The Steering Committee of the Planning Commission has recommended giving of incentives, grants and soft loans to the Ayush industry for prompting voluntary quality assurance certification and requisite upgradation of laboratory and manufacturing infrastructure to meet the stipulated norms for standard and premium markets.
“Support a coordinated programme to establish pharma-technology development platforms in "several" institutions, viz reputed colleges, universities and research institutions to standardize selected processes and products and their pharmacodynamics and kinetics, by building upon the well documented, traditional quality standards, that were achieved traditionally, through home scale production. Research on standardization of Bhasmas should be one of the agendas of this programme,” the steering committee said, ahead of the finalization of the Plan documents.
“All the State Governments should be required to obtain NABL accreditation. Support to R&D Centres for collaborative work with industry to publish definitive technical monographs for raw materials (botanical, mineral, metal, animal biproducts and marine products), in processed and finished formulations. Support for studies, surveys and macro data to develop a firm and complete statistical identity for the Ayush sector and all its aspects including knowledge,” it said.
The panel also recommended a programme to compile a computerized national licenced drug list with unique product codes for both classical and propriety drugs. This programme should be facilitated by developing uniform national software for drug licensing, harmonized for use by all State agencies in the country, the panel said.
“Supplementing of the drugs inspection machinery suffers from paucity of resources. These are available with the State Governments. The States may be supported to utilize professional inspection bodies whose competence to inspect establishments for compliance to Ayush regulations can be established by way of their accreditation by NABCB to the applicable international standards, ISO 17020. Such accredited inspection bodies can then be formally approved by the Drug Regulator and the industry given a choice to get itself inspected by any of these bodies at a prescribed frequency.
“Following this the organizations may submit reports confirming compliance to regulators. In case of any non-compliance, the regulator can initiate suitable action against the erring unit. A system can be developed whereby the establishments are advised to go to accredited inspection bodies by rotation and the accredited inspection bodies can be made to submit reports directly to the regulator. All this while, the regulator shall retain the right to directly inspect the manufacturing unit for any valid reason,” the report said.
Source:Pharmabiz
“Support a coordinated programme to establish pharma-technology development platforms in "several" institutions, viz reputed colleges, universities and research institutions to standardize selected processes and products and their pharmacodynamics and kinetics, by building upon the well documented, traditional quality standards, that were achieved traditionally, through home scale production. Research on standardization of Bhasmas should be one of the agendas of this programme,” the steering committee said, ahead of the finalization of the Plan documents.
“All the State Governments should be required to obtain NABL accreditation. Support to R&D Centres for collaborative work with industry to publish definitive technical monographs for raw materials (botanical, mineral, metal, animal biproducts and marine products), in processed and finished formulations. Support for studies, surveys and macro data to develop a firm and complete statistical identity for the Ayush sector and all its aspects including knowledge,” it said.
The panel also recommended a programme to compile a computerized national licenced drug list with unique product codes for both classical and propriety drugs. This programme should be facilitated by developing uniform national software for drug licensing, harmonized for use by all State agencies in the country, the panel said.
“Supplementing of the drugs inspection machinery suffers from paucity of resources. These are available with the State Governments. The States may be supported to utilize professional inspection bodies whose competence to inspect establishments for compliance to Ayush regulations can be established by way of their accreditation by NABCB to the applicable international standards, ISO 17020. Such accredited inspection bodies can then be formally approved by the Drug Regulator and the industry given a choice to get itself inspected by any of these bodies at a prescribed frequency.
“Following this the organizations may submit reports confirming compliance to regulators. In case of any non-compliance, the regulator can initiate suitable action against the erring unit. A system can be developed whereby the establishments are advised to go to accredited inspection bodies by rotation and the accredited inspection bodies can be made to submit reports directly to the regulator. All this while, the regulator shall retain the right to directly inspect the manufacturing unit for any valid reason,” the report said.
Source:Pharmabiz
Thats very interesting.. so how any industrialist can get benefited..
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