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

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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.