Current Status of Rule 170 in Drugs and Cosmetics Act & Rules, 1940 & 1945

Abstract

Drugs and Cosmetics Act, 1940 (Act 23 of 1940) is a pre-independence Act passed by British Legislature under the Government of India Act, 1935 as the Drugs Act, 1940. The main objective of this act is to regulate the import, manufacture, distribution and sale of Ayurveda, Siddha, Unani drugs. The Drugs and Cosmetic Rule came in existence as a part of force vide Notification No.F.28-10/45 (H) (1), the 21^st December, 1945, Department of Health, Government of India, New Delhi. Drugs and Cosmetic Rules, 1945 composed of 19 parts containing 170 rules. The rules 151 to 170 are pertaining to Ayurveda, Siddha, Unani drugs. The review aims to get a transparency regarding the current status of Rule 170 of Drugs and Cosmetic Rule, 1945, as this rule is in a state of uncertainty. Rule 170 and its provisions 0f Drugs and Cosmetic Rules, 1945 mainly deals with the prohibition of misleading advertisement of Ayurveda, Siddha or Unani drugs. On 29^th August 2023 the notification from Ministry of Ayush in relation to the omission of Rule 170, creates dilemma in public. In that notification it is clearly stated that, With the power confers under section 33P of Drugs and Cosmetic Act, 1940, all States/UTs licensing authorities are here by directed not to initiate or take action under the Rule of 170 of Drugs and Cosmetic Rules, 1945. Together with this notice it also mentioned that the notification for omissions of Rule 170 and its related provisions mentioned in Drugs and Cosmetic Rules, 1945 will take some time. The letter was issued based on a recommendation from the ASUDTAB and developed based on the existing case regarding the Patanjali products. A part from this in “THE INDIAN GAZETTE” of 2^nd February 2024, Ministry of AYUSH notified the draft of certain rules further to amend the Drugs Rules, 1945. In that over the serial number 33 mentions regarding the omission of Rule 170, it is quoted like “The Rule 170 of the principal rules, shall be omitted”. As per the objection/opinion received from the public over the drafted rules published by Ministry of Ayush in relation to Drugs and Cosmetic Rules, 1945, a latest notification of “THE INDIAN GAZETTE” (July 2^nd of 2024) also suggesting that “Rule 170 shall be omitted”. By reviewing this, it is found that still the Rule 170 is not get omitted from the Drugs and Cosmetic Rules, 1945, instead of omission it got neutralised based on the section 33P of Drugs and Cosmetic Act and it is on consideration for omission.