Rising Criticism in the U.S. About Quality of Drug Imports from India
Courtesy Creative Commons
June 24, 2023
Earlier this month, in an emergency move, the U.S. Food and Drug Administration (FDA) allowed imports of cisplatin, a chemotherapy injection, from Qilu Pharmaceutical in China.
The FDA has yet to approve Qilu’s drug but still permitted its sale in the U.S. This is because the U.S. faces a shortage of cisplatin, which is used to treat testicular, lung, bladder, cervical and ovarian cancers. The shortage is due to suspension of imports of the drug from a factory in Gujarat, India, run by Intas Pharmaceuticals.
The cisplatin shortage “is a major crisis situation” across the U.S., Vamsi Velcheti, head of the thoracic oncology program at NYU Langone’s Perlmutter Cancer Center in New York told the Wall Street Journal. Some patients have received lower doses, waited longer between treatments or switched to other drugs with greater side effects, the report stated.
The Journal story this week carried the headline “Drug Shortages (in the United States) Stem from Quality Problems in Indian factories.”
Then, as of May 15, 2023, U.S. health officials identified 81 patients in 18 states, including California, New York, and New Jersey, with a rare strain of extensively drug-resistant infections, including eye infections leading in some cases to the loss of eyesight. These infections, caused by eye drops imported from India, have “never been reported in the United States prior to this outbreak,” the Center for Disease Control said in a statement.
Also, the CDC asked “clinicians and patients to stop using and discard EzriCare Artificial Tears and two additional products made by the same manufacturer (Global Pharma of Chennai, India) Delsam Pharma’s Artificial Tears, and Delsam Pharma’s Artificial Ointment.”
“Just How Dangerous Are India's Generic Drugs? Very,” was the title of a Bloomberg column, which discussed the infections, and which was published in The Washington Post and other media.
While some Indian generic pharmaceutical companies produce high-quality medicines, Bloomberg reports that “The latest drug recalls just add to a long line of scandals that have tainted the sector.”
In January, 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.
In October 2022, 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.”
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.
Lack of Regulatory Oversight
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 over-the-counter medicines that can be bought without a doctor’s prescription like cough syrups and vitamin supplements and other pills. Also, around 60% of the global supply of vaccines come from India.
Nearly a third of India’s drug exports by value 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 though need to be 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.
India relies on the weak oversight of developing countries that make up the bulk of its exports — that’s how it can continue to push substandard and often deadly medicines there, Bloomberg reported.
A law on drug recalls in India has been under discussion since 1976 without resolution. However, Bloomberg notes, that for a nation that seeks to claim the mantle of pharmacy to the world, India is “scandalously short on regulatory oversight.”
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