This notice, issued by the Drugs Controller General of India (DCG I) on June 7, 2013, concerns the examination of the safety and efficacy of Fixed Dose Combinations (FDCs) licensed for manufacture and sale in India without due approval from the DCG I office. It references a previous communication (No. 04012013DC Misc. 13PSC dated January 15, 2013) that requested State Licensing Authorities (SLAs) to direct manufacturers to prove the safety and efficacy of their FDCs within 18 months. The current notice addresses the submission of data, specifically Phase IV clinical trial protocols and results. Manufacturers who have not yet submitted their Phase IV clinical trial data, as per appendix X of Schedule Y of the Drugs and Cosmetics Rules, 1945, are urged to do so immediately. Submitted data should follow the usual procedure. Contact person for inquiries is Dr. G.N. Singh, Drugs Controller General India. Copies of this notice have been sent to the Joint Secretary (R), Ministry of Health and Family Welfare, all State/UT Drugs Controllers, all Zonal/Sub Zonal offices of CDSCO, and various manufacturing associations, including IDMA, OPPI, IPA, CIPI, and FOPE. The notice originates from the FDC Division, FDA Bhawan, Kotla Road, New Delhi-110002.
Key Entities Referenced
Directorate General of Health Services: An organization under the Ministry of Health and Family Welfare, involved in health services and public health.
Drugs Controller General India: The head of the Central Drugs Standard Control Organization (CDSCO) responsible for regulating pharmaceuticals and medical devices in India.
Fixed Dose Combinations (FDCs): A combination of two or more active pharmaceutical ingredients in a single dosage form.
State Licensing Authorities: Authorities in each state responsible for issuing licenses for the manufacture and sale of drugs.
Phase IV Clinical Trials: Post-marketing studies conducted to gather additional information about a drug's effects in various populations and any side effects associated with long-term use.
Drugs and Cosmetics Rules, 1945: The set of rules in India that govern the import, manufacture, distribution, and sale of drugs and cosmetics.
Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi: The government ministry responsible for public health in India, located in Nirman Bhawan, New Delhi.
Central Drugs Standard Control Organization (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India.
F. No. 04-01/2013-DC (Mise. 13-PSC)
Directorate General of Health Services
Office of Drugs Controller General (India)
(FDC Division)
FDA Bhawan, Kotla Road,
New Delhi-110002
Dated:
#7 JUN 20%
NOTICE
Subject: Examination for Safety and Efficacy of Fixed Dose Combinations (FDCs)
licensed for manufacture for sale in the country without due approval from
office of DCG (I)-regarding.
Please refer to this office letter no. 04-01/2013-DC (Misc. 13-PSC) dated:
15.01.2013 whereby State Licensing Authorities were requested to ask the concerned
manufacturers to prove safety and efficacy of FDCs within a period of 18 months which
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per usual procedure.
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Youy§ faithfully,
(Dr. GN. Singh)
Drugs Controller Gengral (India)
Copy to:-
Aw JS (R), Ministry of Health and F: amily Welfare, Nirman Bhawan, New Delhi.
All State/UT Drugs Controllers
All Zonal/Sub Zonal offices of CDSCO
Manufacturing Associations: IDMA/OPPI/IPA/CIPI/FOPE
etc.