CDSCO asks states, UTs to mandate raw material tests for drugmakers

India’s apex drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has asked all state and Union Territory (UT) 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 it is a statutory requirement for licensees to test each batch or lot of raw materials, either in their own laboratories or in laboratories approved by the licensing authority.

“Further, the licensee is also required to maintain records or registers showing the particulars in respect of such tests as specified in schedule,” the notice stated.

State and UT drug regulators have also been asked to ensure robust vendor qualification and sourcing of raw materials and excipients exclusively from reliable, approved vendors to safeguard the quality, safety and efficacy of drug formulations.

The materials to be tested include critical excipients such as propylene glycol, glycerol and sorbitol used in drug manufacturing. Manufacturers have also been asked to test each batch of the finished product.

The move comes a year after the CDSCO asked states to ensure testing before manufacturing and release of batches into the market, following the deaths of at least 22 children linked to toxic cough syrups in Madhya Pradesh’s Chhindwara.

The apex drug regulatory body had subsequently conducted inspections at manufacturing facilities.

The inspections found that several licensed drug manufacturers were not testing each batch of excipients to verify compliance with prescribed standards before using them to manufacture formulations and finished products.

Coldrif, the cough syrup in question during the Chhindwara deaths, was found to contain the industrial chemical diethylene glycol (DEG), commonly used in making products like brake fluids and paints, beyond permissible limits.

DEG is most commonly used in making products like brake fluids and paints. It is a cheap and colourless liquid that can sometimes be mistakenly or illegally used in medicines as a substitute for propylene glycol (a solvent that helps dissolve drugs into liquid form) in syrups.

While propylene glycol is safe in regulated amounts, even a small intake of DEG is known to cause severe poisoning, which can lead to kidney problems, especially in children.