As drug development grows ever more global, India continues to stand out as one of the key places to be. And with President Barack Obama having just wrapped up a high-profile, economic-focused trip to India last week, it’s clear that doing business with and in this country is a top priority across many sectors.
Lately, the focus has been on growing the Indian market for biosimilars, generic versions of drugs made via biotechnology. According to a recent report by Pricewater-houseCoopers, at least 48 products with combined sales of nearly $73 billion in 2009 are due to come off patent over the next decade. The report suggested that India is well positioned to capture 10% of the biosimilars market by 2020 and become one of its top five producers worldwide. “The potential is huge,” said the report, called “Vision 2020: A BioPharma Strategy for India.”
To make all of that happen, though, the country’s infrastructure needs more work.
“If India is to achieve its aim, it will...have to act fast and the [government of India] will have to play a major supporting role by creating a suitable physical, financial, legislative and regulatory infrastructure,” said the report’s authors, adding that this will cost at least $1 billion.
Members of some key drug development-focused trade groups had this report with them on their recent trip to Hyderabad and New Delhi with the U.S. Chamber of Commerce’s U.S.-India Business Council (USIBC) to focus on biologics partnerships. Attending were representatives from BIO (Biotechnology Industry Organization), PhRMA (Pharmaceutical Research and Manufacturers of America), the OPPI (Organization of Pharmaceutical Producers of India) sub-committee on Biotechnology and ACRO (Association of Clinical Research Organizations).
Greg Kalbaugh, director and counsel for the USIBC and the Global Intellectual Property Center, said his group has sent similar missions to India before, but none brought together so many of the industry’s relevant trade associations—and this was key.
“It was very important for showing a unified, consolidated voice when we met with folks there to talk about the industry,” he said.
Over the course of four days, the group sat down with senior executives from Indian and foreign biotech companies, CROs and consulting and legal firms. It also met with P.V. Ramesh, principal secretary for health in the government of Andhra Pradesh, to discuss areas of collaboration for capacity building and innovation in India. There was a large focus on the biosimilars market, but ACRO’s vice president for public affairs, John Lewis, said pressing matters of all kinds were discussed.
“From a CRO perspective, we very much have seen that the timeline for clinical trials approval has slowed down over there,” he said. “We wanted to see some of the reasons why.”
Lewis said he found the answers on the mission: the huge influx of trials to the country has created a bottleneck within the regulatory agencies. “Now we’re working with the regulatory authorities on whether training and information sharing might help improve the infrastructure to better support the clinical trials industry,” he said.
Also on the agenda, said Lewis, was talk of advancing the phase I industry in India as well as lots of discussion about intellectual property, specifically compulsory licensing. During the discussions, the Association of Biotechnology Led Enterprises and the USIBC delegation agreed to explore forming a joint working group to help various government agencies develop guidelines for the regulation of biologics in India.
Many similar missions will follow, Kalbaugh said. After all, PricewaterhouseCoopers predicts the number of clinical trials in India is likely to grow at an annual rate of 25 to 30%. McKinsey & Co. recently predicted the Indian pharmaceuticals market will surge to $55 billion by 2020, quadrupling from the $12.6 billion it was worth in 2009. That report said the Indian market has further potential to nose up into the $70 billion range if aggressive growth efforts are embraced.
The global bio-pharmaceutical market overall is projected to be valued at $319 billion by 2020.
The USIBC was formed in 1975 to advance commercial ties between the world’s two largest free-market democracies. It’s hosted under the aegis of the U.S. Chamber of Commerce.