugs Controller General (India)
To
41. All officers of CDSCO (HQ) Zonal /Sub-zonal/Port Offices of
CDSCO
2. All Stakeholders through website of CDSCO
1. PPS to Secretary, Ministry of Health and Family Welfare
2. PPS to DGHS, Ministry of Health and Family Welfare
3. PPS to Additional Secretary (F&D), Ministry of Health and Family
Welfare
4. PS to JS (R), Ministry of Health and Family Welfare