Ministry of Ayush has published the Drugs (Fifth Amendment) Rules, 2024 dated 28^th October, 2024. In exercise of the powers conferred by sub-section (2) of section 6, sections 12, 33 and 33N of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Ayurvedic, Siddha, Unani Drugs Technical Advisory Board, has published the rules further to amend the Drugs Rules, 1945. These rules provide the forms in which the licenses need to be taken for importing new homeopathic medicines, loan license to manufacture for sale or for distribution of Homoeopathic medicines and granting certificate of Good Manufacturing Practices for homoeopathic medicines manufacturing unit.

Key Terms are described below-

1. “Homoeopathy medicine” includes any drug intended for internal or external use for diagnosis, treatment, mitigation or prevention of diseases or disorder in human beings and animals, which is recorded in homoeopathy provings, or the therapeutic efficacy of which has been established through clinical experience or research, and is used as described in the homoeopathy books specified in the first and second schedule, which is manufactured in accordance with the techniques of homoeopathy pharmacy and covers combination of ingredients of such homoeopathy drugs, but does not include a drug which is administered by injectable route.
2. “Registered Ayurveda or Siddha or Sowa-Rigpa or Unani medical practitioner” means a person

• holding a qualification granted by an authority specified or notified in the Schedules to the Indian Medicine Central Council Act, 1970 (48 of 1970); or National Commission for Indian System of Medicine (NCISM) Act, 2020 (14 of 2020)
• registered or eligible for registration in a medical register of a State or National register meant for the registration of persons practicing the Ayurveda or Siddha or Sowa-Rigpa or Unani system of medicine as under National Commission for Indian System of Medicine (NCISM)Act, 2020

3. “Sowa-Rigpa drugs” includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Sowa-Rigpa systems of medicine as specified in the First Schedule of the Drugs and Cosmetic Act, 1940
4. “Sowa-Rigpa proprietary medicine”, in relation to Sowa-Rigpa systems of medicine means all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Sowa-Rigpa systems of medicine as specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books.

The compliances are as following-

1. New Homeopathic Medicine shall not be imported without taking the written permission by the Licensing Authority after producing the required documents and evidences for analyzing the therapeutic efficacy and safety for such homeopathic medicine.
2. To obtain a license to sell, stock or offer for sale or exhibit or distribute the homeopathic medicines, the applicant can make an application in Form 19-B to the Licensing Authority along with the fees of Rs. 2000. Application to obtain a sale license could be made through portal e-AUSHADHI (eaushadhi.gov.in).
3. A certificate regarding grant of a certificate of Good Manufacturing Practices for homoeopathic medicines manufacturing unit from Licensing Authority could be applied in form 24C2 along with the fees of Rs. 5000.
4. A license to manufacture for sale of homeopathic medicines shall be obtained in Form 25-C. Such license shall be issued by the Licensing Authority within the period of 2 months from the date of receipt of the application.
5. A license regarding the grant of loan license to manufacture for sale or for distribution of Homoeopathic medicines from Licensing Authority appointed by the state government could be applied in form 24C1 along with the fees of Rs. 2000.
6. Licensee to submit a self-declaration of adherence to the conditions of license and the provisions of the Drugs and Cosmetics Act and the Rules every five years from the date of issue of license in Form 20C or 20D or from the date of submission of last self-declaration.

These rules have introduced the changes in the Manufacturing and licensing processes for Ayurvedic and Homeopathic medicines in India. It has streamlined the procedure for obtaining the licenses. The applications can be made through e-AUSHADHI portal for selling, stocking, and distributing Homoeopathic medicines. The quality, safety, and accessibility of homeopathic medications in India are intended to be enhanced by these laws. For authorized producers and merchants, the online application system and everlasting licensing ought to streamline the procedure. Stricter quality control procedures and an emphasis on new homeopathic medicines are intended to guarantee the goods’ safety and effectiveness.

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