IPA refutes US univ's report questioning quality of Indian-made generics

Asserting that quality standards are not region-dependent, the Indian Pharmaceutical Alliance (IPA) on Wednesday refuted findings of a report by the Ohio State University that had linked Indian-made generic drugs to significantly more severe adverse events (SAEs) in patients compared to equivalent drugs produced in the US.

 

The pharma body which represents leading research-driven pharma companies and exporters from India said that the United States Food and Drug Administration (USFDA) follows a stringent process of inspections both for manufacturing sites based within the US and outside in emerging geographies, notably, in India. 

 

“The FDA has established an office in India looking into the number of Indian manufacturers qualified to supply generic medicines to the US,” it said.

 

Industry insiders pointed out that since India accounts for nearly 50 per cent of the generic drugs exported to the US, the share of adverse events also would be higher on a proportionate basis.

 

The report- titled “Are All Generic Drugs Created Equal? An Empirical Analysis of Generic Drug Manufacturing Location and Serious Drug Adverse Events”- had listed opacity in location of drug supply chains and low costs of Indian generics for low quality standards.

 

Disagreeing with the study’s premise that differences in operations and supply chain factors could impact the quality and efficacy of Indian generic drugs, IPA said that generic drugs manufactured in India meet global regulatory standards, with its production facilities subject to far greater scrutiny, as most manufacturers supply in multiple geographies and are inspected additionally and routinely by regulators.

 

“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,” it added.

 

Calling the report ill-researched for claiming lack of transparency in drug manufacturing locations for Indian generics, the IPA said that the 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.

 

While generics are priced lower than the corresponding brands, IPA added it is unfair and unacceptable to link quality with cost.

 

It added that 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,” IPA stated.

 

The IPA added that the report’s reliance upon the FDA Adverse Event Reporting System (FAERS), which is the post marketing surveillance database for adverse events is observational, and thus captures associations between drugs and adverse events, but does not prove causation.

 

“Therefore, a higher rate of SAEs for drugs manufactured in emerging economies does not inherently mean manufacturing quality is inferior,” the pharma body asserted.