Harsh penalties like a 10-year jail term for ethical violations may be unheard of in many countries. But India feels such strong deterrents are essential to ensure fair practice and accountability among the mushrooming CROs in its fast-growing clinical research industry.
Lately, there have been several reports from NGOs and other human rights watchdogs questioning the ethical conduct of human studies run in the country. In November last year, India's drug regulator had to suspend a pediatric pneumoccocal vaccine Phase III trial conducted by Wyeth, following the death of an infant in Bangalore, in south India.
Also, some drug makers and CROs are reportedly testing drugs in India through "ethically problematic" study designs or trials that would not be allowed in other developed countries. These drugs are not even intended to be sold in India.
Besides stringent laws, the health ministry also intends to make auditing and registration of the clinical trials mandatory in the country. Auditing of trial data is not a practice often followed religiously by the majority of CROs, so far. The new Central Drug Authority (CDA) bill proposes compulsory auditing of clinical trials. The FDA has also sought to help train Indian personnel in clinical trail auditing.
Mandatory registration of CROs is expected to begin this month. "Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory," stated Surinder Singh, drugs controller general of India (DCGI). The trials will be registered on the Clinical Trials Registry-India (CTRI) website.
India turned out to be a favorite locale for numerous CROs, clinical trials partnerships and foreign investment by pharma and bio companies around the world. Almost all pharma MNCs and global CROs such as Quintiles, Covance, and Parexel have operations in India either directly or through partnerships.
"India remains a strong market for Quintiles. We already work with the top pharmaceutical companies, who recognize that India has the infrastructure and trained researchers to meet their needs. We expect to add more customers in the future as they see the benefits of conducting clinical research in India," said Dr. Ferzaan Engineer, chief executive officer of Quintiles India. With operations in three cities, Quintiles India claims the prime slot in Indian CRO space. It has already completed more than 130 studies involving 600+ sites.
The proportion of global clinical trials conducted in India is expected to more than double by 2012, as a huge patient pool of both chronic and infectious diseases, and easy recruitment drive down the cost of trials by 50 to 75%, according to market research firm RNCOS.
As these sentiments soar, even more CROs swarm in to test the Indian advantage. The most recent additions to this list are the Cincinnati, OH-based site management organization (SMO) Radiant Research's link up with India's Spectrum Clinical Research, Excel PharmaStudies, a leading Chinese CRO's alliance with GVK Biosciences, and Australian Novotech's JV with ETI Klinical. Kendle, a biopharmaceutical CRO from the U.S. also expanded Indian activities by setting up a second office in Ahmedabad, in western India, in January.
Global consultancy McKinsey & Co. estimates that by 2010, global pharma majors would spend around $1-1.5 billion just for drug trials in the country.
Phase I – Not for Now
The hype and all the regulatory efforts notwithstanding, stakeholders in the CRO industry feel that India is still way behind from being a level playing field for them. Safety of their trial data submitted for regulatory approval process continues to worry them as adequate safeguards in the form of data protection law are not yet in place.
Again, India allows only Phase II and III studies for global companies. Phase I studies are permitted for Indian companies but not for "molecules developed outside." In fact, India very recently reversed an earlier stand for allowing the first-in-man studies, citing inadequate preparedness as reason.
But some of the leading CROs like Quintiles do not find Phase I studies or data protection issues as major hurdles on way of their growth strategies. "Current law prohibits 'first-in-human' studies in India for molecules developed overseas, but does allow some studies that occur later in Phase I and early Phase II, after initial safety data is obtained," explained Dr. Engineer, whose Quintiles unit plans to open Phase I operations in Hyderabad by early 2010.
Similarly, Quintiles has never encountered an issue in protecting data since it began Indian operations in 1997, as it adheres to "global standards and processes," according to Dr. Engineer.