Regulation of Antibiotics: A Step Toward Combating Antimicrobial Resistance in India
- October 17, 2024
- Posted by: OptimizeIAS Team
- Category: DPN Topics
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Regulation of Antibiotics: A Step Toward Combating Antimicrobial Resistance in India
Sub : Sci
Sec: Health
Why in News
The Drugs Technical Advisory Board (DTAB) has proposed the regulation of antibiotic manufacturing and marketing by including all antibiotics under the definition of “new drugs” in the New Drugs and Clinical Trial (NDCT) Rules, 2019. This recommendation aims to address the growing threat of antimicrobial resistance (AMR), which has emerged as a critical global health concern.
Regulation of Antibiotics in India
- The DTAB has recommended that all antibiotics be classified as new drugs under the NDCT Rules, 2019. This move is part of a broader effort to regulate the use and sale of antibiotics to combat antimicrobial resistance.
- Definition of “New Drug”: If accepted, antibiotics will fall under the new drug category, meaning their manufacturing, marketing, and sale will require additional regulatory scrutiny.
- The over-prescription and misuse of antibiotics, antivirals, and antifungals contribute to the rise of antimicrobial resistance. The inclusion of antibiotics in the “new drug” category is seen as a critical measure to prevent misuse.
Curbing Antimicrobial Resistance (AMR)
- Global Health Threat: Antimicrobial resistance (AMR) is increasingly recognized as a major public health threat worldwide. Misuse and overuse of antibiotics have contributed significantly to this issue.
- Infections such as urinary tract infections (UTIs), bloodstream infections, pneumonia, and typhoid have become resistant to commonly used antibiotics in India, posing serious health risks.
About Antimicrobial Resistance (AMR):
- Antimicrobial Resistance (AMR) is theability of a microbe to resist the effects of medication previously used to treat them. It is also known as antibiotic resistance.
- As a result, the medicines become ineffectiveand infections persist in the body.
- The WHO defines antimicrobial resistance as a microorganism’s resistance to an antimicrobial drug that was once able to treat an infection by that microorganism.
- The resistance to antimicrobials is a natural biological phenomenon.However, the misuse and overuse of antibiotics accelerates the development of AMR.
- Microbial resistance to antibiotics has made it harder to treat infections such as pneumonia, tuberculosis (TB), blood poisoning (septicaemia) and several food-borne diseases.
Regulatory Implications
- With the new classification, the manufacturing and marketing of antibiotics will require clearance from the Union government, rather than state drug authorities.
- Antibiotics will only be available with a valid prescription, limiting over-the-counter sales and reducing misuse.
- There are also discussions to amend labelling requirements under the Drugs Rules, 1945, including the addition of a blue strip or box to identify antimicrobial products.