Under the scanner, yet generic cough syrups hit shelves

Tamil Nadu-based Sresan Pharmaceuticals' cough syrup brand Coldrif that allegedly caused the deaths of more than 20 children in Madhya Pradesh is among thousands of generic cough syrup brands currently available in the domestic market, thriving below the regulatory radar.

In less than a fortnight, cough syrups from at least three companies Sresan, Rednex and Shape Pharma have been found to contain diethylene glycol, an industrial solvent known to be poisonous and prohibited for use in producing medicines. However, this could just be the tip of the iceberg.

Difficult to Capture Data

PharmaTrac, a leading prescription audit firm, has coverage on sales of about 1,150 cough syrup brands in India, but sector experts believe the market is extremely fragmented and the actual count could be twice as much. Cough and cold syrups, popular fever drugs, or pain and inflammation medicines are among the most aggressively marketed to doctors by small and regional pharma companies.

"Incentives by smaller and regional companies sway the decisions of the doctors (to prescribe) more than the reputation of brands," said a senior area manager in a Mumbai-based pharma company. "In addition, in small towns, less than 100 kms from Mumbai, a shop chemist can recommend a brand of a drug to the customer."

Retail-level data and trends for such small companies is not captured by audit firms like PharmaTrac as they are either insignificant in size or operate in regions beyond these firms' coverage area. Sresan's Coldrif does not figure in the sales audits of PharmaTrac.

Though data for small pharma units is unavailable, sales of cough and cold syrups in India have risen 30% to ₹3,423 crore from ₹2,627 crore over the last five years outpacing the average pharma industry growth rate of 8-10%, showed data from PharmaTrac.

While unethical trade practices are a major factor, sales of cough and cold syrups are also being fuelled by rapid urbanisation, air pollution, and frequent weather changes triggering dust allergies and respiratory distress across age groups though it is more pronounced in children. Besides, irrational fixed dose combinations are being pumped into the market by small companies despite a sweeping crackdown a few years ago, and a ban on hundreds of cough syrup brands.

Regional Disparity

Inefficient oversight of state Food and Drug Administrators (FDAs) have helped unscrupulous companies to swamp the market with irrational combinations. In 2023, out of 14 irrational drugs banned for sale by the central drug administration, 13 were combinations for the treatment of cough, cold, asthma, and respiratory infections. These included amoxycillin + bromhexine + dextromethorphan, chlorpheniramine maleate + codeine and dextromethorphan + chlorpheniramine + guaifenesin + ammonium chloride.

Leading drugmakers are capitalising on the growth potential. Pfizer's Corex DX is at the top of the heap with sales of ₹266 crore (moving annual total September 2025), followed by AsthaKind DX from Mankind Pharma at ₹129 crore. However, the competition intensifies from the third slot with Maxtra of Emcure Pharma garnering ₹128 crore and Abbott's Tossex at ₹114 crore. Interestingly, as per PharmaTrac data, at least 600 cough syrup brands have not registered any sales during the year.

The sales of cough syrup brands also highlighted regional disparity. PharmaTrac data showed Bihar and Jharkhand are the biggest cough syrup consuming states with sales of ₹315 crore.