**Policy Summary:**
This document, issued by the Drugs Controller General of India (DCGI) on June 05, 2014, clarifies the applicability of safety and efficacy requirements for Fixed Dose Combinations (FDCs) licensed by State Licensing Authorities. It refers to a previous directive (File No. 4012013DC Misc. 13PSC, dated January 15, 2013) that mandated manufacturers to prove the safety and efficacy of FDCs licensed by State Licensing Authorities without DCGI approval within 18 months. This clarification states that the requirement to prove safety and efficacy does *not* apply to FDCs licensed by State Licensing Authorities *before* September 21, 1988. This date marks the introduction of new drug provisions in the Drugs and Cosmetics Rules. The communication is addressed to all State/Union Territory Drug Controllers. Copies are sent to the PPS to ASDG, Ministry of Health and Family Welfare, PPS to DGHS, Ministry of Health and Family Welfare, and all Zonal/Sub-Zonal offices of CDSCO. Contact the Drugs Controller General of India, FDA Bhawan, Kotla Road, New Delhi-110002 for any questions.
Key Entities Referenced
Drugs Controller General India: The office responsible for drug regulation in India.
Fixed Dose Combinations (FDCs): Combinations of two or more active pharmaceutical ingredients in a single dosage form.
State/UTs Drug Controllers: Drug regulatory authorities at the State and Union Territory level in India.
State Licensing Authorities: Agencies at the state level responsible for issuing licenses to manufacture drugs.
Drugs and Cosmetics Rules: The set of rules under the Drugs and Cosmetics Act that govern the import, manufacture, distribution, and sale of drugs and cosmetics in India.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India.
New Delhi: The capital city of India and location of relevant government offices.
CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India.
File No. 4-01/2013-DC (Misc. 13-PSC)
Directorate General of Health Services
Office of Drugs Controller General (india)
(FDC Division)
FDA Bhawan, Kotla Road
+ New Delhi-110002
Dated: M5 JUN 2014 |
To,
.
All State/UTs Drug Controllers
Subject’ Approval of the safety and efficacy of Fixed Dose Combinations
(FDCs) permitted for manufacture for sale in the country without due
approval from office of DCG (I)-regarding.
Please refer to this office letter of even no. dated: 15.01.2013 under which
you were requested to ask the manufacturers to prove the safety and efficacy of
such FDCs which were licensed by the State Licensing Authorities without due
approval of DCG(1), within a period of 18 months.
An issue has been raised regarding applicability of above requirements for
FDCs licensed by State Licensing Authorities before 21.09.1988, after which all
relevant provisions relating to New Drugs were introduced in Drugs and Cosmetics
Rules.
The matter has been considered by this office and it is hereby clarified that
requirements of proving safety and efficacy as mentioned above is not applicable for
such FDCs which are licensed prior to 21" September 1988.
Yours faithfully,
(Dr. G./N. Singh)
Drugs Controller Genéral (india)
Copy to:-
1, PPS to ASDG, Ministry of Health and Family Welfare, Nirman Bhawan. New
Delhi,
2. PPS to DGHS, Ministry of Health and Family Welfare, Nirman Bhawan, New
Delhi.
3. All Zonal/Sub Zonal offices of CDSCO.