The licence for ASU drugs has been made perpetual i.e. with one-time registration fee, the licence of a product will be valid for a lifetime subject to online submission of self-compliance declaration every year or unless suspended or cancelled
Listen to this article
NEW DELHI: The process of granting license to manufacture 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 on Friday.
Manufacturers can now apply for licence on ministry's portal.
The licence for ASU drugs has been made perpetual i.e. with one-time registration fee, the licence of a product will be valid for a lifetime subject to online submission of self-compliance declaration every year or unless suspended or cancelled. Before this, licences were valid for up five years.
The applicants will 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 retention fee of ₹1000. The manufacturing unit of the drugs will be subject to random inspections every five years. Since the validity period of the licence has been increased, the fee has been revised to ₹2,000 from ₹1,000 for any number of generic ASU drugs and ₹3,000 for up to 10 proprietary drugs.
The ministry has also reduced the maximum time taken for granting licences to two months from three months. For six months from the date of gazette notification, both online and offline application process will co-exist before it becomes completely online, the government said in a statement.
Making the application system online will bring uniformity in the whole process. The Ministry of Ayush will act as a facilitator in the licencing process, it said. These 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 said drugs.