Why in the News?
The Drugs Technical Advisory Board (DTAB), the highest statutory body on technical drug-related matters in India, has recommended including all antibiotics under the definition of âNew Drugsâ in the New Drugs and Clinical Trial (NDCT) Rules, 2019.
What are âNew Drugsâ?
- According to Rule 122 E of the Drugs and Cosmetics Rules, 1945, a new drug is one that:
- Has not been used in the country.
- Has not been recognized as effective and safe by the licensing authority.
- May also be an already approved drug with modified claims such as new indications, dosages, or routes of administration.
Implications of Including Antibiotics in the New Drug Category:
- If antibiotics are classified as new drugs:
- Their manufacturing, marketing, and sale will be documented.
- Clearance for manufacturing and marketing will need to be obtained from the Central government instead of State drug administrations.
- Antibiotics will only be sold to patients on prescription.
Additional Recommendations:
- The board is considering amending the labelling rules under the Drugs Rules, 1945, by adding a blue strip or box for antimicrobial products.
- It has recommended that antimicrobials should not be sold to non-pharmaceutical industries unless they have the necessary licences.
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About the Drugs Technical Advisory Board:
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Details |
| Authority |
Highest statutory decision-making body on technical matters related to drugs in India |
| Establishment |
Constituted under the Drugs and Cosmetics Act, 1940 |
| Affiliation |
Part of the 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 Drugs and Cosmetics Act
– Carries out functions assigned by the Act |
| Role of CDSCO |
– Approval of drugs
– Conduct of clinical trials
– Establishing standards for drugs
– Quality control of imported drugs
– Coordination with State Drug Control Organizations |
| Specialized Licenses |
Responsible for granting licenses for critical categories of drugs, including blood products, IV fluids, vaccines, and sera |
| Decision-Making |
Provides expert advice and technical recommendations to ensure drug safety, efficacy, and quality |
PYQ:
[2019] Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India?
- Genetic predisposition of some people
- Taking incorrect doses of antibiotics to cure diseases
- Using antibiotics in livestock farming
- Multiple chronic diseases in some people
Select the correct answer using the code given below.
(a) 1 and 2
(b) 2 and 3 only
(c) 1, 3 and 4
(d) 2, 3 and 4 |