Drug regulator directs states and Union Territories to enforce raw material testing and vendor checks for pharmaceutical firms

Key facts

• The Central Drugs Standard Control Organisation (CDSCO) has asked all state and Union Territory drug control bodies to mandate testing of raw materials and finished formulations by manufacturers under their jurisdiction.
• In a notice dated October 27, Drugs Controller General of India (DCGI) Rajeev Raghuvanshi said licensees must test each batch or lot of raw materials in their own laboratories or in laboratories approved by the licensing authority, and maintain records of such tests.
• State and Union Territory regulators have been asked to ensure robust vendor qualification and sourcing of raw materials and excipients exclusively from reliable, approved vendors.
• Materials to be tested include critical excipients such as propylene glycol, glycerol and sorbitol, and manufacturers must also test each batch of the finished product.
• The directive comes after inspections found several licensed manufacturers were not testing each batch of excipients before using them, following deaths of at least 22 children linked to toxic cough syrups in Madhya Pradesh's Chhindwara.
• The Coldrif cough syrup linked to the Chhindwara deaths was found to contain the industrial chemical diethylene glycol (DEG) beyond permissible limits.
• Diethylene glycol is a cheap, colourless liquid used in brake fluids and paints that can be mistakenly or illegally used as a substitute for propylene glycol in syrups, and even small intake causes severe poisoning leading to kidney problems, especially in children.