The Government of India has introduced new rules allowing the development and licensing of nasal spray formulations for traditional Indian medicine systems – Ayurveda, Siddha, and Unani. These rules are titled the Drugs (First Amendment) Rules, 2025. These rules were published on January 13, 2025 and have come into immediate effect.
The new rules aim to expand treatment options and potentially improve accessibility.
Key Points of the Rules
- The National Licensing Authority will grant licenses for nasal spray products based on specific guidelines outlined in a new Schedule TB.
- While nasal administration (Nasya) has existed in these traditional systems, the new rules focus on nasal sprays delivered through a specialized device.
- Only ingredients defined as Ayurvedic, Siddha, or Unani drugs under the Drugs and Cosmetics Act can be used.
- The rules detail specifications for the device (pump, bottle, actuator) and the finished product.
- Safety and efficacy studies must be conducted in accordance with existing guidelines.
Benefits:
- Potential for improved delivery and effectiveness of certain medications.
- Increased accessibility and convenience for patients.
- Modernization of traditional medicine systems.
The Schedule TB outlines various parameters for the nasal spray, including selection of active ingredients and excipients, device specifications, and finished product testing.
Specific studies like spray pattern, particle size distribution, and cleaning instructions are required for product development. Stability guidelines and safety/efficacy studies follow existing frameworks for traditional medicine.
