In June 2009, the Drug Consultative Committee (DCC) and the Drug Technical Advisory Board (DTAB) approved new formal regulations for India’s medical device sector. The new regulations, titled Schedule M-III, have been sent to the Ministry of Health for final notification, which is expected soon.
As of yet, India’s medical device sector has been largely unregulated. There is currently no specific definition for medical devices, and only certain devices are regulated as drugs by the Drug Controller General of India (DCGI). Schedule M-III will create a specific definition for medical devices as separate from drugs. The Central Licensing Approval Authority (CLAA) will assume primary responsibility for regulating medical devices. Its functions will include classification, conformity assessment, and postmarket surveillance of medical devices. Furthermore, the CLAA will ensure that all medical devices imported into or exported out of India conform with the new regulations.
Besides Schedule M-III, two other proposals for the regulation of medical devices are pending within the Indian government. In 2006, the Department of Science and Technology drafted the Medical Devices Regulation Bill (MDRB). The bill would establish a Medical Devices Regulatory Authority (MDRA) as an independent government ministry to regulate medical devices. However, in light of the newly approved Schedule M-III, this bill is unlikely to come to fruition.
In 2007, the Ministry of Health (MOH) introduced another bill called the Drug and Cosmetics Amendment Bill (DCAB). This bill proposes the creation of a Central Drug Authority (CDA) to function like US FDA. The proposed CDA includes a separate medical devices department with exclusive authority to regulate medical devices. The DCAB was placed before the parliament in 2008, but failed to pass before the parliamentary elections of April and May 2009. It is unclear whether the new parliament intends to pass the bill.
Ames Gross, president and founder of Pacific Bridge Medical (PBM), is recognized nationally and internationally as a leader in the Asian medical markets. In 2008, MD&DI (Medical Device and Diagnostic Industry) magazine named Gross one of the top 100 executives in the medical business. Gross founded PBM in 1988 and has helped hundreds of medical companies with business development and regulatory issues in Asia. He is a frequent contributor of articles on Asian medical issues for Clinica (UK), MD&DI (Los Angeles), and other medically oriented journals. Gross has been a featured speaker on the Asian medical markets at the Medical Design & Manufacturing (MD&M) shows, the Medtrade Home Health Care Exhibition, the Regulatory Affairs Professional Society's annual and regional meetings, and a variety of other medically oriented meetings and conferences. Gross holds a BA, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm's Web site at www.pacificbridgemedical.com.