Pharma companies’ tendency to cut costs key factor behind substandard cough syrups

Contrary to the mandate of providing safe and quality medicines, the tendency of callous cough syrup manufacturers to cut costs by bypassing quality parameters has again proved fatal as seven children in Madhya Pradesh’s Chhindwara district. The kids died after the consumption of Coldrif syrup containing toxic industrial chemical diethylene glycol (DEG).

“DEG is known to cause acute kidney injury in children, which can prove fatal,” opined Dr Manish Kapoor, State Drugs Controller.

The spotlight has also shifted to Himachal Pradesh as the drug authorities initiated an investigation into five firms, which supply cough syrups to hospitals in Madhya Pradesh. While the drug authorities have put on hold the sale of two cough syrups — Nastro DS and Coldrif — consumer confidence has been visibly taken a beating after the emergence of these cases.

The contentious syrup was manufactured by Tamil Nadu-based Sresan Pharmaceuticals. Investigations conducted by the TN drug authorities reveal that the excipient propylene glycol (PG) used in manufacturing the said cough syrup was of non-pharmaceutical grade, instead of the pharmaceutical grade. Contrary to the provisions, it was not tested for the presence of impurities like diethylene glycol (DEG) and ethylene glycol (EG). Since the non-pharmaceutical grade PG is substantially cheaper, the firm, in a bid to save a few extra bucks, compromised with the quality and opted for the substandard excipient.

Pharma experts said the pharmaceutical grade PG was priced at Rs 140 per kg, while its non-pharmaceutical variant was much cheaper at Rs 95 per kg. A manufacturer using a non-pharma grade product would end up saving lakhs in each lot that is manufactured. Excipient is an inactive ingredient, used to dissolve active ingredients to manufacture cough syrups and does not have any medicinal value.

Exposing the chinks in the regulatory framework this practice has been going on unabated. “The seller of commercial grade excipient faces little action for selling the product to a pharmaceutical firm owing to which this practice has been continuing unchecked. It is time the Centre introduced penal provisions against such firms, akin to those manufacturing spurious drugs and tightens its noose or else toxic cough syrups will continue to claim more lives,” opined a pharma expert.

A slew of other critical laxities will also come to fore if cases of toxic cough syrups are examined. “As per the norms, a manufacturer is supposed to undertake pre-testing of the excipient to rule out the presence of contaminants and ensure quality drug manufacturing. For noting critical changes, a firm should evaluate the first batch of cough syrup for possible impact on the product quality. Once a batch is ready for release, the final product is again tested to rule out any adverse health impact. All these key parameters were, however, bypassed failing which toxic contaminants like DEG and EG failed to get detected in the cough syrup,” reveal the investigations of the TN drug authorities accessed by The Tribune.

Pharmaceutical firms, which lack in-house testing facilities, rely on private labs as setting up an in-house lab entails an additional expenditure of Rs 1.5 crore. “A private lab takes about a week to test a sample of an excipient and each test is charged. In a bid to save time and costs, it has been observed that some pharmaceutical firms rely on the test reports provided by excipient traders, which at times are not accurate. Bypassing these key testing mandates has proved dear in several cases where cough manufacturers end up producing toxic products which lead to severe health impact like renal failure,” said a pharmaceutical raw material manufacturer.

The presence of DEG in cough syrups has been a contentious issue. In 2020, as many as 12 infants died and six were disabled after consuming contaminated cough syrup manufactured by Kala Amb-based Digital Vision.

DEG and EG are toxic substances used as industrial solvents and antifreeze agents that can be fatal if taken even in small amount, especially for children. Despite several warnings by the Drug Controller General of India as well as the World Health Organisation over their contamination, drug manufacturers try to save costs while compromising patient safety.