The government approved the sale of two fixed-dose combinations (FDC) medications: chlorpheniramine maleate + ammonium chloride + sodium citrate and imipramine + diazepam. The former FDC drug is used to treat the cough, whereas the latter is used to treat depression.

According to government sources, the expert committee determined that FDCs, medications created by mixing two or more pharmaceuticals in fixed dosage combinations, were reasonable. The expert committee reviewed and approved three FDCs out of nineteen combinations in the meeting.

The rest of the FCD combinations were banned by the committee, which included Pholcodine +Promethazine, Amoxicillin + Bromhexine, Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol, Paracetamol + Bromhexine, Phenylephrine + Chlorpheniramine + Guaiphenesin, and Salbutamol + Bromhexine.

In an editorial, Dr. Y K Gupta, former head of the pharmacology division at the All India Institute of Medical Sciences (AIIMS), and Dr. Suganthi S Ramachandra classified the FDCs available in India into "the good, the bad, and the ugly FDCs."

They explained that the good FDCs were the ones that added therapeutic value to the treatment regimen, for example, carbidopa and levodopa, sulfonamides, trimethoprim, antitubercular drugs, antiretroviral drugs, some antihypertensives, and some antidiabetic medications.

The bad FDCs included combinations formulated with marketing interests in mind and did not add value to the treatment regimen. They noted that most of the combination drugs in India could be placed under the `bad` category, such as a combination of dual nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxants, and NSAIDs with H2 blockers.

The ugly FDCs were defined as combinations that provided no evidence or theoretical justification, such as cough syrups containing two or more antihistamines, decongestants, bronchodilators, cough suppressants, expectorants, etc.

(Source:https://health.economictimes.indiatimes.com/news/policy/government-gives-nod-to-sale-of-2-fixed-dose-combination-drugs/100868723 )