The much-awaited proposal to set up the Central Drug Controller of Ayurveda, Siddha, Unani and Homoeopathy (Ayush) drugs is still stuck with Finance Ministry, despite an allocation of Rs.102 crore for the current 12th Plan and approval of posts.

“The proposal in this regard was sent to Department of Expenditure, Ministry of Finance. 13 posts comprising of one Drug Controller General (Ayush), five Deputy/Assistant Drug Controllers and seven Drug Inspectors have been agreed to. Allocation of Rs.102 crore has been provided for this initiative in the 12th Plan Budget including Rs.7.60 crore for the current financial year,” according to official sources.

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. Though CDSCO was strengthened by appointing more drug inspectors, no posts were sanctioned for the regulation of drugs of Indian Systems of Medicine & Homoeopathy.

According to the sources in the Department, the delay has affected the functioning of the regulatory system for the Ayush sector. The delay has resulted in shortage of manpower and put additional burden on the CDSCO to man the Ayush sector.

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.

Meanwhile, Minister of State for Health and Family Welfare Santosh Chowdhary told the Parliament recently that a number measures were taken to establish the safety and efficacy of Ayush drugs/ medicines and develop their standards.

“Under intramural and extramural research initiatives of the Central Ayush Research Councils and Department of Ayush research projects have been undertaken for safety and efficacy studies of Ayush medicines. Pharmacopoeial Commission of Indian Medicine has been set up to accelerate the work of developing pharmacopoeial standards of Ayurveda, Siddha and Unani drugs. Quality certification scheme for ASU drugs has been introduced in collaboration with the Quality Council of India (QCI). Legal provisions have been made for display of shelf life or expiry date of various categories of Ayurveda, Siddha and Unani drugs and for the use of preservatives, additives etc. in the manufacture of these drugs,” the Minister said.