Central Government bans manufacture for sale/sale/distribution of various fixed dose combinations of drugs; effective 11th January, 2019

Central Government bans manufacture for sale/sale/distribution of various fixed dose combinations of drugs; effective 11th January, 2019

The Ministry of Health and Family Welfare had in 2007 directed cancellation of licenses related to 294 Fixed Dose Combinations (“FDCs”) which were licensed without approval of Drugs Controller General. These directions were challenged by the way of writ petition in the High Court of Judicature at Madras and all proceedings related to the directions were stayed.

The issue was then considered by the Drugs Technical Advisory Board (“Board”) to examine and determine the rationality and safety of these FDCs. After various discussions and recommendations, those FDCs were found to be harmful for human health.

The matter then taken up to the Supreme Court in 2017, and it was held that that certain FDCs out of 294 FDCs were not rational and were therefore required to be prohibited or withdrawn.

So, the Central Government in tandem with the Hon’ble Supreme Court’s order and in public interest, on 11th January, 2019 issued various notifications prohibiting the manufacture for sale, sale and distribution of the following FDCs with immediate effect:

  • 5-bromosalicyl-4-chloranilide + Salicylic acid
  • Activated charcoal + Fungal diastase + Lactic acid
  • Allobarbitone + Phospho-dimethyl-isopropyl-pyrazolone
  • Artesunate + Arteether + Artemether
  • Atorvastatin + Acetyl Salicylic acid + Caffeine
  • Chlormezanone + Paracetamol + Diclofenac sodium
  • Chlormezanone + Paracetamol + Ibuprofen
  • Chlorzoxazone + Ibuprofen + Paracetamol + Diclofenac + Oxyphenbutazone + Magnesium Hydroxide
  • Ciprofloxacin + Tinidazole + Dicyclomine
  • Dicyclomine + Dextromethorphan + Paracetamol

Please be informed that this is not the complete list, we have listed only a few items.

SourceMinistry of Health and Family Welfare

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