The Union Health Ministry has brought in new regulations of licensing under the Drugs Rules, 1945, which makes compliance with Schedule TB mandatory for Ayurvedic, Siddha, and Unani (ASU) nasal sprays. The step will ensure standardization of formulation, safety, and efficacy procedures for these products, along with higher consumer confidence and international market acceptability.

Key Highlights:
Amendment Notice:
The government implemented Rule 158B (VI) to compel licensing authorities to adhere to newly established Schedule TB guidelines for ASU nasal sprays.

Differentiation from Conventional Practices:

• Conventional nasal treatments such as Nasya (Ayurveda), Nastyam (Siddha), and Saoot (Unani) do not require specialized devices.

• Schedule TB, however, prescribes the use of dispensing instruments for nasal sprays.

New Standards for Nasal Sprays:

• Standards of Formulation: Excipients and active ingredients should have high standards to ensure safety and effectiveness.

• Device Characteristics: Material requirements and operating parameters for nasal spray devices are regulated.

• Quality Assurance: Product quality, performance, and a single product development study are needed during licensing.

• Safety Procedures: Pre-market safety, efficacy, and stability studies are required to guarantee product dependability.

Impact on Industry:

• Manufacturers must align production processes with the new framework to obtain licenses.

• The Indian Ayurvedic Pharmacopoeia will establish standards for medication, supplemented by new device-specific regulations under Schedule TB.

Statements from Leaders or Officials:
The Ministry of Health observed, "This initiative is a step forward in integrating traditional medicine with modern pharmaceutical standards, ensuring product safety and efficacy while boosting global market confidence in ASU products."These revised guidelines reinforce the government's intention to push forward traditional systems of medicine using modernization and regulation. It is urged upon industry players that they conform to the new directives in good time, leading to higher consumer confidence as well as overseas expansion for ASU nasal sprays.