Rule 170 of the Drugs and Cosmetics Act - POLITY
News:
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.
What’s
in the news?
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.
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: https://indianexpress.com/article/explained/explained-health/supreme-court-pulled-up-ayush-ministey-over-rule-170-of-drugs-act-heres-what-it-says-9545226/