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Drugs (Fifth Amendment) Rules, 2024 notified

Notification No: G.S.R. 669(E)

Notification Date: 28th October, 2024

Effective Date: 29th October, 2024

Relevant Act/Rule: Drugs and Cosmetics Act, 1940, Drugs Rules, 1945

The Ministry of Ayush has notified the Drugs (Fifth Amendment) Rules, 2024 on October 28, 2024. The said Rules would come into force from 29th October, 2024, viz. the date of publication in the Official Gazette. The said Rules have introduced changes to the licensing and manufacturing processes for Ayurveda, Siddha, Sowa-Rigpa, Unani, Homeopathic medicines in India.

Some of the key changes introduced vide said amendment are as follows:

* New Homeopathic Medicines defined:

These Rules have also defined “New Homeopathic Medicines” and established a clear process for their importation and approval. They require comprehensive evidence of safety, therapeutic efficacy, and minimum homoeopathic provings for any new medicines. A product will be considered “new” for a period of five years following its initial approval. After completion of five years, these medicines will be considered as homoeopathy medicines defined under rule 2 (dd).

*Online applications through the e-AUSHADHI portal:

The rules introduced an online application system via the e-AUSHADHI portal, making it easier to apply for licenses to sell, stock, and distribute homeopathic medicines. License application fees have been standardized. Retail and wholesale licenses for homeopathic medicines will now be perpetual, with a self-declaration of compliance to regulations required every five years. as per new Rule 67E.

*Good Manufacturing Practices (GMP) certificate:

The regulations mandate that manufacturers obtain a Good Manufacturing Practices (GMP) certificate to secure a manufacturing license.

*Quality Control:

The rules also define the qualifications necessary for personnel supervising the production of homeopathic medicines. Regular inspections of manufacturing facilities will be conducted at least once every five years. Additionally, GMP certificates will be valid indefinitely, subject to a renewal fee every five years. The new rules also provide for greater transparency by allowing online access to license applications and, where applicable, details of manufactured medicines, assuming online records are maintained.

These regulations aim to enhance the quality, safety, and availability of homeopathic medicines in India. The introduction of an online application system and perpetual licenses should simplify the licensing process for legitimate manufacturers and sellers. With an emphasis on new medicines and stricter quality control measures, the regulations seek to ensure that homeopathic products meet high standards of efficacy and safety.

Notification Link: Drugs (Fifth) Amendment rules 2024

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