Manufacture, marketing of antibiotics may be regulated; prescription to be mandatory
(Source – The Hindu, International Edition – Page No. – 6)
| Topic: GS2 – Social Justice – Health |
| Context |
| ● The Drugs Technical Advisory Board (DTAB) has recommended that all antibiotics be included in the definition of “new drug” under the New Drugs and Clinical Trial (NDCT) Rules, 2019.
● This recommendation has been made to the Drugs Consultative Committee (DCC) to address the rising threat of antimicrobial resistance (AMR). |
Reasons for the Step
- Antimicrobial resistance (AMR) is recognized as a global public health threat.
- Misuse of antibiotics, antivirals, and antifungals has contributed to rising drug resistance.
- The Indian Council of Medical Research (ICMR) report highlights drug resistance in diseases like urinary tract infections, bloodstream infections, pneumonia, and typhoid.
- This move aims to curb misuse of antibiotics and promote their responsible use to prevent further escalation of drug-resistant infections.
Implications of the Move
- Antibiotics will require manufacturing, marketing, and sale documentation under the “new drug” category.
- Manufacturers will need to obtain clearance from the Union government instead of State drug administrations.
- Patients will only be able to buy antibiotics with a prescription, limiting over-the-counter access.
- A blue strip or box will be added to the labelling of antimicrobial products under the Drugs Rules, 1945.
| Drugs Technical Advisory Board (DTAB) |
| ● The Drugs Technical Advisory Board (DTAB) is a statutory body established under the Drugs and Cosmetics Act, 1940 in India.
● It advises the Central Government on technical matters related to drugs and cosmetics regulation. ● Comprising experts from various fields, DTAB focuses on ensuring drug safety, efficacy, and quality. ● The board addresses issues related to drug approvals, clinical trials, and amendments to existing drug regulations. ● DTAB plays a crucial role in formulating policies and guidelines to combat public health challenges, such as antimicrobial resistance. ● It conducts meetings to review recommendations from subcommittees and provides insights to improve India’s drug regulatory framework. |
| Practice Question: Discuss the global and national challenges posed by antimicrobial resistance (AMR). Analyse the factors contributing to the rise of AMR in India and suggest comprehensive strategies to mitigate its impact on public health and the healthcare system. (250 Words /15 marks) |
