Combination drugs: Easing out of existence?

Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates, gives an insight on various regulatory hurdles hindering the growth of the pharma industry in India

Indian pharmaceutical industry’s growth has been phenomenal from the 70s onwards, primarily due to the combination of ‘friend, philosopher and guide’ attitude of the nationalist government as well as the vision, passion and enthusiasm of the pharma CEOs of current industry leaders who commenced domestic pharma manufacturing activities with modest beginnings. The role that contribution therapy supported by introduction of rational patient convenience-oriented drug combinations such as anti-TB, anti-diabetes, antibacterial, anti-retroviral etc. played in increasing customer confidence on indigenously manufactured combination drugs has been phenomenal. It has helped enhance financial viabilities and encourage innovative approaches. In the later years, from late 90s, when the DPCO provisions started getting tweaked by the NPPA to include (and expand) the list of price-controlled single ingredient medicines, pharma industry resorted to their indigenous innovative adaptations of combination drugs and therapies to escape NPPA’s noose. Oral dosage forms of antibiotics or anti-colic pain relievers were combined with anti-ulcer medications or probiotics and even proton pump inhibitors to provide patient comfort and convenience. Subsequent new drug policies with recommendations of the Mashelkar Committee and other expert committees advised innovative, patented  medicines to be exempted from price control. However, over the years, the NPPA, encouraged by NGOs, have been pricing innovative, patented New Drug Delivery Systems (NDDS) based sustained release/ slow release/ modified release/ delayed release/ orally dispensable/ mouth-melting dosage forms and combination drugs as their standard generic forms in spite the superior patient benefits built into the design of these dosage forms. Domestic or indigenously developed technological advancements have, of late, started receiving scant respect and appreciation, while trivial or incremental improvements on imported patented medicines have become more respectable and appreciated in the market place in spite of their multi-fold, unaffordable pricing. Such scavenger pricing is welcomed by all intermediaries since their commissions or trade margins are linked to the MRPs or the final price to the patient. This is all the more attractive to reputed dispensing hospitals.

In the history of all medicines, it has been common practice to ‘kill the goose that stops laying the golden eggs.’ The patented blockbusters over the last fifty years, were proven to be harmful to health and have serious side effects after their ‘useful patented’ life was over. The very same innovator who has been singing the praise of their path-breaking drug during the life time of the patent, finds independent research (probably with their own inputs) leading to research studies and publications, to highlight life threatening side effects of the now ‘patent expired’ drug. With the full-fledged onset of ‘TRIPs’ based product patent regime, the mostly imported (or locally licenced to distribute) patented drugs need to open up markets in India by displacing low priced patent – friendly combination drugs which were in use for years without any report of adverse effects. It has to be admitted that the ‘concurrent nature’ of the Indian pharma drug control authority wherein the roles of the Central Drug (CDSCO) and State Drug (FDA) authorities are defined in the 1940 Drugs & Cosmetics Act has not been able to keep pace with the technological advances in the recent years.  Consequently, there have been some abuses of the system which led to introduction of a few irrational combinations. However, it is uncalled for to ban combination drugs across the board to weed out some bad drugs. Many traditional formulations, including those based on probiotic or nutritional support-based combinations are likely to be the targets and victims in this massive exercise.

To add insult to injury, the new FSSAI rules on nutraceuticals will cause explosive impact on the Indian pharma industry. The potential of the Indian nutraceutical industry (which is reported to be around Rs 20,000 crores) can even surpass the pharma industry in its growth, if relieved of excessive controls and constraints. Nutraceuticals are mostly combinations based on ingredients proven to be safe and efficacious, including prophylactic and preventive. The combined attack on the otherwise over – regulated Indian pharma industry from the Health Ministry through the CDSCO and the FSSAI reminds me of the ‘Jalianwala Baug Massacre.’ While some victims will be identifiable by the impact on their financial results, the Indian entrepreneurial thrust which has hitherto been on converting challenges and threats to opportunities, will come out with innovative options and alternatives to continue to grow, survive and offer their services to the stakeholders, in spite of these manmade catastrophes and growth barriers.

Amidst these challenges and threats, one wonders, whether the pharma industry is being deprived from ease of doing business in India, relief from Licence Raj and the policies of self-reliance and import-substitution of yesteryears.