Ayush Union Ministry Drafting Regulations for Licensing of Nasal Sprays

India Pharma Outlook Team | Monday, 18 December 2023

 India Pharma Outlook Team

The Union Ministry of Ayush is framing guidelines under the Drugs and Cosmetics Rules, 1945, for the issuance of licenses to the Ayurveda, Siddha, Unani and Homoeopathy drugs with the new dosage form of nasal spray in these systems, which are different from the traditional Nasya treatment.

The Ministry has released a draft notification with proposed amendments to the Drugs and Cosmetics Rules to set standards for the new dosage form nasal spray in these systems of medicines and the guidelines for using the new devices for regulatory purposes.

The draft notification has been prepared after consultation with the Ayurveda, Siddha, and Unani Drug Technical Advisory Board. The ministry has called for objections and suggestions from the stakeholders within 30 days from the date on which copies of the Official Gazette with the draft are published.

The notification suggests the addition of a new sub-rule in Rule 158B, which details the guidelines for the issue of license with respect to Ayurveda, Siddha or Unani drugs, for the issue of license to drugs with nasal spray as dosage for these systems of medicines, the Licensing Authorities shall follow the guidelines as per Schedule TB. Amendment shall also be made in Schedule M-I to enforce the same for the homeopathy medicine with nasal spray as dosage form, it said.

The Schedule TB is also a fresh addition suggested in the draft notification, which details the definition of a nasal spray, differentiating it from the traditional Nasya and putting guidelines for ingredient selection, excipient selection, and other specifications and parameters for the device and finished products.

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