New Delhi : The apex advisory board of the drugs controller general of India (DCGI) has recommended banning 14 of the 19 FDCs — in fixed dose combinations category — citing a lack of therapeutic rationale, people familiar with the matter said.
DCGI, the national drugs regulator, will take a final call on the ban.
Fixed dose combinations refer to combination of two or more active drugs in a fixed ratio in a single medicine.
The drugs that have been recommended for banning include several codeine-based cough syrups such as Dr Reddy’s Dialex DC, Mankind’s TedyKoff, Codistar, Abbott’s Tossex, and Glenmark’s Ascoril C.
The remaining five medicines have been provided interim relief but will have to generate more real-world data to be able to justify their use, said an official familiar with the development.
Dr MS Bhatia, professor and head, department of psychiatry, University College of Medical Sciences, a Delhi University-affiliated medical college, chaired the expert committee that generated a report on the therapeutic use of drugs in question. The drugs and technical advisory board (DTAB) reviewed the report in a meeting held on September 26.
“The advisory board was satisfied by most observations mentioned in the report,” said the official, requesting anonymity.
The board recommended that the makers of the remaining five fixed dose combinations need to generate additional data within a year to continue escaping the ban.
The drugs that have got reprieve include Crocin Cold & Flu, Dolo Cold, and Saridon.
“DTAB examined and agreed to the report submitted by the sub-committee and recommended for further action in the matter with the additional suggestion that wherever generation of additional data is recommended by the sub-committee, a time frame of one year may be provided to the applicants for generation of data on such FDCs,” read the minutes of the DTAB meeting that HT accessed.
Most of these drugs — being reviewed by the regulator — were approved before 1988 for manufacturing and sale in the country without due approval from the central licensing authority. These drugs have been under the DCGI’s radar for the past few years.
On February 2, the Union ministry of health and family welfare constituted an expert committee to review the 19 fixed dose combinations.