CDSCO Proposes Amendment to Include Medical Devices Under Drug Control Act


Published Date : Feb 17, 2015

The Central Drugs Standard Control Organization (CDSCO) is likely to include medical devices ranging from heart stents to artificial limbs under the Drugs and Cosmetics Act, 1940. The organization will present this amendment in the upcoming Parliament session. The CDSCO officials reported that the draft of Drugs and Cosmetics (Amendment) Bill, 2015 has been shared in a public domain.

This move comes as there is a need to standardized and keep an eye on the medical devices used by doctors. Presently, medical practitioners are using devices right from pacemakers to artificial knee joints on their own discretion without consulting the patient. Additionally, there are no prescribed rules for choosing the medical devices. Owing to this, doctors pick devices that have been approved in other countries in the U.S.

The Central Drugs Standard Control Organization (CDSCO) has arranged for a five-day workshop at Gujarat Forensic Sciences University (GFSU) that will invite over 75 drug control officials from all over India to brief them about regulations of medicals devices. This workshop will focus on topics such as existing guidelines in the country and abroad, definition of medical devices, intricacies of quality control and management, regulator audits, safety prerequisites and sterilization, and implications of proposed amendments in the existing procedures.

According to a senior CDSCO official, the innovations in the medical technology, the organization feels that there is serious need to chance the present rules. This will allow the agency to include and denote medical devices as an integral part of medical treatments.