 "We want an efficient, transparent and predictable regime: IPA general secretary")
The Indian Pharmaceutical Alliance (IPA) represents the top 20 research-based national pharmaceutical companies. Collectively, it accounts for almost 85% of the private sector investment in domestic pharmaceutical research and development. It accounts for 60% of the country's exports of drugs and pharmaceuticals and services about 45% of the domestic market. Dilip G Shah, secretary general of IPA, in an e-mail interaction with Gireesh Babu, talks about IPA's views on various issues including price regulation. Edited excerpts:
You have recently highlighted the licensing agreement between Gilead and Indian companies for Hepatitis C drug Sovaldi. How significant is it in the India's patent scenario?
It is a new beginning. It could help find a workable alternative to constant friction between the big pharma and the global generics.
The best way to sell the concept is to demonstrate Gilead's commercial success. The success would be determined by three factors: Firstly, can Gilead make more profit from the royalty under the voluntary licenses than it would have made by selling small quantity at the US prices in the developing and less developed countries?
Secondly, would it have an impact on the price at which it is selling in the USA? And, thirdly, the amount of goodwill generated and savings accrued in managing adverse environment without voluntary licensing.
What is the reason behind increasing the membership of IPA?
More From This Section
Being inclusive gives us greater strength. New members bring different perspectives and guide the IPA to greater heights. The number of members have increased from six founder members to 20 over a period of 15 years. This has strengthened IPA's voice as it represents the single largest segment of the industry, currently at about 50% of the market.
IPA earlier said that the new drug introductions are delayed by regulatory issues. What are the issues the industry is currently facing?
I understand that clearances have significantly improved. But, now the new product introductions are held up by the pricing regulator.
Why is every manufacturer or marketer required to seek price approval from the NPPA for the same product in the same combination, having the same strengths and the same pack size? The pricing formula being what it is, none can get a price different from what is fixed for the first applicant. Yet, company after company has to endlessly wait for NPPA's blessing before it can launch its product.
How is the regulatory system in the country evolving? What are your demands to the government?
Many significant steps have been taken in the last one year to improve working of the drug regulatory authority. Yet, we have a long way to go. We want an efficient, transparent and predictable regime.
You have recommended for a specific clause for the audit of granted patents in the draft National IPR Policy. How would this help the industry?
The post-grant audit will keep the examiners on their toe and improve the quality of patents granted. The fear of audit will avoid collusion between the applicant and the examiner.