End of road for Fixed Dose Combination meds

Last week an advisory body has recommended the banning of fixed dose combination (FDC) medicines. It had been done by the health ministry in 2016 but was challenged in the court and in pursuance to the court order the advisory body had been formed to go through the matter in depth. The fixed dose combinations have been quite popular and advertised heavily in print and electronic media to attract the consumers who might be suffering from certain common ailments, but did not get relief from the simple plain medicine directly meant for that particular ailment, and, hence, preferred to go for a combination drug which typically use a little bit of drug meant for a related problem.

For instance, it is quite common, especially during the rainy season, to suffer from fever, body ache, cold and cough, and for all the symptoms, one compound typically meant for curing fever – paracetamol – will not work and the patient may remain in distress because of related problems even though the fever might have subsided. In these circumstances combination drugs which help not only with bringing down fever but also give relief from cold and cough are obviously preferred by the lay man. However, on several occasions even when the symptoms are clearly not of mixed ailments but simple fever, for instance, there has been a tendency to take the combination medicines due to past experience or as recommended by a near and dear one. Most of these medicines are available over-the-counter encouraging patients to go for over dosage.

The cardinal principle of prescribing medicines is to prescribe the minimum dose for the minimum possible period so as to get the desired results. Over-dosage and over-medication are considered to be sacrilege in medical practice. Availability of a number of medicines over the counter in India has led to serious issues in medication and self-medication has been on the rise. The deluge of information easily available at the click of a mouse has compounded the problem. Now with most of the information available on the smart phone using the Internet, it can easily be said that self-medication, after going through different websites on the Internet, has gone up sharply.

The manner in which the advertisements for the FDCs are almost drilled into the human mind through the television, radio, social media, print media and by the old-style posters and brochures on the street, one is almost made to believe that these FDCs are surely the panacea for all ills. But, this is not true. With very high levels of illiteracy people in India can easily be swayed by the power of advertising and the chemists also perform the role of prescribing medicines for a number of routine problems. It is quite common to watch a customer approaching a chemist and asking for a tablet for body ache. Interestingly, the chemist will question the customer as if he is a qualified doctor, "Do you have fever also?" Depending on the answer yes or no, he will ask a helper in the shop to give him tablet a, or, tablet b.

It is, therefore, a desired move on the part of the health ministry, however, to pharmaceutical companies may suffer a huge loss. They are of the view that these FDCs are useful and patients do get relief faster but somehow the companies have not been able to present the required data to strengthen their case. The government, on the other hand, is of the opinion that India is being used as a dumping ground for these FDCs which are usually banned in foreign countries. The impact of these combination medicines in the long run is harmful as a part of the medicine is irrationally and unnecessarily administered into the body of the patient.

The valid arguments will again be tested in the Supreme Court and in all probability a large number of these FDCs may be banned and several others will have to be strictly monitored and regulated. Misuse and abuse of the combination medicines can only be curbed with effective regulation backed by legal provisions.

The pharmaceutical companies should not, in public interest, cry hoarse.

The author is a professor at IIM-A, akagarwal@iima.ac.in