Pharma Sector – Drug Pricing, NPPA, FDC, Generics, etc.

Over-the-counter sale of 14 steroid creams banned by Health Ministry

Back2basics

Mains Paper 2: Governance | Issues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Schedule H and X drugs.

Mains level: The Drugs and Cosmetics Act, 1940 and the reasons behind the banning of  over-the-counter sale of 14 products.


News

Decision taken by the Health Ministry

  1. The Union Health Ministry has banned over-the-counter sale of 14 products
  2. Why: To prevent the indiscriminate sale of ointments containing steroids and antibiotics without prescription
  3. The decision was taken under the Schedule H of the Drugs and Cosmetics Rules, 1945
  4. The Drugs and Cosmetics Rules, 1945 are the set of rules under the Drugs and Cosmetics Act, 1940 which contains provisions for classification of drugs under given schedules and there are guidelines for the storage, sale, display and prescription of each schedule
  5. The decision was taken following consultation with the Drugs Technical Advisory Board
  6. The board has also submitted their recommendations to the Central Drugs Standards Control Organisation

Background

  1. The move comes after dermatologists complained that pharmaceutical companies were selling steroid-based creams to patients, who use them without medical guidance
  2. Some ointments that have been banned are alclometasone, beclomethasone, desonide and fluocinonide among others

Back2basics

Schedule H drugs

  1. Schedule H is a class of prescription drugs in India appearing as an appendix to the Drugs and Cosmetics Rules, 1945 introduced in 1945
  2. These are drugs which cannot be purchased over the counter without the prescription of a qualified doctor
  3. The manufacture and sale of all drugs are covered under the Drugs and Cosmetics Act and Rules
  4. It is revised at times based on the advice of the Drugs Technical Advisory Board, part of the Central Drugs Standard Control Organization in the Ministry of Health and Family Welfare
  5. However, enforcement of Schedule H laws in India is lax, compared to the more restrictive Schedule X, for which a mandatory documentation trail must be maintained
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