The Department of Ayush has revised norms for the centrally sponsored scheme on quality control of Ayurveda, Unani, Siddha and Homoeopathy (AYUSH) drugs by deleting the high priced testing equipments from the list of mandatory laboratory requirements for companies applying for subsidy to set up in-house quality control facilities.
The department, under the Scheme No 4, extends assistance upto Rs 30 lakh or 30 per cent of total expenditure incurred by Ayush drug manufacturing units with an annual turnover of upto Rs 20 crore to establish an in-house quality control laboratory.
The assistance, for setting up an in-house quality control laboratory for testing of all ingredients and finished products as per pharmacopoeial and other standards, is to set up 30 equipments for chemistry section including HPTLC, HPLC, ICPMS and LC-MS, seven each for pharmacognosy and microbiology section.
In an effort to optimise the use of the scheme, for the benefit of manufacturers, the department has revised the list of equipments so that for the manufacturers desirous of availing the subsidy under Scheme no.4, it is not mandatory to purchase AAS or HPTLC/HPLC/ICPMS/LCMS.
The benefit under the scheme will be now available for any of the equipments purchased from the list appended to the scheme provided that the grant availed should lead to a functional laboratory complying with pharmacopoeial standards, according to Pharmexcil sources.
Pharmexcil is designated as the authority to certify the eligibility of the manufacturing unit to qualify for the assistance. Subsidy of 30 per cent will be released after the inspection of the unit by the director, Pharmexcil and certification that in-house laboratory has become functional and the equipments have been purchased as per the list of mandatory equipments.
As per the notification of the department, the grant will be released as a back ended subsidy through the bank that has sanctioned the loan after acquisition of equipment, training of personnel and the in-house laboratory becoming functional.
The scheme, till recently, has not been widely used by the small scale manufacturers of Indian Systems of Medicines, as the high priced laboratory equipments were made mandatory under the list of required equipments. For instance, an ICPMS and LC-MS equipment has a tentative market price of Rs 1 crore even as the cost of HPLC is Rs 70 lakh and HPTLC costs around Rs 40 lakh.
With the revision of the norms, the companies which are not able to purchase these high cost equipments can also avail the subsidy under Scheme No 4. The step will help more manufacturers to utilise the scheme and to set up in-house quality control laboratory, said Pharmexcil sources.