New Delhi: The Indian Pharmaceutical Alliance on Wednesday asserted that generic drugs manufactured in India meet global regulatory standards and production facilities of the country are subject to far greater scrutiny, as most manufacturers supply in multiple geographies and are inspected additionally and routinely by regulators.
Refuting findings of a study at Ohio State University that stated India-made generic drugs are linked to significantly more “severe adverse events” in patients who use them than equivalent drugs produced in the US, the Indian Pharmaceutical Alliance (IPA) asserted that quality standards are not region-dependent.
“We strongly disagree with the study’s premise that differences in operations and supply chain factors, suppliers, manufacturing and/or distribution practices by different manufacturers, impact the quality and efficacy of Indian generic drugs,” IPA said in a statement.
The USFDA follows a stringent approval process before any generic drug is approved, ensuring that the process, controls, specification of the input API and that of the finished product are governed within a window and are followed throughout the product lifecycle, it said.
“The standards applied to the approval of generic drugs within the US and in India are not different, as the study also acknowledges,” IPA said referring to the findings of the report titled “Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events”.
The alliance representing 23 leading national pharmaceutical companies further said, “Indian manufacturing facilities are subject to far greater scrutiny as most manufacturers supply products to multiple geographies and are inspected additionally and routinely by the regulators from European Union, UK (MHRA), Australia (TGA), Brazil (ANVISA), Health Canada and several others all of which hold high quality standards and share findings under mutual agreement.”
It further noted that in the last decade, there has been a significantly greater engagement that the Indian industry and the regulator have had with the USFDA in addressing manufacturing and quality operations in the Indian subcontinent and some of the outcomes are reflected in the post-inspection categorisation of the facilities.
“The inspection outcome categorisation of Official Action Indicated (OAI) has reduced to 11 per cent in 2024 compared to 23 per cent in 2014 for Indian companies, in line with the global trend of 14 per cent in 2024,” IPA said.
While generics are priced lower than the corresponding brands, IPA said it is unfair and unacceptable to link quality with cost.
“India’s competitive cost is on account of automated high-production capacity plants, continuous process improvement, inherent cost advantage in manpower and manufacturing synergies, including scale of operations. Many products are backward integrated to the actives, realising better cost efficiencies,” it said.
Stating that the study also appears to be ill-researched, claiming lack of transparency in drug manufacturing location for Indian generics, IPA said, “Complete manufacturing address by law is indicated on every single pack of generic products distributed in the US market, besides being available on USFDA’s database, such as the Orange Book.”
An exception to this rule is Over the Counter (OTC) products distributed by private label distributors like Walmart, even those which indicate India as the country of origin, it noted.
IPA also accused the report of misinterpretation of USFDA Adverse Event Reporting System (FAERS) data, saying it relies upon the post-marketing surveillance database for adverse events.
“FAERS data is observational, and thus captures associations between drugs and adverse events but does not prove causation. Therefore, a higher rate of Serious Adverse Events (SAEs) for drugs manufactured in emerging economies does not inherently mean manufacturing quality is inferior,” it said.
Highlighting admission of the authors of the report that there are limitations in terms of information available in the report that may not have been medically confirmed, or that conditions other than the suspect drug may have caused the event, IPA said, “So, a lack of correlation can be observed between the incidence of reported SAEs and the medicinal product”.
“Use of FAERS to conclude product quality has limitations, reporting biases, lack of denominator data, and inability to establish causality, that make it unsuitable for the purpose. The study employs considerate methodologies but remains constrained by the purpose and limitations of FAERS data,” it said.
Asserting that quality is fundamental to pharmaceutical operations, IPA said, “The Indian pharmaceutical sector has made significant strides in strengthening quality systems in response to evolving global regulatory expectations.”
There have been recent developments in Quality Maturity (adherence to regulatory standards, risk-based approaches, and a proactive quality culture) in India, it said, adding the Indian pharmaceutical industry is committed to holding the highest standards in quality and prioritising patient safety and well-being.
