Explanation on Drugs and Cosmetics (11th Amendment) Rules, 2017 for Regulation of Homoeopathic Medicines
Dr Raj K Manchanda, Ms Renu Arya, Dr Deepti Singh
Paper originally published in Homoeopathy for All – reproduced for public information
The Central Government of India, after consultation with the Drugs Technical Advisory Board (DTAB) amended the Drugs and Cosmetics Rules, 1945 for regulating sale of Homoeopathic medicinal products (HMP), making them easily available to users and enhancing safety, qual- ity, efficacy of homoeopathic medi- cines. The main beneficiaries of these amendments are homoeopathic prac- titioners, pharmacists, manufactur- ers & millions of patients in India.
HMP market is witnessing incremental opportunity thus emphasis is laid on maintaining the quality and safety of homoeopathic medicines.
Some objections and suggestions received from the public on the said rules have also been considered by the Central Government thereby putting an end to false and misleading reports about barring homeopathic doctors from selling medicines. Under the amended rules, homoeopathic doctors can continue dispensing medicines from their clinics. The restrictions which are part of existing rules have no amendments. It is also hereby clarified that the dispensing of HMPs in clinic is covered & governed under Homoeopathic Practitioners (Professional Conduct, Etiquette and Code of Ethics) Regulations, 19821 by Central Council of Homoeopathy (CCH) not by the provisions of Drugs & Cosmetics Rules, 1945. It states, “A practitioner of Homoeopathy has a right to prepare and dispense his own prescription.”
The definition of Homoeopathic medicines was introduced under Drugs & Cosmetics Rules, 1945 on 21st December,19452. Since then, the quality, manufacturing, sale and import are governed by the various provisions of its Acts & Rules. Recently, Government of India had issued an amendment in rules of G. S. R. 80 (E), in the month of November’ 2017, these rules may be called the Drugs and Cosmetics 11th Amendment Rules, 20173.
The key amendments are in Rule 67, PART VI A, for Sale of Homoeopathic Medicines and in Rule 67C, 67F, 67G, 85E. The highlights are: