An attempt to substantially modify the Drugs & Cosmetics Act 1940 has been on for some time and a draft bill 2013 for the purpose has been cleared by the Union cabinet. The Bill was expected to be passed by the Parliament in the Monsoon session. The objective of the Bill is to bring in comprehensive changes in the Act in the context of major changes took place in the pharmaceutical sector and allied fields over the years. One key thrust of the amendment is to bring the medical devices sector under the regulatory control of the government as this sector has grown into a critical care segment of the healthcare industry. The medical devices sector in India is still at a nascent stage with more than 60 per cent of India’s requirement of medical devices and equipments are being imported as the domestic production is restricted to low technology and disposable items. Whereas the demand for these life saving products has been steadily growing with a sharp rise in the life style diseases in the country. Medical devices are life saving products and have to be produced with quality materials and as per good manufacturing practices (GMP). But, most of the units engaged in the manufacture of medical devices are small and do not follow GMP voluntarily and there are no specified standards for the materials used. Quality, safety and fair pricing are three factors that determine the growth of any industry and that is not happening in India. Quality of medical devices imported into India needs to be strictly monitored considering the number of device recalls in the US in recent years. According to a recent Global Business Intelligence report, in 2010 alone, 54 device recalls were effected in the US for their high risks of serious health problems or death. The largest number of device recalls during 2005-2010 was in the cardiovascular area, accounting for 16 per cent of total device recalls. Radiology devices accounted for 14 per cent of recalls, whereas orthopaedic therapeutic devices accounted for 12 per cent of recalls. The main reasons for recalls were problems related to device design and process control, which includes developing, controlling and monitoring production processes to ensure that the device conforms to specifications.
It is in this context, the government decided to have an exclusive set of rules and regulatory machinery for this sector and to include provisions for the same in the D&C Act. The proposed amendment Bill thus seeks to establish a Medical Devices Authority to enable all medical devices and equipments to be regulated under the amended D&C Act. In fact, the medical devices units have also been demanding an exclusive authority for regulating medical devices, which are currently being classified as drugs. It is important that an exclusive regulatory authority should be established with adequate powers to ensure standards, efficacy, safety and availability of medical devices manufactured or marketed in the country. The designated authority needs to develop a system of classification of devices, notify standards and guidelines. The Bill also proposes to expand the Drugs Technical Advisory Board (DTAB) and creation of a new cadre of officers for enforcement of rules relating to medical devices on the lines of drugs and cosmetics. The Advisory Board may be necessary to advise both the Central and State governments on technical matters relating to medical devices as is being done by DTAB on drug matters. Now as the Parliament could not take up the Bill for consideration during the just ended Monsoon session, the medical devices sector may have to wait for some more months for getting the regulatory umbrella.