Centre bans 14 more fixed dose combination drugs on expert recommendation

The Centre has banned 14 fixed-dose combination (FDC) drugs in India upon the recommendation of an expert committee which said that there is no ‘therapeutic justification’ for these medicines.

“Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of these FDC under section 26A of the Drugs and Cosmetics Act, 1940,” a notification by the Health Ministry said.

An FDC refers to a combination of two or more active ingredients into a single drug formulation in a fixed dosage ratio. 

One of the key FDCs banned by the Centre includes a commonly used medication – Nimesulide and paracetamol combination – which is used to relieve pain and fever. Certain antibiotic FDCs have also been prohibited – for example amoxicillin and bromhexine combination which is used to treat respiratory tract infections. On top of this, some codeine-based formulations have also been banned. Codeine is used to treat runny nose, sneezing, cough, and common cold symptoms.

A senior pharma industry executive said that the industry has now become more cautious when launching FDCs. "The scrutiny of FDCs began a few years back and the industry has since become cautious about launching new FDCs. Right now most FDCs are in the diabetes segment or some in respiratory therapy etc," the executive said. 

The crackdown on FDCs has been going on for some time. For example, in March 2016, the Health Ministry implemented a ban on 349 FDCs based on recommendations of the Chandrakant Kokate committee that found these drug combinations to be irrational and posing health risks.

 The Supreme Court had referred the matter to the Drug Technical Advisory Board (DTAB) for a fresh review after drugmakers challenged the ban. The DTAB, in a meeting held in 2018 July, reinforced the ban on 343 of the 349 drugs.

At that time, the market for these FDCs was estimated to be around Rs 2000 crore or so.

More recently, last year the Centre moved to ban 19 codeine-based FDCs. Codeine is basically an antitussive (medication that suppresses cough), it is not an expectorant and is generally used for the treatment of dry cough. Such kinds of coughs are basically attributed to allergic manifestations or to patients who are working in dusty environments. Codeine-based formulations constitute roughly a Rs 1000 crore market.

The Indian Drug Manufacturers Association (IDMA) had reached out to the government with a representation to not ban codeine-based cough syrups because some people tend to misuse it. They argued that the government should not prohibit the formulation because of alleged abuse by some as the drug is otherwise clinically safe.
 
Last year instances of unapproved FDCs that were licensed by state licensing authorities came to light. The Drugs Controller General of India (DCGI) prohibited these FDCs. Thereafter state drug controllers were requested to ensure that new drugs and FDCs are not permitted without the approval of the DCGI.

Recently, the DCGI has approved some FDCs. For example, in January Lupin launched a novel FDC of Indacaterol, Glycopyrronium and Mometasone for managing inadequately controlled asthma among patients. An Indacaterol and Mometasone combination drug by Glenmark for asthma had also been approved by the DCGI in 2022.  The domestic market has several combinations of diabetic drugs now.

Some of the banned FDCs –
Nimesulide+ Paracetamol dispersible tablets
Amoxicillin+ Bromhexine
Pholcodine+ Promethazine
Chlorpheniramine + Codeine Phosphate + Menthol Syrup