FDA cancels wholesale drug sales license of Cipla Pharma & Life sciences Ltd

The Food and Drug Administration in Pune has revoked the wholesale drug sale license of Cipla Pharma and Life Sciences Ltd, located in Wadki, Pune. Tukaram Mundhe, the Commissioner of Food and Drug Administration in Maharashtra, revealed that the decision was reached after completing the necessary legal and regulatory steps. Mundhe explained that serious irregularities were discovered during an inspection of the facility, including issues pertaining to the packaging and promotion of Reactin Plus Tablets, as well as shortcomings in the storage, record-keeping, and medicine management within the warehouse.

According to Mundhe, the FDA's objective extends beyond regulatory action, as it prioritizes ensuring the safety and quality of medications and adherence to regulations across the drug supply chain. The proceedings were carried out in line with the Bombay High Court's directives and the principles of natural justice, transparency, the right to a hearing, and a reasoned decision.

During the inspection of the Wadki warehouse, a stock of Reactin Plus, classified as a Schedule H drug, was discovered. The product was marketed as an 'Analgesic and Anti-inflammatory' capable of providing rapid relief from headaches, muscle pain, back pain, joint pain, sprain-related pain, body aches, and toothaches. The carton featured an illustration of a human figure, supposedly demonstrating the reduction of muscular pain upon the use of the medication.

Cipla Pharma's Joint Commissioner (Drug) for Pune, Girish Hukare, disclosed that the inspection discovered that the claims, text, and illustration on the packaging did not align with the applicable statutory requirements. The matter raised concerns of misbranding under the Drugs and Cosmetics Act of 1940, which led to the regulatory action.

Additionally, several shortcomings in storage and medicine management were identified during the inspection. The FDA officials emphasized that the earlier proceedings against Cipla Pharma had been withdrawn, adhering to the Bombay High Court's instructions. However, a revised show-cause notice was issued on September 4, after which the company submitted its written reply on September 11 and was granted an opportunity for a personal hearing on September 21.