Ministry of Health and Family Welfare notifies Drugs and Cosmetics (Fourth Amendment) Rules, 2018

Ministry of Health and Family Welfare notifies Drugs and Cosmetics (Fourth Amendment) Rules, 2018

April 26, 2018 EHS 0

The Ministry of Health and Family Welfare (“Ministry”) has issued the Drugs and Cosmetics (Fourth Amendment) Rules, 2018 (“Amendment Rules”) amending the Drugs and Cosmetics Rules, 1945 (“Principal Rules”). The Amendment Rules are effective from 19th April 2018.

The Amendment Rules have substituted Serial Number 34 of Schedule K relating to the class of drugs and extent and conditions for their exemption in the Principal Rules.

Principal Rules Amendment Rules Impact
 

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.

 

 

For further details, please refer to the link below.

Source: Ministry of Health and Family Welfare

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