AYUSH Simplifies Licensing for Drug Manufacturers with New Fee Structure, Details

The new regulations, officially announced on October 28, 2024, introduce notable changes designed to enhance efficiency and accessibility for practitioners and manufacturers.

A key highlight of the amendments is the implementation of a one-time license retention fee of Rs 1,000 for existing licensed drugs, along with a fee of Rs 100 per product for those under specific categories. For manufacturers of Homoeopathic medicines, a fee structure of Rs 2,000 applies for any number of single-ingredient medicines, and Rs 200 per product for combinations. Additionally, the application fee for obtaining a Good Manufacturing Practices (GMP) certificate is set at Rs 5,000.

The Ministry has established the e-AUSHADHI online portal to streamline the submission of applications for licenses related to ASU and Homoeopathic drugs. The updated rules also introduce provisions for perpetual license validity, provided that licensees submit a self-declaration every five years and adhere to GMP standards.

Significant clarifications have been made regarding the definition of “New Homoeopathic Medicine.” Any new product entering the market will require explicit written permission from the Licensing Authority, which will assess its safety and efficacy based on established guidelines.

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Furthermore, the amendments allow applicants whose licenses or GMP certificates were previously rejected to reapply within six months. If compliance with the stipulated conditions is demonstrated and a nominal inspection fee is paid, a follow-up inspection by the Licensing Authority may lead to successful license or certificate issuance, thereby reducing barriers for manufacturers.

With the indefinite validity of licenses, contingent on the maintenance of GMP certificates, the updated rules require license holders to pay a retention fee every five years to keep these certificates valid. Enhanced oversight of manufacturing processes will be ensured through rigorous inspection protocols conducted by qualified inspectors appointed by the Central or State Government. Manufacturers who maintain detailed online records will be recognized for their adherence to these standards, fostering transparency and accountability in the industry.

The revised regulations emphasize the necessity of qualified technical staff in the manufacturing of AYUSH drugs. Rule 157 mandates that manufacturing processes be overseen by professionals with specified educational qualifications, ensuring that competent individuals uphold the quality and efficacy of the products produced.