Though India is high on the radar of several multinational pharmaceutical companies as a preferred clinical research destination, so far the country has succeeded in attracting only less than one per cent of the global trials, exposing its inefficiencies, including lack of infrastructure, adequate regulations and trained investigators, in this yet to mature market front.
However, there are dedicated efforts from the regulatory authorities, including drug controller general of India and central drugs standard control organisation, to propel this promising industrial sector by streamlining regulations and making the clinical research service providers comply with good laboratory practices, good clinical practices and international conference on harmonisation.
The recent move by the ministry of health to not to allow foreign pharma players to conduct phase I studies of molecules developed outside India in the country until right infrastructure, manpower and guidelines for effective monitoring and supervision are in place shows its determination to take its industry to global standards and grow the country's clinical research market as a hub for global trials. However, the regulators need to move very fast and see that the requirements are in place at the earliest, if they really intend to take Indian clinical research market to the next level of growth. Otherwise, India may not be in a position to cash in on its now proclaimed edge in clinical research over other developing countries.
Also, the decision to make clinical trial registration mandatory from June 2009 is another welcome move from the regulators, as it would bring in more transparency and regulate the growing clinical research industry in the country. With this move, information on all clinical trials taking place in India in areas like new drugs, treatments, therapies, surgical procedures and new medical devices would be made publicly available through clinical trials registry India website.
"Going by the increasing number of trials and the importance given to India by international pharma and biotech majors to carry out global multi-centric human studies, the Ministry of Health and Family Welfare, government of India, is now set to maintain a registry on the volunteers and the patients undergoing trials. It will also mandate the compulsory registration and audit of clinical research organisations in the country. The Drugs Control General of India (DCGI) office inspectorate is now being trained to handle clinical trial inspections. In fact, the US Food and Drug Administration (FDA) is training the inspectors to examine and undertake audits and surprise checks at the clinical research organisations," said, Dr Surinder Singh, DCGI.
"Guidelines are also being framed to compensate trial candidates in the event of a research related injury in India. There is also a need to create widespread sensitisation on clinical trial methodology and to provide an in-depth knowledge on the subject," he added.
Since the industry players also harbour a feeling that India has a long way to go to emerge as a clinical research hub, despite the rosy reports of Indian capabilities in clinical research, the steps taken by the Indian regulators, including its decision to not to allow foreign pharma players to conduct phase I studies of molecules developed abroad in the country soon, certainly deserve much appreciation.
"India needs both skills, expertise of trained and experienced manpower to handle phase I studies and additional specific equipment that might be needed for close monitoring of subjects of such studies. Current expertise in India in doing bioavailability / bioequivalence studies for generic product is not enough. But that could become a great base to build upon necessary competencies and expertise here in coming months," said, Dr Chetan Tamhankar, chief operating officer, Siro Clinpharm Pvt. Ltd.
"It is important to recognise that there is significant gap in skill-sets needed to carry out a phase I clinical trial and merely doing bioavailability (BA) / bioequivalence (BE) studies for generic products. Also for phase I, skill competencies and training needed as well as infrastructure for close monitoring of patients/volunteers is much more than that is needed for BA/BE studies for generic drugs," he added hinting at the areas where India needs to improve since the country was so far focusing on generic drugs development.
While quickly gaining momentum, India's much hyped clinical research industry is yet to take off as it lacks skills and expertise of trained and experienced manpower, adequate infrastructure and robust regulations. In this wake, the regulators' move to strengthen their offices and enact regulations to take clinical research and services sector to next level of growth breaths the much needed life into the industry.
Welcoming a new guideline for allowing foreign companies to conduct phase I studies in India, K V Subramaniam, president and chief executive officer, Reliance Life Sciences, said, "There should be a new guideline created for this purpose. In addition, the amendment to Schedule Y that would allow such phase I trials should also stipulate that such studies should be first approved by the regulatory authorities in the source country, before it is filed for approval in India. This would prevent any exploitation of Indian subjects since the explicit permission from the country of origin would ensure that exposure of human subjects to such a molecule is validated in the source country itself."
"While compliance to good laboratory practice (GLP) is vital, even more important is adopting stringent measures to ensure compliance to good clinical practices (GCP), which is concerned with the protection of human subjects undergoing trials. Adherence to Indian GCP/GLP should be made mandatory by law for all phase I trials. Moreover, the accreditation of CROs, which plan to conduct such studies, should be made mandatory under a special regulation," he added.
Voicing another concern, a section of international clinical research organisations said: "India too needs a regulation in place to seek the confidence of the international sponsors." "Despite no enforcements, the country has been viewed as important site for the conduct of many global studies because of its high degree of medial investigators, who need only to be trained on a regular basis on the good clinical practices protocol," they added.
INDIAN EDGE
The recent regulatory efforts, however, don't cut the picture that the watchdogs are trying to grow the Indian clinical research and services market out of nowhere. They are indeed doing what they could have done a few years back when Indian players were making progress in clinical research and services front and garnering sourcing deals from multinational pharma houses. In fact India is a low cost destination and holds second place after US in conducting clinical trials, offering locations for global multi-centric trials for psychiatry, diabetes, cancer, cardiovascular, dermatology, neurology and tropical diseases like malaria, kala azar and diarrhoea. As a result, companies like Pfizer, Merck, Wyeth, AstraZeneca, GlaxoSmithKline, Johnson and Johnson, Eli Lilly, Sanofi-Aventis, Roche, Bristol-Myers Squibb and Novartis have already started sourcing clinical trial activities to India.
"India has very strong data management capabilities and information technology skills. There are significant cost and patient enrolment advantages. The country offers a large 'treatment naïve' patient population. Diseases are diverse in nature but similar to the epidemiological profile of mature markets. Due to the lack of penetration of effective medical treatment, patient enrolment is high with minimal attrition. They can be recruited for less than one-third the time taken in the US. The average number of patients per site is fifty, which is five times higher than that in the US," said, Dr Kiran Marthak, director, Veeda Clinical Research, throwing light on the advantages India offer in clinical research market front.
"However, uneven infrastructure and shortage of clinical research assistants would hamper future growth in the clinical research market," he added pointing to the areas India lag behind.
India is the signatory of the World Trade Organisation (WTO) agreement and the second largest populated country in the world with large pool of patient population, well developed hospitals and talented workforce. To a large extent, all these factors have helped the country lure global players to conduct their clinical research.
"From paediatric to geriatric population, the country is much sought after for its volunteers and patient population," said, Dr Prem Pais, dean and head, clinical trials division, St John's Medical College.
According to Mahesh Malneedi, founder and president, MakroCare, one of the most important factors attracting clinical trials to India is large pool of physicians, nurses and technical personnel to meet the global requirements for clinical testing. "India is also known for shorter patient recruitment timelines and high patient compliance. These factors are critical when global research and development costs have increased 23 fold in the past 28 years and the average development time in the US has almost approached 15 years," he added.
Endorsing a similar point, Agnes Schiewe, director, clinical research, Ecron Acunova, said, "The main attraction for trials to be held in India is the easy access to large pool of patients and faster recruitment at low cost in this segment. The country is now getting noticed for its quality of the trial site and the data generated from here."
Surging clinical trial market in India is also learned to create enormous opportunities for a number of associated industries, including IVD market, education sector and clinical data management.