Planning Commission wants corrective measures as Ayush units go slow on GMP
With the utilisation of funds for quality control of Ayush drugs falling much below the expectations and manufacturing units till going lacklustre about getting GMP compliant, the Planning Commission has now asked the Ayush Department to initiative corrective measures and push the units to ensure quality of drugs.
The move comes after the Planning Commission held an assessment of the fund utilisation so far in the current Five Year Plan and the number of GMP compliant units in the country. The gaps on both counts are significant as the Ayush industry in the country is under pressure to step up quality of drugs in view of the sterner norms being implemented in European Union and other parts of the world.
According to the assessment done by the Planning Commission, out of total 9837 registered units in the Ayush sector, only 4663 units are GMP complying units. Ratio of GMP compliant /non-GMP compliant units is very unsatisfactory with the maximum gap noticed in States like Assam, Haryana, Kerala, Madhya Pradesh, Maharashtra, UP, Tamil Nadu, Uttarakhand, Punjab, the Plan Panel viewed. As many as 2336 legal notices have been issued/licenses cancelled so far on various grounds including the lack of GMP certification.
At the same time, it was also noted that the Ayush Department could not effectively utilise the funds allocated for improving quality control systems. Against an Eleventh Plan outlay of Rs.225 crore, funds amounting to only Rs.45 crore could be allocated during the first three years of the plan period and expenditure reported was only Rs.27 crore so far.
This has prompted the Planning Commission to ask the Department for corrective measures and liberalise the Drug Quality Control Scheme which put in place to provide financial assistance to establish State Drug Testing Laboratories. Over the years, 29 State Drug Testing Laboratories at a cost of Rs.1.5 crore per lab and 46 State Pharmacies have been set up and upgraded with Rs.2 crore per pharmacy.
The scheme also had components of strengthening of the State enforcement mechanism, upgrading the in-house testing facilities of manufacturing units and assisting manufacturing units desirous of obtaining higher GMP like EU and WHO-GMP. In spite of including these changes, the fund could not be utilised well, the Planning Commission has observed.