Medical devices form an important component of the healthcare sector. In India, the indigenous medical device industry is said to be valued at 250 crores and contributing to only 6% of India’s total healthcare sector, which is pegged at over 4,000 crores. This industry is expected to grow at an annual rate of 15%; the growth of which is attributed to the rise in setting up of new hospitals and the increase in the need for sophisticated devices and equipments that provide reliable treatment to individuals. The current regulatory structure is marred by barriers such as lack of regulatory environment, complex rules & guidelines, low penetration, high capital investment and lack of active participation from the government. Hence, regulatory bodies have acknowledged the need to frame guidelines & regulatory approval processes and for quality benchmark on par with global standards.
Currently, in India, the medical devices and equipment industry is governed by Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. The government is expected to develop a regulatory structure leading to the development and manufacturing of quality products. The current act has the said limitations and Government of India has proposed to address these limitations happy wheels demo by tabling a new bill. The draft of the Drugs and Cosmetic (Amendment) Bill, 2015 was released in January 2015 to the public domain; and the Department of Health and Family Welfare under the aegis of the Union Health Ministry, proposes to introduce this Bill, which is an amendment to the Drugs and Cosmetic Act (known as the Principal Act, 1940), in the upcoming Budget session of the Parliament.
This Bill which is an up gradation of the Principal Act, 1940 introduces provisions for clinical trials and regulation of medical devices. This has been welcomed by the industry as it effectively addresses the problems plaguing the healthcare industry in India and is an improvement on the current regulations, which is imprecise and has done more harm than good.
Some of the key regulations proposed in this Bill include: