Why There Are Concerns About the Quality of Some Indian Drug Exports
Photo: Wikimedia Commons
January 12, 2023
The manufacture of drugs is one of India’s major, rapidly growing businesses. The domestic market, around $45 billion in the fiscal year that ended in March 2022, is forecast to annually grow by more than 9% for the next several decades.
In addition, Indian companies exported drugs and pharmaceutical ingredients totaling $25 billion in fiscal year 2022. India is the largest global supplier of generic medicines, which are copies of branded drugs originally formulated by pharmaceutical companies and whose patents have expired. It is also a major supplier of medicines that can be bought without a doctor’s prescription like cough syrups and vitamin supplements and other pills. And around 60% of the global supply of vaccines come from India.
Nearly a third of India’s drug exports go to the U.S. More than 2,600 products, as well as around 550 sites where they are manufactured in India, are approved by the United States Food and Drug Administration (FDA). The drugs and sites are also regularly tested and inspected by the FDA for contamination, hygiene, and other safety issues.
South Africa, Nigeria, the Philippines, Kenya, Bangladesh, and other developing countries - including The Gambia and Uzbekistan - buy a sizeable share of their drugs from India, given that they are at least a third cheaper than those made in Western countries.
There are some 3,000 manufacturers in India who supply drugs to the domestic market, with some also operating as exporters. The manufacturers range from Indian operations of Pfizer, AstraZeneca, and other giant multinationals, major Indian companies like Cipla to small, local vendors of ayurvedic and other traditional Indian medicines. There is a wide range in quality control and safety measures among the manufacturers. This is reflected in the fact that only around 5% of the roughly 10,500 drug manufacturing sites in India are approved by the U.S. FDA.
This week, questions about the safety of drugs exported from India made headline news around the World. This followed a World Health Organization (WHO) global medical alert that two syrups exported from India “contained unacceptable amounts” of contaminants which “are toxic to humans when consumed and can prove fatal.” The products - AMBRONOL syrup and DOK-1 Max syrup - were allegedly linked to nineteen deaths in Uzbekistan, according to Reuters.
“Inconsistent drug regulation spells danger for India’s global pharma ambitions,” was the headline of an article in TheBMJ, formerly known as The British Medical Journal.
Laboratory tests showed that both the syrups, which reportedly caused the Uzbek tragedy, contained high levels of diethylene glycol and/or ethylene glycol, the WHO noted. Consumption of the syrups, especially by children, the statement added, “may result in serious injury or death. Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
The substandard syrups were made by Marion Biotech, based in Uttar Pradesh, India, according to WHO. The company denied the allegations and disagreed with WHO’s findings, according to media reports. The WHO statement noted that “To date, (Marion) has not provided guarantees to WHO on the safety and quality of these products.”
Test results of samples of the two syrups, taken by Indian health officials on December 29, are awaited, according to The Indian Express. This week, Indian officials reportedly asked Marion to suspend production and its production license was also suspended.
In October last year, WHO issued a similar medical alert about four cough syrups: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. They were manufactured by Maiden Pharmaceuticals in Haryana, India. The syrups were alleged to have caused the deaths of at least 70 children, from acute kidney injury, in The Gambia. A story about the deaths in The New York Times carried the headline: “Indian Drugs, Sold Worldwide, Sometimes Deadly.”
Maiden denied the allegations. Indian health officials said their tests showed the syrups were "complying with specifications" and had no contaminants. The WHO's October statement caused "irreparable damage" to the country's supply chain of pharmaceutical products, an Indian health official stated in a December 13,.2022, letter to WHO. The “presumptuous (WHO) statement was untrue and incorrect," an Indian official told the media, adding that the health body had "[jumped] the gun without valid scientific reasons".
A WHO official, told the BBC in an email, that “WHO stands by the action taken…contaminated syrups are dangerous and should not be in any medicine, ever." WHO reportedly based its findings on tests on the four syrups conducted by laboratories with whom it contracted in Ghana and Switzerland.
A week later, Tribune India reported that an investigation by a Gambian Parliamentary Committee found that all the cases of deaths from acute kidney injury were “linked to the consumption of contaminated medical products...manufactured by Maiden Pharmaceuticals.” The committee, BBC reported, "is convinced that Maiden Pharmaceuticals [is] culpable and should be held accountable for exporting the contaminated medicines.” It recommended the prosecution of Maiden.
Vietnam banned imports from Maiden after finding “quality violations” from 2011 to 2013, according to The Hindustan Times.
The deaths in Uzbekistan and The Gambia, are “an uncanny echo of a tragedy” between December 2019 and January 2020, when “11 children aged from 2 months to 6 years died of renal failure in the northern (Indian) city of Jammu after taking cough syrup that was contaminated with diethylene glycol,” TheBMJ noted.
TheBMJ has been published since 1840. A subsidiary of the British Medical Association, BMJ works with 8,000 medical organizations around the world pursuing a vision for “a healthier world by sharing knowledge and expertise to help health professionals improve healthcare outcomes.” BMJ’s Best Practice content, available in more than 100 languages, gets around 10 million views online a month.
“Three years on,” TheBMJ noted about the Jammu tragedy, “the pharmaceutical company responsible for manufacturing the syrup, Digital Vision, is yet to be penalised.”
(Story updated January 14, 2023)
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