Cough Syrups in Limelight Time to Revisit the Basics of Safe Formulation
The recent tragic reports of child deaths linked to contaminated paediatric cough syrups have raised serious concerns about the manufacturing quality and solvent usage in certain formulations. This unfortunate episode underscores that in pharmaceuticals, safety is not just about active ingredients but also about every excipient and solvent used.

A typical cough syrup contains:
1)Active Pharmaceutical Ingredients (API) like Dextromethorphan, Chlorpheniramine, Guaifenesin, or Ambroxol.
2)Solvents like primarily Purified Water, Glycerin, and Sorbitol Solution (70%).
Co-solvents occasionally Propylene Glycol or Ethanol (up to prescribed limits) to aid solubility.
3)Sweeteners like Sucrose, Sorbitol, or Sodium Saccharin.
4)Flavours and Colours like only those listed under Schedule Q of the Drugs and Cosmetics Rules, 1945.
5)Preservatives like Sodium Benzoate or Methyl Paraben within approved limits.

All excipients must conform to IP (Indian Pharmacopoeia) or USP standards, ensuring pharmaceutical-grade purity.

Industrial-grade solvents such as Diethylene Glycol (DEG) or Ethylene Glycol (EG) should not be used because these are strictly prohibited as they are toxic and nephrotoxic, leading to acute kidney injury and death, especially in children.Non-pharma grade glycerin or propylene glycol may contain impurities or heavy metals.Non-approved colours, flavours, or preservatives should not be used .Plus Excess ethanol, particularly in paediatric formulations .

Permissible Limits (As per IP & WHO Guidelines):
1)Ethanol: ≤ 5% v/v for paediatric syrups; ≤ 10% v/v for adults.
2)Propylene Glycol: ≤ 0.1 g/kg/day (cumulative limit).
3)Sodium Benzoate: ≤ 0.1% w/v.
4)Methyl/Propyl Paraben: ≤ 0.2% w/v (individually or in combination).

Every batch must undergo stringent quality control for the following elements .
-Identity & purity of solvents
-Heavy metal limits
-Microbial load
-pH and viscosity consistency

The tragedy reminds the industry that pharmaceutical manufacturing is not about low cost, but high conscience.
Each excipient, solvent, and preservative must be pharma grade, validated, and traceable to a certified supplier.

“A safe medicine is not just well formulated it’s also well-sourced, well-tested, and well-governed.”

Regards,
JAKSTAR PHARMA