Does India have enough skilled force to handle the big contract research cache that is projected in the next few years? If the current CRO views are to be believed, they have already started feeling the crunch. According to CRO majors in the country, this drawback along with regulatory bottlenecks would put brakes on India's share of the growing global CRO pie. Though the total market value of clinical research performed in India in year 2003 is estimated to be about $ 80 million and the market is expected to touch a billion dollar in the next five years.
Trained manpower is required in project monitoring, protocol design, project management, regulatory affairs, drug distribution to the site, storage, safety reporting, medical reporting, data management, and statistical analysis.
The training so far is conducted by CROs themselves. "As an effort to solve the problem, the CROs, governments, hospitals and the industry need to join hands to devise a training module for personnel working in CROs. The skill sets of the available pharmacologists, allopaths, vets and homeopaths could be honed in this direction with proper training," said Dr. Umakanta Sahoo, project manager, Clininvent Research Pvt Ltd, a CRO owned by The Chatterjee Group (TCG).
"The DCGI on its behalf should train the ethics committee in public hospitals. Furthermore, we are in need to have more well equipped diagnostic labs, adequate regulations and auditing of the CROs, and cold-chain services with proper indicators for efficient transportation of the drugs," he added.
Pfizer India is the only corporate in the country, which has set up an Academy of Clinical Excellence in co-operation with the Bombay College of Pharmacy. This academy offer diploma programmes in clinical research. However Pfizer can accommodate only limited number of students and several such institutions are needed considering the potential of contract research in the country, said experts.
"Like Pfizer, other pharma corporates should initiate similar programmes through tie-ups. The government should also consider making clinical research as one of the prominent subjects for students of Medicine and Pharmacology," said Dr. Chetan Tamhankar, General Manager, Siro Clinpharma Pvt Ltd.
There are about 30 CROs in India. CVS, infections, diabetes, AIDS, Malaria and Kala Azar are the major diseases tracked by the CROs.
"Currently, simultaneous phase II and III studies are allowed in India. With suitable regulatory infrastructure and policies India can expect even phase I trials in the near future," said Dr. Sahoo.
"Oncology, psychiatry and neurology are going to be the key areas, Clininvent will be focusing on," said Dr. Arun Bhatt, President, Clininvent Research.