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Centrally Sponsored Scheme of Quality Control of Ayurveda - amam ...

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<strong>Centrally</strong> <strong>Sponsored</strong> <strong>Scheme</strong> <strong>of</strong> <strong>Quality</strong> <strong>Control</strong> <strong>of</strong> <strong>Ayurveda</strong>,<br />

Siddha, Unani and Homeopathy drugs<br />

Introduction<br />

Enforcement <strong>of</strong> the provisions <strong>of</strong> Chapter IV A <strong>of</strong> the Drugs and Cosmetics Act,<br />

1940 and Rules, 1945 relating to <strong>Ayurveda</strong>, Siddha, Unani and Homoeopathy (ASU&H)<br />

medicines is the responsibility <strong>of</strong> the State Governments. Establishment <strong>of</strong> the State<br />

Drug Testing Laboratories and notification <strong>of</strong> State Analysts is also the statutory<br />

responsibility <strong>of</strong> the States under the Drugs & Cosmetics Act, 1940 and Rules, 1945. In<br />

order to provide financial assistance to the States for strengthening their ASU&H drug<br />

Enforcement Mechanism, the <strong>Centrally</strong> <strong>Sponsored</strong> <strong>Scheme</strong> for <strong>Quality</strong> <strong>Control</strong> <strong>of</strong><br />

ASU&H Drugs was introduced towards the end <strong>of</strong> the 9 th plan with an outlay <strong>of</strong> Rs.<br />

40.00 Crores with the approval <strong>of</strong> Standing Finance Committee (SFC). So far 29 State<br />

Drug Testing Laboratories and 44 State Pharmacies <strong>of</strong> <strong>Ayurveda</strong>, Siddha, Unani and<br />

Homoeopathy have been financially assisted. In addition to assistance to States for the<br />

above purposes, a provision was also made for providing back ended subsidy to<br />

<strong>Ayurveda</strong>, Siddha and Unani manufacturing units to become Good Manufacturing<br />

Practices compliant. The <strong>of</strong>f take under enforcement mechanism and Good<br />

Manufacturing Practices component has been rather negligible. Only 13 States took<br />

some assistance for strengthening <strong>of</strong> State Drug Enforcement Mechanism and<br />

48<strong>Ayurveda</strong>, Siddha, Unani units have been assisted for becoming Good<br />

Manufacturing Practices compliant. An expenditure <strong>of</strong> Rs. 88.14 crore has been incurred<br />

during 9 th & 10 th plan period under this scheme.<br />

Components <strong>of</strong> the revised scheme in 11 th Plan<br />

Reimbursement <strong>of</strong> expenditure incurred by States for Strengthening <strong>of</strong><br />

Enforcement Mechanism <strong>of</strong> <strong>Ayurveda</strong>, Siddha and Unani drugs at the State level<br />

and expenditure incurred in testing <strong>of</strong> ASU&H medicines by NABL accredited<br />

laboratories subject to States having a functional Drug Testing Laboratory and a<br />

separate functional enforcement establishment for <strong>Ayurveda</strong>, Siddha, Unani and<br />

Homeopathy drugs.<br />

Release <strong>of</strong> balance <strong>of</strong> financial assistance to strengthen State AYUSH Drug<br />

Testing Laboratories and Pharmacies subject to the States filling up vacant posts and<br />

ensuring availabilities <strong>of</strong> trained personnel for their proper functioning.<br />

Assistance to ASU&H manufacturing units to establish in-house quality control<br />

laboratories for batch to batch testing <strong>of</strong> raw materials and finished products for<br />

ensuring quality control <strong>of</strong> ASU&H medicines.<br />

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