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The Rediff Business Interview / C Venkateswarlu

'Exclusive marketing rights hold no immediate threat, but the pharma sector has to gear up'

Addressing the 50th Indian Pharmaceutical Congress and the 17th Asian Congress of Pharmaceutical Sciences in Bombay last fortnight, M Venkateswarlu, India's deputy drugs controller, stressed that the Indian pharmaceutical industry needs to lay equal emphasis on bulk drugs and formulations. He also sought to play down the so-called adverse impact the exclusive marketing rights are feared to have on the Indian industry. He elaborated on these points and other issues in an interview to Chris Ann Fichardo.

Why are non-allopathic drugs not being marketed internationally?

The problem with non-allopathic drugs is the manufacturers are not able to show to the world their consistency. They may work, they may not work. The advantage of allopathy is that you can be sure what the drug contains down to the last milligram. I can't do that with ayurveda or even some herbal drugs. The confidence level will vary.

Ayurveda must be able to create confidence in the minds of the patient and the doctor that what is there in the first batch is the same as the hundredth batch. They have not yet been able to establish that it is free of impurities and meets the claims it makes regarding its therapeutic effects.

Ayurveda as a science has to adopt new techniques and methodologies available to the researcher today.

Why are there few India-researched drugs in the market today?

We have a temperament to follow the leader. Earlier, people were more interested in copying the process patent in a foreign researched drug. Today when companies look at other pharmaceutical companies like Dr Reddy's investing millions of rupees in various research projects and bringing out two molecules in less than six years, it works as an incentive. Indian pharmaceutical companies are now realising and have started investing in R&D.

How difficult is it to patent a drug from India?

Quite difficult. The entire patent office has to be modernised and has to be linked with international markets. Also with the rupee quoting at more than 40 rupees to one US dollar, it becomes very expensive for an Indian to fight a legal battle outside India.

There are fears that the exclusive marketing rights to foreign companies will lead to an increase in drug prices across India. Do you agree with this view?

If you look at the national health programme, whatever is required by the common man is indegenously produced and not covered by the Patent Act.

Nearly 90 per cent of the drugs being marketed in the country today are not patented. EMRs may not mean much for the general population. They may have an impact on drugs being introduced now and those that will be investigated in the future.

But as of today, there may not be a problem, in the context of availability of drugs for the disease pattern India has. For example, I may invent another cardio-vascular drug, but we already have enough such drugs to tackle the problem. So, if it is better priced somebody may be happy to take a drug that is available. Exclusive marketing rights hold no immediate threat, but the pharma sector has to gear up.

What is your overview of the Indian pharmaceutical industry?

The industry is at the kickoff stage. There should be a little more emphasis on research and on getting a new drug delivery system and bio-tech products.

The industry has to strengthen its capacity to make formulations as well as bulk drugs so that the international community accepts India as an outsourcing area. Already in bulk drugs we are recognised as such, but now we should top the formulations market. Some of our facilities do not measure up to the international level, so the industry has to create state-of-the-art facilities.

Then people will look to India as a sourcing destination for formulations too. We have the manpower, we have the machinery, we have the capacity to produce to international standards. So these strengths should be projected to the world to attract the global businessman to India.

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