Indian Generic Drugs Meet Global Standards

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.