Delhi High Court Refuses To Stay Ban On Five Fixed Dose Combination Drugs
The Delhi High Court on Wednesday rejected a plea seeking stay on a government notification banning five fixed dose combination drugs earlier this month.
The court's vacation bench of Justice Sanjeev Sachdeva asked the government to file its reply on the petition filed by Mankind Pharma, Akum Drugs & Pharmaceuticals Ltd. and JB Chemicals and Pharmaceuticals Ltd. by the next hearing on June 30.
The petitioners said the ban was invalid as they were not given a three-month prior notice and were also not given a chance of hearing by the government.
The Department of Health and Family Welfare under the Ministry of Health and Family Welfare banned fixed dose combination (FDC) of Nimesulide with Levocetrizine, combination of Ofloxacin with Ornidazole injection; combination of Gemifloxacin with Amboroxol; combination of Etodolac with Paracetamol with immediate effect.
A fixed dose combination drug contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
The central government had constituted a subject expert committee to justify the therapeutic efficacy of various FDCs available in the market. The committee has recommended that the use of these FDCs is irrational and likely to involve risk to human beings.
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