The Maharashtra Food and Drug Administration (Maharashtra FDA) has taken serious action against the pharmaceutical company Cipla by revoking its drug sales license at its C&F center located in Pune. This decision took immediate effect starting August 27, 2026, following an incident related to Reactine Plus tablets.
During the inspection conducted by the FDA, numerous violations concerning inventory, documentation, and medication storage were identified. Furthermore, the placement of advertising on the packaging of a prescription drug without obtaining the necessary permission was discovered.
FDA inspectors checked the company's C&F center in Wadki, Pune. The inspection revealed discrepancies between the actual stock of medicines and the data in computer records. Deficiencies were also found in documentation related to procurement and sales. Medicines were stored directly on the floor, lacking proper organization such as shelves and pallets.
Gaps were noted in the documentation regarding expired medications, and established procedures for managing such drugs were not followed. The FDA considered all these shortcomings as serious. Questions also arose during the inspection regarding the packaging of Reactine Plus tablets. This drug falls under the Schedule-H category, requiring a prescription, yet its packaging contained information related to pain relief and fever reduction medications, which, according to the FDA, was done without appropriate authorization.
Government officials deemed this a violation of medical regulations. Approximately 11.91 million rupees worth of medicines were confiscated as part of the case. The FDA emphasized that the sale, storage, and distribution of prescription drugs must strictly adhere to established rules.
The FDA had previously issued a directive requiring the company to withdraw batches of Reactine Plus containing incorrect information from the market. However, further investigation revealed that the company had not fully complied with these directives. Subsequently, the company was sent a notice demanding an explanation. After reviewing the company's response and the collected facts, the FDA decided to revoke the license.
The FDA officially revoked the license for the sale and distribution of Cipla Pharma and Life Sciences Limited, located in Wadki, Pune, effective August 27, 2026. Following this measure, the permit for selling and distributing medicines at this center was terminated.
The FDA stated that there can be no compromise on drug quality and patient safety, stressing the need for correct inventory management and record-keeping. Additionally, rules regarding the storage and distribution of medicines must be observed. The Maharashtra FDA clearly indicated that ignoring regulations, especially concerning prescription drugs like Schedule-H, will not be tolerated; all established legal provisions regarding their advertising, sale, storage, and distribution must be followed.
In conclusion, the FDA warned that any violations in the pharmaceutical business would be prosecuted according to the law. The department strongly recommended that pharmaceutical companies and sellers adhere to standards of drug quality and patient safety.