The World Health Organisation on Monday released an urgent ‘call to action’ to countries to prevent, detect and respond to incidents of falsified medical reports. This comes after several incidents of deaths were reported following the consumption of certain cough syrups in Gambia, Indonesia and Uzbekistan.
Some of these cough syrups were made by India's Maiden Pharmaceuticals and Marion Biotech, and were linked with deaths in Gambia and Uzbekistan respectively.
It said that in the past four months, several countries reported incidents of suspected contamination of over-the-counter cough syrups for children with high levels of diethylene glycol (DEG) and ethylene glycol (EG). WHO said that these cases from at least seven countries were associated with the death of more than 300 people, most of whom were young children under the age of five.
The contaminants are toxic chemicals and should never be found in medicines, stated the organisation. These contaminants can be fatal even if taken in small amounts, it further added.
WHO’s medical product alerts that were issued following these reports urged for the detection and removal of these products from circulation, increased surveillance within supply chains, and immediate notification to WHO if these substandard products are discovered in-country.
The organisation has also asked regulators and governments to detect and remove these medical products from circulation, ensure that all medical products in respective markets are approved for sale by competent authorities, assign appropriate resources to increase risk-based inspections of manufacturing sites, increase market surveillance, and enact and enforce laws and legal measures to combat manufacturing, distribution and use of substandard and falsified medicines.
It also asked manufacturers to purchase pharmaceutical grade excipients from qualified and bona fide suppliers only, conduct comprehensive testing of supplies once received, provide assurance of product quality, keep accurate and complete record of purchase of materials, testing, manufacturing and distribution.
WHO further asked suppliers and distributors of medical products to check for signs of falsification and physical condition of medicines, distribute products authorised by competent authorities, keep accurate and complete records relating to the medicines and its distribution and sale, and engage competent personnel to handle medicines.
Also read: Uzbekistan cough syrup deaths: Marion Biotech halts manufacturing; drugs controller launches probe
Also read: Child deaths in Gambia linked to Maiden Pharma's cough syrups; CDSCO initiates probe