Around 20-30% of global clinical trial activities are being conducted in developing countries. More than 40% of drug development costs are incurred in clinical trials and India offers immense savings on this aspect. India emerges as a preferred destination for outsourcing clinical trials because of the availability of a large patient population, 40% reduced clinical trial cost as compared to West and well-trained medical professionals along with excellent technological infrastructure. Indian CRO industry is expected to increase five folds till 2010. There is lot of factors attributing to the CRO industry for the market to flourish as expected in the next 5 years.
Drug Controller General of India (DCGI) is the nodal agency to evaluate the product safety, efficacy, clinical trials, market authoritisation and post market surveillance in India. There are many regulatory agencies under DCGI like ICMR (vaccines), NIB (biologicals), GEAC-DBT (genetically modified drugs), DGFT (export/import) and CRI/CDTL (drug testing). Genetic Engineering Approval Committee (GEAC) is responsible to regulate the proposals involving large scale use of living modified organisms (LMOs) in the pharmaceutical industry.
Current Situation
As per Indian regulations, it should ideally take 3-6 months for clinical trail drug approval whereas USFDA provides clinical trial approval within 30 days. Most of the CRO feels that there is too much of delay in the timelines for drug approvals. If it's a phase III drug, DCGI will approve in a very short period but if it is a Phase II or first time trial drug in India, the period could be infinite or unknown. Along with regulations, deficiencies in the functioning of the ethics committees (EC), investigators' unethical approach to the recruitment of subjects and the quality of Indian clinical trials makes India a rash and risky place to outsource. The delay in the process of approval after filing the application with the regulatory agencies and the absence of clear guidelines from these agencies is putting enormous pressure on drug development companies.
The timelines for approval are often unpredictable in India as the Drugs Controller's office depends on external experts and other government agencies such as the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) for advice and there are additional permissions required from Director General of Foreign Trade for the import of trial samples and export of blood samples to foreign central laboratories. Delay in approval has resulted into conducting unethical/illegal trials at private clinics without the fear of regulatory authorities as they fail to take action against such mischief makers in the society leaving the patients with no avenue for seeking compensation for any mishaps involving the trial drugs. Hence the government is planning to revise the Biomedical Research on Human Subjects Bill on Regulation, Control and Safeguards.
As the CRO industry in India is booming, applications for clinical trials are flourishing in DCGI's office. DCGI do not have adequate experience and manpower to tackle the increasing application for clinical trial activity in different phases and therapeutic segments in India
Changing Scenario
The pharma and biotech companies have been demanding restructuring of the regulatory mechanism in the fast emerging sector. Regulatory association has realized the fact and trying to improve the situation. Regulatory authorities are recommending effective mechanisms and have introduced the Schedule Y. DCGI has revised adoption of Good Clinical Practices (GCP) guidelines, removal of import duty on clinical trial samples, elimination of restrictions on concurrent trials and anticipated patent law changes.
The Drug and Controller General of India (DCGI) planning to put in place inspection systems to track the progress of drug trials from beginning to end and a new set of rules "to emphasize incorporating good clinical-practices protocols". Indian Government is also planning to introduce draft guidelines on ethical and patient safety issues in different fields like stem cell research, genetically modified food, genetically modified drugs, biomedical and behavioral research on HIV/AIDS, assisted reproductive techniques (ARTs), gene therapy by DBT, policy statement fro genetics and genomics by DBT. Sponsors are now looking at positive action by the insurance companies to cover the people working in clinical trial projects and also to protect the interest of the patients.
The Central Government along with the World Health Organisation (WHO) has undertaken a massive campaign to train regulatory personnel as well as private clinical investigators of the subtleties of good clinical practices (GCP). Training involves regulatory personnel to understand the intricacies of inspecting and auditing clinical trials as well as educating the investigators involved and of complying to the benchmarks set by the government. The workshops will also focus on standard operating procedures as well as the role of investigators and ethics committees.
Regulatory bodies are gaining acceptance & visibility after sustained efforts from the industry leaders. Pharmaceutical sponsors and Contract Research Organizations (CROs) want the regulatory approval process to be more predictable, accountable and less cumbersome. If the India has to leverage the clinical trials activity, its regulatory body needs to be proactive in their set procedures and timelines, be accountable and transparent for any delays in the approval process and reach the international/US regulatory standards.
(Swati Chaturvedi is senior research analyst-Healthcare Practice Frost & Sullivan. The author can be reached through: sdedhia@frost.com)