Cipla's Pune Godown Loses Drug Licence Over 'Misbranding, Storage Violations'
A major reason for the action was the misbranding of 'Reactin Plus', a Schedule-H drug that cannot be sold over the counter.
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- The Maharashtra FDA suspended Cipla's Pune warehouse drug sale licence
- Misbranding of Reactin Plus, a Schedule-H drug, was among the major violations
- Storage violations included lack of inspection book and unsegregated expired drugs
Can the company appeal this suspension in court?
Mumbai:
The drug sale and distribution licences of a Pune warehouse of Cipla Pharma and Life Sciences Ltd have been suspended by the Maharashtra Food and Drug Administration (FDA) over alleged misbranding and storage violations.
The strict action was taken against the godown in Wadki under the guidance of FDA Commissioner Tukaram Mundhe following directives from the Bombay High Court.
A major reason for the action was the misbranding of 'Reactin Plus', a Schedule-H drug that cannot be sold over the counter. The medicine's packaging illegally displayed advertising claims and figures promising quick relief from headache, muscular pain, backache, joint pain, sprain, body ache, and toothache.
READ | Cipla Pune Unit's Drug Sale Licence Cancelled Over 'Irregularities'
The inspectors also uncovered severe storage and hygiene violations at the facility. Medicine boxes were found dumped on the floor with visible dust accumulation, the FDA said.
The facility lacked a mandatory inspection book, and expired medicines were not kept in a separate 'Not for Sale' zone. The officials also found significant discrepancies between the physical stock of medicines, including antibiotics, and computer records.
The FDA rejected the company's explanation, stating that maintaining digital records does not exempt it from physical safety, hygiene, and statutory paperwork.
READ | "Do You Feel You Are A Lord?" High Court Pulls Up Tukaram Mundhe's Food Safety Body
Following a detailed hearing process, the final cancellation order was officially passed on October 1, after withdrawing its earlier proceedings in compliance with the high court's directions.
Mundhe said that the FDA's objective is not just to take action but ensure the safety, quality, and legal compliance of drugs in the supply chain.
"In this case, the proceedings have been completed by fully respecting the directions of the Bombay High Court, following the principles of natural justice, transparency, hearing, and reasoned decisions or following all aspects," he said in a statement.
Got a follow‑up question on this article? Go on
- How will this suspension affect the company's medicine supplies in the region?
- What specific steps does the company need to take to restore its licence?
- Are other warehouses belonging to the same company facing similar FDA inspections?
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