Ayush sector concerned over delay in implementing central scheme for quality control of drugs under 12th plan
The ayurvedic industry has expressed serious concern over the lacklustre attitude adopted by the government in its failure to deliver the promises mentioned in the 12th five-year plan. This backlash comes in the wake of lack of any action taken by the ministry of Ayush to act upon the revised draft of centrally sponsored scheme of quality control of ASU and H drugs to be implemented under the 12th Five-Year Plan.
It is understood that the objective of this scheme was to strengthen the state government ASU&H pharmacies and drug testing laboratories along with making the ASU&H framework strong by indulging in capacity building measures to support the industry. Other driving force through this was to tap and improve the quality of ASU&H drugs so as to enable their export in the international markets.
Industry experts stressed that in spite of the fact that over two years have already gone by since it was last announced, no steps have been taken on this front by the government to enforce these much needed schemes. Ironically, experts state that this comes even after the Centre had set up a ministry for Ayush over an year ago, for better representation of the industry.
In order to provide financial assistance to the states for strengthening their ASU&H drug regulatory mechanism, the centrally sponsored scheme for quality control of ASU&H drugs was first introduced towards the end of the 9th plan with an outlay of Rs. 40.00 crore with the approval of Standing Finance Committee (SFC). However following repeated demand and representation from the industry the government relented to revise the scheme with some changes and additions to be implemented in 12th five-year plan.
In addition to assistance to states for the above, provisions were also made for providing back-ended subsidy to ASU manufacturing units to become good manufacturing practices compliant.
Other important factors included in the revised scheme under the 12th five-year plan was grant-in-aid for strengthening of ASU&H drug control framework; providing subsidy for infrastructural and functional improvement of in-house quality control laboratory for ASU&H drug manufacturing units; grant in aid to state licensing authority of ASU&H drugs for construction of warehouse for ASU&H drugs; subsidy to ASU&H drug manufacturing units for getting WHO GMP, EU GMP etc. among others.
A highly placed source from ADMA informed that enforcement mechanism and good manufacturing practices component has been rather negligible in this sector. Only 30 states took assistance for strengthening of state drug enforcement mechanism and 67 Ayurveda, Siddha, Unani units have been assisted for becoming GMP compliant. Moreover, it is reported that the government is yet to implement many provisions under this scheme keeping the sector from utilising its benefits.
The source further informed that considering the current market challenges and issues faced by the sector, the Centre should take immediate measures to implement these schemes without any further delay, in a systematic manner. “The country has 8896 manufacturing units of ASU&H drugs licensed by the state authorities. For the development and growth of these companies it is essential that at least now some concrete steps should be taken towards it. The industry is already struggling over challenges like ABS tax and likes, wherein financial assistance in any kind through strategic implementation of this scheme under the 12th five-year plan will go a long way in boosting the confidence of the industry,” stressed the source.