The ambitious programme of strengthening the state drug regulatory systems with a centrally sponsored scheme, that initially proposed to spend Rs.1200 crore, is gathering dust with the state governments showing apathy in furnishing requisite details on the existing infrastructure and required infrastructure facilities.

Despite the Centre writing to the state governments to forward the details on the existing facilities and their requirements for strengthening the regulatory mechanism, only a few states have so far responded to the request, putting the scheme in limbo.

For the want of details, the Union health ministry is yet to make even the basic framework of the scheme that initially proposed to spend Rs.1200 crore during the current five year plan period on improving the infrastructure in the States. Due to this, the approval by the Planning Commission to the same is also held up, it is learnt.

Though the Government had allotted token amount of Rs.2 crore to begin the process during the current financial year, the scheme is unlikely to take off in the near future. As per the original proposal, Rs.100 crore was to be allocated for the purpose, but in the absence of a final scheme, the allocation could not be made.

The scheme was proposed as a crucial measure in monitoring the substandard and spurious drugs, since State units are so significant in strengthening the overall regulatory mechanism in the country and improve the quality of drugs. Sources said that due to lack of manpower and facilities in the States, the monitoring the quality of drugs was affected. This also resulted in less number of samples being collected from the States for testing by the officials and tardy progress in the prosecution of the guilty.

At present, hence proper sampling and testing are done only by the Central system and central drug testing labs. During the year 2010-11, a total of 10,055 samples were tested by various Central Drug Testing Laboratories, out of which 713 were found not-of-standard quality and 28 were found spurious/adulterated. Accordingly, four prosecutions were launched by CDSCO and in the remaining cases the concerned state licensing authorities were yet to take action.

During the year 2011-12, a total of 9,685 samples were tested, out of which 525 were found not-of-standard quality and nine were found spurious/ adulterated. Accordingly, four prosecutions were launched by CDSCO while in the remaining cases, the States were supposed to take action.