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Impact of FDCs ban on pharmaceutical industry

Dr Sanjay Agrawal
Wednesday, July 27, 2016, 08:00 Hrs  [IST]

Fixed dose combinations (FDCs) refer to pharmaceutical preparations containing two or more drugs in a fixed ratio. They were conceptualized on the idea that certain drugs potentiate the action of other drugs when given together.

Fixed dose combinations have to be very rationally and carefully prescribed, because -
1. Patient may not actually need those many drugs, thus patient is subjected to additional side effects.
2. Some drug doses have to be individualized based on patient's response. You cannot do that if you are using a fixed dose combinations.
3. Some pharmaceutical companies have been selling fixed dose combinations in India under this pretext without consulting the Central government, like the cefixime-azithromycin combination, which has already been banned in the United Kingdom.
4. These non-essential fixed dose combinations thus do more harm than good by encouraging irrational and indiscriminate prescribing of more drugs than needed.
It is utmost require to stop production or marketing of irrational fixed dose combinations because in evolutionary terms, the drugs you give will kill the susceptible bacteria leading to selection of those strains which are resistant to the drug. When the drug resistant strains attack, the same drug will never work. Now because you have given a fixed dose combination, other drugs in that fixed dose combination will not work as well. This is very dangerous because we have limited types of antibiotics against any particular species of microbes.

In an effort to stop this, the Union government of India with vide notification dated10th March 2016, has banned 344 fixed dose combinations across the country. Over 2000 branded drug products involving these 344 fixed dose combinations will be now out of sale due to the ban by the government, and that also all at once. These 2000 branded fixed dose combination products are used widely by diabetic, cardiac, psychiatric, asthmatic and other patients suffering from chronic diseases. All these patients are medically stabilized by these combination drugs for several years. The sudden overnight ban of these 344 fixed dose combinations and discontinuation of these drug products will definitely undermine millions of patients on medications.

Ban - short term setback for pharma cos
Short term, it will be a major setback for pharmaceutical companies, like it has been to Pfizer India because the Corex cough syrup got banned. People used to self-medicating using fixed dose combinations as well as physicians reliant on prescribing these will have to look for alternatives. The ban will have a negative impact on growth of Indian pharmaceutical sector and it will not only affect revenues, turnover and profitability of the drug companies but also weaken their research and development (R&D) capability.

So, many pharmaceutical industries nowadays are inclined to produce and market more nutraceuticals rather than pharmaceutical drugs. One of the prime reasons of this unjustifiable laws and regulations by Indian government on nutraceuticals, in addition to that these banned 344 fixed dose combinations may also increase production of nutraceuticals drugs rather than pharmaceutical products. Lots of competitive products of pharmaceutical companies have been facing difficulty to sustain in market in addition no more innovator products are coming up and the change has been shifting towards production of nutraceuticals.

There is a huge awareness for wellness driving the growth of nutraceuticals sector. Vitamins are widely used as dietary supplements. They are commonly prescribed by physicians as a concomitant medication for mild illness to severe chronic illnesses. It is believed that they help in enhancing immunity, improve well being and aid in faster recovery of the illness.

Because of unjustifiable laws and regulations by the government on nutraceuticals sector in market so many irrational nutraceutical combinations are existing, which do not treat condition and does not play any role in improving patient’s condition. Examples such as there is a well-known and highly marketed product of fixed dose combinations (FDCs) named metformin and vitamin B12 for diabetic neuropathy which is a long term complication in case of type 2 diabetes mellitus. There is good reason to make and improve patient’s condition with this combination, but there are so many other combinations having amino acid and other vitamins also available in the market in addition of these two ingredients, which safety and efficacy have not been established. Other important example is vitamin E. There is a documentary proof of effectiveness of vitamin E in a dose of 200 mg RDA which is a very good antioxidant available in the market. But in this era so many different dose strengths of vitamin E (400 mg) also available which is really a very high in dose as compared to the recommended daily allowance. This much dose can even generate free radicals which even further damage to cells and worsen the patients’ condition. Another good example in CVS disorder, omega 3 fatty acid plays a vital role in lowering cholesterol but adding this with other amino acids and vitamins make this combination irrational because safety and efficacy of this is not established. Another very important example of marketing irrational combinations is of vitamin B12 preparations with variable dose strengths. Only 1500 mcg dose strength of RDA is rational in combination, rest combinations with different strengths are irrational.

There is only one check point regarding quality control by FSSAI (Food Safety and Standards Authority of India) before coming any nutraceutical product, Food Safety and Standards Authority of India does not have authority to disapprove nutraceutical products. According to law there is no prerequisite of conducting clinical trials before nutraceutical approval in Indian market if it does not claim any health related benefit. So, there is big gap in establishment of safety and efficacy data for nutraceuticals. The nutraceuticals only perform an action of preventing aspects of diseases, and it does not cure diseases. In nutshell there should be a scientific evidence for approval of nutraceuticals.

(Author is a pharmaceutical consultant)


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Sanjay Pandey Jul 29, 2016 5:58 PM
Very informative
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