New Delhi : India’s drug regulator has recognized 19 fixed-dose combinations (FDCs) that have been marketed with out prior regulatory approval and has now requested the producers to generate security information by the best way of conducting phase-IV scientific trials for regularisation of those FDCs. These cocktail drugs have been licensed for manufacture and marketed by the state licensing authority. The 19 FDCs are generally used for situations like headache, migraine, arthritis, muscular pain, nausea, vomiting, amongst others.
“There are 19 FDCs which require further generation of data,” stated the discover from drug regulator VG Somani in a be aware dated August 27.
The regulator directed the drug manufacturing associations holding licences from state licensing authority that didn’t get hold of a ‘no objection certificates’ (NOC) from the drug regulator to submit their purposes inside “six months.”
The listing of FDCs embrace Aceclofenac+Paracetamol+Chlorzoxaone, Aceclofenac+ paracetamol + Serratiopeptidase, Aceclofenac+ Paracetamol+Tezanidine, Aceclofenac+paracetamol+Tramadol, Alprazolam+Propranolol, Calcium dobesilate+Decusate Sodium amongst others. Earlier India’s chief drug advisory physique had fashioned an knowledgeable committee to overview 344 FDCs drugs banned in 2015.
The panel has been reviewing the protection, efficacy and therapeutic justification of those drugs earlier than recommending any motion.
In April 2021 DTAB submitted a report and suggestions of a subcommittee and located that “there are 19 FDCs which require further generation of data by way of conducting phase-IV trials/active post marketing surveillance study as the case may be,” it added.
