The Ministry of Ayush has issued the final notification omitting Rule 170 and related Forms in the Drugs Rules, 194. The rule, which was incorporated in 2018, made the permission of the state drug regulators mandatory for publishing advertisements of Ayurvedic, Siddha and Unani drugs.
Along with the omission of Rule 170, the final notification also omits the Form 26 E4 and Form 26 E5 under the Schedule A of the Rules, which are application forms for advertisement of ayurvedic, Siddha and Unani drugs and the form for the State Licensing Authority to approve such an application.
Rule 170 stipulated that the manufacturer of ayurvedic, Siddha or Unani drugs cannot participate in the advertisement of any drug for use against any health condition and that advertisement of these drugs for any other purpose shall be carried out only after the allotment of a Unique Identification Number (UIN), and after getting permission from the drug regulator.
This was subsequently challenged before various High Courts and some of them even had issued interim orders stopping action against the companies. The Ayurveda, Siddha, Unani Drugs Technical Advisory Board (ASUDTAB) had recommended the omission of the Rule on March 15, 2021.
Since 2018, a total of 36,040 cases of misleading advertisements were reported across the country, including 2091 in the year 2024. Action has been taken on 354 cases up to March 2024, in six states, the ministry’s note added.
The final notification follows the Ministry’s affidavit in April 2024 in the Supreme Court in a matter related to the Indian Medical Association’s petition against Union of India, Patanjali Ayurved and Divya Yoga Pharmacy promoted by Yoga Guru Ramdev.
