Mandatory Guidelines for ASU Nasal Spray
Licensing Authorities shall follow Guidelines issued under Schedule TB while issuing Licence for Nasal Sprays of Ayurveda, Siddha and Unani medicines.
The Ministry of Health and Family Welfare vide notification GSR 28 (E) dated 10.01.2025 has amended Drugs Rules, 1945 with respect to the Ayurvedic, Siddha and Unani Nasal Sprays. Now, newly inserted Rule 158B (VI) under Drugs Rules, 1945, mandates Licensing Authorities to follow Guidelines for development of nasal spray as dosage form for Ayurvedic, Siddha and Unani drugs, as provided under Schedule TB to the said rules.
A nasal spray is a liquid or powder formulation dispensed as a fine spray from a container or device into the nostril. Traditionally, these are referred as Snehana Nasya or Shamana Nasya in Ayurveda or Nastyam and Nasika aparanam in Siddha or Saoot or Qutoor or Shamoom or Nashuq or Naswar in Unani medicines.
While the medication standards for nasya will remain as indicated under Ayurvedic Pharmacopoeia of India, the standards for the new dosage form “Nasal Spray” and the guidelines for the usage of the new device are now defined in newly inserted Schedule TB. The differentiation between the Nasya and Nasal Spray is Nasya is a traditional method of using nose as route of administration without support of any specialized instrument or device, while Nasal Spray is administered with support of a specific device.
Under the Schedule TB following specifications are introduced which shall be applicable for the nasal sprays of ASU drugs.