With the move to create separate post of Central Drug Controller for Ayush sector is still stuck without approval and allocation, the functioning of the regulatory system has been affected badly with shortage of manpower in the sector and lack of expertise.

Though the proposal had been cleared by the Finance Ministry, the process is yet to start as the Department of Ayush is waiting for the required allocation of Rs.160 crore to set up the separate central control mechanism to ensure quality of the Ayurveda, Unani, Siddha and Homoeopathy drugs, it is learnt.

The delay has resulted in shortage of manpower and put additional burden on the CDSCO to man the Ayush sector. “Another major fall-out is that some crucial issues like ensuring standards set by the European regulatory authorities in the Ayurveda sector also have to be handled by CDSCO, without enough manpower and expertise in the absence of a separate DCGI,” a senior official pointed out.

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. The CDSCO was strengthened by appointing more drug inspectors but no posts were sanctioned for the regulation of drugs of Indian Systems of Medicine & Homoeopathy. Similarly, the State Drug Testing Laboratories, funded by Department of Ayush under the quality control scheme, failed to deliver the desired outputs for want of adequate scientific manpower, the official pointed out.

In October 2010, the Expenditure Finance Committee (EFC) chaired by Secretary (Expenditure) cleared the proposal for setting up the infrastructure for Central ASU&H Drug Controller and scientific manpower for State Drug Testing Laboratories. Thereafter, the matter has been taken up with the Department of Expenditure for creation of regular posts as well as for hiring of manpower on contractual or outsourcing basis for five years in State Drug Testing laboratories. Allocation of Rs.160 crore for this purpose has been sought in the 12th Five-Year Plan.

The CDSCO has no expertise in ASU&H drugs and thus they have to rely on the inputs and advice of the Department of Ayush in related matters. There are 8644 drug manufacturing units of Ayurveda, Siddha, Unani and Homoeopathy in the country and it is estimated that not more than 100 manufacturing firms would have an annual turnover of Rs.5 crore and above. This brings out a strong indication of requirement of a separate infrastructure with technical expertise to handle the regulatory matters of different kinds.

“In order to enhance acceptability of ASU&H drugs, there is need to develop formulations based on globally accepted practices like Good Agricultural & Collection Practices (GACP), Good Manufacturing Practices (GMP), Good Clinical Practices (GCP) and Good Laboratory Practices (GLP). Apart from good industry practices, manufacturers need to have established accreditation mechanism for various processes of manufacturing. Regulatory norms laid out by US Food & Drug Administration (US FDA), European Medicines Evaluation Agency (EMEA), Australian Therapeutic Goods Administration (TGA) and other such regulatory bodies, where ASU&H Drugs may attempt registration for market authorization to expand their international trade, need to be complied. These needs at present are not being taken care of by the Central Drugs Controller Office due to non-availability of requisite expertise and due to huge workload of matters related to allopathic drug,” the official said.