 "Govt to spend Rs 1750 cr on drug regulatory system upgradation")
The central government is planning to spend Rs 1750 crore for strengthening the drug regulatory system both at the Central and the State levels. A proposal to this effect was approved by the Cabinet Committee on Economic Affairs (CCEA) on August 12, 2015. The upgradation of the system will be spread over a period of three years. Out 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.
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.
As per the proposal, assistance will be provided to the states for strengthening their drug regulatory structures. The measure is expected to 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 pharmaceutical products from India. Besides, it will also help trigger growth of the domestic medical devices sector.
“India is one of the largest manufacturers of drugs and exports pharmaceutical products to over 200 countries/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,” said a CCEA press release.
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.
As per the proposal, assistance will be provided to the states for strengthening their drug regulatory structures. The measure is expected to 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 pharmaceutical products from India. Besides, it will also help trigger growth of the domestic medical devices sector.
“India is one of the largest manufacturers of drugs and exports pharmaceutical products to over 200 countries/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,” said a CCEA press release.