ABANTIKA GHOSH explains the whys and hows of the ban on 344 combination drugs
How many drugs have been banned and why?
The Health Ministry in a gazette notification issued on March 12 banned 344 fixed dose drug combinations, many of them popular brands of over-the-counter anti-pyretic (used to prevent or reduce fever) and anti-inflammatory drugs that have been household names for several years now. Health experts have pointed to their many side-effects — some of them fatal — and the lack of therapeutic justification for their sale. Eventually, it was the view of an expert committee formed expressly for the purpose of examining these drugs that the government used to accede to the longstanding demand for a ban.
What are fixed dose combinations?
When two or more active pharmaceutical ingredients (APIs) are combined in a fixed dose medicine to form a single drug. Fixed dose combinations have caused some apprehension as the side-effects of the combined product — and its effects — are different from those of its individual components, and sometimes, the combination can come with risks that are not there in the components by themselves. The added danger is that when an adverse reaction happens in a patient, it is often difficult to place which ingredient is responsible for that reaction.
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Which medicines now stand banned?
Among the commonly used brands that stand banned after the notification are the cough syrups Phensedyl and Corex, the popular and widely advertised cold medicine Vicks Action 500, antibiotic combination Zimnic AZ, and a host of other combination drugs involving commonly used medications like paracetamol, aceclofenac, nimesulide, amoxycillin sildenafil, atorvastatin etc.
Did the government go by the opinion of the expert committee alone?
Independent studies conducted across the world that have pointed out that many of these combinations do not have any advantage over the individual drugs. For example, a study published in the Indian Journal of Pharmacology in 2010 found “Nimesulide and paracetamol combination offers no advantage over nimesulide alone or paracetamol alone, either in terms of degree of analgesia or onset of action.”
At what other fora has the demand for a ban on FDCs been raised in the past?
The section of the medical fraternity that feels strongly about rational drug use has been advocating it for long. The first editorial on the need to crack down on FDCs appeared in the Monthly Index of Medical Specialities — a well known journal in medical circles — back in January 1982. The original report of the Kokate Committee on policy guidelines for approval of FDCs made the same recommendation. The organisation Social Jurist filed a case in Delhi High Court asking for the Nimesulide paracetamol combination to be banned. In that case, the Drug Controller General of India (DCGI) told the court that there was nothing wrong with the medicine.
What did the Standing Committee say?
The Parliamentary Standing Committee on Health and Family Welfare in its 59th report on the functioning of the Central Drugs and Standards Control Authority tabled in May 2012 pointed out several loopholes in the approvals of FDCs, and noted that many of these already stood banned in western countries.
“The Committee is of the view that those unauthorized FDCs that pose risk to patients and communities such as a combination of two antibacterials need to be withdrawn immediately due to danger of developing resistance that affects the entire population.
“The Committee is of the view that… there is a need to make the process of approving and banning FDCs more transparent and fair. In general, if an FDC is not approved anywhere in the world, it may not be cleared for use in India unless there is a specific disease or disorder prevalent in India, or a very specific reason backed by scientific evidence and irrefutable data applicable specifically to India that justifies the approval of a particular FDC. The Committee strongly recommends that a clear, transparent policy may be framed for approving FDCs based on scientific principles,” the committee said.
Aceclofenac + Paracetamol + Rabeprazole
Nimesulide + Diclofenac
Nimesulide + Cetirizine + Caffeine
Nimesulide + Tizanidine
Paracetamol + Cetirizine + Caffeine
Diclofenac + Tramadol + Chlorzoxazone
Dicyclomine + Paracetamol + Domperidone
Nimesulide + Paracetamol dispersible tablets
Paracetamol + Phenylephrine + Caffeine
Diclofenac + Tramadol + Paracetamol
Diclofenac + Paracetamol + Chlorzoxazone + Famotidine
Naproxen + Paracetamol
Nimesulide + Serratiopeptidase
Paracetamol + Diclofenac + Famotidine
Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
Omeprazole + Paracetamol + Diclofenac
Nimesulide + Paracetamol injection