The Ministry of AYUSH vide notification dated 1st October, 2021 has issued the Drugs (4th Amendment) Rules, 2021. The amendment provides that the following applications shall be made through the portal e-AUSHADHI:
- Application for licence to manufacture Ayurvedic, Siddha or Unani drugs in Form 24D;
- Application for loan licence to manufacture Ayurvedic, Siddha or Unani drugs in Form 24E;
- Application for Certificate of Good Manufacturing Practices for Ayurvedic, Siddha or Unani drugs in Form 24E-1.
The amendment also provides duration of these licenses. The inspection procedure is also clarified. The Inspector or Inspectors shall examine all areas of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed and he shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the Requirements of Good Manufacturing Practices and Plant and Equipments. The Inspector after completion of his inspection shall forward a detailed report giving his findings on each aspect of inspection along with his recommendations, to the Licensing Authority.
