The Indian clinical research industry, valued at Rs. 8,000 crore ending fiscal 2010-2011 , is making rapid strides in the global arena leaving even China way behind in conducting clinical trials according to experts. The industry which was valued at Rs. 1,200 crore in 2006 has grown to Rs. 6,500 crore in 2009-10.
The key growth factors driving the sector are the sound medical expertise, English speaking work force, capability in information technology, large patient pool and modern hospital infrastructure. Supporting these capabilities are quick turnaround time and the data management skills.
The global economic slowdown which has seriously impacted western world has benefited the Indian clinical research industry. Scores of assignments are pouring in to conduct clinical trials, pharmacovigilance studies and data management works.
The India clinical trials industry has around 40 major players. Of these the leading names are global players like Quintile, PharmaNet, PharmaOlam and Clin Tech International to name a few. The well-known Indian names include Ecron AcuNova, Lotus Labs, Clingene ,part of Biocon Ltd, Omnicare, ICON, Vaatsalya, St. John’s Medical College Clinical Trial Centre, Triesta Life Sceicnes part of Health Care Global Enterprises Ltd, Siro, Synchron, D2L, SMO India and Infinitus.
According to Dr Saral Thangam, Technical Director, Lotus Clinical Research Academy, the main attraction of India is the availability and confidence in the qualified trained personnel comprising pharmacy graduates and doctors who are sound in spoken and written English.
In fact, the global recession has led companies in the West to largely look at low cost markets which include India and China. However, India is preferred to China in the area of clinical record documentation because of the better standards in English, she added.
According to Ashis Mukherjee, senior director , Hospitals & Oncology BU and Corporate Hospitals, Sanofi Aventis, India’s sound knowledge in information technology has been a key growth driver of the clinical research industry. Although the clinical research industry started off in India in 1992, it gained momentum only from 2004 and the last three years have seen an exponential growth. An important factor for such fast paced activity in the sector is the sound IT and English skills supported by qualified doctors, trained medical personnel including investigators, research-hospital infrastructure, economies-of-scale and access to recruiting large number of patients. There is a huge disease burden in the country from cancer, diabetes, tropical fevers to genetic disorders.
The installation of electronic medical records (EMRs) by hospitals in the country have also proved as a major attraction for international clinical research organizations (CROs) and multinational companies to offload human studies to India, he added.
There is a growing global demand for clinical trial management which provides opportunities in IT specific to clinical trial industry. These include data management and medical writing which have widened the scope for outsourcing clinical research business to India.
India is now at the helm of clinical research and speed is the essence of this sector. Pharma companies are looking to hasten the drug development process and CROs are scrambling to access right talent. Clinical research training centres are working to groom candidates as industry ready professionals at a faster pace, said Dr Ramananda S Nadig, dean and chief operating officer, Clinical Research Education Management Academy.
The hospital infrastructure and medical expertise have facilitated smooth conduct of phase-III and phase-IV human studies. However, India needs to look at conducting phase-I trials immediately. The expertise in phase-III and phase-IV have given the country much of the recognition to become a hub in clinical research. In order to grow the clinical research industry here, phase-I needs to be taken on. The country has been a hub for human studies cardiology, oncology, diabetes, thrombosis, central nervous system disorders and tropical diseases.
Global companies are eager to set up pharmacovigilance centres in India. The CROs here have demonstrated competence in quality deliverables in human studies and pharmacovigilance is an extension of this which covers reporting of adverse drug reaction (ADR) and post marketing surveillance.
In fact, for CRO pharmacovigilance is a logical extension. Even Indian pharma companies have started pharmacovigilance as back end services. IT majors like Accenture, TCS and Infosys are particularly focusing on pharmacovigilance, according to Sudhir Pai, Managing Director, Lotus Clinical Research Academy.
Clinical research education
Along with the worldwide growth in clinical trials, enforcement of regulation has also become stringent. In India Schedule Y is considerably regulating the industry. According to Dr Arun Bhatt, president, Indian Society for Clinical Research and president, ClinInvent Research India Pvt Ltd,the Government of India should notify amendment to Schedule Y-1 without delay so as to make registration of clinical research organizations mandatory in the country. In this regard, the Indian Society of Clinical Research had worked on the revised guidelines and made a submission to the Drugs Controller General of India (DCGI) in September 2009. Only a speedy tabulation of the guidelines could provide the industry the much needed fillip, he added.
Supporting this strict adherence and creating an awareness on the need to ensure right conduct of human studies, several clinical research education centres have sprung up. Some of the leading names are Institute of Clinical Research India (ICRI), CREMA and Lotus Clinical Research Academy .
The estimated shortage in the Indian clinical research industry is at 65,000, of which 15,000 are for pharmacovigilance jobs alone. “Global demand is annually around 2.50 lakh trained professionals of which only four per cent of the requirements is met,” said Vijay Moza, chairman, CREMA.
According to Pai, managing director, Lotus Clinical Research Academy, there are bright career opportunities in this industry in India for professionals like doctors, pharmacy, IT and science graduates and post graduates.
The transfer of jobs from global locations to India will give an opportunity to Ecron Acunova to scale up operations and improve processes, said DA Prasanna, founder, Ecron Acunova.
There is also an expansion of facilities by CROs. GVK Biosciences has commissioned its new clinical pharmacology unit (CPU) in Ahmedabad. The DCGI-audited facility is the second centre after its Hyderabad unit which has added 110 beds to the company's existing capacity of 144 beds and will aid faster recruitment solutions to our global customers, said Manni Kantipudi, president, GVK Biosciences.
Challenges
The challenges of this industry in India is that the knowledge of product patent is low. There has been no focus on drug development till 2005. Despite the presence of large and young team of clinical research professionals, they lack training on Good Clinical Practices (GCP) and Good Lab Practices (GLP). Other issues are that medical education curriculum in India does not have a component on research methodologies and there is no standardized training on clinical research. In addition, there is also a need for accreditation of hospitals on similar lines of NABH for sites selected to carry out human studies, opines Mukherjee.