Many of the Indian pharmaceutical companies who have made it to the top in domestic formulation market owe their success to fixed dose combinations (FDCs) which have been marketed by them over the years. These FDCs are different from pharmacopoeal combinations of two or more drugs. Attempts by the regulatory authorities viz. the Drugs Controller General of India (DCGI) have yielded limited results. The main point of contentions are rationality of these combinations as well as their safety. Whilst the industry is of the view that since these FDCs have been in the market for almost a couple of decades and no serious side effects or adverse reactions have been noted, the safety of the FDCs may be deemed to be established. No serious attempts have been made to establish the safety independently. To consider a drug or a combination safe without going through the established protocols of proof of safety is hazardous particularly in Indian conditions. The patients often are poor, illiterate, ill-fed and malnourished and do not often complain of the minor adverse reactions because they or their physicians cannot attribute it solely to the drug and often hold their personal hygiene, living standards and poor quality of food responsible for some of the reactions. It is, therefore, absolutely essential for the industry and manufacturers and marketers of these combinations to independently assess the safety of these FDCs because the logic “Proof of the pudding is in the eating” does not strictly apply here.

The other aspect is the rationality of these combinations. There is absolutely no rationale in providing a tablet or a capsule or any other dosage form of medicines having two analgesics like paracetamol and ibuprofen or paracetamol and mefenacic acid or a host of other such combinations. The half life of the combined drugs differ appreciably and the picture in the blood of the patient may be totally different to the sum of the two or three drugs in the FDC. However, medical practitioners have been more than happy to prescribe such combinations as it differentiates them as a special doctor who understands the illness of the patient better. Added to this is their confidence that since the regulatory authority of a state or India has approved and licenced these combinations, their rationality and safety can be taken for granted.

Recently, the Drugs Controller General of India has ordered that no fixed dose combinations outside of the list of approved fixed dose combinations by the DCGI be permitted by the State Licencing Authorities (SLAs). This stipulation has yielded good results but only for those who are applying fresh licences to manufacture these products. Renewals have been granted by default  and until the next renewal of the licence and permission arises, this state of affairs may continue.

Several Indian pharmaceutical companies have established their brands for these fixed dose combinations and a cursory look at the turnover of these companies will reveal that the contribution of the FDC brands is 60 per cent of their company’s sales if not more. In the scenario that the Drugs Controller General of India takes the extreme step of banning these fixed dose combinations by not renewing permissions to manufacture after the expiry of the present licence or some fixed dose combinations having failed the test of rationality (which they are bound not to pass) and safety (which is questionable even if established) will these brands be permitted to be manufactured and marketed in the domestic market after having drastically changed the composition so as to be not called an FDC? In the safety of the patients and for the information of the medical practitioners these brands having altered compositions should not be allowed to be marketed since these will be big misnomers. Will these brands with altered compositions if allowed be commanding the same market in terms of rupees and as a corollary to this argument, will their brand value be the same?

With a lot of mergers and acquisitions taking place in the pharmaceutical industry worldwide and in India too, the value of a company is assessed by the value of individual brands of products. As explained above the value of these brands of fixed dose combinations is likely to be eroded drastically. There are exceptions to these. Some Indian companies have not depended so much on fixed dose combinations and still established themselves as top players in Indian pharmaceutical market. These companies have nothing to fear. Multinationals in India by and large are not depending on such fixed dose combinations there are some companies where the company name is a big brand and adds value to whatever drug is being manufactured and marketed by them. For others the future is uncertain.


(Author is a pharma professional with over 3 decades of experience in pharma manufacturing and marketing, and also past president of Goa Pharmaceutical Manufacturers’ Association)