Five samples of cough syrup manufactured by Baddi-based Maiden pharma declared substandard

Tribune News Service

Ambika Sharma

Solan, January 17

Five samples of CSP cough syrup manufactured by the Baddi-based Maiden Pharmaceuticals have been found to be substandard in the monthly alert issued by the national level regulator, Central Drugs Standard Control Organisation (CDSCO) on Tuesday.

This has put a question mark on the quality of drugs manufactured in the said unit though it is closed since February 2022.

The five cough syrup samples pertain to five different batches- LOCG21-85, LOCG21-94, LOCG21-95, LOCG21-84 and LOCG21-96- manufactured in August 2021. These samples were drawn by the officials of the Drug Control Department, at Baddi and tested at the Central Drugs Laboratory (CDL), Kolkata.

Deputy Drugs Controller, Baddi, Manish Kapoor said five samples of cough syrups found at Maiden Pharmaceuticals had been drawn after the World Health Organisation (WHO) alert issued in October last year.

They were sent for lab analysis at CDL Kolkata with special instructions to check for the presence of propylene glycol (PG).

“The lab reports have confirmed that PG was not found in the five samples of cough syrups. This has come as a relief to the officials though the cough samples have been declared substandard on account of lack of assay of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate and Menthol. These were, however, not life-threatening causes though it would affect the efficacy,” added Kapoor.

As per the alert issue by the World Health Organisation (WHO) on October 5, cough syrups made by Maiden Pharmaceuticals Limited’s sister concern at Sonepat were found containing a toxic substance diethylene glycol and ethylene glycol. The duo has been found as a contaminant in products where propylene glycol (PG ) is used in manufacturing. The four products which have come under the scanner were Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

None of the four products mentioned by the WHO alert are manufactured by the said unit at Manpura village in Baddi industrial area. The officials had drawn samples as a precaution following the WHO alert.

The said unit was under renovation since February 2022 and had halted its manufacturing operations as per the written information furnished by the unit management to the officials, confirmed Manish Kapoor, Deputy Drugs Controller-cum licensing authority, for the said unit.

“The drug inspector concerned has been directed to issue a show-cause notice to the firm and withdraw the cough syrups of the batches concerned from the markets while investigating further,” added Kapoor.

As many as 1,375 drug samples were drawn across the country by the CDSCO with 70 being declared not of standard quality while 1,305 were declared of standard quality. As many as 27 pertain to those manufactured in the drug firms of Baddi, Paonta Sahib and Kala Amb.

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