What are ‘New Drugs’?

• 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.

PYQ:

[2019] Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India?

1. Genetic predisposition of some people
2. Taking incorrect doses of antibiotics to cure diseases
3. Using antibiotics in livestock farming
4. 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