Licensing process to ASU drug manufacturers made Paperless

Download notification GSR 716(E) dt 01-10-2021 Drugs (4th Amendment) Rules 2021 

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Last Updated on October 10, 2021 by The Health Master

Download notification GSR 716(E) dt 01-10-2021 Drugs (4th Amendment) Rules 2021: The process for granting licenses for manufacturing Ayurveda, Siddha and Unani (ASU) drugs has been made swift, paperless and more transparent by bringing the application system online, the Ministry of Ayush said.

The manufacturers will now be saved from the trouble of being physically present at the office of the licensing authority and can apply for the license online at”, it said in the statement.

The Ministry of Ayush issued a gazette order notifying the implementation of the Drugs (4thAmendment) Rules 2021, with effect from October 1, 2021.

The statement said the license of 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.

Prior to the notification, it had a validity period of five years, it said.

The applicants will only have to get their Good Manufacturing Practices (GMP) certification validated every five years to keep their license in force, it stated.

The GMP certificate can also be retained with online submission of retention fee of Rs. 1,000.

The manufacturing unit of ASU drugs will be subjected to inspection in a randomized manner every five years, it said.

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 3,000 for up to 10 proprietary ASU drugs, the statement said.

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

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

“Making the application system online will bring uniformity in the whole process. The Ministry of Ayush will act as a facilitator in the licensing process,” the statement said.

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

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