Mumbai: Organization of Pharmaceuticals Producers of India or OPPI, an industry lobby that mainly represents foreign drug companies in India, has a tough time ahead tackling issues pertaining to the country’s “loosely drafted” intellectual property regulations, the consequent legal battles, criticism over high drug prices, and beyond that, a declining share of its member companies in the predominantly generic-driven domestic market.
The task before OPPI’s new president Ranga Iyer, also the managing director of the Indian arm of US drug company Wyeth, is not as easy as it was for his predecessors. But Iyer, in his first media interview after taking over the OPPI post, says these issues are part of positive growth in the evolving Indian pharma sector. Edited excerpts.
Are concerns about Indian patent laws still on top of the agenda for OPPI?
There are improvements required in the country’s patent law. The innovator companies, which have been investing heavily on research and development, will find it difficult to cope with such issues in the law that deny patent protection for deserving intellectual properties.
Positive growth: MD of Wyeth India and OPPI president Ranga Iyer.
The organization has a very clear view on its demands. We ask for more clarity on certain clauses such as the provision for patenting incremental innovation. Currently, section 3 (d) of the law does not include innovations such as enhanced safety of a drug, or improved patient compliance.
Indian law has now narrowed down the scope of incremental innovation only to efficacy. As a result, research efforts made by drug companies to improve the safety and comfort for patient go un-rewarded here. The patent protection sought for such incremental innovation is not intended for extending the patent life of the molecule, but only for that particular innovation, and for a comparatively shorter period.
Similarly, there should be a time frame fixed for filing pre-grant opposition to a patent application. These two issues are still major concerns for the research-oriented companies (both foreign and local). But we don’t expect all these changes to take place overnight. The industry here is evolving, and the current disputes and debates are all part of this evolution.
Multinational companies have been criticized for being focused on high value specialty drugs, which are being introduced here from the parents’ portfolio under patent protection. There is suspicion that over time, these companies will completely withdraw from low-cost medicines and concentrate on such segments where they can make more profit. Is this the direction that your member companies are moving?
These are totally misplaced thoughts. Foreign drug makers have been in the local market for decades with drugs for almost all disease segments priced at all ranges. It will remain the strategy in future. Certainly, there will be extra effort taken by each company to establish newer brands. It doesn’t mean the older ones will be discarded. Top-selling drugs such as Voveran and Augmentin and several such top-of-the-mind brands in India’s traditional drug market belong to foreign drug firms.
Will patent protection and high drug prices lead to poor patient access?
The access of medicine and the prices are not directly linked. Even today, only 30% of the Indian population has access to modern medicine, at a time when the country has the lowest drug prices compared to other markets. So, the real issue is the lack of infrastructure and health care institutions for offering widespread modern medical care in the country. It is an area where only the government can play an active role.
The increased focus on rural health care and creation of hospitals by the government is a welcome move and it will help in resolving the issue. The allegations of high drug prices for new products are also not based on factual analysis.
The companies are well aware of the market economy. They can’t blindly charge 100% premium on these products, though more rational approaches are being worked out by these companies now.
What is OPPI’s reaction to the recent Delhi high court ruling allowing a generic company to sell in India a copy of Roche Scientific India’s Tarceva (a lung cancer drug) despite a patent protection?
The matter is subjudice at present. So, I can’t comment.
Has the cut in excise duty announced in Budget 2008 helped companies to rationalize prices?
Our members have already passed on the benefit to the customers. After adjusting the abatement and the transportational charges, etc., about 4-5% reduction should have been reflected on the retail prices of all the excisable drugs.
What’s your view on the perception that foreign drug firms will not invest in R&D here unless the patent law is tightened?
Foreign drug firms are committed to India and investment in the country is a strategic decision of each company. But, in general, there should not be any reluctance among the multinational companies to invest in a country like India, where better resources and skill-sets are available, and it is mutually beneficial.