The Drugs and Cosmetics (Fourth Amendment) Rules, 2018

Apr 24, 2018 | by Avantis RegTech Legal Research Team

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General Compliance

Ministry of Health and Family Welfare vide notification dated April 19, 20118 has issued the Drugs and Cosmetics (Fourth Amendment) Rules, 2018 further amending the Drugs and Cosmetics Rules, 1945. Vide this amendment in Schedule K, in the Table, for serial number 34 and the entries relating thereto, the following shall be substituted namely-

Class of Drug

Extent and Conditions of Exemption

Production of Oxygen 93% USP or Oxygen 93% IP produced from air by the molecular sieve process or Oxygen 93 per cent. supplied from liquid Oxygen, by a hospital or medical institute for their captive consumptions

The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered by manufacturing licence under the rules, provided that the production facilities shall be open to inspections by an Inspector appointed under the Act, who can, if necessary, take samples for test


[G.S.R. 385(E)]




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