India shuts pharma firms after tainted cough syrup deaths. Is it enough?

India has launched a crackdown against pharmaceutical companies, with health ministry officials inspecting more than a hundred factories, following the deaths of dozens of children linked to made-in-India cough syrups.

At least four pharmaceutical companies, which had sold products in Cameroon, The Gambia and Uzbekistan, have been asked to shut down their operations in recent days.

In the latest case, authorities found violations related to manufacturing and laboratory practices at drugmaker Riemann Labs, whose cough syrup is suspected to be behind the deaths of a dozen children in Cameroon. The firm was asked to stop manufacturing on Wednesday.

India is one of the world’s largest drug manufacturers, providing generics and cheaper medicines to millions of people in developing countries. This year, its pharmaceutical exports are projected to grow to approximately $27 billion.

“This is not enough. I think the Indian government needs to do more,” says Dr Peter Adebayo Adewuyi, resident advisor to The Gambia’s Field Epidemiology Training Programme, who has closely followed the cough syrup-related controversy.

“It’s important to have a system in place to verify every batch of medicines being exported and to check the quality of raw materials they use to make those medicines,” he told TRT World.

Indian firms import raw materials from China, whose sellers have been found to mislabel chemicals. Without proper controls, tainted chemicals can easily get into medicines, making them potentially hazardous, Adewuyi says.

Almost all the deaths in Cameroon, The Gambia and Uzbekistan have been traced back to the presence of unacceptable amounts of diethylene glycol (DEG) and ethylene glycol (EG) in cough syrups, according to the World Health Organisation (WHO).

For almost a century, DEG – a viscous, sweet chemical – has been known to cause mass poisonings when mixed with medicines. In most cases, like what happened in The Gambia, people taking a high dose of DEG suffer kidney failure and die within a few days.

Yet, from time to time, the poisonous chemical has found its way into medicines in countries ranging from Bangladesh to Haiti and ended up killing scores of unsuspecting patients.

DEG is generally used in industrial products such as brake fluids, resins, inks, cosmetics, and as an antifreeze agent. To save money, some drug companies — mistakenly or by design — mix DEG as a diluent in liquid medicines in place of costlier medicinal glycerine or polyethylene glycol (PEG). It is an easy way for criminals to make money by obtaining DEG and mislabelling and selling it as PEG or glycerine.

After the deaths were reported last year, The Gambian authorities found that the level of DEG present in the syrups was around 19 percent, when it should not have been above 0.1 per cent.

The Gambian government says it is also exploring options of taking legal action against the Indian manufacturers of the unsafe drugs in order to extract compensation for their victims. The New Delhi-based Maiden Pharmaceuticals was the main supplier of the tainted cough syrups sold in the Gambia.

A reactionary cough

Indian cough syrups have been linked to the death of at least 95 children overseas.

Recent risk-based inspections of 162 Indian factories and 14 public laboratories revealed issues including poor documentation and quality control system, said the Indian health ministry on Wednesday.

It also flagged an absence of raw materials testing, a lack of measures to avoid cross-contamination, an absence of professionally qualified employees, and faulty design of manufacturing and testing facilities.

India has tightened its testing of cough syrup exports since June, making it mandatory for companies to obtain a certificate of analysis from a government laboratory before exporting products.