196 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 2021-Dec-28 123 KB

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File No. 4-01/2013-DC (Misc. 13 PSC Part Il) Govt. of India Directorate General of Health Services p 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.

3 (SanjeevoNumar) Deputy Drugs Controller (India)

• Copy to: 4. Dr. MS. 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.