With the proposed Central Drug Authority (CDA) excluding the affairs of Ayush sector from its purview, the Centre is planning to bring in a new bill to govern the manufacturing, marketing and other activities of Indian streams of medicines.

“There was a plan to include Ayush also under the CDA. But it did not happen. Now we are planning to draft a bill to govern the Ayush sector. But it will take time as many things are involved,” secretary of Ayush Department Nilanjan Sanyal confirmed to Pharmabiz.

Based on the recommendations of the Mashelkar Committee, the central government introduced the Drugs and Cosmetics (Amendment) Bill, 2007 in the Rajya Sabha in August, 2007. This original bill, among other things, had sought to bring Ayush also under the CDA. This Bill was referred to the Department-related Parliamentary Standing Committee on Health and Family Welfare for examination. The committee made several recommendations including for creation of a separate chapter for regulating medical devices.

Accordingly, Drugs and Cosmetics (Amendment) Bill 2013 was drafted and was tabled in Rajya Sabha last week. However, it had dropped all matters relating to Ayush drugs while incorporating many recommendations including provisions to regulate the clinical trials and exports.

It is learnt that considering the significance and growth of the Ayush sector, the government wants to create a separate regulatory mechanism and rules for Ayurveda, Unani, Siddha and Homoeopathy drugs. The pending proposal for creating the post of Central Drugs Controller for Ayush sector also will be taken up along with this.

The much-awaited proposal for DCGI for Ayush is still stuck with Finance Ministry, despite an allocation of Rs.102 crore for the current 12th Plan and approval of posts. The proposal was sent to Department of Expenditure, Ministry of Finance. Thirteen 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.