Schedule for 19 FDCs permitted pre-1988 to give online presentation

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.

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Last Updated on December 25, 2021 by The Health Master

The Expert Committee appointed to evaluate the fixed dose combinations (FDCs) permitted before 1988, has invited stakeholders related to 19 FDCs for 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 Office of Drugs Controller General (India) has issued a notice 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 by December 27, 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 are 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 are 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 (CDSCO) 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 the information on the rationality, safety and efficacy with regards to these FDCs as per the format prescribed by the Committee within August 25, 2021.

Later, on August 19, the CDSCO announced that the last date for submission of the information has been extended to October 25, 2021, as the Committee received various representations requesting for extension of the timeline.

While there has been direction from the Centre that the FDCs should not be issued license without the approval of the CDSCO, at data released by the ministry of chemicals and fertilisers recently said that a total of 68 cases in which the FDCs considered as new drugs unapproved by the Central Drugs Standard Control Organisation getting licensed by State Licensing Authorities (SLAs) were reported during the period 2017 to the beginning of December, 2021.

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