Centrally Sponsored Scheme of Quality Control of Ayurveda, Siddha ...
Centrally Sponsored Scheme of Quality Control of Ayurveda, Siddha ...
Centrally Sponsored Scheme of Quality Control of Ayurveda, Siddha ...
- No tags were found...
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
SCHEME NO. 4ASSISTANCE TO AYURVEDA, SIDDHA & UNANI (ASU) DRUG MANUFACTURINGUNITS TO ESTABLISH AN IN-HOUSE QUALITY CONTROL LABORATORY FOR THEPURPOSE OF QUALITY CONTROL TESTING OF ALL RAW MATERIALS/FINISHEDPRODUCTS AS PER PHARMACOPOEIAL PARAMETERS INCLUDING TESTING OFINGREDIENTS/HEAVY METALS/PESTICIDE RESIDUE/MICROBIAL LOAD ETC.Assistance to ASU&H drug manufacturing units having an annual turnover <strong>of</strong> upto Rs.20.00 crores for acquisition <strong>of</strong> prescribed essential quality control equipment for in-house<strong>Quality</strong> <strong>Control</strong> Lab shall be limited to Rs. 30.00 lakhs or 30% <strong>of</strong> expenditure incurred onthe basis <strong>of</strong> a MoU between the manufacturing unit / State Drug <strong>Control</strong>ler and Department<strong>of</strong> AYUSH with a condition that the quality control equipment purchased with Government <strong>of</strong>India assistance shall not be disposed <strong>of</strong> and that Government <strong>of</strong> India will have lien onsuch equipment in case <strong>of</strong> company going into liquidation. The acquisition <strong>of</strong> quality controlequipments would be as per Annexure for setting up an in-house quality control laboratoryfor testing <strong>of</strong> all ingredients and finished products as per Pharmacopoeial and otherstandards laid down by Deptt. <strong>of</strong> AYUSH/WHO from time to time. In the 10 th plan anassistance <strong>of</strong> upto Rs.5.00 lakh as back- ended subsidy was allowed to all ASUmanufacturing units for becoming Good Manufacturing Practices complaint. However, the<strong>of</strong>f take in the scheme was negligible on account <strong>of</strong> assistance being very meager. Further,it has been felt that Good Manufacturing Practices notified under Schedule ‘T’ <strong>of</strong> the Drugs &Cosmetics Act, 1940 and Rules, 1945 does not provide for a mandatory in-house laboratoryfor every manufacturing unit as a result <strong>of</strong> which most <strong>of</strong> the manufacturing units haveobtained Good Manufacturing Practices on the basis <strong>of</strong> having a tie up with an outsidelaboratory. For all practical purposes testing <strong>of</strong> all raw material and finished products is notcommercially viable unless a manufacturing unit has an in-house laboratory. Development<strong>of</strong> quality control laboratory is highly capital intensive. Acquisition <strong>of</strong> equipments like AtomicAbsorption Spectrometer, High Performance Thin Layer Chromatography Spectrometer, etcfor an in-house quality control laboratory entails heavy expenditure. Small and mediumunits find it very burdensome to obtain loans without any subsidy. The Parliamentarystanding Committee <strong>of</strong> Ministry <strong>of</strong> Health & Family Welfare has also recommendedsubstantial increase in assistance to manufacturing units for becoming Good ManufacturingPractices complaint. The grantee institute/ State Govt. may apply in the following performa4 for seeking grant-in-aid under the scheme.
Change language