THE ECONOMIC TIMES

28 September 2000

India can be a super power in pharma R&D

HARINDER SIKKA

Even a casual reading of our Shastras and Vedas would confirm the in-depth knowledge acquired through R&D by our scientists thousands of years ago, especially in the area of biotechnology. One of the major differences of yesteryear research was that it was proactive to general masses. Whereas today's research is mainly proactive to customer, not necessarily from the lowest strata of the society.  Today's R&D revolve around the existing rules of the market, i.e., what products to sell, at what price and to whom. 

As the world is becoming smaller and smaller, India too is undergoing a cultural change.  A doctor is no longer seen as a 'God' but only as a 'service provider'.  The rapidly shrinking global boundaries have given a new impetus to the imagination of Indian scientists, which, if channeled correctly, could take India to the top.  Synergised with in-house strength of IT, it could well catapult our nation to become a super power in an area that would be the very pillars of the future world.

There are however, a few areas that need focussed attention of both the Private and the Public Sectors.  For starters, the Government is expected to play a lead role in removal of red tape and bottlenecks. As a first step, a concerted effort needs to be put to set up patent offices that match the international standards and speed.  It is an irony that the Patent Office in Calcutta does not have even a computer. Hundreds of important patent cases await their turn on one in number manual typewriter that goes clickty-click the whole day.  The babudom has, as of now, ensured that the files relating to new patents remain unattended for over a decade.  Even countries like China have established 'State of the Art' patent offices to ensure adequate protection to its inherited wealth.

The second most important aspect is the removal of restriction of experimentation on genetically engineered animals in the name of prevention of cruelty.  The subject itself should be primarily under the Ministry of Health/Drugs & Chemicals. For some strange reasons however, it is placed under the purview of Social and Justice Department which for obvious reasons, does not appreciate the fact that no drug is qualified for commercial use without its successful clinical trials on genetically engineered mice and other compatible animals.  In fact, the Department links even the collection of honey as anti-nature and harmful to the environment. 

Therefore a new anti-malarial/anti-cancer drug or a life saving vaccine cannot be cleared commercially because of the whims and fancies of a department that wishes to instead safeguard the mice that has been specifically engineered for the trials. Not only it has been a major setback for the Indian scientists and doctors; it has also forced large pharmaceutical companies like Ranbaxy to shift their R&D units overseas.  This in turn would not only force the Indian consumer to pay many times more for the same drug due to increased research costs overseas, it would also put at risk vital data falling into the alien hands.

The Task Force on R&D, headed by eminent scientist from CSIR Dr. R.A. Mashelkar, laid great emphasis on the importance of the testing of the drugs on genetically engineered animals.  In its recommendations the task force stressed upon the urgent need of shifting the controls of animal testing to the Ministry of Health.  According to Dr. J.M Khanna, Chief Research Officer of M/s. Ranbaxy, "unless the government allows the testing of drugs on genetically engineered mice and animals, the Indian drug industry stands doomed".  Dr. Bhandari of CSIR links the clinical trials to the very oxygen or a nerve centre of a drug industry. Yet another eminent scientist Dr. Lele in his book has stated on how medical sciences has benefited from study of animals over the past 100 years.

The centuries old and time-tested Indian herbal-based drugs too do not find any recognition overseas due to non-availability of clinical trials on animals, a data absolutely necessary for commercial acceptability worldwide.  Ironically, the same herbal based drug are being imported from Germany and sold at fanciful prices to the Indian consumer over the counter.

It is therefore of paramount importance for the Government to lift the existing ban of testing of drugs on genetically engineered mice and animals and place its checks and controls to the Ministry of Health.  The private industry is thereafter expected to take the lead in putting its act together and focus on advanced bioengineering.  It is an old saying that technology in short term is always over estimated and in the long term grossly under estimated.  India and its very large pool of scientists therefore need to focus on the long term R&D so that in the coming decade it can make its mark and make our country a super power.

(The author is president, Piramal Enterprises Limited)