Maharashtra FDA has cancelled Cipla Pharma & Life Sciences Ltd.’s drug sale licence for its Wadki facility in Pune after an inspection found stock-record discrepancies, storage lapses and other regulatory violations linked to Reactin Plus Tablets.
Pune, India — Maharashtra’s Food and Drug Administration (FDA) has cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd.’s C&F facility in Wadki, Pune, following findings related to the storage, record-keeping and distribution of Reactin Plus Tablets.
Key Highlights
- Maharashtra FDA cancelled the drug sale licence of Cipla Pharma & Life Sciences Ltd.’s Wadki facility with immediate effect from August 27, 2026.
- An inspection found differences between physical stock and computerised records, along with stock-management and storage lapses.
- Reactin Plus Tablets were flagged over packaging that referred to analgesic and antipyretic properties without the required permission.
- Drug stock worth around Rs 11.91 lakh was seized during the regulatory action.
- The FDA said recall instructions for misbranded Reactin Plus Tablets had not been fully complied with.
Cipla Pune Licence Cancelled After FDA Inspection
The Maharashtra FDA took action after inspecting Cipla Pharma & Life Sciences Ltd.’s Wadki facility in Pune. According to the supplied source, officials found discrepancies between the physical stock available at the facility and the corresponding computerised records.
The inspection also identified lapses in stock management and inadequate storage arrangements. The FDA further found that expired medicines were not being handled according to the prescribed procedures.
Reactin Plus Packaging Came Under FDA Scrutiny
The regulatory action also involved the packaging of Reactin Plus Tablets, which the FDA identified as a Schedule H prescription medicine. The regulator found that the packaging carried a reference to the medicine’s analgesic and antipyretic properties without the required permission.
The FDA said the activity was contrary to provisions of the Drugs and Cosmetics Act, 1940, and relevant drug rules. The findings led to the seizure of stock valued at around Rs 11.91 lakh.
Recall Instructions Not Fully Followed
The FDA had previously directed the company to withdraw misbranded Reactin Plus Tablets from the market. A subsequent inspection, however, found that the recall instructions and other regulatory requirements had not been fully complied with.
Following the findings, the FDA issued a show-cause notice to the company. After examining the explanation submitted by the company, the regulator proceeded with cancellation of the drug sale licence.
Licence Cancelled With Immediate Effect
The drug sale licence of Cipla Pharma & Life Sciences Ltd., Wadki, Pune, was cancelled with immediate effect from August 27, 2026.
The Maharashtra FDA said it would not tolerate lapses involving drug safety, quality and lawful distribution, particularly when Schedule H prescription medicines are concerned.
What the FDA Action Covers
The regulatory action follows findings concerning multiple aspects of the facility’s operations, including stock records, inventory management, storage conditions, handling of expired medicines, packaging-related compliance and the implementation of recall instructions.
The latest action means the drug sale licence of the concerned Wadki facility has been cancelled with immediate effect following the FDA’s examination of the matter.
Frequently Asked Questions
Why did Maharashtra FDA cancel Cipla’s Pune drug sale licence?
The licence was cancelled after an inspection found discrepancies between physical and computerised stock records, stock-management and storage lapses, improper handling of expired medicines and other regulatory issues.
Which medicine was involved in the FDA action?
The regulatory findings were linked to Reactin Plus Tablets, which the source identifies as a Schedule H prescription medicine.
How much stock was seized?
The FDA seized stock worth around Rs 11.91 lakh following its findings.
When did the licence cancellation take effect?
The drug sale licence of Cipla Pharma & Life Sciences Ltd.’s Wadki facility was cancelled with immediate effect from August 27, 2026.
Praveen Yadav is the Founder and Editor at The Nation Bulletin. With over 3 years of experience in digital journalism and news reporting, he covers national affairs, governance, and breaking current events with a commitment to factual accuracy and verified reporting.
