The Food and Drug Administration (FDA) has issued a show-cause notice to public sector undertaking Hindustan Antibiotics Limited in Pimpri over critical manufacturing lapses, threatening the permanent cancellation of its drug manufacturing licences. The state regulatory body has handed down a strict seven-day deadline for the pharmaceutical facility to submit a satisfactory technical explanation.
Notably, as a precautionary safety measure, all manufacturing operations at the Pune-based facility have already been temporarily suspended for the past 1.5 months following initial safety inspections. Failure to comply with the deadline will result in the immediate and permanent revocation of its production licences, NDTV Marathi reported.
A joint surprise inspection by the FDA and CDSCO has uncovered severe manufacturing flaws at Hindustan Antibiotics Limited in Pimpri, according to local media.
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Inspectors found inadequate cleanliness in manufacturing areas, along with deficiencies in technical systems and laboratory testing procedures, sparking concerns about the safety, quality, and regulatory compliance of medicines produced there, as per reports.
Prioritising citizen safety, regulators ordered an immediate halt to operations, completely shutting down the production of life-saving injections and saline.
This facility is a primary supplier of antibiotics, painkillers, and various saline bottles widely utilised in government hospitals. Consequently, no new medicine batches have been produced for the last 45 days, sparking deep concerns over an impending drug shortage in public healthcare facilities.
Authorities have emphasised that production cannot be restarted until all safety errors are completely corrected and the FDA officially grants the green light to resume operations. Government hospitals will now be required to procure these medicines from the open market or private manufacturers, likely at higher costs, according to a local news agency.
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