WHO wants all substandard medicines removed from market

The World Health Organisation on Monday asked drug regulators to "detect and remove" all sub-standard medicines from the market in the wake of the UN body issuing three medical alerts in the last four months, two of which involve cough and cold syrups made in India.

Without naming any country, the WHO called on regulators and governments to detect and remove any substandard medical products that have been identified by the WHO as potential causes of death and disease.

The two India-linked alerts were linked to the deaths of children in The Gambia and Uzbekistan reportedly following the consumption of syrups made by two companies in Haryana (Maiden Pharmaceutical) and Uttar Pradesh (Marion Biotech) respectively.

The third alert was issued after deaths were reported in Indonesia from medicines by another manufacturer.

Over the past four months, countries have reported on several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG)," the WHO said.

The cases are from at least seven countries, associated with more than 300 fatalities in three of these countries.

Most are young children under the age of five.

"These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even taken in small amounts, and should never be found in medicines," it said.

The WHO asked regulators like India's CDSCO to ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized suppliers.

The regulators have also been asked to assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards.

The manufacturers have been asked to purchase only pharmaceutical-grade excipients and that too from qualified and bona fide suppliers.

They are to conduct comprehensive testing upon receipt of supplies and before use besides providing assurance of product quality including certificates of analyses based on appropriate testing results.

The medicine manufacturers are to keep accurate, complete and proper records of the purchase of materials, testing, manufacture, and distribution to facilitate traceability during investigations in case of incidents.

This is an area where both Indian companies were found wanting as an investigation by government inspectors could not find several important documents and logs in the factory of Maiden and Marion.

Releasing an urgent call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products, the WHO said that suppliers and distributors of medical products should always check for signs of falsification and the physical condition of medicines and other health products they sell.