The apex panel under the drug regulatory body of India is set to decide the fate of cocktail medicines, including codeine-based cough syrups soon, News18.com has learnt.
The panel — Drugs Technical Advisory Board (DTAB) — is expected to meet on September 26 to take the final call on the selected fixed-dose combination (FDC) medicines.
Overall, the Central Drugs Standard and Control Organisation (CDSCO) had made a list of 19 FDCs which were deemed “irrational combinations”. The list has been reviewed by the expert committee constituted under the chairmanship of Dr MS Bhatia, professor and head, Department of Psychiatry, University College of Medical Sciences.
Medicines such as Sumo, D’Cold Total, TeddyKoff, Tossex, Ascoril, Codistar, Dolo Cold, Piriton, and Saridon among others are part of the list of 19 cocktail drug formulations.
Apart from cocktail medicines, the central government is focused on eliminating codeine-based medicines from the market.
“The DTAB committee is slated to meet coming Monday to start deliberations over the FDC medicines, including codeine-based formulations,” the government official privy to the development told News18.com.
“The availability of all members of the panel has been checked and finalised. Deciding the fate of FDCs is one of the most important decisions pending from the office of drug regulator.”
To put things in perspective, Drug Controller General of India (DCGI) VG Somani was given two major tasks while the Centre extended his tenure by three months recently.
The DCGI has been asked to complete two projects in the coming months — banning irrational cocktail drugs and codeine-based medicines in a phased manner.
Focus on banning codeine-based medicines
The Ministry of Health and Family Welfare is reviewing the policy to ban the manufacturing and sale of codeine-based cough syrups after several Members of Parliament raised concerns that they are being used as narcotic drugs than as medicines.
Codeine is an opioid-based analgesic, mostly used to treat cough, pain, and diarrhoea, and it is one of the natural plant alkaloids found in extracts of opium.
Based on the request by several politicians to Health Minister Mansukh Mandaviya to ban cough syrups, a copy of which was accessed by News18.com, the health ministry had asked DCGI in March to “conduct a review and submit recommendation”.
Recently, the DCGI submitted its review to the health ministry where it suggested taking out five FDCs from the ban list based on certain conditions and banning the rest 14 formulations.
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