The apex panel under the drug regulatory body of India has given a go-ahead for banning 14 cocktail medicines in its meeting held this week, News18.com has learnt.
The panel — Drugs Technical Advisory Board (DTAB) — which met on September 26 to take the final call on the selected 19 fixed-dose-combination (FDC) medicines – has agreed to the report submitted by the sub-committee and recommended further action.
Now the drug controller general of India (DCGI) will take the final decision to ban the selected cocktail drugs.
On their way out?
If approved by DCGI, India will ban the manufacturing and sales of several cocktail medicines including a variety of codeine-based cough syrups such as Mankind’s TedyKoff, Codistar, Abbott’s Tossex, Glenmark’s Ascoril C, Dr Reddy’s Dialex DC, and Taurus Lab’s Codeb.
DTAB examined the report submitted by the expert committee constituted under the chairmanship of Dr MS Bhatia, professor and head of the department of psychiatry, University College of Medical Sciences.
According to the report submitted by the committee to the Central Drugs Standard and Control Organisation (CDSCO) and the ministry of health and family welfare, five FDCs have been proved rational by the manufacturers which will escape the ban but with a condition.
‘Generate data within one year’
While DTAB has suggested further action on 14 FDCs, it has recommended that the makers of the remaining five FDCs must generate “additional data” within one year to continue escaping the ban.
“…wherever generation of additional data is recommended by the sub-committee, a timeframe of one year may be provided to the applicants for generation of data on such FDCs,” the DTAB panel recommended.
For instance: Makers of D’Cold Total, Crocin Cold & Flu, Micro Lab’s Dolo Cold and Glenmark’s Alex Cold have been asked to generate safety and efficacy data apart from the recommendation of conducting phase four clinical trials. Cough syrup Piriton, Cofton and headache pill Saridon were also cleared by the former committee based on certain conditions.
The popular combination of paracetamol, caffeine, and propyphenazone, which is used to manufacture the headache relieving pill Saridon, will also generate safety data.
The FDC is globally approved in 31 countries, including the European Union, Italy, Spain, Hungary, and the Netherlands, and meanwhile, till the new data is generated, the drug can only be sold on prescription and the dose should not exceed five to seven days.
(Following certain developments, this story has been amended on 12th January, 2023.)
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