CCEA approves proposal for strengthening drug regulatory system

• In line with the Make in India campaign, to facilitate domestic manufacturing of quality medical products, the Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister Shri Narendra Modi, today approved a proposal for strengthening and upgrading the drug regulatory system both at the Central and state level, at a total cost of Rs 1750 crore which will be spread over a period of three years.
• In an official statement the CCEA said, “Out of the total amount of Rs 1750 crore, Rs 900 crore will be spent on strengthening central structures and Rs 850 crore will be made available to the state governments after signing a Memorandum of Understanding”.

Provisions of the upgrade:

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

• It will also 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.

• This will also include creation of additional manpower for regulatory structures, including for new and emerging areas such as stem cell, regenerative medicine, biologicals and medical devices in addition to drugs.

Impacts:

• The implementation of the scheme will facilitate domestic manufacturing 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.

• This will also introduce organisation wide e-governance and information technology enabled online services.