Last Updated on January 24, 2024 by The Health Master
The meeting scheduled by the Expert Committee, which is looking into the 19 fixed dose combinations (FDCs) at the end of December has been postponed till further decision, following a request from the stakeholders.
The Expert Committee, appointed to evaluate the FDCs permitted before 1988, invited stakeholders related to 19 FDCs to an online hearing on December 29 and 30, 2021. The committee is headed by Dr M S Bhatia, Professor and Head, Department of Psychiatry, UCMS, New Delhi.
The Committee received various representations from stakeholders with the request to postpone the Expert Committee meeting scheduled, as most of the companies will not be available for the meeting on account of year end holidays.
The meeting has been postponed and the schedule for the next meeting will be communicated shortly, said a notice issued by the Central Drugs Standard Control Organisation (CDSCO).
The Office of Drugs Controller General (India) issued a notice last week, inviting the concerned stakeholders to be present in the video conference and give a presentation before the Expert Committee on these FDCs.
“In the event that the stakeholder does not attend the hearing, the Committee reserves the right to make its decision on the basis of information available before it,” said the notice.
It has also asked the stakeholders to confirm their participation through e-mail, and also submit the power point presentation along with the presenter details, mobile number, e-mail ID and others.
According to the notice, the presentations on following ten FDCs were scheduled to be held between 11.30 am to 6 pm on December 29, 2021:
- 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,
The rest of the following nine formulations were listed for hearing between 11.30 am to 6 pm on December 30, 202:
- Caffiene+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+hydroxyethyltheophyline (etofylline)+bromhexine
- Chloropheniramine maleate+ammonium chloride+sodium citrate,
The Central Drugs Standard Control Organisation has formed the Expert Committee following the judgements from the Supreme Court of India in December, 2017 and February, 2019, that the central government may, if it so chooses, de novo carry out an inquiry as to whether the FDCs licensed prior to 1988 for manufacture for sale in the country without due approval from the Central Licensing Authority, should be a subject matter of a notification under Section 26A of the Drugs and Cosmetics Act, 1940.
The Section 26A of the Act deals with the powers of the Central Government to regulate, restrict or prohibit manufacture, etc., of drugs and cosmetics in public interest.
The Committee, in July, this year, directed the concerned stakeholders of the 19 FDCs to submit information on the rationality, safety, and efficacy with regards to these FDCs as per the format prescribed by the Committee within a certain timeline.
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