The Union Ministry of Ayush has announced a revision to the Drugs and Cosmetics Act of 1940, introducing the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia as acceptable standards for the import and manufacture of homoeopathic medicines within India. Additionally, it has incorporated literature on the Homoeopathic and Sowa-Rigpa medicine systems into the Act’s First Schedule.
Earlier this year, the Ministry of Ayush released a draft version of this amendment, proposing the inclusion of the French Homoeopathic Pharmacopoeia and the European Pharmacopoeia alongside the German Homoeopathic Pharmacopoeia under the ‘Class of drug’ category in item 4A of the Second Schedule. The final notification now formalizes these amendments.
The draft amendment, circulated in January, provided a three-month period for affected individuals to raise objections. The final notice, dated December 4, confirms that public feedback on the amendment was considered by the Central government.
Previously, imported drugs and locally manufactured homoeopathic medicines were required to conform to standards outlined in the Homoeopathic Pharmacopoeia of India, as well as those in the US, UK, and German Pharmacopoeia, indicated in the Act’s Second Schedule.
The Act’s First Schedule has also been updated to include texts on the Homoeopathic and Sowa-Rigpa medicine systems, supplementing the existing compendium covering Ayurveda, Siddha, and Unani Tibb medicine.
The amendment incorporates 20 new texts from the Homoeopathic discipline, including the Indian Homoeopathic Pharmacopoeia, several editions of Materia Medica Pura, and publications by Samuel Hahnemann, the pioneer of Homoeopathy.
Additionally, the Act now recognizes 34 Sowa-Rigpa texts, enhancing the legislative framework around this traditional healing system.
According to the National Commission for Indian System of Medicine, established under the NCISM Act of 2020, Sowa Rigpa employs an intricate healing approach, utilizing pulse and urine analyses, alongside therapeutic lifestyle and dietary interventions. Remedies are derived from natural elements such as herbs and minerals, and focus extensively on physical therapies to treat various ailments.
The Four Tantras or Gyushi are pivotal Tibetan texts amalgamating Indian, Chinese, and Greco-Arab medicinal doctrines. Revered within Sowa Rigpa, they comprise Root Tantra, Exegetical Tantra, Instructional Tantra, and Subsequent Tantra. Despite written guidelines present in the Four Tantras, the tradition sustains oral transmission as an integral facet of Tibetan Medicine.
“Since 2012, the Sowa Rigpa System, including these renowned texts, has been recognized by the Central Council of Indian Medicine, as per Gazette Notification No. 2345 dated December 16, 2011,” affirms the Commission.