Dozens of children in Gambia lost their lives after reportedly consuming cough syrups imported from India. But the tragedy is only the latest issue faced by India's pharmaceutical companies.
The recent deaths of 66 children in Gambia put the spotlight on India's drug manufacturers following reports that the children's condition deteriorated after they were given Indian-made cough syrup. The syrup was manufactured by India's Maiden Pharmaceuticals and exported to the African country under four different brands. The World Health Organization (WHO) warned that the products were "contaminated" and triggered symptoms including "abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death."
Maiden Pharmaceuticals responded by saying it was "diligently following the protocols of the health authorities" in their production process, and was "shocked" and "deeply saddened" by the incident.
A special panel formed by India's government has yet to present its findings on the tragedy.
However, the scandal has already prompted painful questions about India's expansive pharmaceutical industry.
India's is the world's leading manufacturer of vaccines, and is also the largest producer of generic drugs — cheaper pharmaceutical products made to match brand-name drugs in quality and performance as well as safety.
Over 20% of global supply of generic drugs already comes from India.
With rising export share, credit ratings agency Care Ratings projects that India's pharma industry will continue to grow and be worth around $60.9 billion (€60.8 billion) by next year.
However, a massive pharmaceutical market also carries more risk of tainted and counterfeit medicine as many question the strength of India's regulators.
Scandals plague pharma market
The Gambia tragedy is not the first incident of its kind to be linked to Indian-made cough syrup.
Just two years ago, 17 children died in the Indian state of Jammu and Kashmir after consuming a syrup made by a company called Digital Vision.
Subsequent tests found that the product contained high levels of diethylene glycol. The same chemical, in addition to ethylene glycol, was detected in "unacceptable amounts" by the WHO following the Gambia deaths.
The poisonings in Jammu and Kashmir prompted the Indian government to phase out this cough syrup in favor of other products that do not have the risk of containing the two toxins.
A few years earlier, in 2016, two Indian pharmaceutical companies were charged for exporting counterfeit diabetes drugs.
India's Food and Drug Administration (FDA) investigated Pharmaceutical Products of India and Wanbury and found the firms had a manufacturing and export deal with which they were illegally rebranding and exporting the diabetic drug metformin hydrochloride to Bangladesh, Brazil, Mexico and Pakistan. The illegal activity had been going on for several years.
In 2013, a company called Ranbaxy Laboratories pleaded guilty to felony charges over the manufacture and distribution of adulterated drugs.
The company agreed to pay $500 million under a settlement agreement with the US Department of Justice to settle civil and criminal cases relating to sub-standard drugs and false data given to the US health authorities.
And as recently as last year, as India was swept by a new wave of coronavirus infections, fake vials of remdesivir, an antiviral drug used to treat COVID, were sold in bulk at astronomical prices and even exported.
"Drug regulation in India is governed by an antiquated Drugs and Cosmetics Act. This law and subsequent changes that have been made to this law are ill-equipped to regulate a complex market like India which is a union of states," Dinesh Thakur, a former pharma executive who works as a public health activist told DW.
"Furthermore, the bureaucracy that is responsible for its implementation and compliance is dysfunctional and incompetent at best and corrupt and callous at worst," he said.
Thousands of drugs failed safety tests
A report by United States Trade Representative (USTR) found that 20% of all pharmaceutical products sold on the Indian market are counterfeit.
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.
In 2018, the Central Drug Standard Control Organization identified about 4.5% of all generic drugs in the Indian market to be substandard.
Furthermore, just one-fourth of the 12,000 manufacturing units in India were found to fulfill with the WHO's good manufacturing practices, the obligatory quality regulations that drug makers must adhere to.
"Drug regulators in India are under-resourced," notes Nakul Pasricha, president and CEO of India's Pharma Secure, who works with leading pharmaceutical makers to track and verify their supply chains and ensure the authenticity of their drugs.
"We need to strengthen that arm of our system," he told DW. "If our exports are under any kind of shadow because of such high profile incidents, it is clearly not good for the reputation of India's pharmaceutical industry."
Pasricha also believes that manufacturers need to obtain best quality and anti-counterfeiting checks and ensure that "substandard medicines are not leaving their doors."
Danger 'must be zero'
Commenting on the recent string of scandals in India's pharmaceutical industry, Rajeev Jayadevan, former president of the Kochi chapter of the Indian Medical Association, says there is still "no clear and present danger for patients and doctors."
"But reputations can be affected if there are incidents such as Gambia," Jayadevan told DW. "There is no excuse for a spurious drug at all. It must be zero."
A top health ministry official government official told DW that all stages of the healthcare supply chain must be subjected to "a high degree of monitoring and assessment" in order to clamp down of counterfeit drug peddlers.
This sentiment is echoed by pharma-executive-turned-activist Thakur, who calls for "greater transparency and accountability built into the law."
"We need to fundamentally re-write the law and give it teeth to enforce compliance," said Thakur.