THE DATA TRIAL

The move to bring in a new law for data protection has started a debate in the government and the pharmaceutical industry

‘Research companies need to be protected from pirates’

Harinder S. Sikka

The Indian pharma industry is growing at a rapid pace overseas, touching almost every part of the world. In the process, it’s also giving MNCs a run for their money and putting to rest all apprehensions. With its low cost, speed and high quality advantage, India is also gearing to become a hub for contract research and manufacturing which, in years to come, could act as a catalyst in cutting the enormously high research costs abroad.

There are a few hurdles still. After nearly two years of becoming IPR compliant, we are still surrounded with unfounded fears of patents even as drug manufacturers are flourishing in countries governed by similar laws. Data protection is a contentious issue, hotly debated by the government and the industry. Lack of protection to an innovator’s intellectual property is seen as a big stumbling block, especially by research-based companies since no firm can afford to see its hard work stolen by fly-by-night operators.

As per the prevailing laws, the regulator in India can rely on an innovator’s data to approve the competitor’s product. While the system in general is responsible for maintaining the necessary secrecy, it is not accountable for the same. As a consequence, the competitor gets undue advantage over the innovator even when he is clandestinely abusing an innovator’s intellectual property.

Data protection laws are prevalent all over the world. India is one of the few nations which doesn’t have this provision. Consequently, research-based pharma majors are being forced to undertake vital clinical trials abroad. Huge expenditures in turn are incurred overseas, draining precious foreign exchange even when this could be done at home at a fraction of the cost.

Having competitive edge over other countries is one thing, but maintaining the same is quite another.

If countries such as China, Singapore, Vietnam and Korea don’t have a large pool of scientists, they make up by facilitating foreign researchers in every conceivable way. Canada, in fact, has gone a step further and provided tax incentives up to a whopping 46 percent for research carried out within the country.

India doesn’t do any of this and so continues its struggle with diseases that it has been inflicted with since independence. It is a great irony that diseases like TB and malaria kill more people even today than almost all other diseases put together. While Indian companies have only focused in reverse engineering blockbuster drugs from the MNC stables, overseas scientists too have displayed little interest in researching sub-continent specific diseases. Simply put, MNCs find more profits and interests in lifestyle drugs such as impotency, obesity etc which in turn fund the expensive research as well as give a healthy look to their balance sheets.

Effective January 2005, Indian companies can no longer copy patent protected foreign drugs. It’s time that India takes every possible step to put in place a robust system, at par with the best, that would help in making our country a hub for clinical research. At present over 95 percent of drugs in India are off patent. Therefore, there is no real panic for the next few years. But with the rapidly changing urban lifestyles, the situation is set to change swiftly. It would be prudent to be prepared than to be sorry.

Data protection varies between three and ten years in most countries. Patent laws on the other hand provide a 20-year cover to an innovation. If the government agrees to provide up to a 5-year data protection, with a condition that the protection period shall begin from the first registration date of the product worldwide and end within the stipulated period or along with the patent—whichever is earlier—it will solve the ensuing conflict without compromising national interests.

Besides, protecting an innovator’s data would also help us in doing away with the prevailing image of India as a land of copycats. Contract research and manufacturing is a US $100 billion market waiting to be tapped provided we have a right set of rules for the international players. We will have only ourselves to blame if we are caught napping due to bureaucratic red tape and unfounded fears.

If Indian research has to grow, then research companies need to be protected from pirates. Data protection is the first and vital step towards it.

The writer is senior president, Nicholas Piramal India Limited