The US FDA has allowed Intas to continue supplying 24 critical products that are in short supply in the US, after the completion of necessary testing and verification; Image: Shutterstock
On June 1, Intas Pharmaceuticals received communication from the US Food and Drug Administration (FDA) stating that the company’s manufacturing facility in Ahmedabad—Special Economic Zone (Pharmez), near Matoda—has been listed under ‘Import Alert’.
Import Alerts inform the FDA’s field staff and the public that federal agency has enough evidence to allow for Detention without Physical Examination (DWPE) of products that appear to be in violation of the FDA’s laws and regulations. It prevents potentially violative products from being distributed in the US.
The US FDA had inspected this facility between November and December 2022, when the company was given an 11-observation Form 483—mostly around data integrity and quality compliance. “…We found a truck full of transparent plastic bags containing shredded documents and black plastic bags mostly containing documents torn randomly into pieces by hand mixed with other scrap materials…” stated the FDA’s compliance record
. After receiving the Form 483 observations, Intas claims it took the immediate and voluntary decision to temporarily cease the manufacturing and distribution of products manufactured at the SEZ facility that were designated for the US.The US FDA has allowed Intas to continue supplying 24 critical products that are in short supply in the US, after the completion of necessary testing and verification. Critical drugs excluded include injectable products belonging to therapeutic areas such as vitamins, oncology, bacterial infections, cardiology, and for sedation and tablet products in the areas of neuro therapy, kidney stone diseases, cancer care, hormonal complications and heart issues, according to the USFDA list.Also read: India's 'pharmacy of the world' moniker is under threat. Here's why
In a written statement to Forbes India, Intas stated that: “Patient safety will always be our primary focus. As part of that commitment, Intas has worked collaboratively with external cGMP experts to conduct a baseline assessment of its quality management systems, personnel, and is implementing remediation measures. Additionally, Intas is working with FDA on a plan for it to return to manufacturing at SEZ for the US market beginning with certain critical oncology products. Intas is fully dedicated to continuing its heritage of supplying quality medicines.”Of the company’s total turnover—about Rs18,400 crore (March 2022)—the US market accounts for 18 percent and 32 percent of the total revenue comes from its domestic business.However, the issue is not just with Intas, but with many Indian pharma giants that have been caught in a regulatory crossfire with the US FDA. Why the repeated lapses? “Costs are increasing, but prices are dropping due to increased competition and growing bargaining power of buyers. In an attempt to cope with the drop in value, companies have been trying to increase the volume of products, which makes managing regulatory compliance even tougher,” explains Vishal Manchanda, senior vice president—institutional research, Systematix Group.A section of the Indian pharma sector suggests, off the record, that the increasing regulatory scrutiny could have something to do with US Big Pharma lobbying against Indian generic manufacturers.