The Food and Drugs Administration (FDA), Maharashtra, has flagged a batch of government-supplied Aspirin Tablets IP 75 mg (branded as Opirin-75) as not of standard quality, raising red flags about patient safety in public healthcare facilities.
The issue came to light during a routine inspection conducted at Rural Hospital, Chakan, under Pune District's Khed Taluka.
The inspection was a part of the FDA’s ongoing surveillance to ensure the quality and safety of medicines distributed under government health schemes. It was conducted on April 23 by FDA Drug Inspector Manoj N. Ayya.
During the inspection, the officials found out that a stock of Opirin-75 tablets, Batch No. 23K-T2727, was manufactured at Orison Pharma International in Himachal Pradesh. The tablets had been supplied to the rural hospital through the District Drug Store, Aundh, Pune, on June 6, 2024.
While the records and physical stock were in order, a sample was sent for quality testing to the FDA's Government Laboratory in Aurangabad. The report revealed that the tablets do not meet IP (Indian Pharmacopoeia) standards for physical description. The tablets were found to be brittle and had rough surfaces, which can affect the drug’s efficacy.
The test results read, “The sample does not comply with the description, as almost all the tablets are brittle in nature with rough surfaces.”
Such deficiencies are considered significant under the Drugs and Cosmetics Act, 1940, especially when drugs are supplied to public healthcare institutions.
However, the letter issued by the inspecting FDA officer claims that the Pharmacist Officer at the hospital has been informed about the substandard quality of the medicine. But the rural hospital medical supplier refused to receive any information or to stop the distribution.
Speaking to The Free Press Journal, Sachin Kamble, Medical Superintendent, Chakan Rural Hospital, said, "The FDA did the inspection, and usually they collect the samples and send them to the labs for testing. We haven't received any information from them regarding the substandard quality of medicines. We don't purchase it locally; we give patients the medicines that we get from the central drug store that is in Aundh."
FPJ got in touch with Dr Nagnath Yempale, Civil Surgeon, Aundh District Hospital. He said, "We don't have that medicine in stock now. The Aspirin Tablets were not of substandard quality; they were brittle. The samples were collected a year ago, and now they are releasing the report."
Commenting on this, Ashwin Thakare, Assistant Commissioner (Drugs), FDA, Pune, said, "We have done a sampling programme under the Maharashtra government. We collected some samples from a rural hospital in Khed taluka in January, and the tablets seem to be easily breakable, but they contain the considered drug. The issue could be due to the quality or storage. However, the drug content was up to the mark and failed the physical parameters."
