Date: 2021-12-28Category: Not ApplicableState: Union GovernmentCountry: India
Evaluation of certain pre 1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture for sale in the country without due approval from Central Licensing Authority
**Summary:**
This notice, issued by the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India on December 27, 2021, announces the postponement of the expert committee meeting originally scheduled for December 29-30, 2021. The meeting was convened to evaluate certain pre-1988 permitted Fixed Dose Combinations (FDCs) de novo for manufacture and sale in the country without due approval from the Central Licensing Authority. The postponement is in response to requests from stakeholders citing unavailability due to year-end holidays. A rescheduled date for the meeting will be communicated in the near future. Stakeholders including the Indian Drug Pharmaceuticals Association (IDMA), FOPECI, IIPA, and OPPI are requested to disseminate this information to their members. The notice is for the information of all concerned and is also available on the CDSCO website. Contact for further information: Sanjeev Kumar, Deputy Drugs Controller India. File No. 4012013DC Misc. 13 PSC Part II.
Key Entities Referenced
Central Drugs Standard Control Organization: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Fixed Dose Combinations: Refers to the combination of two or more active pharmaceutical ingredients in a single dosage form.
Central Licensing Authority: The authority responsible for granting licenses for the manufacture and sale of drugs in India.
Expert Committee: A committee formed to evaluate pre-1988 permitted Fixed Dose Combinations (FDCs).
Sanjeev kumar: Deputy Drugs Controller of India.
UCMS, New Delhi: University College of Medical Sciences, located in New Delhi, Delhi.
Indian DrugPharmaceuticals Association: An association representing the Indian pharmaceutical industry.
FDC Division FDA Bhawan, Kotla Road New Delhi: Location of the FDC division of Central Drugs Standard Control Organization in New Delhi, Delhi.
File No. 4-01/2013-DC (Misc. 13 PSC Part Il)
Govt. of India
Directorate General of Health Services
Central Drugs Standard Control Organization
(FDC Division)
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 27.12.2021
NOTICE
Subject: Evaluation of certain pre 1988 permitted Fixed Dose Combinations
(FDCs) de novo for manufacture for sale in the country without due
approval from Central Licensing Authority -regarding.
This is with reference to this office Notice of even no. dated 21.12.2021 on the
subject cited above. In this regard, various representations have been received from
Stakeholders with the request to postpone the expert committee meeting scheduled
to be held on 29.12.2021 & 30.12.2021 as most of the companies will not be
available for the meeting on account of year end holidays.
In view of above, the said meeting has been postponed and schedule for the
next meeting will be communicated shortly.
This is for information of all the concerned.
é ¢
(Sanjeev umar)
Deputy Drugs Controller (India)
C 1.o p Dy r. to M: S. Bhatia, Prof. & Head, D/o Psychiatry, UCMS, New Delhi, Chairman,
Expert Committee.
2. To all the experts committee members.
3. Indian Drug/Pharmaceuticals Association (IDMA/FOPE/CIPI/IPA/OPPI, etc.,)
with the request to communicate it to your members and publicize it widely so
that all concerned can avail this opportunity.
4. Website of CDSCO for information and necessary action by concerned
stakeholders.