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PM nod for proposal to fortify drug regulatory system

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Strengthening/ up-gradation of the system will be spread over a period of three years, both at the central and the state levels at a total cost of Rs 1750 crores

The Cabinet Committee on Economic Affairs, chaired by the Prime Minister Narendra Modi, has approved the proposal for strengthening the drug regulatory system both at the central and the state levels at a total cost of Rs 1750 crores. The strengthening/ up-gradation of the system will be spread over a period of three years. Out of the total amount of Rs 1750 crores, an amount of 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.

A report in PIB states that 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, making mobile drug testing laboratories available, 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 organisation wide e-Governance and information technology-enabled/ online services, and setting up a training academy for regulatory and drug testing officials, of both the central and state governments.

Assistance will be provided to the states for strengthening their drug regulatory structures. The measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country, and thereby help mitigate the disease burden as also increase export of pharma products from India. Besides, it will also help trigger growth of the domestic medical devices sector.

The implementation of the scheme is expected to 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.

EP News BureauMumbai

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