The Hindu Business Line : Drug rule changes may leave patients gasping for oxygen

Come January 1, 2005, critically ill patients in need of oxygen support could be left gasping for breath due to scarcity of medical oxygen supplied to hospitals and other healthcare facilities.

A seemingly innocuous amendment to the Drugs and Cosmetics Rules by the Health Ministry, which requires industrial units whose premises are used for producing drugs to discontinue all other manufacturing activities, has brought about the possibility of an acute shortage of medical oxygen in the country. The amendment comes into effect at the turn of the year.

The Health Ministry had revised Schedule M of the Drugs and Cosmetics Rules to ensure compliance of Good Manufacturing Practises, a global standard for drug manufactures.

The All-India Industrial Gases Manufacturers' Association (AIIGMA) that is lobbying hard with the Ministry of Industry and Health Ministry for getting the amendment reversed has pointed out that most of the gas units might have to stop manufacture of medical oxygen from the day the stipulation becomes effective.

Industrial gas units spread across the country are the only source of medical oxygen that finds its way to hospitals and nursing homes.

"Hindrance in the supply of medical gases will bring to a standstill all major surgeries including cardio-vascular operations. Hence, it is important to appreciate the grave nature of the problem and its repercussion," the President, AIIGMA, Mr R.P. Khator, told Business Line.

He pointed out that industrial and medical oxygen are produced in the same plant with the latter accounting for just a meagre one or two per cent of the total oxygen produced.

The Industry Ministry has come out in support of the gas manufacturers' plea. In a recent communication to the Health Ministry, it has called for a re-look at the amendment to the rules. The Drug Controller General of India also seems to be in favour of granting a waiver for the industry.

The Health Ministry, however, seems to be determined to go ahead with the implementation of the new regime that was initially supposed to come into effect from January 1, 2004 but was deferred by a year after similar protests from industry.

"There will be no further extension; however, we could make some concessions for certain industries," said officials in the Health Ministry.