According to the monthly CDSCO alert for December, the cough syrup samples pertain to five different batches manufactured in August 2021 (Representative Image)
The Central Drugs Standards Control Organisation (CDSCO) has flagged five cough syrup samples manufactured by Maiden Pharmaceuticals at its Baddi plant in Himachal Pradesh after being found as ‘not of standard quality’.
These Cough Syrup for throat and chest coughs, are not the ones that had recently landed the company in trouble, after Gambia linked the death of 66 children there to company’s syrups. The cough syrups linked to the Gambia incident were manufactured at the company’s Sonipat plant in Haryana.
The founders of Maiden Pharma confirmed that they had another manufacturing unit in Baddi, Himachal Pradesh.
In the latest incident, the samples were drawn from that unit by the Drugs Control Department and tested at the Central Drugs Laboratory (CDL), Kolkata. They were declared as not of standard quality on account of lack of assay of Diphenhydramine Hydrochloride, Codeine Phosphate, Sodium Citrate and Menthol.
According to the monthly CDSCO alert for December, the cough syrup samples pertain to five different batches — LOCG21-85, LOCG21-94, LOCG21-95, LOCG21-84 and LOCG21-96 — manufactured in August 2021.
“We have a plant in Baddi, Himachal Pradesh, but the four cough syrups mentioned by the WHO last year in the medical alert were manufactured only in the Sonipat unit in Haryana,” Vivek Goyal, director of Maiden Pharmaceuticals, told Moneycontrol.
Goyal didn’t comment on the reasons behind the repeated flaws being identified by regulators in the drugs manufactured by them.
CDSCO officials drew 1,375 drug samples across the country, with 70 being declared as ‘not of standard quality’, while 1,305 were declared as being ‘standard quality’.
Clean chit after Gambia deaths
Last month, Maiden Pharma had received a clean chit from the government on the charge of supplying contaminated cough syrups that allegedly caused the deaths of 66 children in Gambia.
Bhagwant Khuba, Minister of State (MoS) for Chemicals and Fertilisers, in a written reply in the Rajya Sabha, said the samples of the four syrups were analysed by the Regional Drug Testing Laboratory in Chandigarh.
“As per the report of the government analyst, the samples have been declared to be of standard quality. The said samples were also found negative for both diethylene glycol and ethylene glycol,” Khuba said.
The cough syrups Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, had recently landed the company in trouble, after Gambia linked the death of 66 children there to the syrups.
The WHO flagged these four cough syrups for having a high presence of diethylene glycol (DEG) and ethylene glycol (EG).
In October, Maiden Pharmaceuticals was asked to halt all manufacturing at its Sonipat plant after the Haryana drug authorities and CDSCO officials found several flaws at the facility during a joint inspection.
A show-cause notice issued to the company reviewed by Moneycontrol had highlighted several discrepancies linked to manufacturing and product permissions for the four paediatric cough syrups.
The Union Government had set up a committee chaired by YK Gupta, vice chairperson of the standing national committee on medicines, and comprising Pragya D Yadav from the National Institute of Virology, Arti Bahl from the division of epidemiology at the National Centre for Disease Control, and AK Pradhan, joint drugs controller of India, Central Drugs Standard Control Organisation (CDSCO), to examine the issue.
