Haryana regulator halts production at Maiden Pharmaceutical
October 13, 2022:
The Haryana government on Wednesday ordered Maiden Pharmaceuticals to stop production at the Sonipat plant after the central and state regulators detected irregularities and violations of good manufacturing processes at the plant.
Contaminated cough syrups made at the plant have been linked to the death of 66 infants in the Gambia. The World Health Organization (WHO) issued a global alert about the children in the Gambia developing kidney problems after consuming Maiden’s cough syrups.
The government has sent samples of Maiden’s drugs to the Central Drug Lab in Kolkata for further analysis. According to Haryana’s health minister, Anil Vij, authorities found 12 violations by the company so the state government decided to stop production. The government has issued a notice to the company and further action would be taken after receiving reports from the Kolkata lab, the minister said.
India’s drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has also launched its investigations. CDSCO has taken samples from the same batch manufactured by Maiden Pharmaceuticals and sent them for testing to the Regional Drug Testing Lab, Chandigarh.
The WHO had said that the laboratory analysis of samples confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. Apart from the Gambia, these medicines could have been distributed, through informal markets, to other countries or regions, WHO said.
Among the violations committed by Maiden Pharma were the absence of the log book of equipment and instruments used to manufacture and test the drugs, batch numbers of chemicals used in the manufacture of cough syrups, discrepancies in the date of manufacturing and product permissions. The Sonipat plant was under renovation which could tamper with evidence, missing manufacturing and expiry dates and no analytical validation carried out by the company for the four cough syrups. The WHO identified Maiden Pharma’s Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup as contaminated paediatric medicines. Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal, the WHO said. Toxic effects include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. “All batches of these products should be considered unsafe until they can be analysed by the relevant National Regulatory Authorities,” WHO said. Financial Express