Cipla Pune Godown: Drug Licence Cancelled Over Misbranding and Storage Violations
The Maharashtra Food and Drug Administration has cancelled the drug sale and distribution licence of a Cipla Pharma and Life Sciences warehouse in Wadki, Pune, citing alleged misbranding and storage-related violations. The action included concerns over the sale and labelling of the Schedule-H drug Reactin Plus.
Pune: The Maharashtra Food and Drug Administration (FDA) has taken action against a Cipla Pharma and Life Sciences Ltd warehouse in Wadki, Pune, over alleged violations related to drug misbranding, storage and statutory requirements.
The action was taken under the guidance of FDA Commissioner Tukaram Mundhe, following directions from the Bombay High Court. After a detailed hearing process, the FDA passed the final cancellation order on October 1.
One of the key issues identified by the FDA was the alleged misbranding of Reactin Plus, a Schedule-H drug that cannot be sold over the counter. According to the FDA, the packaging carried advertising claims and figures promising quick relief from conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache.
FDA inspectors also reportedly found several storage and hygiene-related irregularities at the Wadki facility. Medicine boxes were found placed directly on the floor with visible dust accumulation.
The facility was also reportedly found without a mandatory inspection book. Expired medicines were allegedly not kept separately in a designated “Not for Sale” area, as required.
Officials further identified discrepancies between the physical stock of medicines and the computer records maintained at the facility. These discrepancies reportedly involved medicines including antibiotics.
The FDA rejected the company's explanation that digital records were sufficient, stating that electronic records do not replace requirements relating to physical stock safety, hygiene and mandatory statutory documentation.
The proceedings were completed after following the directions of the Bombay High Court and providing the company an opportunity to present its case. The FDA said the action was taken following the principles of natural justice, transparency and a reasoned decision-making process.
FDA Commissioner Tukaram Mundhe said the department's objective is to ensure the safety, quality and legal compliance of medicines throughout the drug supply chain, apart from taking enforcement action when violations are detected.