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 view of the Directorate General of Health Services (DGHS) on continuing manufacturing and distribution relaxations for certain mercury-based topical antiseptics under Schedule K of the Drugs Rules.

 

In a meeting last month, the Drugs Consultative Committee (DCC) of the CDSCO discussed the position and continued inclusion under Schedule K of the topical antiseptic Mercurochrome (Merbromin), which contains mercury.

 

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

 

This helps make basic medical treatments easily available in remote, rural or underserved regions where formal pharmacies may be scarce.

 

 

Merbromin’s inclusion is, however, conditional and limited to its sale or distribution in containers not exceeding 100 millilitres.

 

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

 

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

 

They added that a final view on discontinuation of manufacture, 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.