Monday, August 18, 2014

Challenging Times for India’s CRO Industry

Today, we feature a guest post from Amar Bhat, PhD, President, TwoFour Insight Group. Amar Bhat, PhD, is the President of TwoFour Insight Group, LLC, an information and research advisory service providing western companies with regulatory and policy intelligence about the Indian life sciences market. An expert in international government relations and stakeholder engagement, Dr. Bhat has spent his career focused on global health and biomedical research policy issues while at the Pharmaceutical Research and Manufacturers Association (PhRMA) and the U.S. Department of Health and Human Services.  Dr. Bhat can be reached at

In less then two years, the clinical research industry in India has gone from boom to bust. As recently as early 2012, the country seemingly had positioned itself as an ideal destination for clinical trials for Western companies with all of the key elements in place (e.g., naïve patient population, low-cost skilled labor, etc.). Unfortunately, growth in this burgeoning industry has since come to an almost immediate standstill. The clinical research organization (CRO) industry is still trying to overcome this regulatory stalemate, especially the local (Indian) CRO companies that are heavily dependent on conducting trials in India. On the other hand, the global CRO and life sciences industry are well on their way of placing India at the bottom of their list of clinical trial destinations.

By way of recap, in January 2012, a local non-governmental organization filed a lawsuit in the Supreme Court of India alleging malpractice by the clinical research industry and the Government of India in the conduct and regulation of clinical trials in the country. As a result, the Central drug regulator (CDSCO/DCGI) has been taking steps to increase the regulatory oversight of trials conducted in India, by issuing a slew of new requirements by way of “notices”, “orders”, and “office memorandums” – as recently as July 2014. To the chagrin of industry and academic research institutions such as the U.S. National Institutes of Health (NIH), the new requirements give more pause than comfort in making investments in this industry in India. For example, a recently issued memorandum declared a list of events as automatically attributable to negligence during the conduct of the trial and thus, requiring compensation by the clinical trial sponsor/applicant (e.g., trial drug not having the intended therapeutic effect). This is clearly not any type of assurance for industry that the process has been streamlined with international best practices in mind.

In another example of what sometimes seems as if the government is issuing new rules to appease the Supreme Court without fully thinking through the consequences, CDSCO/DCGI posted a notice of a proposal to create an online portal for clinical trials in India. The preamble of this document indicates that this proposal is designed to enhance the transparency and efficiency in the approval process and oversight of clinical trials taking place in India by creating an IT-enabled “real-time” database with the obligation on industry, including, but not limited to, sponsors, investigators and ethics committees to submit daily information. Not only is this proposal ambitious, but is also very troublesome for industry in terms of the cost required for compliance, uncertainty of the safeguards available for patient information, the potential for premature decisions based on time-limited and incomplete information, and the challenge by sponsors/applicants of ensuring that all stakeholders submit information into the portal that has been properly vetted and uploaded in a timely manner.

A significant amount of information has been provided in these documents issued by CDSCO with the regulator clearly taking considerable liberty in its authority to regulate the industry. Several of these areas will require further clarification/modification and may be counterproductive to revitalizing the clinical trials industry in India. For more on these developments, feel free to monitor our website, where we post regularly on updates in India’s clinical research environment or contact us directly at A list of all our alerts regarding clinical trials can be found here. TwoFour Insight Group, LLC continues to monitor the evolving situation, including, any notices, orders and other documents issued by the Indian government that can have an impact on this industry.

*The services offered by TwoFour Insight Group, LLC are consulting services and are not and should not be considered legal services or legal advice. Neither this communication, nor any proposal nor any contract you may enter into with TwoFour Insight Group, LLC will create any type of attorney-client relationship between the parties.

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