Ayush Ministry opens online licensing portal for manufacturers

The Ministry of Ayush has made the process to grant the license to manufacture Ayurveda, Siddha and Unani (ASU) drugs swift, paperless and more transparent by bringing the application system online. Manufacturers can now save the trouble of making a physical presence at the office of the licensing authority and can now apply for the license online at www.e-aushadhi.gov.in. The license of the ASU drugs has been made perpetual i.e. with a onetime registration fee the license of the product will be valid lifetime subject to online submission of self-compliance declaration every year or unless suspended or cancelled. While before the notification it had a validity period of five years. The applicants will only have to get their Good Manufacturing Practices (GMP) certification validated every five years to keep their license in force. The GMP certificate can also be retained with online submission of a retention fee of Rs 1000. The manufacturing unit of the ASU drugs will be subjected to inspection in a randomised manner every five years. Since the validity of the license has been increased, the license fee has also been revised from Rs 1,000 to Rs 2,000 for any number of generic ASU drugs and Rs 3000 for up to 10 proprietary ASU drugs.