DTAB to review 19 fixed-dose combinations drugs, codeine formulations today

CDSCO aims to phase out these combinations and codeine-based drugs in a phased manner

The Drugs Technical Advisory Board (DTAB) is likely to meet on Monday to decide the fate of 19 fixed-dose combinations (FDCs) drugs that are considered 'irrational combinations'.  

Some of the common medicine brands which are under the scanner include cough syrup Ascoril C, TeddyKoff, and some cold medicines like D'Cold Total, Dolo Cold, headache medicines like Saridon etc.

The drugmakers have been asked to generate additional data on these drugs through phase-4 trials (trials done after marketing approval). The Drugs Controller General of India (DCGI) feels that additional data is required for these drugs, and thus pharma companies have been asked to generate additional safety data.

The expert panel is also likely to discuss the fate of codeine-based medicines. Sources say that the Central Drugs Standard Control Organisation (CDSCO) is focussing on phasing out irrational FDCs and codeine-based formulations in a phased manner.

In 2018, the government banned 343 FDC drugs on the advice of DTAB.

At that time, the FDC drugs comprised almost 50 per cent of the Rs 1.25-trillion domestic market in 2018.

Respiratory molecules form the bulk of the FDCs under the scanner.

The cocktail drugs under the radar

• Aceclofenac+Paracetamol+Chlorzoxaone,
• Aceclofenac+ paracetamol + Serratiopeptidase,
• Aceclofenac+ Paracetamol+Tezanidine,
• Aceclofenac+paracetamol+Tramadol,
• Alprazolam+Propranolol,
• Calcium dobesilate+Decusate Sodium