The Department of Ayush is proposing to revise the manufacturing license fee structure for Ayurvedic and other traditional drug products. The revision, which includes a hike in the fee and an extension of validity period, would be effected in the Drugs & Cosmetics Act soon.
A revision in the manufacturing licence fee structure for the Indian system of medicines is being proposed now after 32 years. According to sources in the Drug Technical Advisory Board (DTAB) for Ayurveda, Sidha and Unani (ASU), the restructuring is due to the tremendous escalation in the cost for processing licensing documents.
As per the draft of the revised licensing structure, the licence fee would be increased from 50 to 150 per cent on various products. The manufacturing licence fee in the ASU sector varies from product to product. In addition to the fee hike, the validity period of the licence will be extended from 1 year to 3 years.
There were suggestions from the DTAB members to extend the validity period of manufacturing licence from one year to five years as it has been done for the allopathic drugs. Considering the higher frequency occurring in the product shift in the ASU drug-manufacturing sector, it has been extended to only three years for the time being, the sources said.
A notification in this regard is expected soon as the draft for enhancing the licensing fee and the validity, which has been prepared by a subcommittee in the ASU DTAB along with its recommendation, has been already forwarded to the Department.