New Delhi: For Indian drugmakers rattled by the possibility of the Trump administration imposing a 25 percent tariff on pharmaceutical imports, a study published in a peer-reviewed journal has come as a double whammy.
According to the study, the number of severe adverse events linked to generic drugs made in India was 54 percent higher than for those made locally in the US. Titled Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events, the study by researchers associated with The Ohio State University was published in Production and Operations Management this month.
For the analysis, researchers matched 2,443 drugs made in the US and in emerging economies. While they included other countries, emphasis was laid on data for generic drugs made in India since India accounts for 93 percent of generic drugs imported by the US from emerging economies.
Researchers compared the frequency with which generic drugs made in India, and the same made in the US, were associated with adverse event reports. Adverse event reports they relied on are available in the FDA Adverse Event Reporting System (FAERS) database.
“Using exact matching analyses based on the equivalency criteria established by the US Food and Drug Administration (FDA), we find that generic drugs manufactured in India, where a majority of emerging economy generic drugs are made, are associated with significantly higher instances of serious adverse events than equivalent generic drugs made in the US, where a majority of advanced economy generic drugs are made,” researchers said.
Also Read: Drug regulator tightens sampling norms to test quality of medicines & cosmetics reaching market
US: key market for Indian pharma
For a number of Indian pharma companies, including some of the bigger players, more than 40 percent of their business comes from the US, making it the most important market for them, even ahead of India.
Overall, Indian companies supply 47 percent of total generic medicine sold in the US.
In FY 2023-24, drugs worth an estimated $8.7 billion—over 31 percent of India’s total pharma exports—went to the US, according to a report by the market research firm IQVIA.
In 2022, supplies by Indian drugmakers accounted for more than half of all generic medicine prescriptions in the US, which IQVIA estimated saved the US healthcare system $408 billion that year.
At 603, India had the largest number of FDA-approved pharma units outside of the US as of 2023.
Contacted for comment on the findings in the study, Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance (IPA), a network of 23 Indian drugmakers most of whom are major exporters to the US, told ThePrint that, while he has not seen the study, there has been “remarkable improvement in quality parameters of the drugs supplied to the US”.
Serious questions
Over the past few years, a number of Indian pharma firms were linked with serious adverse reactions, including deaths, following supply of adulterated drugs and cough syrups to Gambia and Uzbekistan, among others.
Not just smaller companies, accused of taking advantage of India’s lax regulatory norms to manufacture substandard drugs for developing and underdeveloped countries in Africa and Asia with poor regulatory oversight, those who export crucial generics to developed nations such as the US have also come under the scanner on more occasions than one.
The study also noted that drug manufacturing regulations, and therefore quality assurance practices, differ between emerging economies like India and advanced economies like the US. And although FAERS includes all reported adverse events, researchers only used those with the most serious outcomes, including hospitalization, disability and death.
The findings revealed that the number of severe adverse events for generic drugs made in India was higher, despite taking into account a host of factors that could have impacted the results, such as volume of drugs sold. It found that mature generic drugs—those that had been on the market for a relatively long time—were responsible for the most serious adverse events including hospitalization, disability, and in some cases, deaths.
According to the researchers, in the pharma sector, older drugs get cheaper and the competition gets more intense to lower costs and this often results in operations and supply chain issues that can compromise drug quality. “Our study finding leads to implications for the FDA in their regulation of generic drugs,” the researchers stated.
(Edited by Amrtansh Arora)
Also Read: Indian pharma market can more than treble by 2030, says industry report, urges focus on quality