Biotech ind seeks clarity on regulatory framework

The opportunity of India becoming a global research hub for the pharmaceutical sector will be lost if the regulatory issues and policy ambiguities are not rectified, and thereby would fail to attract global partnerships, according to industry leaders.

Speaking at the Bio India International partnering conference here on Wednesday, Biocon chairman Kiran Majumdar Shaw said the next big economic growth in the country would come from biopharmaceuticals and biosimilars. However, the global pharma industry was finding it difficult to do anything in India.

Referring to the recent controversy over clinical trials in Andhra Pradesh, she said the problem was arising not out of any major violations of protocols but because of poor understanding of processes involved in drug development amplified by regulatory guidelines.

The guidelines for biosimilars were framed by the department of biotechnology recently at the behest of the industry, which earlier focused on policy matters. But, now it was voicing very serious concerns over the regulatory problems faced by the sector, according to her.

Huge time delays in giving regulatory approvals are resulting in 2-3 times longer duration to complete the research because of which many companies feel it is not optimal to do drug development in India.

The US Indian Industry Dialogue, a partnering platform of the industries of both the countries, has decided to develop a white paper, which outlines areas of concern as well as recommendations to ease the difficulties faced by the industry. The two-day second annual conference is focusing on these issues apart from facilitating partnership meetings by domestic and foreign biotech companies.

Sharing similar sentiments, Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, and Aaron Schasct, executive director, global external R&D of Eli Lilly, said speedy regulatory approvals and proper support from the government were required to ensure the growth of the Indian pharmaceutical industry in drug innovation.

The Indian pharmaceutical industry is largely benefiting from global partnerships, especially in the area of research. High cost involved in drug research and talent pool along with low-cost models available here are bringing global and domestic companies together in several areas, including research, co-development, and out-licensing.

According to Schasct, the capabilities already developed by the Indian industry needs to be integrated before it readies for undertaking innovation research on its own. “Eco system for innovation is not fully formed. The growth of capital markets and emergence of venture capital funds to support the innovation has a long way to go,” he said.

Saldanha said bulk of the partnerships were happening at the preclinical drug development stage. Straight out-licensing and co-development were the preferred modes of partnership by larger companies and contract research by smaller companies.

Even global companies like Eli Lilly are pursuing multiplefund partnerships for the risk capital requirements as there is a limit to investments into drug research by larger companies as well, according to Schasct.

The Indian biotech industry is currently pegged at $4 billion with a year-on-year growth rate of around 25 per cent.