CCEA approval to strengthen regulatory system of medical products

Read Article

The upgradation and strengthening of the system will also include setting up of new laboratories and training academy for regulatory and drug testing officials

In order to improve the regulatory system and give a boost to local manufacturing, government approved drug and medical devices testing laboratories in the country. The approval comes through the Cabinet Committee on Economic Affairs (CCEA) to strengthen regulatory system of medical products both at the Centre and the state.

The upgradation and strengthening of the system will also include setting up of new laboratories and training academy for regulatory and drug testing officials. The CCEA chaired by Prime Minister Narendra Modi approved the proposal for strengthening the drug regulatory system at a total cost of Rs 1750 crores which will be spread over a period of three years. “Out of the total amount of Rs 1750 crores, Rs 900 crores will be spent on strengthening central structures and Rs 850 crores will be made available to the state governments after signing a Memorandum of Understanding,” an official statement said. “The implementation of the scheme will facilitate domestic manufacture of quality medical products and help establish a robust industry in the field of medical devices, biologicals and other areas. The common training programmes for regulatory and laboratory staff will also help in evolving uniform practices throughout the country,” the statement said.

This will include provision of additional equipment and manpower in existing drug testing laboratories, setting up of new laboratories for testing drugs, medical devices and cosmetics and making mobile drug testing laboratories available amongst others. India is one of the largest manufacturers of drugs and exports pharma products to over 200 countries and economies.

Whereas there exist a heavy dependence on import of devices. In the absence of a single testing laboratory dedicated for medical devices, and insufficient number of laboratory for drugs, this decision comes as a big boost for the domestic manufacturing sector.

Besides mitigating the disease burden, it will also help trigger growth of the domestic medical devices sector and contribute to the ‘Make in India’ initiative.

CCEAmedical devicesregulatory systems for medical products