Cough syrup detahs: Why drug made in India are sparking safety concerns

In the winter of 2019, a number of children living in India's Jammu region began
falling sick with what many thought was a mysterious illness.
The children, suffering from cough and cold, had been prescribed a cough
syrup by local doctors. Instead of recovering, they fell seriously ill, vomiting,
running high fever and kidneys shutting down. By the time the mystery was
solved, 11 children, aged between two months and six years, had died.
Tests found that three samples of the cough syrup, made by an Indian drug
company called Digital Vision, contained diethylene glycol or DEG, an industrial
solvent used in the making of paints, ink, brake fluids. Kidney failure is common
after consuming this poisonous alcohol.
India production halted after Gambia child fatalities
Earlier this month, the World Health Organization (WHO) put out a global
warning over four India-made cough syrups thought to be linked to the deaths of
66 children in The Gambia. Lab analysis of the samples of a syrup made by a
32-year-old firm called Maiden Pharmaceuticals Limited confirmed the presence
of "unacceptable amounts" of diethylene glycol and another toxic alcohol called
ethylene glycol.
The tainted drugs and the tragic deaths again shone a spotlight on India's
$42bn - half of the revenues come from exports - drug manufacturing industry.
Some 3,000 firms operate 10,000 pharmaceutical factories making generics
(copies of branded medicines that usually sell for a fraction of their price), over-
the-counter medicines, vaccines and ingredients in what is one of the world's
largest drug-making countries. Although India imports 70% of the active
ingredient chemicals for its medicines from China, it is trying to make more of
them at home.
Prime Minister Narendra Modi has championed India as the "pharmacy of the
world". India's traditional expertise in making generics has helped make it a
formidable low-cost maker of drugs and become a global manufacturing base.
Some 40% 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. Outside
the USA, India has the most number of drug making plants - 800 - that are
compliant with the US health and safety requirements.
Yet such breathless growth - the industry has been running at a clip of over 9%
every year for nearly a decade - has been clouded by allegations of problems of
quality and weak regulation.
Gambia cough syrup scandal: Mothers demand justice
Many believe that India has always battled a flood of counterfeit drugs, mostly
sold in small towns and villages. But analysts say the physicians and patients
are possibly conflating sub-standard drugs with what they think are fake
medicines. State-run drug testing labs in many states are under-funded, short-
staffed and poorly equipped. Regulatory oversight and enforcement is
unsurprisingly spotty, analysts say. In 2014, India's top drug regulator famously
told a newspaper: "If I follow US standards I will have to shut almost all drug
facilities."
More than 70 people, mostly children, have died in five separate mass
poisoning incidents related to drugs spiked with DEG since 1972.
In 2013, after a seven-year long investigation, top Indian drug maker Ranbaxy
Laboratories was ordered to pay a record $500m fine in the US, the biggest
handed down to a generic drug maker for improper manufacturing, storing and
testing of drugs.
Official government records reveal that between 2007 and 2020, more than
7,500 drugs sampled in just three of India's 28 states and three union territories
had failed quality tests and had been declared drugs "not of standard quality" or
inferior, research by Dinesh Thakur, a former Indian drug executive-turned-
public health expert, found.
These drugs failed tests for not having enough of ingredient chemicals,
impaired ability to dissolve in the patients' blood or were found to be
contaminated.
Each failed sample typically represents a batch of the medicine, which in turn
could run into hundreds of thousands of tablets, capsules and injections. "The
total number of patients affected by such inferior drugs possibly runs into
hundreds of thousands, perhaps millions over the last decade," says Mr Thakur,
co-author of The Truth Pill, a piercing look at drug regulation in India.
Cough-syrup scandal: How did it end up in The Gambia?
Mr Thakur says he worries that many Indian firms are not following "good
manufacturing practices" or GMP, a drug industry term to refer to testing for
quality control. He believes that the DEG-related incidents had occurred at
home - and now abroad - because some firms "quite often fail to test either the
raw materials or the final formulation before shipping it to the market".
"Given the sheer quality of drugs detected as "not of standard quality" over the
last decade from the open market it is obvious that a large number of
manufacturing facilities are completely flouting quality and process control
procedures that form the core of 'good manufacturing practices'" says Mr
Thakur.
That's not all. Using right to information law, Mr Thakur found many of India's
state-owned drug testing labs lacked key equipment. Drug sampling practices,
he noted, date back to a colonial 1875 law where inspectors pick up a small
number of random samples from the market.
India has been debating a law to recall drugs that have been found to be inferior
from the market since nearly half a century. "All it has are guidelines, which
many state regulators seem to be unaware of. Have you ever heard of a drug
recalled in India?" says Mr Thakur.
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.
Dr Rahul Baxi, a Mumbai-based diabetologist, told me that only once in recent
years he became suspicious about a drug when glucose levels of a patient shot
up after he switched off from branded drug to a cheaper generic.
But he suspects that there could be counterfeit or inferior drugs being sold in
small towns and villages. "Many of my patients that come from far flung parts of
India buy six months of prescribed drugs from pharmacies in the city because
they say they don't trust drugs available in their areas," Dr Baxi said.
After the deaths of the children in The Gambia, India claimed that its federal
regulator was "robust" and sought more details from the WHO on the causality
of the deaths with the exported cough syrup.
Food and Drug Administration (FDA), which regulates medical products in the
US, posts inspection status of firms supplying drugs to the US and warning
letters. A spokesperson told me that its policies ensure that "companies -
regardless of where the are located - meet the FDA's strict standards for
producing medicines for US patients that are high quality, safe and effective".
A pharmaceutical industry leader, insisting on anonymity, told me that "although
some countries do have very rigid quality standards", India's drugs were
completely safe. "We are not defending the mishaps," he said, "but these are
aberrations". Mr Thakur says: "An aberration should only happen once. You
can't play with people's lives".