Clinical research organizations (CROs) are required to register with India’s Licensing Authority to conduct clinical trials. Once permission to conduct clinical trials has been granted by the Drugs Controller General of India (DCGI), companies are required to register these clinical trials in the Indian Council of Medical Research (ICMR) clinical trial registry at www.ctri.inbefore the initiation of the trial.
In January 2011, the Ministry of Health and Family Welfare issued a notification to amend the Drugs and Cosmetics Rules, 1945, with proposals (draft rules) on clinical trial establishments. One of the proposals is a five-year validity on the registration of a CRO, unless it is suspended or cancelled earlier. CROs whose registration has been suspended or cancelled by the Licensing Authority may, within 90 days of receiving the suspension/cancellation order, appeal to the central government to reverse or modify the order.
The proposals also require CROs to implement quality assurance and quality control measures. These include well-documented standard operating procedures and complete, accurate documentation on the conduct of clinical trials and related investigations. All documentation and communication records are required to be dated, filed and preserved for five years after the completion of the study, or submission of data to CDSCO. This five-year window allows the government to perform audits and checks when needed.
While most of the above issues pertain to drug clinical studies in India, it is expected that riskier foreign medical devices also may need to supplement overseas clinical trials with local clinical trials in India to become registered.
Constant changes in India’s healthcare regulations may make business decisions difficult for foreign medical device companies. However, there still is enormous potential in India’s medical device market. With rapid economic and social development, India’s 1.2 billion people increasingly are demanding better healthcare services and facilities. Due to the public sector’s limited capabilities in providing comprehensive healthcare facilities, more than 75 percent of India’s healthcare delivery is provided by the private sector. Indian government officials estimate that 60 percent of inpatient care and 80 percent of outpatient care currently are given by private hospitals or clinics. As more private healthcare providers seek to offer high-level and more sophisticated forms of treatment, medical device companies that can supply quality products at competitive prices should stand a good chance at penetrating India’s medical device market.