193 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 2022-Jan-06

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: 0 i) JAN 1022

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 in continuation to this office notice dated 27.12.2021 whereby the meeting of the Expert Committee was postponed which was scheduled to be held on 29" & 30"" December 2021.

Now, the expert committee again invites the concerned stakeholders for hearing through WebEx (Video Conference) on 27" & 28" January 2022 w.r.t. FDCs mentioned under Annexure A. Date and time of hearing is also mentioned under Annexure A.

It is requested that the concerned stakeholders may kindly make it convenient to give a presentation through WebEx (Video Conference) before the Expert Committee on these FDCs. In the event that the Stakeholders does not attend the hearing, the Committee reserves the right to make its decision on the basis of information available before it.

You are requested to kindly confirm your participation through e-mail at fdc@cdsco.nic.in by 24.01.2022 and also submit Power Point presentation (PPT) alongwith the presenter details, Mobile number, email ID, s. No. of FDC as per Annexure-A.

This is for information of all the concerned.

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----- Start of picture text -----<br> 0<br>ae 4<br>Deputy Drugs Controller (India)<br>----- End of picture text -----<br>

Copy to:

1. Dr. M.S. Bhatia, Prof. & Head, D/o Psychiatry, UCMS, New Delhi, Chairman, Expert Committee.

2. Toall 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.

3. Website of CDSCO for information and necessary action by concerned stakeholders.

Annexure-A

_____1|NO. || PG(eeeNO aoe | BearingsDate & Time of 2 Nimesulide+Paracetamoldispersible tablets aT O12UE2 |Paro a cetamol+ Phenylephrine + Caffeine feta Ae 3 ee 06:00 PM | Amoxicillin+ Bromhexine | | : Pholcodine + Promethazine | | 5 | Imipramine + Diazepam a eee Chlorpheniramine maleate+ Dextromethorphan+ | Dextromethorphan + Guaifenesin + Ammonium chloride + ___ 6 | Menthol I __7 | Chlorpheniramine Maleate +Codeine syru 8 | Ammonium Chloride + Bromhexine + Dextromethorphan | Bromhexine +Dextromethorphan +Ammonium Chloride 9 | +Menthol a | Dextromethorphan +Chlorpheniramine + Guaifenesin 10 |+Ammonium Chloride ae | Caffeine +Paracetamol +Phenylephrine + 28.01.2022 | _11|ChlorpheniramineParacetamol + Bromhexine +Phenylephrinesss 11:3006:00AMPMto | 12 | +Chlorpheniramine Guaifenesin+ - ____13 | Salbutamol + Bromhexine _14____15 | Chlorpheniramine+Codeine phosphate +Menthol syru | 16 ||PhenytoinParacetamol+ Phenobarbitone+ Propyphenazonesodium+ Caffeine | Ammonium Chloride + Sodium Citrate + Salbutamol + Hydroxyethyltheophylline (Etofylline) + **** | 1817]| Saal Bromhexine Maleatei + Menthol Chlorpheniramine Maleate + Ammonium Chloride + 19) | Sodium Citrate __|