CDSCO seeks DGHS view on exemptions for mercury-based topical antiseptics

The Drugs Consultative Committee has sought the DGHS opinion and data on Merbromin's manufacture and use before deciding on its continued inclusion under Schedule K

The Central Drugs Standard Control Organisation (CDSCO) has sought the Directorate General of Health Services’ (DGHS) view on keeping intact the manufacturing and distribution relaxations for mercury-based topical antiseptic Mercurochrome (Merbromin) under Schedule K of the Drugs Rules.

 

Schedule K outlines specific classes of drugs that are exempted from certain provisions pertaining to the manufacturing, sale, or distribution for essential and household medicines. 

 

This facilitates the easy availability of basic medical treatments in remote, rural or underserved regions where formal pharmacies may be scarce. 

 

According to the minutes of the meeting reviewed by Business Standard, the DCC was informed that only a limited number of manufacturers appeared to be manufacturing the product and that alternative topical antiseptics are already available.

 

“DCC has recommended that the opinion of the DGHS be obtained, along with the available data on the manufacturing and use of the product in the country,” officials in the know said.

 They added that a final view on discontinuation of manufacturing, import and export, and the consequential position under Schedule K may be taken after consideration of the said opinion. 

 

The body also observed that the matter will be examined primarily from the standpoint of patient safety and clinical need

 

Merbromin’s inclusion is limited to sale or distribution in containers not exceeding 100 ml.

 

However, under the framework of the 2013 Minamata Convention on mercury, the manufacturing, import and export of many mercury-added consumer products are to be phased out or prohibited to prevent toxic runoff and chronic exposure.