New Delhi, Wednesday, June 16, 2010: Soon there will be a regulatory check on the quality of all medical devices, diagnostics and equipments as per the latest plans of the central government. The regulatory checks will be implemented on all the manufacturers, importers and suppliers of the medical devices where they will be required to get themselves registered with the country’s drug regulatory authority, the Drug Controller General of India (DCGI).

The central government has formulated a new law, the Central Devices Act (CDA) with the aim to regulate the entire medical device industry. Currently the Drugs and Cosmetics Act regulates only 14 medical devices which are primarily concerned to regulate medicines. The step is seen as an extension

of the comprehensive amendment to the current drug law and aims to bring all the medical devices under the regulatory preview of the health ministry.

Dinesh Trivedi minister of state for health and family welfare informed that the low end devices like thermometers and X-rays will be left to the companies for self- regulation but high end devices like cardiac stents will be directly regulated by DGCI. He was addressing the national workshop on medical devices organized by the Federation of Indian Chambers of Commerce and Industry. He also said, “We will give the states a deadline to respond and take the bill forward.” The amendment waits for the state government’s views since health is a state issue.

Mr. Trivedi also informed that the ministry is keen on quick finalization of the bill and waits for the state government feedback. He said, “The states want to keep the right for giving licenses for the equipment. We need uniform standards. Each state cannot have its own regulation.”

It is interesting to note that the medical device, diagnostics and equipment market is small at present and collectively accounts for just 6% of the country’s total $3 billion healthcare market but is anticipated to expand with the growing healthcare facilities in the country.

Ref: infocera