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Ayush Ministry to amend D&C Act to add French Homoeopathic Pharmacopoeia in Second Schedule

Ayush Ministry to amend D&C Act to add French Homoeopathic Pharmacopoeia in Second Schedule


Posted on January 18, 2024 Updated on January 17, 2024

The Union Ministry of Ayush (MoA) is taking steps to amend the Drugs and Cosmetics Act, 1940 to add the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia under the standards on which the imports and manufacturing of homoeopathic drugs will be allowed in the country. It will also add books on Homoeopathic and Sowa-Rigpa systems of medicines in the first schedule of the Act.

The standards to be complied with by imported drugs and by drugs manufactured for sale, sold, stocked or exhibited for sale or distributed in the country under the Act includes homoeopathic medicines which are included in the Homoeopathic Pharmacopoeia of India and those included in the US, UK and German Homoeopathic Pharmacopoeia, according to the Second Schedule of Act.

The Ministry of Ayush has come out with a draft amendment to the Act, to include the French Homoeopathic Pharmacopoeia or the European Pharmacopoeia along with the German Homoeopathic Pharmacopoeia under the ‘Class of drug’ in item 4A of the Second Schedule of the Act.

It has also proposed amendment of the Act to include books under the Homoeopathic systems and Sowa-Rigpa systems of medicines, in the first schedule of the Act, along with the existing books on Ayurvedic, Siddha and Unani Tibb systems of medicines.

The draft amendment issued a notice of three months for any persons likely tobe affected by the proposed amendment to submit their objections and suggestions in three months from the date of publication of the draft. The draft notification is dated January 11, 2024.

The amendment proposes to add 20 books from the Homoeopathic system, including the Homoeopathic Pharmacopoeia India, Materia Medica Pura volumes and other books of Samuel Hahneman, known as the creator of the Homoeopathic system of medicines.

A total of 34 books from the Sowa-Rigpa system of medicine is also proposed to be added to the Act, through the amendment.

According to the National Commission For Indian System Of Medicine is the statutory body constituted under NCISM Act, 2020, Sowa Rigpa is a centuries-old traditional medical system that employs a complex approach to diagnosis, incorporating techniques such as pulse analysis and urinalysis, and utilizes behaviour and dietary modification, medicines composed of natural materials (e.g., herbs and minerals) and physical therapies to treat illness.

The Four Tantras (Gyushi, rGyu-bzhi) are native Tibetan texts incorporating Indian, Chinese and Greco-Arab medical systems. The Four Tantras is the common name for the text of the Secret Tantra Instruction on the Eight Branches, the Immortality Elixir essence.

“The four Tantras are as follows, Root Tantra – Exegetical Tantra – Instructional Tantra – Subsequent Tantra. Although there is clear written instruction in the Four Tantra, the oral transmission of medical knowledge still remains a strong element in Tibetan Medicine. The Sowa Rigpa System of Medicine is included in the Central Council of Indian Medicine from the year 2012 as per Gazette Notification No. 2345 dated December 16, 2011,” says the Commission.

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