Daily Current Affairs : 17-October-2024
The Drugs Technical Advisory Board (DTAB) has recently made important recommendations to address the growing problem of antimicrobial resistance (AMR) in India. The proposal suggests bringing all antibiotics under the definition of “new drug” according to the New Drugs and Clinical Trial (NDCT) Rules, 2019. This move aims to regulate antibiotics more strictly, reducing the misuse of these life-saving medicines.
Recent Recommendations by DTAB
Inclusion of Antibiotics as “New Drugs”
- DTAB has recommended that all antibiotics be classified as “new drugs.”
- This change would require stricter documentation for the manufacturing, marketing, and sale of antibiotics.
Union Government Control
- Antibiotics would now require approval from the Union government, instead of state authorities.
- Centralized control will ensure uniformity in regulation across the country.
Prescription-Only Availability
- Antibiotics would only be sold with a valid prescription.
- This will prevent the over-the-counter sale of antibiotics, reducing their misuse.
Changes in Labeling
- Antibiotic packaging would have a distinct blue strip or box to help identify antimicrobial products.
- This visual change aims to raise public awareness about the importance of proper antibiotic use.
Focus on Combating AMR
- The primary goal of these recommendations is to combat antimicrobial resistance (AMR) in India.
- Common infections like urinary tract infections (UTIs), pneumonia, and typhoid are increasingly becoming resistant to antibiotics.
- By restricting the overuse of antibiotics, DTAB hopes to slow the rise of drug-resistant infections.
Significance of the Recommendations
Curbing Antimicrobial Resistance
- These steps will reduce the misuse and overuse of antibiotics, helping to slow the development of drug-resistant bacteria.
Centralized Regulation
- Bringing antibiotics under the control of the Union government ensures uniform regulations across India, which can lead to more effective management of antibiotic use.
Public Health Protection
- Mandatory prescriptions and new labeling would help prevent self-medication and improper usage, ultimately safeguarding public health.
About the Drugs Technical Advisory Board (DTAB)
DTAB is the highest statutory body in India for advising on technical drug-related matters.
- Established Under: The Drugs and Cosmetics Act, 1940
- Part of: The Central Drugs Standard Control Organization (CDSCO)
- Nodal Ministry: Ministry of Health and Family Welfare
- Functions: DTAB advises the central and state governments on matters related to drug regulation and performs other tasks under the Drugs and Cosmetics Act.
Important Points:
- DTAB’s Recommendation: All antibiotics should be classified as “new drugs” under the NDCT Rules, 2019.
- Centralized Control: Antibiotics will require approval from the Union government for manufacturing, marketing, and sale.
- Prescription-Only: Antibiotics will be available only with a valid prescription to curb misuse and over-the-counter sales.
- Labeling Changes: Antibiotic packaging will feature a distinct blue strip or box to raise awareness and distinguish antimicrobial products.
- Focus on AMR: The recommendations aim to combat antimicrobial resistance (AMR), which is making common infections resistant to treatment.
- Public Health Protection: Stricter regulations will help reduce self-medication, improving public health outcomes.
- DTAB’s Role: The Drugs Technical Advisory Board advises the government on drug-related matters and ensures compliance with the Drugs and Cosmetics Act, 1940.
- Impact on AMR: These measures will help slow the rise of drug-resistant infections, safeguarding public health.
Why In News
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, as part of a strategic move to combat the growing threat of antimicrobial resistance (AMR) and ensure better control over antibiotic use and distribution. This step aims to strengthen regulations and reduce the misuse of antibiotics, which is a major contributor to the rise of drug-resistant infections.
MCQs about DTAB’s New Guidelines to Combat Antibiotic Resistance
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What is the main purpose of DTAB’s recommendation to classify all antibiotics as “new drugs”?
A. To increase the availability of antibiotics in the market
B. To regulate the manufacturing, marketing, and sale of antibiotics more strictly
C. To reduce the cost of antibiotics
D. To make antibiotics available over the counter
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Under the new recommendation, who will be responsible for approving the manufacturing and marketing of antibiotics?
A. Local authorities
B. State governments
C. Union government
D. Private companies
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What is one of the key changes in the labeling of antibiotics, according to DTAB’s new recommendations?
A. Antibiotics will be labeled with a red box
B. Antibiotics will be labeled with a blue strip or box
C. Antibiotics will no longer have any labeling
D. Antibiotics will be labeled with a green strip
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What is the primary focus of DTAB’s recommendations on antibiotics?
A. To make antibiotics available to everyone without restrictions
B. To combat antimicrobial resistance (AMR) and reduce misuse of antibiotics
C. To increase the number of antibiotics in the market
D. To make antibiotics available only in hospitals
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