Govt bans 14 fixed dose combination drugs including Nimesulide and Paracetamol over health risk- full list here

The government of India has banned 14 fixed dose combination (FDC) drugs saying that there is “no therapeutic justification” for these medicines. FDC is the combination of two or more drugs in certain fixed dosage prescribed by doctors to cure a illness. If it were combined at first, it would fall under the definition of a new drug.

“There were many medicines that were being sold as mixed dose combinations which were not conducive or helpful for public health,” said sources in the union health ministry.

In the 59th report on the functioning of CDSCO (Central Drugs Standard Control Organisation), the Parliamentary Standing Committee of the Ministry of Health and Family Welfare said that they have observed that some of the State Licensing Authorities had issued manufacturing licenses for a very large number of FDCs without prior clearance from CDSCO. Hence, resulting into the availability of many FDCs in the market which were not tested for efficacy and safety, eventually putting patients at risk.

CDSCO requested all state/UT drug controllers to ask the concerned manufacturers in their state/UT to prove the safety and efficacy of such FDCs before the CDSCO within a period of 18 months, failing which such FDCs will be considered for being prohibited for manufacture and marketing in the country.

After receiving a large number of applications, the CDSCO approached an expert committee headed by Prof. C.K. Kokate in order to examine such a huge number of applications.

Accordingly, the committee examined the applications in the following categories:

Category A – FDCs which were considered irrational.
Category B – FDCs which require further deliberation with experts
Category C – FDCs which are considered rational
Category D – FDCs which are rational but also require a generation of data

After putting the forms under their respective categories, the FDC is submitting various reports to the health ministry from time to time.

Here’s the list of all the drug combinations that has been banned:

• Nimesulide + Paracetamol dispersible tablets
• Paracetamol + Phenylephrine + Caffeine
•  Amoxicillin + Bromhexine
•  Pholcodine + Promethazine
• Imipramine + Diazepam
•  Chlorpheniramine maleate+ Dextromethorphan+Dextromethorphan + Guaifenesin + Ammonium
  Menthol
•  Chlorpheniramine Maleate +Codeine Syrup
•  Ammonium Chloride + Bromhexine + Dextromethorph
•  Bromhexine +Dextromethorphan +Ammonium Chloride + Menthol
•  Dextromethorphan +Chlorpheniramine + Guaifenesin+ Ammonium Chloride
•  Caffeine + Paracetamol + Phenylephrine + Chlorpheniramine
•  Paracetamol + Bromhexine +Phenylephrine +Chlorpheniramine+Guaifenesin
•  Salbutamol + Bromhexine
•  Chlorpheniramine +Codeine phosphate + Menthol
•  Phenytoin + Phenobarbitone sodium
•  Paracetamol + Propyphenazone + Caffeine
• Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
• Salbutamol + Hydroxyethyltheophylline (Etofylline) + Bromhexine
• Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate

However, since these medicines were sold before 1988, they cannot be outright banned. Meanwhile, data is being tested for some of these medicines and the result will be out soon.

Furthermore, expert committee has approved combinations like Imipramine + Diazepam and Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate, to be accepted for rational use.