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 in Wadki, Pune, citing alleged regulatory violations involving drug packaging, storage conditions, inventory management and documentation. The cancellation order was issued on 1 October 2026 by the Assistant Commissioner (Drugs), Division 3, Pune, following a court-directed review.

Background and Court Direction

The current proceedings stem from an earlier action initiated against the facility on 27 August, which was subsequently withdrawn and reconsidered under a revised regulatory process following directions from the Bombay High Court. Acting on the court's directives, the FDA issued a revised show-cause notice to Cipla on 4 September. The company filed its written response on 11 September and appeared for a personal hearing on 21 September. After examining Cipla's submissions, inspection reports, records and applicable legal provisions, the licensing authority issued the fresh revocation order.

Packaging Violations: Reactin Plus Under Scrutiny

A central concern in the FDA's review was the packaging of Reactin Plus Tablets, a Schedule H prescription medicine marketed by Cipla. According to the regulator, the product's packaging described it as an analgesic and listed multiple uses — including relief from headache, muscular pain, backache, joint pain, sprain, body ache and toothache — and featured a human figure alongside visual depictions suggesting pain relief.

The FDA alleged that these claims, descriptions and illustrations did not comply with statutory requirements and amounted to misbranding under the Drugs and Cosmetics Act, 1940. Notably, the regulator stated that Cipla's responsibility as the product's marketer could not be avoided merely because the medicine was manufactured by a separate entity.

Warehouse Management Deficiencies

Beyond packaging concerns, the FDA inspection reportedly uncovered multiple deficiencies in the Wadki warehouse's operations. These included the absence of the mandatory Form 35 inspection book, inadequate storage infrastructure that resulted in medicines being stored directly on the floor, dust accumulation on drug stocks and overall cleanliness shortcomings.

The regulator also alleged that expired medicines were not stored in a separately designated area clearly marked as 'Expiry-Not for Sale', as required under applicable norms. Additionally, the FDA cited the absence of prescribed standard operating procedures and disposal records for expired drugs.

FDA's Position on the Fresh Order

The Maharashtra FDA clarified that the latest licence revocation represented an independent regulatory determination based on the findings of the renewed proceedings, and was not a simple repetition of the earlier withdrawn action. The regulator's position underscores the seriousness with which it views the cumulative lapses identified at the facility.

This case highlights the growing regulatory scrutiny on pharmaceutical warehousing and labelling practices across Maharashtra, where the FDA has stepped up inspections of C&F operations in recent months. For Cipla — one of India's largest drug manufacturers — the development adds a compliance overhang on its domestic distribution network as the company navigates ongoing audits.