Why in News
The Drugs Technical Advisory Board (DTAB) has recommended that all antibiotics be classified as "new drugs" under the New Drugs and Clinical Trial (NDCT) Rules, 2019.
This move aims to address the growing public health threat of antimicrobial resistance (AMR).
Its Impact
If implemented, the manufacturing, marketing, and sale of antibiotics will be more tightly regulated, requiring clearance from the Central government rather than State authorities.
Patients will only be able to purchase antibiotics with a prescription, which may reduce misuse.
Proposed amendments include new labeling requirements, such as a blue strip or box for antimicrobial products, to clearly identify them.
Antimicrobials will not be sold to non-pharmaceutical industries without proper licenses, further controlling distribution.
This initiative is part of broader efforts to combat antimicrobial resistance, which has been recognized as a serious global health threat, especially with increasing cases of drug-resistant infections in India.
COMMENTS