Ministry of Health and Family Welfare issues the Drugs and Cosmetics (Second Amendment) Rules, 2018

Ministry of Health and Family Welfare issues the Drugs and Cosmetics (Second Amendment) Rules, 2018

The Ministry of Health and Family Welfare (“Ministry”) has, vide a notification dated 23rd March, 2018 in the Official Gazette, issued the Drugs and Cosmetics (Second Amendment) Rules, 2018 (“Amendment Rules”) to further amend the Drugs and Cosmetics Rules, 1945 (“Principal Rules”).

The Amendment Rules have inserted additional ‘prescription drugs’, after serial number 537 and the entries relating thereto, under Schedule H to the Principal Rules, which are as follows:

  • 538. Alclometasone
  • 539. Beclomethasone
  • 540. Betamethasone
  • 541. Desonide
  • 542. Desoximetasone
  • 543. Dexamethasone
  • 544. Diflorasone diacetate
  • 545. Fluocinonide
  • 546. Fluocinolone acetonide
  • 547. Halobetasol propionate
  • 548. Halometasone
  • 549. Methylprednisone
  • 550. Prednicarbate
  • 551. Triamcinolone acetonide


The Ministry had published a draft of the Amendment Rules in the Official Gazette on 1st November, 2017, inviting objections and suggestions from all persons likely to be affected thereby within 45 days from the date on which copies of the Official Gazette containing the said notification were made available to the public i.e. before 16thDecember, 2017.

Thereafter, the Ministry, after considering the objections and suggestions received from the public on the draft of the Amendment Rules, has issued the Amendment Rules.

The Amendment Rules shall come into force on the date of their publication in the Official Gazette.

Kindly note that, the notification regarding the Amendment Rules was uploaded on the website of the Central Drugs Standard Control Organization on 6th April, 2018.

Please refer to the hyperlinked source below for further details.

Source: Ministry of Health and Family Welfare

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