Tribulation tapers down

Thangaraj Nagasamy

Over the past two decades India has successfully developed significant capabilities in clinical trials. With sufficient capabilities in project and data management, India has been able to provide notable cost savings to the tune of 50 to 60 percent in clinical trials. India has a sizeable, heterogeneous population pool of over one billion where shorter recruitment timelines and increased patient compliance are prevalent. That is why drug manufacturers have increasingly shifted their drug trials to India.
However, in a far-reaching interim judgment in January 2013, the Supreme Court of India suspended 157 previously approved trials pending review by new committees. This has slowed down new trials, especially those by foreign companies or those being lined up with foreign collaboration. Following the judgment, the Federal Government of India made sweeping changes to the rules of the Drugs and Cosmetics Act of 1940 which governs clinical trials, making it mandatory for the principal investigator of the pharmaceutical company to reveal the contract between the subject and the company to the Drugs Controller-General of India. This resulted in a 50 percent drop in clinical trials in the country.

Going by clinical trial history, one cannot surmise that imposing more restrictions on clinical trials will put the clock back. Food, Drug, and Cosmetics Act of the US came into being in 1938 in the wake of a clinical research in which over 100 people who consumed sulphanilamide elixir had died. Thereafter, rules and regulations pertaining to clinical trials were being tightened at regular intervals based on the outcomes and needs for the safety of human lives. Over the years clinical trial laws have become more stringent and, in 1990, the international Conference on Harmonization of Clinical Trials laid down strict Guidelines for Good Clinical Practice.

Within India there have been series of debates by various intellectuals regarding the recent setback to clinical trials. Those who are critical of the decision of the Indian government are of the view that the standard of care in clinical trials is much higher than what many hospitals have for their routine diagnosis and treatment.
The Indian Federal Health Minister, Ghulam Nabi Azad, has recently stated that the Supreme Court ruling on, and stringent regulations for, clinical trials had set drugs research back in India. But he exuded confidence that the sector would gather pace soon. This raises hope that the office of the Drug Controller General of India will quickly look into over 1200 applications pending for DCGI approval.
This view is further strengthened by a recent Frost & Sullivan report that says that India is being increasingly viewed as a drug-discovery destination and the market is likely to exceed $1 billion by 2016.

For more information, please contact:
T. Nagasamy
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