Chandigarh: The manufacture, sale or distribution of 328 fixed dose combination (FDC) drugs have been strictly prohibited by the government for human use with immediate effect.
Painkillers, antibiotics, antiseptics for treatment of mouth and throat conditions and anti-diabetic drugs got a relief but with caveats, according to two people aware of the matter.
“These six FDCs have not been given a clean chit. They are going to be restricted or regulated.”
The panel after considering these drugs “irrational”, citing safety issues and lack of therapeutic justification, leading to continuing the ban.
In its report submitted on 20 January 2015, the panel led by Chandrakant Kokate, vice-chancellor of KLE University, Karnataka, deemed these FDCs irrational, saying they posed health risks.
Last December, the apex court referred the matter to DTAB for a fresh review on whether these drugs should continue to be marketed.
The Supreme Court suggested DTAB decide whether the manufacture and sale of these drugs should be regulated, restricted or banned outright, and submit its report and recommendations to the government within six months.
Under the chairmanship of Nilima Kshirsagar, professor-head clinical pharmacology, G.S. Medical College and KEM Hospital, Mumbai a special panel was formed to review the safety, efficacy and therapeutic justification of these drugs.
The health ministry’s ban on FDCs included painkillers, anti-diabetic, respiratory and gastro-intestinal medicines, covering 6,000 brands.