Thursday, October 17, 2013

Clinical Trial in India - The Untold Growth Story

Today's post comes from guest blogger Rashmi Pant. She is the Deputy General Manager Market Research at Veeda Clinical Research.  Veeda Clinical Research is a phase I and IIa clinical research organization headquartered in India.

It needs to be seen as to how and when the predicted boom for the Indian clinical trials market is expected to pick up. Seeing the controversies clouding the market, Pharmaceutical companies in the WEST and even the National Institute of Health (NIH) have withdrawn their clinical trials from India. With the declaration by the Supreme Court in India in the last week that not a single trial would be approved until the laws are in place will further worsen the situation. Not only the clinical trials will get withdrawn from the country, the same will also get shifted to other emerging nations.

Clinical trials market in India-Will the same pick up in India?

This is the key question with analysts, investors and all stakeholders who have been observing this market in the recent times. The clinical trial industry since the year 2006 has been expected to grow in double digits because of its vast patient population.

However, things have not been bright for the industry particularly since 2009.

Data at the CTRI (Clinical Trial Registry of India) has witnessed a step hike in clinical trial registration since it came into inception. On an international level, data at the Clinical trials Gov. site has also captured this aspect.

Due to some unavoidable circumstances, flaws in clinical research practices came to light in a hospital based trial in Madhya Pradesh (Indore city) in India, two years ago. This was despite the fact that the trial was registered at all accredited sites and was being done by a known pharmaceutical company. The matter came into light when an NGO filed a petition in the Supreme Court in protest against flaws (possible anomalies) in the associated practices. Seeing the same, the Supreme Court bench issued an order to the Indian drug regulator to outline clear cut laws to conduct clinical trials in India raising concerns with respect to Ethics and Ethics Committees, safety of volunteers, informed consent issues and volunteer compensation in case of adverse events. Based on the same, the Ranjit Roy Chowdhury Committee was formed to present before the parliament its recommendations. The recommendations of the committee were brought to the notice of the regulators and the industry leaders for their further action and comments.

However today, the Supreme Court has now placed an order that no clinical trials can be approved until the laws are in place. (30th Sep2013)

This news has been published in major newspapers in India and now the Indian regulator cannot approve clinical trials even if the same are in view of public interest. Whether this decision is going to expedite the rule formation process is something which is difficult to say. But for sure, it is likely to take away the clinical research away from India.

In the name of ethics, a lot of suffering is likely to fall on the world of new drug research. New drug research is heavily dependent on outsourced clinical research and people will continue to suffer and die of incurable diseases. Humanity will be at its losing best if the law makers continue to support "only humanity" without realizing that the future of humanity is at stake as “unknown" disease prevalence is continuously lurking.




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