Serial Number 34 of the Schedule K

Class of Drugs:

Production of Oxygen 93 per cent USP, produced from air by the molecular sieve process, by a hospital or Medical Institute for their captive consumption.

Extent and Conditions of Exemption:

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 inspection by an Inspector appointed under the Act, who can, if necessary, take samples for test.

Serial number 34 of the Schedule K stands substituted

Class of Drugs:

Production of Oxygen 93 per cent USP or Oxygen 93 per cent. 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.

Extent and Conditions of Exemption:

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

The Amendment Rules have included Oxygen 93% supplied from liquid oxygen in the production of Oxygen 93% USP by a hospital or medical institute for their captive consumption, in addition to oxygen being produced from air by the molecular sieve process. This is exempted from the applicability of provisions of Chapter IV (Manufacture, Sale and Distribution of Drugs and Cosmetics) of the Act and 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.