The proposal for creating the post of Central Drug Controller separately for Ayush is still stuck with the Department of Expenditure which has sought some more clarifications, it is learnt.

The Ministry of Health has reportedly submitted `certain specific clarifications and justifications’ for the required posts sometime back, according to the sources in the Ayush department which feels that separate and exclusive drug controller would be helpful to improve the monitoring of the sector. The matter has been constantly pursued with the department.

“Allocation of Rs.102 crore in 12th Plan and Rs.7.60 crore in the annual plan 2013-14 has been budgeted to undertake the establishment of infrastructure and manpower for the Central Ayush Drug Controller’s office. Proposal is also being moved for acquiring additional space to accommodate the Ayush Drug Controller’s office,” an official said.

Meanwhile, the Ayush department contented that the lack of a separate controllers was affecting the overall functioning of the regulatory system. CDSCO has been basically dealing with quality control of allopathic drugs and accordingly, the whole paraphernalia there does not have the wherewithal to effectively regulate ASU&H drugs. The basic reason is that ASU&H drugs are distinct from allopathic drugs in terms of philosophy, principles, concepts, standards, quality aspects, applications, numbers and count of manufacturing units and testing requirements and they need to have different regulations.

In-spite of common Drugs & Cosmetics Act, 1940, the regulatory issues of ASU&H drugs are not being taken care of by the Central Drugs Controller Office due to non-availability of requisite expertise and huge workload of matters related to allopathic drugs. The idea of having a common Central Drugs Authority with Additional Drug Controller of Ayush had not been earlier agreed to, sources said.

The proposal was made way back in June 2010 to create Central Drug Controller for ASU drugs, along with drug control infrastructure at the Central and State levels by appointing separate drug controllers and drug inspectors. Though the bill came up to set up Central Drugs Authority with separate division for Ayush, it did not materialize.