It seemed like a symbolic tipping point for Indian clinical trials industry when Bangalore-based Stempeutics Research recently got the Drugs Controller General of India?s (DGCI) go-ahead to conduct human clinical trials on stem cell-based drugs for cardiovascular diseases. Depending on the success of clinical studies, the first stem cell-based drug will be available in the market by 2012. The development is significant and seen as the step forward for the Indian clinical trials industrygoing global.
Stempeutics is not alone in undertaking niche clinical trials. After successfully completing phase-I trials on its drug molecule for Alzheimer?s disease in Switzerland, Hyderabad-based Suven Life Sciences is gearing up to commence phase-II trials in the US, Europe and India. ?The SUVN-502 molecule is our first invention and has the potential to be a blockbuster drug for the treatment of Alzheimer?s disease and other disorders of memory like Schizophrenia and Parkinson?s. We anticipate that SUVN-502 can be launched in the major regulated markets by 2013,? says Venkat Jasti, CEO, Suven Life Sciences.
That?s not all. Clinical trials are on in India for the treatment of a particular variant of lung cancer. One of the reasons is that India has a huge number of patients infected by this type of lung cancer, which is primarily triggered by the use of tobacco products. India is also being considered as a prospective site for future clinical trials involving new drugs and therapies for treatment of different variants of blood cancer and colorectal diseases.
There is also growing popularity of India among global pharmaceutical majors to base their trials in different areas like oncology, endocrinology, traumatology, sports medicine, paediatric diseases and infectious diseases. ?The companies conducting clinical trials in India include the largest of the multinational pharma, including companies like GlaxoSmithKline, Eli Lilly, Merck and Pfizer; these companies do a lot of work in niche areas and have the competence to run complex trials. Many biotech companies from the US, with innovative products are also including India in their trials with innovative medicines,? says Anand Bidarkar, vice-president (business development), SIRO Clinpharm.
Trials are on for a drug by Boehringer Ingelheim for reduction of mortality in adult patients from lung cancer. Clinical trials have already been held by GlaxoSmithKline on an antigen-specific cancer immunotherapeutic as adjuvant therapy in patients with non-small cell lung cancer. Trials are being conducted by Biogen Idec to test the efficacy and safety of an oral drug for multiple sclerosis. GlobeImmune is conducting trials on a vaccine for the treatment of pancreas cancer, while a trial by Eli Lilly is seeking to study the long-term progression of Alzheimer?s disease. Astra Zencea is undertaking drug trials for schizophrenia, bipolar disorder, cancer and diabetes.
Some of the other companies include Johnson & Johnson, Sanofi Aventis, Wyeth, Roche, Bristol-Meyers Squibb who are among the list of companies conducting clinical research. In all, over 100 pharmaceutical companies are currently outsourcing clinical trials to India.
Broad contours of the changing face of Indian clinical trials landscape are not difficult to find out?the days of undertaking the mundane task of clinical trial data management or bio-equivalence (BE) and bio-availability (BA) are over. Instead, India is emerging as the hub of clinical trials in the niche category.
?There are around 400 clinical trials that are currently recruiting patients in India and this is a significant jump from the situation two years ago when there were hardly 100 actively recruiting trials at any given point of time. Around 30% of these trials are for niche indications,? informs Bidarkar. Currently, there are at least two key stem cell trials being conducted, apart from around five studies in Alzheimer?s disease, around 10 studies in pediatrics, 15 acute trauma studies and several oncology studies.
?There is recognition for the niche trials being conducted in the country and the acceptability factor is fast gaining momentum by global majors too,? says Jasti. The reasons for this are not hard to find. The clinical trials industry in the country has achieved a reasonable degree of maturity. Some of the leading healthcare institutes like CMC, Vellore, PGI Chandigarh and Rajiv Gandhi Cancer Institute, Delhi are capable of handling complex trials in niche therapeutic areas.
In fact, this has led to a number of global clinical research organisations (CROs) setting up offices in India and who have started including India in their niche global studies.
Several reasons are attributed for the Indian market?s transition from traditionally BA/BE service providers to being the full service providers for the pharmaceutical sponsors. This is on account of growing clinical trial market globally and further, the growing share of Indian sites for trials; stringent regulations with respect to documentation, pharmacovigilance, among others; more qualified and experienced principal investigators; regulatory guidelines have been amended in favour of the industry in the last couple of years and so on.
With increasing shift towards lifestyle diseases, India presents a vast patient pool for the pharmaceutical sponsors. Further, with new geographies within India, the patient population is also found to be more receptive to the treatment. In addition to the cost arbitrage, India also presents the opportunity for the pharmaceutical companies to market their drugs in future, informs Ajit Mahadevan, partner, health sciences practice, Ernst & Young.
In the process, the country is also emerging as the beneficiary of multi-location trials of global pharmaceutical majors. These trials have indirectly helped in building up of infrastructure at hospitals, especially those in the non-corporate sector and increased peer interaction of Indian doctors with their counterparts in the west is also beneficial.
At the same time, adequate safety standards and protocol adherence are very important for all trials, informs Bidarkar. In case of niche areas, the companies conducting the trial should ensure adequate investigator and site education, rigorous monitoring and continued evaluation of safety parameters.
Companies with drugs in niche therapeutic areas should work only with CROs that have the expertise to understand the complexities involved and the capabilities to execute the study. Often trials in niche areas are beneficial to patients as there are not many effective treatments, but these should be handled with adequate care.
According to Mahadevan, in some of the special conditions, the drug administration in phase-I cannot be administered to healthy population. Secondly, for oncology drugs, only those patients with the specific cancer site?for example, lung cancer?can be recruited. Hence, these protocols are built in the study design itself and are monitored from the inception of the trial.
However, Apurva Shah, co-managing director, Veeda Clinical Research says, ?There needs to be an apex body, which grades the CROs and weed out the inefficient ones, so that there are no disasters and the country and the industry gets a bad name because of a few CROs who don?t follow the principles of good clinical practice (GCP) or good laboratory practice (GLP).?
Besides the low-cost advantage for India, the country offers several additional advantages such as a strong labour pool with good chemistry skills, a disease profile, which is gradually mirroring the western countries, faster patient recruitment, increasing compliance to international standards and an improving regulatory environment. On the other hand, given the growing pressures on MNC pharma majors to optimise cost and allocation of resources, the inclination to increasingly outsource to low-cost destinations such as India is only becoming stronger. Hence, both these factors have culminated into India?s gradual emergence as one of the preferred destinations for clinical trials globally.
Going forward, as the clinical trials industry in India matures further and investigators as well as local CROs gain experience, the ratio of niche clinical trials will increase.