Following the discovery of violation of at least a dozen rules on medicine-making including skipping a key test to check contaminants, drug regulators on Wednesday stopped all manufacturing activities at Maiden Pharmaceuticals whose four cough syrups are reportedly linked to the death of more than 60 kids in The Gambia.
“In view of the seriousness of the contraventions observed during the investigation and its potential risk to the quality, safety and efficacy of the drugs being produced, all the manufacturing activities of the firm are being stopped with immediate effect,” the CDSCO and Haryana Food and Drug Administration said in a joint statement.
According to the Haryana officials who inspected the plant, the company has not carried out the quality testing of propylene glycol for diethylene glycol and ethylene glycol – the two toxic chemicals that are suspected to be the reason behind the deaths, prompting the World Health Organization to issue a global alert.
Laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
While the four syrups have been reported only from The Gambia so far, the WHO said the medicines might have been distributed, through informal markets, to other countries or regions. There is no clarity yet on why a company would manufacture multiple products if the market is one tiny African nation.
“The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol,” the Haryana FDA said in its October 7th show-cause notice to the firm, which had been asked to respond by October 14.
Three officials from the state drug controller cum licensing authority inspected Maiden’s production units on October 1 and October 3 after the controversy broke out.
During the investigations it is observed that the firm has been manufacturing and testing drugs without adhering to and in contravention of the various GMP (Good Manufacturing Practice) requirements of the Drugs Rules.
“The company did not test the products for contaminants. This is their biggest fault. If you are not testing for toxic chemicals in your products, then you are gone,” said public health campaigner S Srinivasan from Low Cost Standard Therapeutics, a non-governmental outfit promoting affordable medicine and rational use of drugs.
Industry sources told DH that testing of the two contaminants were critical as they needed to be removed through a purification process.
Moreover, the firm failed to produce the log books of equipment and instruments needed for manufacturing and testing for the drugs in question. There is a mismatch between the manufacturing date and the date mentioned in the batch manufacturing record.