Gambia children deaths: India finds serious disruptions, halts production

The Gambian government has informed that the death toll has risen to 70, as the world turns their eyes to the cough syrup deaths of children. The reason of the deaths, caught World Health Organisation (WHO)'s attention, which was connected to the four made-in-India cough syrups. After the WHO issued a medical product alert recently warning of "contaminated" products manufactured by Maiden Pharmaceuticals, the deaths made global headlines.

Subsequently the Indian government and the Haryana government imposed a ban on Maiden Pharmaceuticals, the cough syrup manufacturer’s production facilities in Haryana's Sonepat district, near the national capital.

India is concerned about the country's reputation as a "pharmacy of the world" could be ruined. Hence the nation rushes to investigate four locally made cough and cold syrups suspected in the deaths of the children in the West African nation.

Reported by Gambian police that the deaths of the children from acute kidney injury was interrelated to the cough syrups made in India and imported through Atlantic Pharmaceuticals, a Atlanta, USA, based company.

According to the police report, Atlantic Pharmaceuticals has ordered a combined total of 50,000 bottles of those syrups as it has permission to export medicines to Gambia.

According to India's health ministry, samples of all four Maiden products had been sent for testing to a federal laboratory. The results would "guide the further course of action and bring clarity on the inputs received/to be received from WHO."

India supplies 45 percent of all generic medicines to Africa. The deaths of children have come as a blow to the industry whose exports more than doubled in the last decade to hit $24.5bn last fiscal year.
Maiden’s website informs that there is 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 at its Haryana factories. Besides, it has two other factories in the state.

Based on the UN health agency’s updates, the laboratory analysis of four Maiden products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup had “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be contaminated and lead to acute kidney injury.

According to certain News website, Maiden did not perform quality testing of propylene glycol, diethylene glycol and ethylene glycol, as certain batches of propylene glycol did not have the manufacturing and expiry dates.

"We are all victims of the malpractice from manufacturers. As a country, we don't have all the resources and the personnel. We don't have a drug testing laboratory," said Dr. Ahmadou Lamin Samateh, Minister of Health, Gambia. “International partners will help the country tighten medicine monitoring systems and import regulations, noting that the government was taking action against manufacturers in India,” he added.

Around 40 percent of over-the-counter and generic medicines sold in the US and a quarter of all medicines dispensed in the UK come from India. The country supplies some two-thirds of anti-retroviral drugs globally to fight HIV. India has like 800 drug making plants outside the USA, compliant with the US health and safety requirements.

Many believe that India has always fought a flood of forged drugs, mostly sold in small towns and villages. But analysts say the physicians and patients are possibly combined sub-standard drugs with fake medicines. State-run drug testing labs in many states are under-funded, short-staffed and poorly equipped.

According to V G Somani, Drugs Controller General of India (DCGI), WHO, the committee set up by the government to examine reports has observed that the clinical information shared by the WHO till date is inadequate, hence recommend follow up action.

Following the WHO alert, the Haryana government had sent samples of the four cough syrups manufactured by the company to the Central Drugs Laboratory (CDL), Kolkata.

“The report is awaited and further action shall be taken accordingly. But, in the joint inspection conducted by the teams of the central and state drugs department, 12 flaws were found. We have decided hence, that the production at this pharmaceutical company should be stopped,” said Anil Vij Home Minister Haryana, India.

“A senior official of the Centre’s Department of Pharmaceuticals also spoke with Haryana’s Additional Chief Secretary (Health) in the matter. The cough syrups manufactured by the pharmaceutical company were approved for export. We shall be able to arrive at a conclusion once we get the report of CDL,” the minister said.

It is difficult to understand the scale of the problem - many of India's drug factories are indeed world-class. Physicians say they largely trust India-made drugs.