The Indian medical device market is booming. It is currently worth about $3 billion and is expected to grow 12-16% during the next five years.
Medical Devices Regulation Bill
Though abolished in 2006, the Medical Devices Regulation Bill (MDRB) is likely to be reintroduced in late 2011 or early 2012. The bill plans to consolidate medical devices laws and establish the Medical Device Regulatory Authority of India (MDRA).
If enacted, MDRB will govern all medical devices throughout India. It will regulate the registration, design, manufacture, packaging, labeling, import, sale, use, and disposal of medical devices in the country.
The bill will establish MDRA as the regulatory body for medical devices. If passed, MDRA will be an autonomous committee under the Ministry of Health, separate from the responsibilities of the proposed Central Drug Authority. In addition, Medical Device Safety Appellate Tribunals will be created to hear appeals made by medical device companies about MDRA decisions.
Some of MDRA’s responsibilities might include the following: product approval, issuing regulations regarding the safety and performance of medical devices, providing a risk-based classification of medical devices, etc. However, the agency’s responsibilities in regards to medical device registration and licensing are still under deliberation. Currently, a registration certificate and an import license are required before a medical device can be sold in India.
Draft Guidelines on Reporting Serious Adverse Events
On May 11, 2011, the Central Drugs Standard Control Organization (CDSCO) drafted guidelines on reporting serious adverse events (SAE) in medical device clinical trials. At present, clinical research organizations (CRO) and medical companies are using multiple and different formats to report SAEs. But as of May 2011, CDSCO is standardizing the reporting procedures.
These guidelines include the following documents required for reporting SAEs: every report regarding an SAE, cover letter, and a follow-up report, if possible. Additionally, the medical device company/sponsor/CRO is responsible for reporting the SAEs.
Inspections of Foreign Manufacturing Facilities
CDSCO has also begun inspections of medical device manufacturing facilities in foreign countries to ensure the quality of imported drugs and medical devices into India. Once initial pilot projects are successful, CDSCO will introduce the audit and inspection of manufacturing in more countries.
New Clinical Trial Regulations
MDRB also discusses new regulations on clinical trials and CROs in India. Once the act is enacted, some risky medical devices will require local clinical trials in India. In addition, these regulations will stress the quality of the clinical trials and the need for more skilled CRO staff. CROs and clinical trials will be more strictly regulated in India to reduce corruption and increase accuracy so they can be used for more global clinical trials and product registration.
Indian CROs are required to register with the licensing authority in order to conduct clinical trials. Once permission by the Drug Controller General of India is granted for clinical trials, companies are required to register these clinical trials in the Indian Council of Medical Research clinical trial registry before the initiation of the trial.
Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, MD-based consulting firm that helps medical device companies doing business in the Asian market. A recognized national and international leader in the Asian medical markets, Gross founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia.