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New licensing rules mandate compliance with Schedule TB for ASU nasal sprays for patient safety

Shardul Nautiyal, Mumbai
Friday, January 24, 2025, 08:00 Hrs  [IST]

The Union ministry of health has announced a significant amendment to the Drugs Rules, 1945, concerning Ayurvedic, Siddha, and Unani (ASU) nasal sprays. Through a notification, the government has introduced Rule 158B (VI), mandating licensing authorities to adhere to the newly defined guidelines under Schedule TB while issuing licenses for ASU nasal sprays.

This regulatory move aims to standardize the formulation, safety, and efficacy of nasal sprays in traditional medicine systems. Nasal sprays, which are liquid or powder formulations delivered through a specialized device into the nostril, have long been recognized in Ayurveda as Snehana Nasya or Shamana Nasya, in Siddha as Nastyam and Nasika aparanam, and in Unani medicine as Saoot, Qutoor, Shamoom, Nashuq, or Naswar.

Key features of Schedule TB for ASU nasal sprays include differentiation from traditional Nasya. While traditional Nasya involves nasal administration without a specialized device, the new nasal spray dosage form mandates the use of a specific dispensing instrument.

It also includes standards for formulation. The Ayurvedic Pharmacopoeia of India will continue to define medication standards, but Schedule TB establishes new standards for nasal spray dosage forms and device specifications.

The new Schedule TB has guidelines for active ingredients and excipients. Strict selection criteria for formulation components ensure safety and efficacy. It stipulates device specifications.  Requirements for nasal spray devices, including material standards and functional parameters, are outlined to ensure consistency in administration.

The government has introduced mandatory and optional criteria for final product quality and performance. A one-time product development study must be submitted when applying for a license to demonstrate adherence to quality standards.

Safety, efficacy, and stability protocols have also been introduced and defined for pre-market safety, efficacy, and stability studies to ensure the reliability of ASU nasal sprays.

The introduction of these stringent regulations marks a significant step in integrating traditional medicine with modern pharmaceutical standards. By ensuring the safety and efficacy of nasal spray formulations, the government aims to enhance consumer confidence and expand the global market for ASU medicines. Industry stakeholders are now required to align their production processes with the new regulatory framework to secure product approvals.

 

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