India had only less than 50 contract research organizations doing clinical studies in 2002. Today, there are nearly 200 CROs operating across the country. This steady spurt in CRO business over the last two years is set to touch a higher water mark with India opening up its floodgates through making some daring regulatory changes in the Schedule Y of its Drugs & Cosmetics Act allowing the MNCs to conduct phase 3 studies simultaneously as they do it in other countries, at the beginning of the year 2005.
Earlier, foreign pharma firms were permitted to hold only phase 2 trials in India as they conduct phase 3 studies elsewhere. The resultant momentum along with India's vow to strictly adhere to TRIPS, infused a new vigour into the CRO business which is estimated to peak to the level of $ 1-1.5 billion (from $ 35 billion in 2003) by 2005.
As the CRO industry reaches a crucial phase, experts in the sector are debating one vital issue: do we have sufficient numbers in terms of well-trained clinical investigators to take care of the current requirements.
True that out of around 14,000 general hospitals in the country only 150 of them have the infrastructure, or ethical committees to conduct clinical studies or it has hardly a dozen GLP-complaint path labs. It is also true that though India became TRIPs-complaint, it is yet to sort out certain issues on data exclusivity which is very sensitive while carrying out clinical studies.
Despite all these odds, why the question on investigators comes foremost? The answer is simple. Along with a vast pool of genetically diverse, drug naïve population, India triumphs on being home for more than half a million medical practitioners. Yet, for anybody's shock, out of this immense base of practicing doctors, we have only 150-200 investigators who are trained in GCP!
This paucity of trained investigators is really a matter of concern in an industry which is flourishing otherwise. Increasing number of new investigations virtually give a run for sponsors to identify a trained investigator. And those investigators having a proven track record are heavily overloaded with work and they would rather refuse than accepting a new study despite the hefty remuneration packages they carry, experts observe.
``In India we have a large pool of doctors and specialists. But we have very few investigators,'' says Dr Arun Bhatt, president, ClinInvent, a CRO based in Mumbai.
To become a clinical investigator a doctor needs to be trained in a variety of procedures. He has to handle several issues including obtaining patient consent to record keeping. It's really a tough job and not easy money, he explains.
Dr D S Bakhle, Sr. director, Medical & Scientific Affairs, Aventis Pharma Ltd, the Indian arm of multinational pharma giant Sanofi-Aventis, also agrees that though India has a good resource base of GCP trained investigators the numbers are not quite enough, ``Considering the huge potential of a country with such a vast population base, we need to increase capacity, '' he avers. Compared to the National Institute of Health (NIH) in the US which has about 7000 sites for clinical research, we have hardly 150-200 active clinical research centres in the country, he notes.
Searching for the cause of the current situation, Dr Bhatt says it's basically the lack of a proper machanism to impart training to the aspiring doctors that has resulted in this scenario. This is not because of the dearth of doctors. There are numerous doctors in the academia. As there is no mechanism exists to train them, they have to be trained as they conduct clinical investigations.
Very few of our medical colleges (which come over 1000 in number) seriously consider or give priority to GCP training. There is no proper curriculum to impart training in this highly important medical discipline.
It is not merely the lack of proper training or curriculum alone, but this situation has something to do with the mindset of doctors, as well. ``The mindset of our doctors turns more conservative, or rather orthodox when it comes to clinical investigations. Their ability to conduct good practice does not necessarily give them the capability to conduct good clinical research unless they acquire specific training ,'' comments Dr Bakhle.
Though all the major players recognise the dearth of GCP trained investigators, several of them believe this may not pose a hurdle. Some of the domestically operating CROs are rather confident the numbers will not be problem and will improve as per the requirement.
``There's neither more [investigators] nor less.'' says Dr Ashok Ghone, project manager, Siro Clinpharm Pvt Ltd, ``of course, there was a shortage in 4-5 years ago. Now we have the capacity.'' A specialist in late stage clinical development solutions, Siro imparts training in specific protocols with regard to the area of investigation apart from the mandatory training in general GCP guidelines, he summarises.
Meanwhile a few transnational players maintain the view that the numbers are adequate for the current quantum of studies, we need to build capacities for the future requirements. ``An increasing number of physicians are being exposed to GCP and clinical research methodology. These numbers of investigators are adequate for the current quantum of studies. However, it is important for us to build our capacities to cope with future projections of increased clinical research activity in the country. It is important to structure capacity building efforts with clear targets,'' says Dr C N Potkar, director, Clinical Research, Pfizer Limited.
Novartis India Limited, which is currently into about 10-12 projects spread across 25-30 sites in the country, in a variety of therapeutic categories including hepatitis B, dermatology, diabetology, anti-hypertension, oncology and immunosuppressants is also of similar view.
"We have been involved in global studies for the last 2 years and fortunately have not yet really faced serious problems with selecting either appropriate investigators or hospitals which can set up global clinical trials. Before embarking on any global clinical studies, we ensure that all our participating investigators are appropriately trained to conduct the study as per ICH GCP norms and follow standard operating procedures in doing the same," Dr Suresh Menon, medical director, Novartis India Ltd.
At the same time, there is no denying the fact that the way clinical research is expanding in the country, there could be problems in finding adequate number of GCP trained investigators and more importantly GCP compliant sites, opines Dr Menon.
Realising the importance and urgency of training, a number of centres have already started programmes in Clinical Research. Haffkine Institute, a central government sponsored research centre, based in Mumbai is soon to start a 6 month course to provide training in the various aspects of clinical research. ``Our course will focus on training professionals for conducting successful clinical trials on human volunteers," said Dr Ranjana Deshmukh, Director, Haffkine Institute.
Nevertheless, one section of experts believes that we don't have to be wary about the numbers. Foreign drug firms are unlikely to start full-scale clinical studies unless the government agrees on the data exclusivity clause in the TRIPS agreement which guarantees protection of clinical data submitted to regulator for drug approval from copying and using for other commercial purposes, they contend.
``Without ensuring adequate protection of the data generated, will any MNC conduct full-fledged clinical studies on new molecules in the country? Whatever (10-20) trials now going on are either exploratory or supportive studies,'' asks Dr Chandra M Gulhati, editor, Monthly Index of Medical Specialities (MIMS).
Commenting on the training aspect, Dr Gulhati asked, an investigator can be trained only through hospitals, but how many of our hospitals have the GCP/GLP complaint facilities to train an investigator. Developed countries would never accept the data unless it is as per the norms stipulated by GCP/GLP standards. Countries like US have their own standards. The US FDA does not accept solo clinical trails conducted in developing countries. It insists that the percentage of study subjects from a developing country should not be more than 20%. It also insists that a good proportion of the subject in the study should be generated from the ``old world Europe.''
``Right now we have more than enough investigators to take care of the current requirement in clinical studies. I don't see any more additional requirement anywhere in the near future,'' he avers.