Cough syrup producers ordered to ensure 100% testing of high-risk raw materials

In a bid to ensure patient safety, the state’s Health and Family Welfare Department has directed the manufacturers to ensure 100 per cent testing of high-risk components used in manufacturing cough syrups besides testing all batches before their commercial release.

The step has been taken after recent death of children in Madhya Pradesh occurred due to consumption of adulterated cough syrups.

The move will help in tracing toxic impurities like diethylene glycol (DEG) and ethylene glycol (EG) used in manufacturing cough syrups at an initial stage.

The Drugs Control Administration has identified various high-risk drug components like DEG, EG, sorbitol, maltitol solution, hydrogenated starch, hydrolysate where DEG and EG are present as impurities.

Drug formulations like cough syrups face high risk of adulteration if these high-risk components are not tested in the initial stage of the manufacturing process.

State Drugs Controller Dr Manish Kapoor, in his orders issued on October 9, directed the manufacturers to ensure 100 per cent sampling of all containers of excipients which are used to manufacture drug formulations like cough syrups and also all batches of drug formulations before releasing them in the market.

It is known that manufacturers, who do not have in-house quality testing laboratories, depend on private labs for testing. At times, they merely rely upon test reports of the components provided by the excipient traders and do not undertake any testing, exposing the consumers to high risk. In a bid to save time, they do not test all batches of raw material or the cough syrups before their release into the market thus compromising with patient safety.

In a bid to ensure safety of drug formulations, the DCA has defined the permissible limit of these components. “The percentage of diethylene glycol (DEG) of ethylene glycol (EG) in the excipients as well as the final drug formulation is supposed to be less than 0.1 per cent as defined in their monographs. The manufacturers have been directed to adhere to these directions in letter and spirit,” informed Dr Kapoor.

The manufacturers have also been directed to purchase the components directly from the manufacturers or the authorised vendors to rule out the probability of contamination or mixing if multiple levels are involved in the vendor chain.

It was, however, observed that in a bid to save an extra buck some manufacturers at times purchase industrial grade excipients which are cheaper than the pharmaceutical grade and end up manufacturing toxic cough syrups. Failure to test these components then adds to the peril.

“The pharmaceutical grade PG is available at Rs 140 per kg as against the industrial grade which is sold at Rs 95 per kg,” said a pharmaceutical expert. “A manufacturer will end up saving lakhs for each lot he manufactures using the industrial grade component,” said a pharma expert.