PIB · Government of India ·

Union Health Ministry Proposes Strict Curbs on Prescription Drug Advertisements by Retailers and Wholesalers

Distilled Policy Brief

  • The proposed regulations aim to curb unauthorized promotion of prescription-only medicines, mitigate risks of self-medication, and enhance safeguards for critical pharmaceuticals like antibiotics and psychiatric drugs.

🎯 Prelims High-Yield Examination Points

Note that the proposed sub-rule (22) under Rule 65 of the Drugs Rules, 1945 extends prior Central Government ad approval mandates for Schedule H, H1, and X drugs beyond manufacturers to include retail and wholesale drug licensees.

⚖️ Mains Analytical & Syllabus Linkages

Discuss how plugging regulatory loopholes in prescription drug advertising strengthens public health governance and curbs antimicrobial resistance (AMR) caused by self-medication in India.

🎯 UPSC Prelims Practice Drill

Polity & Governance

With reference to the draft amendments to the Drugs Rules, 1945 proposed by the Union Ministry of Health and Family Welfare, consider the following statements: 1. It proposes to extend the requirement of prior Central Government approval for advertising Schedule H, H1, and X drugs to retail and wholesale drug license holders. 2. Under the existing framework, the restriction on advertising these scheduled drugs without prior approval applies only to drug manufacturers. 3. The amendment has been drafted in consultation with the Drugs Technical Advisory Board (DTAB). Which of the statements given above are correct?

  • [A] 1 and 2 only
  • [B] 2 and 3 only
  • [C] 1 and 3 only
  • [D] 1, 2 and 3
▶ Reveal Official Answer & Analytical Explanation
✓ Correct Option: [D] 1, 2 and 3

All three statements are correct. The proposed amendment to Rule 65 of the Drugs Rules, 1945, aims to plug a regulatory gap by extending the advertisement restrictions on Schedule H, H1, and X drugs (which currently apply only to manufacturers) to retail and wholesale drug license holders. This draft amendment was prepared in consultation with the Drugs Technical Advisory Board (DTAB) to curb unauthorized promotion and self-medication of critical drugs like antibiotics and psychiatric medicines.

Tark High-Yield Question Bank ⚡ Practice Full Test in Testing Arena ↗

🏛️ Historical Twin PYQ Anchor (2021)

UPSC Prelims 2021

Consider the following statements regarding the "National Clean Air Programme (NCAP)": 1. It is implemented by the Ministry of Environment, Forest and Climate Change. 2. Central Pollution Control Board acts as the sole regulatory executive body.

Forensic Anchor: Cabinet Allocation of Business Rules & NCAP Framework
Examiner Trap Takeaway: UPSC swapped Central Pollution Control Board role with State Pollution Control Boards for state-level monitoring.

📚 Static Syllabus & Constitutional Linkages

Drugs and Cosmetics Act, 1940 & Drugs Rules, 1945: The statutory framework governing the manufacture, distribution, and sale of drugs in India, detailing classification under various schedules like Schedule H (prescription drugs), H1 (restricted antibiotics/habit-forming drugs), and X (narcotics/psychotropics).
Drugs Technical Advisory Board (DTAB): The apex statutory body constituted under the Drugs and Cosmetics Act, 1940 to advise the Central and State Governments on technical matters arising out of the administration of the Act.