Gambia deaths: Experts question safety norms after WHO alarm
The WHO medical product alert on Wednesday evening was over four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – made by the Indian firm Maiden Pharmaceuticals.
Thedeaths of 66 children in West Africa’s Gambia, possibly due to contaminated cough syrups manufactured by an Indian pharmaceutical company, have raised fresh questions over drug safety procedures and norms, experts said on Friday.
“Usually in such a scenario, the standard blame game starts between the central and state drugs regulatory authorities. State licensing authorities may have been issuing licences to manufacturers locally but that does not mean the central regulator has no role to play. There are gaps in the process that need to be plugged,” said a senior public health expert, who asked not to be named.
The World Health Organization (WHO) medical product alert on Wednesday evening was over four medicines – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup – made by the Indian firm Maiden Pharmaceuticals.
After the UN body’s alert potentially linking the medicines with acute kidney injuries among children, the Union health ministry issued a statement that the central drugs regulator was investigating the matter in collaboration with the state regulator. It added that the state regulator -- the drugs are produced in the firm’s Sonepat, Haryana facility -- issued the licence to the firm for export of these drugs.
“The State Drug Controller had given licences to the said company only for export of these four drugs… All these four drugs manufactured only for exports by Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India,” the Union government said in a statement.
The government also clarified that the medicines were not given permission for sale in India.
The state drugs controller, Food and Drugs Administration (FDA), told HT that all operations of the company, including its export, will remain suspended until the report of the collected samples arrive.
“The government will take action only after the Central Drugs Laboratory report comes,” said Manmohan Taneja.
Some experts pointed out on Friday that the company’s track record has not been clean, and sought to know why no one paid attention to that.
In 2005, a drugs inspector from Kerala filed for prosecution against the company, for which in 2017 a first-class judicial magistrate’s court in the state fined it; it was one of the 39 companies blacklisted by Vietnam for violation of quality control and drug regulations; the Bihar government also black-listed it in 2011 for substandard drugs.
“The company was certified by the CDSCO through the Certificate of Pharmaceutical Product process to assure overseas buyers that the company is compliant with the requisite standards. With this kind of track record, on what basis was the certificate issued?” asked Dinesh Thakur, a senior public health activist working to ensure quality drug supply.
“We are trying to find out with the buyer (in Gambia) and all that what has happened exactly. We are not selling anything in India,” said Naresh Kumar Goyal of Maiden Pharmaceuticals to Reuters news agency.
Some experts questioned whether Indian regulatory authorities were equipped to regulate manufacturing, sale, or distribution.
“There are not enough drug inspectors in the country to conduct as many inspections as is ideally required in such as vast set-up, there are not an adequate number of laboratories to test the samples in time if all the samples that should be lifted for testing are picked up, among other logistical issues that create a problem; even though with our limited resources, our regulators are trying to do the best they can,” said Subhash Mandal, regulatory affairs expert, Indian Pharma Association.
It will be a few days before the results of the samples taken at the manufacturing unit come, and the Indian drugs regulator is also awaiting a further detailed analysis by WHO experts, including the exact one-to-one causal relation of death, to chart the further course of action.
“As a robust national regulatory authority, CDSCO has requested WHO to share at the earliest with it the report on establishment of causal relation to death with the medical products in question, etc,” said the government.
Experts say it could be too early to blame anyone as the investigation is on.
“Till such time the investigation is over, it will not be prudent to pin the blame on anyone. It has not been established yet who is responsible for the deaths of these children. It will make sense to wait for the investigation to be over,” said Mandal.