Cabinet okays Rs1,750-cr move to strengthen drug regulation

The Cabinet Committee on Economic Affairs (CCEA) has approved a proposal for strengthening and upgrading the drug regulatory system both at the central and state levels in order to facilitate domestic manufacture of quality medical products.

The upgrading 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 Rs1,750 crore. which will be spread over a period of three years.

"Out of the total amount of Rs1,750 crore, Rs900 crore will be spent on strengthening central structures and Rs850 crore will be made available to the state governments after signing a memorandum of understanding," an official statement said.

The upgradation 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 pharmaceutical products to over 200 countries and economies.

"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.

The upgradation 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.

"The upgradation will also introduce organising wide e-governance and information technology enabled and online services and setting up a training academy for regulatory and drug testing officials of both the central and state governments," the statement said.

Noting that assistance will be provided to the states for strengthening their drug regulatory structures, the statement said that the measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country.

It will also help mitigate the disease burden and also increase export of pharmaceutical products from India.

 Besides, it will help trigger growth of the domestic medical devices sector, the statement added.