**Summary:**
This communication, dated March 25, 2014, from the Drugs Controller General of India (DCGI), addresses all State/UT Drugs Controllers regarding the approval process for Fixed Dose Combinations (FDCs) permitted for manufacture and sale in India without prior DCGI approval. It is a continuation of previous directives issued on January 15, 2013, July 5, 2013, September 2, 2013, and February 3, 2014, on the same subject.
The letter mandates that presentations seeking approval for such FDCs must include the following information:
1. Name of the product, its composition, and intended indication.
2. Rationale for the combination.
3. Pharmacological details of individual drugs, including dosages, indications, and contraindications.
4. Pharmacokinetic data of individual drugs along with published data regarding the safety and efficacy of the specific FDC.
5. Original data generated by the applicant on the applied FDC.
6. Post-marketing surveillance (PMS) data generated by the applicant on the applied FDC.
7. Regulatory status of the FDC in other countries.
8. Information on similar FDCs approved by DCGI, if any.
9. Details of any further studies planned.
The communication emphasizes the mandatory inclusion of this information in the product's package insert during the presentation. State/UT Drugs Controllers are requested to communicate the actions taken in response to this directive to the DCGI's office.
The letter is addressed to All State/UT Drugs Controllers. Copies are sent to ADG(S), DGHS, Ministry of Health & Family Welfare, PS to Hon'ble HFM, Nirman Bhawan, New Delhi, PS to JS, Ministry of Health & Family Welfare, Nirman Bhawan, New Delhi, All Zonal Officers of CDSCO, Members of Committees constituted for evaluation of such FDCs, and Manufacturing Associations (IPA, IDMA, OPPI, SPICS).
The communication is issued by Dr. G.N. Singh, Drugs Controller General India. The office is located in FDC Division, FDA Bhawan, Kotla Road, New Delhi-110002. File No. is 4012013DC Mise. 13PSC.
Key Entities Referenced
Fixed Dose Combinations (FDCs): Pharmaceutical products containing two or more active pharmaceutical ingredients (APIs) in a fixed ratio of doses, used in the context of drug regulation and approval.
Drugs Controller General India (DCGI): The authority responsible for regulating pharmaceuticals and medical devices in India. Mentioned in the context of approval of FDCs.
All State/UT Drugs Controllers: Regulatory bodies at the state and union territory level in India responsible for drug control.
FDA Bhawan, Kotla Road New Delhi: Location of Office of Drugs Controller General India.
Ministry of Health and Family Welfare, New Delhi: Government ministry responsible for health policy in India.
Dr. . N. Singh: Drugs Controller General of India, the signatory of the letter.
PMS data: Post-marketing surveillance data, related to the safety and efficacy of drugs after they have been released to the market.
IPA, IDMA, OPPI, SPICS: Manufacturing Associations related to pharmaceutical domain in India
File No.4-01/2013-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:25 MAR Zul4
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All State/UT Drugs 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.
Sir,
This is in continuation to this office letter dated: 15.01.2013, 05.07.201 3, 02.09.213 and
03.02.2014 on the subject cited above.
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1. Name of product with composition and indication.
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PMS data generated by the applicant on applied FDC, if any.
Regulatory status of FDC in-other countries, if any.
Similar FDC approved, if any by DCG(I).
Further studies planned, if any.
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package insert while coming for presentation.
Action taken in the matter may kindly be intimated to this office
Yours faithfully,
(Dr. &. N. Singh)
Drugs Controller General (India)
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- PS to JS, Ministry of Health and Family Welfare, Nirman Bhawan, New Delhi.
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. F MaD nC us f. acturing Associations: IPA, IDMA, OPPI, SPICS.
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