The Centre is planning to spend up to Rs 150 crore to improve the quality of Ayurveda, Sidha, Unani (ASU) and Homoeo medicines in the country and help the manufacturing units of Indian System of Medicines to go for GMP compliance during the next five years.
According to the plans by the Department of the AYUSH, Rs 20 crore would be spent during the current financial year for the quality control programmes in the sector. Rs 25 crore would be given in the next fiscal. It will be increased to Rs 30 crore, Rs 35 crore and Rs 40 crore in the next three years respectively.
Under the existing Drug Quality Control Scheme so far, a meagre assistance of Rs 5.00 lakh or 20 per cent of the costs whichever is less, was given as subsidy to AYUSH manufacturing unit for becoming GMP compliant. Now, the Department of AYUSH has made testing for raw materials, finished products, heavy metals etc. mandatory for which manufacturing units require costly equipments like Atomic Absorption Spectometer.
In view of these additional burdens, a back ended subsidy of Rs 50.00 lakh or 50 per cent of the total project cost whichever is less, is being proposed on establishment of in-house Drug Quality Control R&D laboratory. The assistance will be provided only to those ASU units having annual turnover below Rs 10.00 crore. This subsidy will be released to AYUSH manufacturing units through a Scheduled Bank on installation of the requisite equipment and on submission of report by any State Licensing Authority or a NABL laboratory to the effect that such unit has started testing of its raw materials/finished products in their in-house drug quality control, R&D labs.
State Drug Testing Laboratories are now assisted with maximum of Rs. 150 lakh the three components (building, machinery/equipment and manpower on contractual basis) as per the existing schemes. Apart from the State Drug Testing Laboratories eminent Laboratories, universities laboratories, research councils are also eligible for grant-in-aid to strengthen their AYUSH Department with a maximum of financial assistance of Rs 85.00 Lakh. Likewise, Rs 200 lakh was being given to strengthen the State Pharmacies of ASU and Homoeo drugs. Now it is planned that second and third instalments would be given to them only on the completion of the first phase.
It has been felt that efforts to ensure quality did not yield desired results so far, notwithstanding the schemes. Hence the Department is planning to rework the strategy to improve the quality aspects. It is also being proposed to institute a random testing of AYUSH medicines at the Central as well as at the State levels by involving NABL accredited laboratories spread over the country. The Centre may reimburse the expenditure caused by the States on such random testings through NABL laboratories @ Rs 500 to Rs 1000 per sample depending upon various parameters.
During the last four years, the Centre has spent Rs 55 crore for improving the quality of ASU drugs. Eight State Drug Testing Laboratories, 15 State Pharmacies of ASU&H drugs were assisted, and till date 26 ASU State Drug Testing Laboratories and 43 State ASU&H Pharmacies were assisted. In addition 13 States have been assisted to start Enforcement Mechanism of ASU&H drugs and incentives to 45 AS&U drug manufacturers for getting GMP license have been given under GMP Scheme.