Why government has banned 14 Fixed Dose Combination drugs?

FDC Drugs – The government has recently banned 14 fixed dose combination (FDCs) drugs including Nimesulide and Paracetamol dispersible tablets and Chlopheniramine Maleate and Codeine syrup.

FDC drugs are those which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. In other words, an FDC product is when 2 or more drugs are combined physically into one preparation such as a tablet or pill.

The recent banned drugs included those used for treating common infections including cough and fever.

These banned combinations drugs includes:

Nimesulide + Paracetamol dispersible tablets
Chlopheniramine Maleate + Codeine Syrup
Pholcodine +Promethazine
Amoxicillin + Bromhexine
Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
Paracetamol + Bromhexine+ Phenylephrine + Chlorpheniramine + Guaiphenesin
Salbutamol + Bromhexine

In 2016, the government had announced the ban on the manufacture, sale and distribution of 344 drug combinations after an expert panel, set up at the behest of the Supreme Court had stated they were being sold to patients without scientific data and the order was challenged by the manufacturers in court. The currently banned 14 FDCs are part of those 344 drug combinations.

Ideally, the Central Drugs Standard Control Organization (CDSCO), after due examination of data on rationality, safety, and efficacy, issues approval for FDCs.

On the basis on this, the State Licensing Authority (SLA) gives the manufacturing and marketing permission. Incidentally, in the past, SLAs issued the license to manufacture and market without asking for no-objection from CDSCO.

The expert committee have stated that there is ‘no therapeutic justification’ for these FDC medicines and they may involve ‘risk’ to people. The Union Health Ministry also issued a notification earlier in this regard.

The committee further said that it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act of 1940, in the larger public interest, as reported by PTI.

While 1,292 FDCs have been approved officially from 1961 to mid-2018 by the CLA, their actual numbers in the Indian market – including those approved by several SLAs – is estimated to be around 6,000, says a study on Fixed dose drug combinations: Issues and challenges in India by Yogendra Kumar Gupta, Suganthi S Ramachandran. Indian medicine market has become the world leader of FDCs.

Irrational FDC Drugs

There are FDCs and there are ‘irrational FDCs’. The FDCs are justified when they demonstrate clear benefits in terms of potentiating the therapeutic efficacy. The FDCs formulated without due diligence can pose problems namely pharmacodynamic mismatch between the two components, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced toxicity and are called “irrational FDCs”.

The high sales turnover and high prescription trend from Medical Colleges, Primary Health Centers, and general practitioners are often projected as their rationality, safety, and efficacy.

The study conducted by Yogendra Kumar Gupta, Suganthi S Ramachandran reveals that “Although FDCs are available in almost all therapeutic categories, many of them are bizarre combinations.

The therapeutic categories having high number of FDCs are cough, cold, and fever preparations; analgesics and muscle relaxants; antimicrobials; drugs for hypertension, dyslipidemia, diabetes, and psychiatric disorders; and vitamins and minerals. The FDC formulation may have up to 5 or even more ingredients with or without rationality of their presence and in the quantity”.