The Department of Ayush will revise the existing centrally sponsored scheme of quality control of Ayurveda, Siddha, Unani and Homoeopathic (ASU and H) drugs and will spend Rs.80 crore during the remaining period of the current Five Year Plan.
An outlay of Rs.80 crore had been approved in the 12th Plan for the Centrally Sponsored Scheme of Quality Control of ASU&H drugs. It is intended to revise the scheme based on its evaluation report and suggestions from stakeholders and add new components, sources informed.
The allocation is envisaged to be spent for focused outcomes in terms of effective quality control of ASU&H drugs including strengthening of regulatory infrastructure, mechanism and capacity in the states; improving drug manufacturing, storage and testing facilities in public sector; implementation of regulatory capacity building initiatives; and development of regulatory and quality control materials.
So far, one State Drug Testing Laboratory (DLT) and one State Ayurvedic Pharmacy have been assisted with grant-in-aid of Rs.21.31 lakhs and Rs.43.46 lakhs respectively. Two GMP compliant private drugs manufacturing units have availed subsidy in 2012-13. The proposals of three more State DTLs and one pharmacy for balance grant-in-aid have been approved by the Project Screening Committee and are in pipeline for release of funds.
With the available funds and existing funding pattern of the scheme, it is intended to support five DTLs, five Pharmacies, five Licensing Authorities and six manufacturing units during the current year. However, revision of the scheme with inclusion of new components may revise these targets.
There is a separate chapter IV A in the Drugs and Cosmetics (D&C) Act 1940 which regulates the manufacture and sale of ASU drugs. Since the enforcement of provisions of D&C Act and Rules made thereunder is under the purview of State Drug Licensing and Drug Control Authorities, the state drugs regulatory framework has a crucial role to play in ensuring safety and quality of ASU&H drugs. The strengthening of testing laboratories, which are facing infrastructure constraints, and shortage of manpower, is hence one of the key elements of the scheme.