US pharma cos want clinical trial regulations in India lifted

MNC pharma companies that have ganged up against India's lax patent regime, now wants the government to remove all regulations on drug trials.

Foreign pharma majors, mostly American companies, that flocked to India buying up local drug units and research labs in the hope of unfettered clinical trial opportunities, now say Indian policy on clinical research is restrictive. The MNCs and their advocacy groups say regulation of drug research is harming their drug research in India and adding up cost of drug development and thereby reducing profits.

They also blame a proactive media that is more inquisitive and often tend to "sensationalise" the bad effects of the so-called clinical research on human health. "Clinical research has become a highly politicised topic in India fuelled, at least in part, by a sensational press," John J Lewis, from the Association of Clinical Research Organization (ACRO) told the US International Trade Commission (USITC).

The US International Trade Commission (USITC) is hearing US business groups, including the powerful pharmaceutical industry, on the impact of India's trade policies on their businesses, amidst fresh challenges to India's policies related to intellectual property rights in the manufacture and sale of medicines. The USITC, a quasi-judicial federal agency, conducted a hearing stakeholders in connection with its investigation 'Trade, Investment, and Industrial Policies in India: Effects on the US Economy' at the behest of powerful lawmakers.

 Describing the current situation in India as "troubling", Lewis said US companies are harmed by Indian policies on clinical research and that if things continue US companies will be forced to relocate their research to more hospitable countries in eastern Europe or China. Lewis said the regulations on clinical trials in India not only limit US companies' ability to conduct lifesaving biomedical research but also global health and the profitability of pharma MNCs .

"The real loss is to the global research environment that is critical to the efficient development of new treatments and therapies for patients in need, in the US, India and around the world," he said.

Testifying on behalf of Biotechnology Industry Organisation (BIO) Roy Zwahlen said the difficulty in obtaining and enforcing intellectual property rights in India remains a barrier to biotechnology companies.

"In the past year, the Government of India has taken a number of very serious steps to revoke protection on widely-patented biopharmaceutical products," he said, alleging that these actions amount to what are "localisation barriers to trade".

By systematically curtailing the IP rights of innovative biotechnology and pharmaceutical companies - US industry's research and development investment is negatively impacted, he said.

He said beyond the short-term financial impact on US companies operating in the Indian market, these actions have an extended impact on US companies in other markets.

Since Indian companies are now in a position to legally export medicines to third countries where US companies do not normally seek patent protection, he said, these actions would have a negative impact on US companies that serve these markets.

Zwahlen, however, acknowledged that by doing so the Indian government is seeking to keep the prices of medicines down and improve access to medicines.

"However, we contend that these actions are in reality a form of industrial policy designed to improve local commercial interests at the expense of US biotechnology companies.

These steps by the Indian government benefit in a very tangible manner its domestic pharmaceutical industry," he said.

The patent controversies centre around India's decisions to deny patents to certain cancer drugs such as Novartis' Glivec and Bayer's Nexavar and granting compulsory licences to domestic producers of generic versions of these drugs.

Zwahlen said the Indian policies on clinical research, is impossible to implement. "The most controversial of these new guidelines were provisions regarding financial compensation to human subjects and their families in cases of death or injury.

These guidelines were widely viewed to be impossible to implement given that compensation, including medical management, would be given even in cases where placebos were administered to the subject or the investigational drug did not have the intended therapeutic effect," he said.