Source: TH
Context: The Drugs Technical Advisory Board (DTAB) has recommended bringing all antibiotics under the definition of “new drug” in the New Drugs and Clinical Trial (NDCT) Rules, 2019 to combat antimicrobial resistance (AMR).
Recent Recommendations by DTAB:
- Inclusion of antibiotics as “New Drugs”:
All antibiotics would fall under the category of “new drugs,” requiring manufacturing, marketing, and sale to be more strictly documented and regulated. - Union government control:
Manufacturing and marketing approvals for antibiotics would need clearance from the Union government, rather than state authorities. - Prescription mandatory:
Antibiotics would only be available with a valid prescription, curbing over-the-counter purchases and indiscriminate use. - Labeling changes:
A blue strip or box would be added to antibiotic packaging to distinguish antimicrobial products, improving public awareness. - Focus on AMR:
This move is part of efforts to address rising antimicrobial resistance in India, where common infections like UTIs, pneumonia, and typhoid are becoming resistant to standard treatments.
Significance:
- Curbing Antimicrobial Resistance: Reducing misuse of antibiotics will help slow the rise of drug-resistant infections.
- Centralized Regulation: Bringing antibiotics under central control ensures uniform regulation across the country.
- Public Health Protection: Mandatory prescriptions and labeling aim to safeguard public health by preventing self-medication and misuse.
About Drugs Technical Advisory Board (DTAB):
- Role: It is the highest statutory body for advising on technical drug-related matters in India.
- Established under: The Drugs and Cosmetics Act, 1940.
- Part of: Central Drugs Standard Control Organization (CDSCO).
- Nodal ministry: Ministry of Health and Family Welfare.
- Functions: Advises the central and state governments on technical matters related to the administration of the Drugs and Cosmetics Act and performs other assigned functions under the Act.
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