Origin of solvent ‘traced’ to S Korea, Delhi trader raided, record seized

Bhartesh Singh Thakur

Chandigarh, October 13

The solvent, propylene glycol, used in cough syrups by Sonepat-based Maiden Pharmaceuticals was supplied by a Delhi trader, the probe has revealed. The syrups are suspected to have caused the death of 66 children in Gambia.

PGIMS stops using Maiden Pharma drug

Pt Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences has stopped using omeprazole 20 mg, manufactured by Maiden Pharmaceuticals, Sonepat, whose cough syrups are under lens in connection with Gambia casualties.

Its contamination can prove fatal: WHO

• Propylene glycol used in exported syrups by Maiden Pharma. Solvent was supplied by Goel Pharma Chem, Samaypur, Delhi
• Sources claim solvent came from S Korea; Goel Pharma says it bought it from Delhi. As per the World Health Organization, syrups exported to Gambia were contaminated.

Propylene glycol is used as a solvent in medicines. If contaminated with diethylene glycol and ethylene glycol, it can prove fatal for the patient.

Sources in Delhi’s Drugs Control Department said the supplier came under the scanner after raids at the Sonepat firm. A joint team of the Central Drugs Standard Control Organisation (CDSCO) and Food and Drug Administration (FDA), Haryana, found out that the batch number, manufacturer’s name and manufacturing and expiry dates were not mentioned on purchase invoices of propylene glycol.

On questioning the firm’s owners, the name of Goel Pharma Chem, Samaypur, Delhi, came to the fore. When officials raided the latter’s premises on Thursday, no raw material was found. Its record was seized.

While sources in the Haryana regulatory authority revealed the solvent came from a firm based in South Korea, Goel Pharma Chem claimed it bought it from another Delhi trader. The sources said the investigations were still underway and the authorities were scanning the records.

The Delhi firm claimed not all propylene glycol used by Maiden Pharmaceuticals was supplied by it. Though the report from the CDSCO’s laboratory hasn’t been revealed yet, the World Health Organization has shared the test results with India, reflecting adulteration of syrups with diethylene glycol and ethylene glycol. According to the World Health Organization , the adulteration can cause abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury, leading to death.

The sources said the inspection at the Sonepat unit revealed that two batches of propylene glycol had failed quality test. Maiden Pharmaceuticals had produced 10,000 bottles each of Promethazine Oral Solution and Kofexmalin Baby Cough Syrup, and 15,000 bottles each of Makoff Baby Cough Syrup and Magrip N Cold Syrup, which were supplied to Gambia.