Nineteen fixed-dose combos (FDCs) that were marketed without prior regulatory permission have been identified by India′s drug regulator. The manufacturers of these FDCs have been asked to produce safety data for regularizing these FDCs. The state licensing authority had granted manufacturing and marketing licenses for these cocktail medications. The 19 FDCs included frequently prescribed drugs for migraines, headaches, muscle pain, arthritis, nausea, and vomiting.

Drug regulator VG Somani instructed the drug manufacturing associations with licenses from state licensing bodies to submit their applications within "six months" if they did not receive a "no objection certificate" (NOC) from the drug regulator.

Combination drugs listed in the radar include Alprazolam + Propranolol, Calcium dobesilate + Decusate Sodium, Aceclofenac + Paracetamol + Chlorzoxaone, Aceclofenac + Paracetamol + Serratiopeptidase, Aceclofenac + Paracetamol + Tezanidine, Aceclofenac + Paracetamol + Tramadol, and others. An expert committee was established previously by India′s top drug advisory body to assess the 344 FDCs medications that were banned in 2015.

Before making a recommendation, the panel examined the medications′ safety, effectiveness, and therapeutic justification.

The DTAB′s report and subcommittee recommendations that were submitted in April 2021 stated that 19 FDCs needed more data by conducting either phase-IV clinical trials or an active post-marketing surveillance study. (ETHealthWorld, September 02, 2022)