amendment proposed for exemption of hospitals from manufacturing licence for production of oxygen

Thursday, January 20, 2005

The Centre has proposed to amend Schedule K of the Drugs and Cosmetics Act, 1945. The amendment will enable hospitals and medical institutions to be outside the ambit of the provisions of the manufacturing license under the Drugs and Cosmetics Rules for the production of 93% oxygen from air by the molecular sieve process. Before giving effect to this amendment, the Government has issued a notification on 13th December, 2004 inviting objections and suggestions from the public within 45 days.

Medicinal oxygen is a drug under the Drugs and Cosmetics Act, 1945 and the rules thereunder. Normally medicinal oxygen is manufactured by the manufacturers of gases filled in cylinders and then supplied to the hospitals. However, now hospitals have started a new state of art technology for use of medicinal oxygen by molecular sieving of air for their captive consumption.

EK/MK.