New Delhi: Commonly used medical devices, such as digital thermometers and blood pressure (BP) monitoring equipment, will soon come with quality assurance certificates from the government, with India’s regulatory body set to regulate manufacturing, import and sale of such devices in the country, two people aware of the matter said.
India’s highest drug advisory body, the Drug Technical Advisory Body (DTAB) on Wednesday, approved the proposal to include mercury-free thermometers and BP monitoring equipment under the purview of the Drugs and Cosmetics Act, 1940. Once regulated, such devices will have to be registered under the quality parameters set by the Bureau of Indian Standard (BIS) certification.
The proposal was initiated by the ministry of consumer affairs, food and public distribution, which had asked the regulator, Central Drugs Standard Control Organization (CDSCO), to include both devices under the ambit of the Act. “DTAB has deliberated on the proposal and decided to include the high-end devices under regulation,” said one of the people cited above, requesting anonymity.
The move gains significance, as it will allow DTAB to set quality standards for the equipment. “Due to ease of use, non-contact digital body thermometers are expected to grow substantially and, hence, safety regulations are important,” said the second person, also requesting anonymity.
In India, most medical devices are unregulated, including digital thermometers and BP monitoring machines. Once regulated, the CDSCO will become the approving authority for import, manufacturing and sale of the devices. The companies will also have to apply for permission to the Drug Controller General of India, who is responsible for approval of licences, before such medical devices are sold in India.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), said there was a need to regulate the medical device industry, given the spike in Chinese imports. “There was a need to address patient safety. The country is flooded with cheap Chinese imports and pre-owned medical electronic imports.”
“These need to be regulated under the regulations and, until we have a sector-specific medical devices law, we seek certain parts of medical devices rules to be made mandatory for all medical devices at one go under the BIS Act, and not item by item regulatory controls.”
However, thermometer industry insiders believe that the new regulation was unnecessary.
“It will increase paper work. Digital thermometers are imported from China in either finished and semi-finished form. The BIS has no machinery for surveillance over the clandestine activities. There is a huge market which has been taken over by unauthorized players, but instead of taking any action against them, they have decided to come up with another regulation,” said H.C. Gupta, managing director of Hicks Thermometer Pvt. Ltd.