The Spotlight Falls on India

Clinical research in India has again come under scrutiny. A comprehensive new market report has highlighted the pros and cons of organizing trials in India, and in the wake of a case of suspected fraud, the regulators have issued new guidelines for CROs.

Number of Phase III Trials Started in 2008

India is a very attractive cost-value proposition, but tax incentives are lacking and infrastructure weaknesses continue to be a problem, according to the authors of "Taking Wings: Coming of Age of the Indian Pharmaceutical Outsourcing Industry," published by Ernst & Young and the Organisation of Pharmaceutical Producers of India.

Strong growth has occurred in recent years, particularly in Phase II and III clinical trials (see chart). The fiscal constraints on global pharmaceutical and biotech companies have contributed to this growth, along with the Indian government's commitment to support the life sciences sector. The Indian population's strong technical drug chemistry skills, as well as the responsiveness of sites, have also helped. Data protection and exclusivity are still major areas of concern, however.

"There are no provisions in Indian laws regarding whether the data collected from clinical trials can be used by the Drug Controller General of India in its approval procedures for other drugs," the authors note. "In addition, there is a debate about whether data exclusivity laws need to be enacted in India."

You can download the report free-of-charge at www.indiaoppi.com

Meanwhile, the New Delhi-based regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has issued draft guidelines that require the registration of CROs that conduct human studies on drugs, cosmetics, and medical devices. Under the guidelines, CROs must adhere to SOPs to obtain a license of registration, which is valid for five years. CDSCO is currently seeking feedback on the proposed changes.

"This is an attempt by the government to control scientific and ethical standards for clinical trials in India," said Nermeen Varawalla, MD, MBA, president and chief executive officer of ECCRO (Emerging Country Contract Research Organisation). "It reflects the government's keenness to promote the sector and the realization that highest standards are critical for the sector to thrive. Hence, they are a good thing and a significant statement to the international community, although in themselves, the impact of these rules will be less significant."

Also in India, suspected fraud has prompted Glenmark Pharmaceuticals to close its clinical trial site at Guru Gobind Hospital, Jamnagar, Gujarat. At the site, Omnicare Clinical Research was conducting a Phase IIb study for Glenmark's chronic obstructive pulmonary disease/asthma product, Oglemilast.

During monitoring activities immediately after initiation of the site in late 2008, Omnicare suspected fraudulent activity, and the clinical investigator, A. Bhattacharya, MD, has now been suspended.—Philip Ward