Use of cheaper raw material in cough syrups can be fatal: Expert

Ambika Sharma

Solan, October 8

The use of commercial grade excipients like propylene glycol (PG) instead of those meant for Indian Pharmacopoeia (IP) by pharmaceutical manufacturers for cough syrups is the reason for the presence of contaminants like diethylene glycol (DG).

This severely compromises the quality and can also prove fatal as DG is known to cause adverse reactions like renal failure. PG is a solvent used to prepare a cough syrup.

Investigations in the case of Coldbest-PC syrup, which had claimed the lives of 12 infants in Udhampur in February 2020, had pointed to this laxity. PG was found to have been purchased from an unauthorised vendor where quality had been compromised.

Rajesh Gupta, who heads the All-India Pharma Committee of Laghu Udyog Bharti, said, “To cut costs, it has been observed that manufacturers at times opt for cheaper commercial brand excipients which fail to be tested in-house and proves fatal. It maligns the image of pharmaceutical industry.”

Excipients are substances which do not have any therapeutic value in a drug but are inert substances as diluents.

He advocated the need for the suspension of licence of manufacturers for longer period extending up to a year if drug samples are declared not of standard quality repeatedly and manufacturers should utilise that period to rectify their short-comings.

Gupta said manufacturers should act responsibly and desist from shoddy cost-cutting methods as such instances shake a customer’s faith and also tarnish the pharma industry’s image internationally.

In a bid to maintain quality, he added that, “Manufacturers should focus on the select molecules to maintain quality. Problems arise when a unit focuses on various items like liquids, tablets, capsules, injections, ointment, etc, in one plant without having the requisite human resource. This can compromise the drug quality as various quality control and quality assurance parameters like pre-testing, final testing, etc, fail to be adhered to.”

Gupta added that, “After two drug firms having food licence were found manufacturing spurious drugs in Baddi recently, the association has directed the packaging association to bill only the licensed pharmaceutical companies.”

Manufacturers should act responsibly

Manufacturers should act responsibly and desist from shoddy cost-cutting methods as such instances shake a customer’s faith and also tarnish the pharma industry’s image. — Rajesh Gupta, chief, All-India Pharma Committee