RULE 70 OF THE DRUGS ACT

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Context:

The Supreme Court of India criticized the AYUSH Ministry for directing state authority to prohibit the application of Rule 170 of the Drugs and Cosmetics Act.

About Rule 170

• In 2018, Rule 170 was introduced under the Drugs and Cosmetics Act 1940 to regulate the production, storage, and marketing of Ayurvedic, Siddha, and Unani medicines in India.
• The key objective is to prohibit false advertisements about AYUSH products.
• It aims to ensure that any health claims made by AYUSH products are supported by scientific data and do not mislead customers.

Key Provisions of Rule 170

• It clarifies that AYUSH drug makers are prohibited from marketing their products without acquiring formal approval and a unique identification number from the state licensing authority.
• Manufacturers must apply to the state licensing authority that includes product-related detail information.
• The rule outlines criteria for rejecting an advertisement application, such as celebrity endorsements, references to government organizations, or false or exaggerated claims.

Challenges in Regulating AYUSH Drugs

• AYUSH drugs do not require strict clinical trials to establish safety and efficacy, as allopathic drugs do.
  • • The majority of AYUSH medications are approved based on textual references from authoritative books within their traditional systems.
    • Only formulations that contain specified chemicals, such as heavy metals or poisons, are required to undergo safety testing.
• Compliance with Rule 170 across all states and jurisdictions can be difficult due to differences in regulatory capacity and enforcement resources.
• Many people are unaware of the difference between regulated and unregulated products, which can lead to the purchase of products with misleading claims.

About Drugs and Cosmetics Act 1940 ●It regulates the import, manufacture, distribution, and sale of pharmaceuticals and cosmetics. ●Drug and cosmetic manufacturers, importers, and distributors must get licenses from the proper regulatory agencies. ●It specifies requirements for the quality, purity, and strength of pharmaceuticals and cosmetics. ●It prohibits the production, sale, and distribution of forged, or contaminated pharmaceuticals and cosmetics. ●It allows drug inspectors to investigate sites, collect samples, and prosecute violators.

Source:

Indian Express

AYUSH Ministry

Wikipedia

PRACTICE QUESTION Q. Rule 170 of the Drugs and Cosmetics Act 1940, is frequently seen in the news, it is related to: A) Regulating pharmaceutical exports from India. B) Preventing misleading advertisements of AYUSH products. C) Standardizing the production processes for AYUSH drugs. D) Developing guidelines for clinical trials for new AYUSH drugs.   Answer: B Explanation: Rule 170 of the Drugs and Cosmetics Act regulates the manufacture, storage, and sale of Ayurvedic, Siddha, and Unani medicines in India. Its major goal is to prohibit misleading advertisements about AYUSH products.