2 hrs ago
Maharashtra FDA Cancels Cipla Pune Warehouse Drug Licences
Maharashtra’s drug regulator cancelled the licences for a Cipla warehouse in Pune.
The warehouse stores and distributes medicines.
Inspectors said the package for Reactin Plus made claims that were not allowed for that prescription medicine.
They also found medicines on the floor, dusty stocks and problems with records.
Expired medicines were not kept in a clearly marked separate area.
The regulator had taken action earlier but restarted the process after directions from the Bombay High Court.
Cipla sent a written reply and attended a hearing.
After reviewing the company’s response and inspection findings, the regulator issued a fresh cancellation order.
Maharashtra FDA cancelled Cipla Pharma & Life Sciences Ltd.’s wholesale sale and distribution licences for its Wadki warehouse in Pune.
The fresh order followed proceedings conducted under directions from the Bombay High Court.
The regulator cited alleged misbranding of Reactin Plus, a Schedule H prescription medicine.
Inspectors reported deficiencies involving storage, cleanliness, records, invoices, inventory and expired-medicine disposal.
Cipla submitted a written reply on September 11 and received a personal hearing on September 21 before the October 1 order.
- Who
- The Maharashtra Food and Drug Administration and Cipla Pharma & Life Sciences Ltd.
- What
- The FDA cancelled the wholesale drug sale and distribution licences of Cipla’s carrying and forwarding warehouse.
- Where
- Cipla’s facility is located at Wadki in Pune, Maharashtra.
- When
- The fresh order was passed on October 1; the FDA announced it on Friday.
- Why
- The FDA cited alleged misbranding of Reactin Plus and deficiencies in storage, documentation, inventory control and expired-medicine handling.
Key facts
- Facility
- Cipla Pharma & Life Sciences Ltd.’s carrying and forwarding warehouse at Wadki, Pune
- Regulator
- Maharashtra Food and Drug Administration
- Order date
- October 1
- Medicine involved
- Reactin Plus Tablets, a Schedule H prescription drug
- Revised notice
- Issued on September 4
- Company proceedings
- Written reply submitted on September 11; personal hearing held on September 21
- Earlier action
- The FDA acted against the facility on August 27 over alleged packaging, storage, documentation and recall irregularities
Quotes
Tukaram Mundhe
Commissioner of Food and Drug Administration, Maharashtra
“There were serious irregularities identified during the inspection of the establishment, including issues relating to the packaging and promotion of Reactin Plus Tablets, as well as deficiencies in the storage, record-keeping and management of medicines at the warehouse.”
indianexpress.com
“In this case, the proceedings have been completed in accordance with the directions of the Bombay High Court and by following the principles of natural justice, transparency, opportunity of hearing and a reasoned decision.”
indianexpress.com
Sources
FDA cancels wholesale drug sales license of Cipla Pharma & Life sciences Ltd
Maharashtra FDA Cancels Cipla Pharma & Life Sciences’ Pune Warehouse Drug Licences Over Multiple Lapses
FDA cancels drug sale licence of Cipla facility in Pune
Maharashtra FDA cancels Cipla Pune warehouse licences after fresh probe into alleged drug violations - Telegraph India
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