M|A|N|A|G|E|M|E|N|T INSIGHT
FSSA and the emerging OTC landscape Anil Khanna, an independent strategic consultant and investment banker, talks about FSSA guidelines and its implications OTC drugs inally Food Safety & Standards Act (FSSA) guidelines were drafted and finalised in the third quarter of last year, after much delay. It would be instructive to mention here that the law was passed by the Indian Parliament way back in 2006. But this speed of forward movement seems to be at par for the course in Indian scenario. Despite the delay, we now have, at least, a clear definition and classification of nutritional food, novel food, health claim, nutritional claims etc. This is a much better situation, than having no definition of Over the Counter (OTC) medicines. Readers may be reminded that as per Indian Drug laws, there is no clear definition / categorisation of OTC medicines, even though the OTC segment is decent in size and growing as well. So what will be the impact of FSSA on the OTC landscape? The clue to the answer for this ques-
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tion lies in a simple exercise. If we were to divide the Indian OTC landscape before 2000 and post 2000, and were to list the key OTC brands of both these periods, a clear and interesting trend emerges. It is quite clear that, the pre-2000 period was dominated by the therapeutic / curative segments like analgesic, cough / cold etc., while the post2000 period is dominated by supplements brands. It seems, what Thomas Edison said long back - “The doctor of the future will no longer treat the human frame with drugs, but rather will cure and prevent disease with nutrition.� is coming true with a little twist! Thus in this context, the final guidelines of FSSA, notified last year, have come at an appropriate time. The question is, will FSSA give further impetus to this trend and how? While the jury is out on the likely impact, the chances seem bright that more companies will want to capitalise
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on this growing opportunity and regulatory clarity.
Key highlights of FSSA Before analysing its impact, it would be prudent to briefly mention the key highlights of the Act. Key point is that this Act will impact the entire spectrum of the nutritional market, which is more than $ 1 billion plus, as mentioned below The Act defines health supplements as foods intended to supplement the normal diet of a person, and which are concentrated sources of one or more nutrients, like minerals, vitamins, proteins, metals or their compounds, amino acids or enzymes, other dietary substances, plants or botanicals , substances from animal origin or other similar substances with known and established nutritional or physiological effect, and which are presented as such, wherein the composition of these foodstuffs differ significantly from the composition of ordinary foods of comparable nature, and are offered alone or in combination, but are not drugs as per the Drugs and Cosmetics Act 1940 and Rules made there under. The Act also defines a novel food - as a food that does not have a history of
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