The Ministry of AYUSH has proposed amendments to the Drugs Rules, 1945, introducing guidelines for the issuance of licenses for Ayurveda, Siddha, Unani, and Homoeopathy drugs in nasal spray dosage forms. The draft rules, titled “Draft Drugs Rules (Amendment), 2023,” outlines the procedures and specifications for the development and regulation of nasal spray formulations in these traditional systems of medicine. These draft rules were published on December 12, 2023.
The proposed amendments introduce a new process for issuing licenses for Ayurveda, Siddha, and Unani drugs in nasal spray dosage form. They also introduce guidelines for development of nasal spray as dosage form for Ayush, Siddha, Unani and Homoeopathy Drugs. These are contained in Schedule TB.
Schedule TB: Guidelines for Ayush Nasal Spray Development
The guidelines cover various aspects, including the introduction, differentiation from traditional methods, and specifications for active ingredients, excipients, and the nasal spray device.
Highlights of Schedule TB:
I. Introduction: The document emphasizes the significance of Nasika (nasal) administration in Ayurveda and its applications in treating various conditions related to the head and neck. It elaborates on different Nasya procedures used in Ayurveda, Siddha, Unani, and Homoeopathy.
II. Definition: Defines a nasal spray as a liquid/powder formulation dispensed as a fine spray into the nostril, highlighting its local delivery of medications in the nasal cavity.
III. Differentiation from Nasya: Clarifies the distinction between traditional Nasya and the new Ayush nasal spray, emphasizing the use of a specific device in the latter.
IV. Guidelines for Active Ingredient and Excipient Selection: Specifies criteria for selecting active ingredients and excipients based on the Drugs and Cosmetics Act, 1940, and Rules 1945.
V. Specifications for the Device: Outlines quality parameters for the selection of packaging material, pump, actuator, and other components, ensuring compatibility and safety.
VI. Specifications for the Finished Product: Mandatory specifications include description, assay of active ingredients, pump delivery, net content, pH value, osmolality, microbial limits, and other crucial parameters.
VII. Stability Guidelines: Advises following stability guidelines provided in the concerned Pharmacopeia.
VIII. Safety and Efficacy Studies: Underlines the need for safety and efficacy studies as per Rule 158(B) of the Drug and Cosmetics Rules, 1945, and other relevant guidelines.
IX. One-Time Studies as part of Product Development: Mandatory and optional one-time studies for priming, temperature cycling, preservative effectiveness, stability studies, cleaning instructions, and other considerations.
The proposed draft rules aim to regulate the development and quality of AYUSH nasal spray formulations, ensuring safety, efficacy, and adherence to traditional practices. Stakeholders and the public are invited to provide feedback on the draft before January 12, 2024. Objections or suggestions, if any, may be addressed to the Secretary, Ministry of Ayush, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at [email protected] .
