Major Blow to Cipla: Maharashtra FDA Cancels Pune Warehouse Licences Over Misbranding

October 3, 2026 PuneTV Team 0 Comments

Pune / Mumbai, October 3, 2026 — The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse at Wadki (also referred to as Vadki) in Pune. The order, issued on October 1, follows a fresh round of proceedings ordered by the Bombay High Court and cites alleged misbranding of a prescription medicine along with multiple deficiencies in storage, record-keeping, and warehouse management.

The Cipla Pune warehouse licences cancelled order marks one of the most significant regulatory actions taken against a major pharmaceutical company in recent years.

Cipla Pune Warehouse Licences Cancelled: Background & Timeline

The case began with an inspection of the company’s main warehouse at Wadki around June 2026. Officials examined the packaging of Reactin Plus Tablets, a Schedule H prescription drug that requires a doctor’s prescription and is not meant for over-the-counter sale.Inspectors found that the packaging carried unauthorised promotional text describing the medicine as an “analgesic and antipyretic.” Additional claims and illustrations promoted its use for relief from headache, muscular pain, backache, joint pain, sprain, body ache, and toothache. The FDA classified this as misbranding under the Drugs and Cosmetics Act, 1940, and the Drugs Rules, 1945. Stock valued at approximately ₹11.19 lakh was seized, and the company was directed to recall the “misbranded” product from the market.An earlier cancellation of the licences took effect on August 27, 2026. Cipla challenged the action, and the matter reached the Bombay High Court (Writ Petition No. 11376/2026). In compliance with the court’s directions, the FDA withdrew its earlier proceedings and initiated a fresh process.

Fresh Proceedings

A revised show-cause notice was issued on September 4, 2026.Cipla submitted a written reply on September 11.A personal hearing was held on September 21.After reviewing the company’s submissions, inspection findings, records, and applicable legal provisions, the Licensing Authority & Assistant Commissioner (Drugs), FDA Pune Circle-3, passed a reasoned order on October 1 cancelling the licences.

Key Violations Cited by the FDA

1. Packaging and Misbranding

Unauthorised claims and illustrations on Reactin Plus packaging that went beyond permitted labelling for a Schedule H drug.

2. Storage and Warehouse Conditions

Medicines stored directly on the floor due to inadequate pallets or racks.
Dust accumulation on stock and deficiencies in overall cleanliness.
Absence of a mandatory Form 35 inspection book.
No clearly designated “Expiry – Not for Sale” area for expired medicines, along with gaps in related records and procedures.

3. Inventory and Record-Keeping

Discrepancies between purchase/sales records, computerised inventory, and physical stock. Non-compliance with earlier recall directions was also noted.

The Cipla Pune warehouse licences cancelled decision was based on a detailed review of inspection findings and legal provisions.

Cipla’s Response

Cipla described the decision as “disappointing.” In a statement, the company said:
“Cipla maintains an unwavering commitment to quality and patient safety… We believe our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards. We are reviewing the order and evaluating further options. Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers.”The company has indicated it is examining legal options against the order.

Current Status of the Cipla FDA Case (as of October 3, 2026)

The drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding (C&F) warehouse at Wadki (Vadki), Pune, remain cancelled.

Key Timeline of Recent Developments

June 2026: FDA inspection of the Wadki warehouse flagged issues with the packaging of Reactin Plus Tablets (a Schedule H prescription drug) and other operational deficiencies.
August 27, 2026: FDA first cancelled the licences.
Late August 2026: Cipla challenged the order in the Bombay High Court (Writ Petition No. 11376/2026). The Court criticised the FDA for procedural lapses and acting against the principles of natural justice. The FDA withdrew the earlier cancellation order.
September 4, 2026: Fresh/revised show-cause notice issued.
September 11, 2026: Cipla submitted its written reply.
September 21, 2026: Personal hearing held.
October 1, 2026: Licensing Authority & Assistant Commissioner (Drugs), FDA Pune Circle-3, issued a fresh reasoned order cancelling the licences after considering the company’s submissions, inspection findings, and legal provisions.

Cipla’s Position

Cipla has described the October 1 order as “disappointing.” The company maintains that its Wadki warehouse complies with distribution, storage, and digital record-keeping standards. It has stated that it is reviewing the order and evaluating further options. No public confirmation of a new court petition, stay application, or other formal challenge against the latest order has been reported as of October 3, 2026.

Official Stance

The Maharashtra FDA has confirmed that the latest proceedings were completed in full compliance with the Bombay High Court’s directions and the principles of natural justice (including an opportunity of hearing and a reasoned decision). The cancellation specifically affects the wholesale drug sale and distribution operations of this particular C&F warehouse.

In summary: The licences are currently cancelled under the fresh October 1 order. The matter is at the stage where Cipla is reviewing its next legal or regulatory steps. There are no reports of a stay or reinstatement of the licences at this time. For the absolute latest developments, checking official FDA Maharashtra statements or Cipla’s disclosures is recommended, as the situation could evolve if the company files a fresh challenge.

Impact on Patients and Healthcare Providers

Cipla has stated that it remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers. The cancellation specifically affects the wholesale drug sale and distribution operations of this particular C&F warehouse at Wadki. It does not affect Cipla’s manufacturing operations or its other distribution channels.

Industry experts note that while this is a significant regulatory action, patients are unlikely to face immediate shortages as Cipla has a large distribution network. However, the case highlights the importance of strict compliance with storage and labelling norms, especially for Schedule H drugs that require a doctor’s prescription.

The Cipla Pune warehouse licences cancelled order remains in effect, and Cipla is expected to file a fresh legal challenge in the coming days.