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Gambia cough syrup deaths: Centre, Haryana team inspect Sonepat pharma firm, collect samples
WHO has issued a medical product alert over four cough syrups made by Haryana-based Maiden Pharmaceuticals, warning they could be linked to acute kidney injuries and deaths of 66 children in Gambia
Senior drug inspectors of the central and Haryana governments on Thursday inspected the Sonepat-based pharmaceutical company for the third time in the past six days and collected samples after the World Health Organisation (WHO) raised an alert, linking 66 children’s death in The Gambia to supply of four syrups made by Maiden Pharmaceuticals.
The Central Drugs Standard Control Organisation (CDSCO), a top drug regulatory authority of India, had launched an inquiry and alerted Haryana last week after learning about The Gambia tragedy, sources in the Haryana government said.
Thursday’s joint inspection of the pharmaceutical company comes after the central and state teams collected samples on October 1 and 3 and a day after the WHO officially issued a medical product alert over four cold and cough syrups and cautioned that they could be linked to acute kidney injuries and deaths of the 66 children.
According to Sonepat-based senior drug inspector Rakesh Dahiya, a few samples were collected in the past six days and sent to the Central Drugs Laboratory in Kolkata for examination.
Haryana health minister Anil Vij said all four cough syrups in question were manufactured for export only and not marketed in India. “It has been decided by the central and state governments that we should first get these cough syrup samples tested indigenously before arriving at a conclusion. Further action will be taken subsequently,” Vij said.
A state government official said the probe into the matter was started on October 1 after the Union government alerted the state health department. “The company in question is a small-scale unit and during the joint inspection and as per the standard operating procedure, all necessary samples and documents were collected,” said a Haryana government official, requesting anonymity.
The official said that documents, including the company’s reports of stability studies of the product and the vendors’ list, were being scrutinised. “The probe is at a preliminary stage,” he said.
According to Manmohan Taneja, state drug controller, all the operations of the company, including its products’ export, will remain suspended till the reports of the collected samples come. “It is a matter of investigation whether the deaths in the African nation were linked to the products made by Maiden Pharmaceuticals. The investigation is at a preliminary stage,” he added. “The government will take action only once the Central Drugs Laboratory (CDL) report comes,” Taneja said.
‘Plant under renovation’
HT team visited the Maiden Pharmaceuticals unit at Kundli in Sonepat district where security guards said the entry of outsiders was barred and that renovation work was underway. Also, pasted on the company’s main gates was ‘plant under renovation’.
On its website, the pharmaceuticals company says it has two manufacturing units in Kundli and Panipat.
A Haryana official, who wished not to be named, said the Kundli-based pharmaceutical company’s all four cough syrups were exported only to The Gambia and the company is not selling these syrups in India.
“The company is going under renovation and it has over 100 employees. One of the company’s four directors, Naresh Kumar Goyal told Reuters, “We are trying to find out with the buyer and all that what has happened exactly. We are not selling anything in India.”
The company has been making and supplying medical products for more than 30 years and has a presence across multiple countries in Africa, Asia, Eastern Europe, the Middle East and Russia, according to its website. The company’s date of incorporation is November 22, 1990.
It has an annual production capacity of 2.2 million syrup bottles, 600 million capsules, 18 million injections, 300,000 ointment tubes and 1.2 billion tablets.
Sources say the joint inspection team will again visit the pharmaceutical unit plant in Sonepat and collect more samples.
“The inspection was not completed on Thursday and will continue on Friday. We plan to collect more samples of each and every ingredient used in the manufacturing of the syrups in question. There are a number of items used as raw materials, apart from the active material. This process could not be completed today and it will continue on Friday,” an official privy to the developments said.
