The national pharmaceutical regulatory body Central Drugs Standards Control Organisation (CDSCO) has flagged five cough syrup samples produced by Maiden Pharmaceuticals at its Baddi plant in Himachal Pradesh as "not of standard quality" or spurious". The development comes on the back of a major controversy involving its Haryana plant, which came under the scanner of the probe agencies in October 2022.
The latest syrup batches flagged by the government body are cough syrups for throat and chesty coughs, manufactured in August 2021 and they will expire in July 2024. The monthly CDSCO alert reports for December show the flagged cough syrups are from five batches — LOCG21-85, LOCG21-94, LOCG21-95, LOCG21-84 and LOCG21-96.
These have been manufactured at the company's Baddi, Himachal Pradesh, plant, and are not related to the cough syrups that faced intense government scrutiny after they were linked to the deaths of 66 children in the African nation of The Gambia.
The company runs a separate manufacturing unit in the Baddi district of Himachal Pradesh.
The reasons for failing the quality standard are mentioned as the assay of codeine phosphate & menthol; assay of codeine phosphate, sodium citrate and menthol; assay of diphenhydramine hydrochloride, codeine phosphate, sodium citrate and menthol; assay of diphenhydramine hydrochloride, codeine phosphate, sodium citrate and menthol; and an assay of diphenhydramine hydrochloride, codeine phosphate, sodium citrate and menthol.
The Gambia row
The pharma company Maiden Pharmaceuticals had come under scanner in October 2022 after the global health body World Health Organisation (WHO) issued a 'global alert' over the deaths of 66 children in The Gambia. The WHO even warned the four cough syrups made by the company's Haryana unit could be linked to children's deaths in the African nation.
However, in a letter to the WHO on December 13, India’s drug regulator DCGI stated the sample of all four products in question was sourced from Maiden Pharma's Haryana unit and sent for quality testing to a government laboratory. The results said the products were found to be "complying with all specifications". “DEG and EG were not found to be detected in these products,” it said.
As regards the use of propylene glycol, the DCGI said the sample of this expedient available at the manufacturing site at the time of inspection was also sampled and tested and found to be "complying with quality specifications". The DCGI letter suggests these medicines would not have been the primary cause of death.
However, a parliamentary panel of the National Assembly of Gambia last month reiterated its accusation that the consumption of contaminated medicines sourced from Maiden is linked to acute kidney injury related to the children's deaths in that country. The inquiry report of the Select Committee on Health, Disaster, Refugees and Humanitarian Relief, of Gambia’s Parliament, was released on December 20, 2022, days after the Drugs Controller General of India (DCGI) "ruled out contamination possibilities" in the four products Maiden Pharma supplied to Gambia.
Meanwhile, the health ministry of Uzbekistan on December 27, 2022, linked another Indian pharma company, Marion Biotech, Noida, to the death of 18 children in Uzbekistan. The Uzbekistan government said an internal inquiry conducted by its regulatory agencies found the deceased children, before admission to hospital treatment, took Dok-1 Max syrup manufactured by Marion Biotech for 2-7 days 3-4 times a day, 2.5-5 ml, which exceeds the standard dose of the drug for children. It also mentioned the preliminary laboratory studies conducted by them found the particular series of Dok-1 Max syrup contained ethylene glycol, a substance that is "toxic". The WHO has also issued an alert advisory on cough syrups, saying these should not be used for kids. The health ministry has also stopped all manufacturing activities of Marion Biotech until the probe is undergoing.
