The United States Food and Drug Administration’s (USFDA) recently inspected of two manufacturing units of Aurobindo Pharmaceutical Company in Hyderabad, and has raised concerns about contamination of equipment.
While the manufacturing facility in Pashamylaram (which largely manufactures sterile injectable drugs and several pharmaceutical products required for eye surgeries) was inspected between October 21 and 28, the facility at Gaddapotharam was checked between October 21 and 25. The USFDA raised concerns over the lack of hygiene and cleanliness at these facilities.
So far, there has been no official statement from the FDA or Aurobindo regarding the potency of the drugs produced in the unhygienic facilities. Drugs must be manufactured under very specific conditions to ensure their potency and sterility. If a facility is not following the protocols for cleanliness, this can lead to contamination of drugs which can cause health risks.
“Contamination of drugs can cause reactions, allergies and side-effects that doctors cannot anticipate. While they can anticipate the adverse effects of correctly manufactured drugs, if the manufacturing equipment isn’t clean, we don’t know what kind of side-effects to expect,” explains public health expert Dr Syliva Karpagam.
The drug company issued a statement after the investigations.
“We believe that these observations are related to procedural improvements and none of the observations are related to data integrity. The Company will be responding to USFDA as per the prescribed timelines. With respect to Unit IV [of the] formulation manufacturing facility at Pashamylaram, Hyderabad, the inspection is in progress. We further inform you that USFDA audit is an activity under the normal course of business in the pharmaceutical industry. The Company regularly informs all material events and currently we do not have any information which is material to the Company's operations. We will continue to intimate stock exchanges if there is any material development,” it said.
Aurobindo was earlier called out by the USFDA on October 7 after the company was issued a warning for managers of the facility had to take appropriate corrective measures to ensure that the plant was functioning as per regulations. This came after several of the company’s data records pertaining to quality control and checks were found to be incomplete or irregular, raising concerns over the effectiveness and potency of the drugs.
“The responsibilities and procedures applicable to the quality control unit are not fully followed. Several lists of documents requested were either provided as incomplete, inaccurate and/or explained with potentially misleading statements throughout the inspection,” the USFDA had stated at the time.
In addition to Aurobindo Pharmaceuticals, three other companies -- Cadila Healthcare Ltd., Glenmark Pharmaceuticals Ltd. and Lupin Ltd. -- have come under the FDA scanner earlier.
Aurobindo Pharmaceuticals was under scrutiny earlier in January too after stocks of the company’s drug Valsartan, to treat high blood pressure, had to be recalled due to suspected contamination by a cancer causing agent (carcinogen).