Centre looking to phase out codeine-based cough syrups, select FDCs

The Centre has moved to phase out codeine-based cough syrups and some fixed-dose combination (FDC) drugs that are deemed ‘irrational’.

The fate of 19 FDCs and several codeine-based cough syrups is yet to be decided and the Drugs Technical Advisory Board (DTAB) is discussing the matter.

The industry is divided on the issue of phasing out codeine-based cough syrups, which are used by many as intoxicants.

Recently, the Narcotics Control Bureau (NCB) arrested a group for smuggling drugs between Uttar Pradesh and Mumbai. The NCB team recovered 13,248 bottles of codeine-based cough syrup weighing 1,600 kg from the gang.

Arvind Badiger, technical director, BDR Pharmaceuticals said: “Codeine is basically an antitussive (medication that suppresses cough). It is not an expectorant and is generally used for treatment of dry cough. Such kinds of cough are due to allergic manifestations or occur in people working in a dusty environment. Also, there are various other antitussives or expectorants available for the consumer. It is not that codeine-based drugs are not replaceable.”

Badiger feels that with emerging treatment, the impact of codeine-based drugs, which is phased out, will be very less.

However, the Indian Drug Manufacturers Association (IDMA) has reached out to the government with a representation to not ban codeine-based cough syrups because some people tend to misuse it.

IDMA secretary general Daara Patel said the government should not take any action to ban the sale of codeine-based cough syrups based on alleged abuse. They are otherwise clinically safe.

The reason for industry’s concern is clear – codeine-based formulations constitute a Rs 1,000-crore market, said a Mumbai-based analyst.

The DTAB, however, is also deliberating on the fate of the 19 FDCs. They include common cold medicines and headache medicines (Saridon for example), among others.

The drugmakers have been asked to generate additional data on these drugs through phase 4 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. 

Badiger said FDCs, which are used particularly for cold and body ache treatment, definitely have some irrational combinations. But FDCs are very important for the treatment of tuberculosis or malaria.

“The current FDCs, which are under scanner belong to the first category, that is either they are for cough treatment or the treatment of body ache or cold. Such FDCs can definitely be revoked because these FDCs are not approved in other parts of the world. They are specifically approved in India and some of them definitely fall under irrational combinations,” he added.

In 2018, the government had banned 343 FDCs under the advice of the DTAB. At that time, the FDC drugs comprised almost 50 per cent of the Rs 1.25-trillion domestic drug market.

Respiratory molecules form the bulk of the FDCs under scanner. Such drug makers are staying away from launching new FDCs since the 2018 ban.

DRUG-CHECK

Combinations on the radar

• Aceclofenac + paracetamol + chlorzoxazone  
• Aceclofenac + paracetamol + serratiopeptidase  
• Aceclofenac + Paracetamol+ Tizanidine 
• Aceclofenac + paracetamol + tramadol 
• Alprazolam + Propranolol  
• Calcium dobesilate + docusate sodium

• Government plans to phase out 
• Codeine-based cough formulations
• Several people misuse codeine for intoxication and drug rackets have been busted
• DTAB is looking closely at 19 FDC drugs — mainly cold and bodyache medicines — which they feel are ‘irrational’ 
• Pharma industry feels a drug should not be banned just because some people misuse it