Contaminated cough syrups cast unprecedented shadow on Indian pharma
Toxic diethylene glycol (DEG) was substituted for safe solvents like propylene glycol for economic gain, with test results showing alarming concentrations, in one case 47% which is way beyond the acceptable limit (the global acceptable standard for DEG set by the WHO is 0.10%). This has amplified calls for the sector to urgently adopt the highest standards of good manufacturing practice (GMP), with a sharp focus on the final packaged product.
03 Nov 2025 | By Prabhat Prakash
The revised Schedule M demands that all printed packaging materials, such as labels, cartons, and package inserts, must be stored in secure, segregated areas to eliminate the risk of product mix-ups
The recent wave of tragic child deaths linked to contaminated cough syrups has cast an unprecedented shadow over India’s pharmaceutical sector, prompting an urgent re-evaluation of manufacturing ethics and regulatory stringency. Discussions among industry experts have confirmed that the core issue is deliberate product adulteration, not medication side effects.
The primary systemic response has been the push for universal compliance with the revised Schedule M regulations. This overhaul moves India’s GMP standards closer to global norms, creating a Pharmaceutical Quality System (PQS) that mandates control over every input, from raw material to finished goods. Crucially, the regulations now place immense emphasis on vendor qualification and quality risk management (QRM), ensuring that manufacturers can no longer rely solely on a supplier's certificate of analysis but must actively audit and test raw materials to prevent the fraudulent introduction of contaminants like DEG.
For the printing and packaging industry, the regulatory noose is tightening around the final presentation and information delivery. The revised Schedule M demands that all printed packaging materials, such as labels, cartons, and package inserts, must be stored in secure, segregated areas to eliminate the risk of product mix-ups. Furthermore, manufacturers are responsible for ensuring that all packaging materials are chemically non-reactive and non-leachable, meaning the container itself must not contaminate or compromise the medicine within, a crucial step for drug stability and patient safety.
Beyond integrity, labelling accuracy is now a public safety imperative. Following the recent crises, the government has moved to restrict the use of the fixed-dose combination (FDC) of chlorpheniramine maleate and phenylephrine in children under four years of age. This regulatory restriction (effective April 2025) requires manufacturers to prominently display a clear warning on the label and package insert, making the printed communication a mandatory legal gatekeeper for prescription safety.
The industry is being pushed to invest in digital and validated inventory systems to maintain complete traceability of packaging components, ensuring that the correct batch information and warnings are meticulously applied to every single unit. Ultimately, the quality of a medicine, its integrity in the supply chain, and its safety instructions are now all inextricably linked to the performance and compliance of the packaging sector.