InFocus | India
New hotspot for clinical trials
Global pharmaceutical sponsors are looking seriously at India for carrying forward their drug development initiatives. The clinical research outsourcing market in India, valued at Rs3.1 billion in 2005, is expected to grow to Rs13.2 billion by 2010.
- By Rajendar Menen, Gulf News Report
- Published: 00:00 August 14, 2006
- The world is watching the growth and performance of India in the clinical research segment. Thanks to a vast pool of patients, well-trained medical professionals and sophisticated technological infrastructure, the clinical research outsourcing market in the country is set for tremendous growth.
- Image Credit: Gulf News file
India is fast emerging as an attractive destination for conducting global clinical trials thanks to a vast pool of patients, well-trained medical professionals and sophisticated technological infrastructure.
The clinical research outsourcing market in India, valued at Rs3.1 billion in 2005, is expected to grow to Rs13.2 billion by 2010.
"Most American and European nations are outsourcing clinical trials to India," says Mahesh Sawant of Healthcare Practice, Frost and Sullivan, a market research company.
"A huge patient population, genetically distinct groups, speciality hospitals with state-of-the-art facilities, about 700,000 hospital beds and 221 medical colleges, and skilled English speaking investigators are India's trump cards."
Pharmaceutical sponsors
According to Dr Umakanta Sahoo, head of India operations, Chiltern International, a clinical research organisation, "The entire world is watching the growth and performance of India in this business segment. There are positive signals and reports which justify the trends for pharmaceutical sponsors to look seriously at India for carrying forward their drug development initiatives."
Global consultancy McKinsey estimates clinical outsourcing in India to grow to $1.5 billion to $2 billion by 2010. There are about 100 players involved in several outsourcing businesses related to clinical research in India including Pfizer, Novartis, Eli Lilly, Dr Reddy's, Ranbaxy, Dabur, Merk and Astra Zeneca. Several trials are also being carried out in psychiatry, neurology, cardiology, gastroenterology, endocrinology, dermatology, respiratory and ophthalmic areas.
"India's experience in clinical trials, while most of them are for USFDA and European submission, suggest the quality of data is acceptable to meet global standards," says Sahoo.
"But the success of clinical research in India is entirely dependent on the availability of sufficiently high-end, skilled personnel to work on trials for global sponsors."
In preparation, several initiatives, both by industry and private institutes, have started to train people in clinical research.
"The field is emerging as a lucrative career option for bioscience, medical and pharma graduates," says Rajiv Verma, Dean, Institute of Clinical Research (ICR), New Delhi.
To train international quality professionals, ICR has tied up with UK's Cranfield University for the PG course.
Regulatory framework
Fortunately, India's regulatory framework is also compliant with international standards in areas such as Good Manufacturing Practice and Good Laboratory Practice and the country has its own Good Clinical Practice guidelines.
The 2005 amendment to the Schedule Y of the Drugs and Cosmetics Act is pushing India towards acceptance of the International Conference on Harmonisation guidelines for clinical research.
The implementation of the Product Patient Act also confirms the willingness to accept global confidentiality and data security norms. Even the Medical Devices Guideline, necessary for globalisation of clinical research, is in place.
Ethics committee
The fear that Indians could be treated like guinea pigs is also unwarranted. "The accountability is well laid out on paper.
Besides the ethics committees of hospitals that monitor the trials, international agencies such as the FDA, which have to finally approve the drug, also keep an eye on these trials. The controls are so strict that if anything wrong is found happening, the drug is immediately rejected," says Dr B.K. Rao, Chairman, Sir Ganga Ram Hospital in New Delhi.
The Drugs Controller General of India and other regulatory bodies in the country have been stringent in the approval of clinical trials carried out in India.
As the volume of trials goes up, the government will have to think about setting up a Central Regulatory Authority to act as a watchdog.
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