Intas Pharmaceuticals Limited has informed that its manufacturing facility SEZ (Pharmez) near Ahmedabad has been listed under ‘Import Alert’ by the US Food and Drug Administration (USFDA).
The USFDA’s issuance of Import Alert #66-40 published on June 1, 2023, calls for “detention without physical examination (DWPE), which may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP).”
Commenting on businessline’s query, Intas confirmed receiving a “communication from USFDA stating that their manufacturing facility SEZ (Pharmez) has been listed under Import alert.”
“This import alert is limited to this specific manufacturing site of Intas. The USFDA has allowed Intas to continue to supply from that site 24 critical products in short supply in the US after completion of necessary testing and verification.”
The critical care drugs excluded from DWPE 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, the USFDA list showed.
Notably, between November 22 and December 2, 2022, three USFDA inspectors inspected Intas’ facility located at Pharmez Special Economic Zone (SEZ) near Ahmedabad, after which they issued Form-483 with 11 observations. These highlighted glaring lapses on the part of company in the areas such as data integrity, standard documentation practices, accuracy, sensitivity, specificity and reproducibility of test methods on products and the procedures designed to prevent microbiological contamination of drug products among others.
Intas makes solid oral products, injectables and liquid oral products at the Pharmez unit - inspected by the USFDA.
Responding to businessline’s queries, Intas said, “When the initial FDA findings were first received in December, Intas took the immediate and voluntary decision to temporarily cease the manufacturing and distribution of products manufactured at the SEZ facility that were destined for the US. Intas is committed to providing safe and effective medicines for patients.”
The company also stated that it “worked collaboratively with external cGMP experts to conduct a baseline assessment of its quality management systems, personnel, and is implementing remediation measures.”
As part of the commitment to supply critical medicines to the patients who need them most, Intas and its US subsidiary, Accord Healthcare, Inc., have worked with the FDA’s Drug Shortage Staff and the Office of Compliance to identify certain critical drugs that it will continue to supply to the US market after further testing and verification.”
“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,” the company said in a statement.
Intas’ US revenues are 18 per cent of its overall revenues of about ₹18,400 crore as on March 2022, whereas it gets about 32 per cent of the total turnover from domestic business. The company gets a maximum of 42 per cent of its revenues from the European Markets, while a higher single-digit share is from emerging markets. Intas has 18 manufacturing facilities of which 15 are located in India while three are located in UK and Mexico.