Date: 2022-01-06Category: 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 regarding
**Subject: Evaluation of Pre-1988 Fixed Dose Combinations (FDCs) for Manufacture and Sale in India**
This notice, dated January 11, revises a previous announcement (December 27, 2021) regarding the evaluation of certain pre-1988 permitted Fixed Dose Combinations (FDCs) for manufacture and sale in the country without prior approval from the Central Licensing Authority. An Expert Committee will conduct a hearing via WebEx Video Conference on January 27th and 28th, 2022, to evaluate the FDCs listed in Annexure A.
**Hearing Details:**
* **Dates:** January 27th and 28th, 2022
* **Time:** 11:30 AM to 06:00 PM (both days)
* **Platform:** WebEx Video Conference
**FDCs Under Evaluation (Annexure A):**
* **January 27, 2022:**
* Nimesulide + Paracetamol dispersible tablets
* Paracetamol + Phenylephrine + Caffeine
* Amoxicillin + Bromhexine + Pholcodine + Promethazine
* Imipramine + Diazepam
* Chlorpheniramine maleate + Dextromethorphan
* Dextromethorphan + Guaifenesin + Ammonium chloride + Menthol
* Chlorpheniramine Maleate + Codeine syrup
* Ammonium Chloride + Bromhexine + Dextromethorphan
* Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
* Dextromethorphan + Chlorpheniramine + Guaifenesin + Ammonium Chloride
* **January 28, 2022:**
* Caffeine + Paracetamol + Phenylephrine
* Chlorpheniramine + Paracetamol
* Bromhexine + Phenylephrine + Chlorpheniramine + Guaifenesin
* Salbutamol + Bromhexine
* Chlorpheniramine + Codeine phosphate + Menthol syrup
* Phenytoin + Phenobarbitone sodium
* Paracetamol + Propyphenazone + Caffeine
* Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol + Salbutamol + Hydroxyethyltheophylline + Etofylline
* Bromhexine + Chlorpheniramine Maleate + Ammonium Chloride
* Sodium Citrate
**Instructions for Stakeholders:**
Concerned stakeholders are requested to present their information to the Expert Committee via WebEx. Failure to attend may result in a decision based solely on available information. Confirmation of participation, along with a PowerPoint presentation (PPT) including presenter details (name, mobile number, email ID) and the FDC's serial number (as per Annexure A), must be submitted to fdccdsco.nic.in by January 24, 2022.
**Contact:** fdccdsco.nic.in
Key Entities Referenced
Fixed Dose Combinations FDCs: Refers to the drug formulations that combine two or more active pharmaceutical ingredients in a single dosage form. The notice concerns the evaluation of certain pre-1988 permitted FDCs.
Central Licensing Authority: The regulatory body responsible for granting manufacturing and sales licenses for drugs. The notice addresses FDCs manufactured or sold without due approval from this authority.
Expert Committee: A committee formed to evaluate the safety and efficacy of the specified FDCs. The notice announces a hearing by the Expert Committee.
WebEx Video Conference: The online platform used for stakeholders to present information to the Expert Committee regarding FDCs.
CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India. The notice mentions the CDSCO website for information dissemination.
Dr. M.S. Bhatia: Professor & Head, Department of Psychiatry, UCMS, New Delhi and Chairman of the Expert Committee.
UCMS, New Delhi: University College of Medical Sciences, located in New Delhi.
Indian DrugPharmaceuticals Association IDMA: An association of pharmaceutical manufacturers in India, requested to disseminate the information to its members.
FDA Bhawan, Kotla Road
New Delhi-110002
Dated: 0 § JAN 11
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.
Copy to:
1. Dr. 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.Annexure-A
Date & Time of
| S.No. | FDC Name | Hearing
Nimesulide +Paracetamol dispersible tablets _
27.01.2022
Paracetamol + Phenylephrine + Caffeine 11:30 AM to
06:00 PM
Amoxicillin + Bromhexine _
Pholcodine + Promethazine
_Imipramine + Diazepam :
Chlorpheniramine maleate+ Dextromethorphan+
Dextromethorphan + Guaifenesin + Ammonium chloride +
Menthol
Chlorpheniramine Maleate +Codeine syrup
Ammonium Chloride + Bromhexine + Dextromethorphan
Bromhexine +Dextromethorphan +Ammonium Chloride
| +Menthol
Dextromethorphan +Chlorpheniramine + Guaifenesin
_10 _+Ammonium Chloride
| Caffeine +Paracetamol +Phenylephrine +
28.01.2022
11__ Chlorpheniramine 11:30 AM to
Paracetamol
12
+ Bromhexine +Phenylephrine _ 06:00 PM
+Chlorpheniramine + Guaifenesin
13 Salbutamol + Bromhexine
14 Chlorpheniramine +Codeine phosphate +Menthol syrup
5 | Phenytoin + Phenobarbitone sodium
| Paracetamol + Propyphenazone + Caffeine
| Ammonium Chloride + Sodium Citrate +
Chlorpheniramine Maleate + Menthol
Salbutamol + Hydroxyethyltheophylline (Etofylline) +
Bromhexine
Chlorpheniramine Maleate + Ammonium Chloride +
19 | Sodium Citrate