The Ministry of Ayush on 8th October 2021 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.
The manufacturers can now apply for the license online at www.e-aushadhi.gov.in and the license of the ASU drugs has been made perpetual i.e. with one-time 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 prior to the notification it had a validity period of 5 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 retention fee of Rs. 1000. The manufacturing unit of the ASU drugs will be subjected to inspection in a randomized manner every 5 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 upto 10 proprietary ASU drugs and the ministry has also reduced the maximum time in granting the license from three months to two months.
