The Ministry of Ayush on December 12, 2023, issued the draft of the Drugs Rules (Amendment), 2023 to further amend the Drugs and Cosmetics Rules, 1945.
The following amendments have been stated:
• In rule 158B which states “Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drags”, after sub-rule (V), the following sub-rule shall be inserted, namely: —
“VI. For issue of license to the Ayurveda, Siddha and Unani drugs with nasal spray as dosage form, the Licensing Authorities shall follow the guidelines as per Schedule TB.”
• After Schedule TA, Schedule TB has been inserted.
• In Schedule M-I, after sub-clause 3.7, the following sub-clause 3.8 has been inserted, namely:
“3.8. For issue of license to the homoeopathy medicine with nasal spray as dosage form, the Licensing Authorities shall follow the guidelines as per Schedule TB.”
The notice is hereby given that the objections or suggestions of the stakeholders on the said draft rules will be taken into consideration after the expiry of a period of 30 days from the date on which copies of the Official Gazette in which this notification is published, are made available to the public.
Any objection or suggestion, which may be received from any person with respect to the said draft rules within the period specified above, will be taken into consideration by the Central Government.
These rules will come into force from the date of their final publication in the Official Gazette.
[Notification No. G.S.R. 891(E)]
