In order to address issues relating to the quality of the medical devices imported or manufactured in the country, health ministry has set up a committee to give suggestions on proposed amendment of Schedule M III under the D&C Rules towards enhancing good manufacturing practices (GMP) globally.  

This according to experts will expand the purview of law on all medical devices and make it harmonious to the requirements being followed internationally. The committee is also supposed to give suggestions relating to requirements of factory premises for manufacture of medical devices under the Drugs and Cosmetics Rules, 1945.

The present Schedule M III contains requirements of factory premises for manufacture of sterile perfusion and blood collection sets, sterile hypodermic syringes and needles only. At present, large number of medical devices is being regulated under the Drugs and Cosmetics Act, 1940. Schedule M III was therefore required to be amended to make it applicable for all medical devices and harmonious to the requirements globally.

Based on the deliberations in the recent Drug Technical Advisory Board (DTAB) meet held in Delhi recently, it was specified that there are also many issues relating to Adverse Drug Reactions (ADRs) in the case of new medical devices and provisions regarding manufacture of medical devices in the country.

Drugs Controller General of India (DCGI) in the meeting informed the committee members that Schedule M III relating to requirements of factory premises for manufacture of medical devices under the Drugs and Cosmetics Rules, 1945, was proposed to be amended to provide good manufacturing practices. The requirements of premises, plant and equipment for medical devices and in-vitro diagnostic kits and reagents also need to be addressed.

The DTAB after deliberations recommended that the committee consisting of officials from Maharashtra and Gujarat Food and Drug Administration, Pharmacy Council of India (PCI), representatives from the medical device industry and experts in the field of cardiology, orthopedic and ophthalmology may examine the issue in totality including the proposed amendment and give its recommendations.