Daijiworld Media Network - New Delhi

New Delhi, Oct 1: The Central Drugs Standard Control Organisation (CDSCO) has sought the Directorate General of Health Services’ (DGHS) opinion on whether existing relaxations for the manufacture and distribution of mercury-based topical antiseptic Mercurochrome (Merbromin) under Schedule K of the Drugs Rules should continue.

Schedule K provides exemptions from certain requirements related to the manufacture, sale and distribution of specified drugs, particularly to facilitate access to essential medicines in remote and underserved areas.

According to minutes of a meeting reviewed by Business Standard, the Drugs Consultative Committee (DCC) was informed that only a limited number of manufacturers appeared to be producing Mercurochrome, while alternative topical antiseptics are already available.

The DCC recommended obtaining the DGHS's opinion along with available data on the manufacture and use of Mercurochrome in India before taking a final decision on its manufacturing, import and export.

Officials said the matter would primarily be examined from the perspective of patient safety and clinical need.

Under Schedule K, Mercurochrome is covered only for sale or distribution in containers of up to 100 ml.

The issue also comes against the backdrop of the 2013 Minamata Convention on Mercury, under which the manufacture, import and export of several mercury-added consumer products are being phased out or prohibited to reduce toxic exposure and environmental contamination.