FICCI calls for single authority to deal with medical devices

NEW DELHI: The government should set up a dedicated authority for dealing with issues related to medical devices, industry chamber FICCI said today.

In its recommendation to the government on the proposed amendments to the Drugs and Cosmetic Act, FICCI said that the term "Clinical Investigation" (trials) for medical devices need to be defined separately and specifically.

"Medical devices be regulated on the basis of comprehensive, harmonised regulatory guidance developed by Global Harmonisation Task Force (GHTF), including international standards like ISO and IEC. Adoption of GHTF guidance will help prepare India's domestic medical device industry to meet the regulatory requirements of major export markets," FICCI said.

The regulations on medical devices should be implemented in stages (as per WHO guidelines) over a period of time while allowing the industry to comply with the regulatory issues.

"The bill should provide new and separate provisions in the Act for regulatory controls specific to medical devices. Such separate provisions will be analogous to those already existing in the Act for Ayurvedic, Siddha, Unani, or homeopathic drugs," FICCI said.