The Maharashtra Food and Drug Administration revoked the drug distribution licences of Cipla Pharma & Life Sciences Ltd’s Wadki facility. Consequently, the Cipla Pune warehouse licence was cancelled and order took effect on October 1, 2026, following Bombay High Court directives. The licensing authority cited misbranding of Reactin Plus Tablets and significant storage lapses for revoking operational permits.
Misbranding of prescription drug triggers regulatory crackdown
During inspections, officials discovered that the carrying and forwarding warehouse made illegal marketing claims for Reactin Plus. Specifically, the company promoted the Schedule H prescription medicine as an over-the-counter analgesic offering quick pain relief.
Furthermore, the packaging displayed visual human figures suggesting relief from muscular and joint pain. Therefore, regulators ruled that the product violated statutory rules under the Drugs and Cosmetics Act, 1940.
| Regulatory Violation Category | Specific Inspection Findings |
| Product Misbranding | Illegal claims & human figures on Schedule H Reactin Plus packaging |
| Storage Infrastructure | Medicines kept directly on floor due to missing pallets |
| Hygiene & Handling | Dust accumulation on drug stocks; unsegregated expired medicines |
| Compliance Records | Missing Form 35 inspection book & SOPs for expired drug disposal |
Warehouse storage lapses worsen regulatory trouble
Additionally, FDA inspectors uncovered severe operational deficiencies across the Wadki facility. Inspectors observed medicine boxes stored directly on bare floors without required pallets or racks. Meanwhile, dust accumulated heavily on drug stock, and expired medicines lacked segregated storage spaces.
The department issued a revised show-cause notice on September 4 following High Court instructions. Furthermore, officials gave Cipla a personal hearing on September 21 before finalizing the order.
Thus, the authority clarified that maintaining digital SAP records does not exempt firms from mandatory physical compliance. Consequently, the regulatory action highlights strict enforcement across India’s pharmaceutical supply chains.
