Rule 170 Of The Drugs And Cosmetics Rules 1945

Recently, the Supreme Court stayed a notification issued by the AYUSH Ministry for omitting a rule prohibiting misleading ads.

The Supreme Court while hearing a case against Patanjali Ayurved stayed the AYUSH ministry’s July 1 notification, asking state licensing authorities “not to initiate/take any action under” Rule 170 of the Drugs and Cosmetics Rules, 1945.
Earlier, May 7 order of the Supreme Court had directed the Ministry to withdraw its August 29, 2023 letter sent to drug licensing authorities across States and Union Territories informing them that Rule 170 was no longer operational.
However, the Ministry went on to issue the July 1 notification, which did not withdraw the August 2023 letter, while also omitting Rule 170 once again.
The government considered that the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board (ASUDTAB) recommended that Rule 170 could be omitted as amendments in the Drugs and Magic Remedies Act — another law to govern such misleading advertisements — were also being taken up by the health and AYUSH ministries.

The Ayurvedic, Siddha, and Unani Drugs Technical Advisory Board (ASUDTAB) is a statutory body formed under the Drugs and Cosmetics Act of 1940.
It serves as an advisory body to the central and state governments on regulatory issues related to Ayurvedic, Siddha, and Unani (ASU) drugs.
The board is instrumental in establishing standards and ensuring the quality, safety, and efficacy of these traditional medicines.

In 2018, the government brought Rule 170 under Drugs and Cosmetics Rules 1945 to govern the manufacture, storage, and sale of medicines in the country, “specifically for controlling inappropriate and misleading advertisements of Ayurvedic, Siddha and Unani medicines”.
The rule prohibits AYUSH drug manufacturers from advertising their products without approval and allotment of a unique identification number from the state licensing authority.
The manufacturers have to submit details such as textual references and rationale for the medicine from authoritative books, indication for use, evidence of safety, effectiveness, and quality of drugs.

The Drugs and Cosmetic Rule came into existence as a part of the Drugs and Cosmetics Act, of 1940 in, 1945. They are composed of 19 parts and contain 170 rules.
Drugs and Cosmetics Act, of 1940 is a pre-independence Act passed by the British Legislature under the Government of India Act, 1935.
The main objective of this act is to regulate the import, manufacture, distribution and sale of Ayurveda, Siddha, and Unani drugs.