In order to bring about a comprehensive legislation for the regulation of medical device sector, Drugs and Cosmetics (Amendment) Bill, 2013 which seeks to replace the Drugs and Cosmetics Act, 1940 will be tabled in the next winter session of Parliament. The new legislation will bring about standardization and hence spur new innovations leading to competitive pricing.

Revising the now-defunct bill of 2007, the new bill seeks to centralise licensing in 17 categories of very critical drugs included in the proposed Third Schedule of the Act. A separate Chapter containing regulatory provisions for medical devices and more comprehensive provisions for regulating clinical trials and exports are included in the bill.

Informed Dr S Eswara Reddy, deputy drugs controller of India, "The new bill which seeks to establish the Central Drugs Authority (CDA) to regulate the drugs and cosmetics sector envisages to strengthen the infrastructure, manpower, medical device testing labs and training the regulators.

"Government has allocated Rs.3000 crore in the 12th Five Year Plan for the development of medical device sector. It plans to appoint 300 medical device officers, ten experts from the bio medical, bio materials, plastic engineering and electronic engineering to give fillip to medical device sector," he added.

The planned allocation also envisages to appoint 50 personnel each at the upcoming medical devices testing labs, diagnostic testing labs and national drug regulators training academy. In order to understand the global regulatory needs, Rs.five crore will be spent on professionals for international travel along with opening of overseas country offices at a cost of Rs.175 crores.

The bill once it gets passed by the parliament will clearly define the authority of Central Drugs Standard Control Organisation (CDSCO) to regulate imports, manufacturing and exports and State Regulating Authorities to regulate sale, stock and exhibition of medical devices under the new Drugs and Cosmetics Act, 2013.

The new legislation will give central government the power to make rules for classification of medical devices based on the degree of risk associated with its use. The central government will be able to prescribe standards for different classes of medical devices, prescribe procedures for assessment of conformity to standards and overseas inspections, reporting adverse events, post marketing surveillance and recall of medical devices.

The bill which seeks to set up the CDA was introduced on August 29 in the Parliament. However, the bill was not taken for discussion by the Rajya Sabha till it adjourned sine die on September 6, 2013. Later the bill was referred to the Parliamentary standing committee on September 9, 2013 for examination and report thereon within a period of two months.