Obtaining a licence to manufacture Ayurveda, Siddha and Unani (ASU), drugs have gone online with the ministry of Ayush streamlining the process.

The manufacturers can now apply for the license online. The Ministry of Ayush issued a gazette order notifying the implementation of the Drugs (4^thAmendment) Rules 2021, with effect from 1^st October 2021.

The license of the ASU drugs has been made perpetual i.e. with a 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 before the notification it had a validity period of 5 years.

The applicants will only have to get their Good Manufacturing Practices 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 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 up to 10 proprietary ASU drugs.

The ministry has also reduced the maximum time in granting the license from three months to two months.

For six months from the date of gazette notification, both the online and offline application process will co-exist before it turns completely online. 

Making the application system online will bring uniformity to the whole process. The Ministry of Ayush will act as a facilitator in the licensing process.

These reforms/ measures will reduce the regulatory compliance burden on the ASU Drugs manufacturers to bring in ease of doing business while ensuring the quality, safety and efficacy of the ASU drugs.