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

According to the FDA commissioner, the aim of the FDA is not merely to take regulatory action, but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain.

4 min readPuneUpdated: Oct 2, 2026 10:07 PM IST

There were serious irregularities identified during the inspection of the establishment, including issues relating to the packaging and promotion of Reactin Plus Tablets, said Commissioner of Food and Drug Administration, Maharashtra, Tukaram Mundhe. (Express photo)

The Food and Drug Administration, Pune cancelled the wholesale drug sale license of Cipla Pharma and Life Sciences Ltd, Wadki in Pune. Tukaram Mundhe, Commissioner of Food and Drug Administration, Maharashtra, said after completing the legal and regulatory procedures, the action was taken.

“There were serious irregularities identified during the inspection of the establishment, including issues relating to the packaging and promotion of Reactin Plus Tablets, as well as deficiencies in the storage, record-keeping and management of medicines at the warehouse,” Mundhe said.

According to the FDA commissioner, the aim of the FDA is not merely to take regulatory action, but to ensure the safety and quality of medicines and statutory compliance throughout the drug supply chain. “In this case, the proceedings have been completed in accordance with the directions of the Bombay High Court and by following the principles of natural justice, transparency, opportunity of hearing and a reasoned decision,” Mundhe added.

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It may be recalled that during the inspection of the Wadki warehouse, stock of Reactin Plus, a Schedule H drug, was found. The product was advertised as an ‘Analgesic and Anti-inflammatory’ providing quick relief from headache, muscular pain, backache, joint pain, pain due to sprain, body ache and toothache. The carton also carried an illustration of a human figure intended to indicate the reduction of muscular pain following use of the medicine, officials said.

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Girish Hukare, Joint Commissioner (Drug), Pune said that the inspection found that the claims, text and illustration appearing on the packaging did not comply with the applicable statutory requirements. “The matter raised issues of misbranding under the Drugs and Cosmetics Act, 1940 which resulted in the regulatory action,” he added.

The inspection also identified several deficiencies relating to the storage and management of medicines. According to an official press statement, there was non-availability of the Form 35 inspection book required under the applicable rules while medicine boxes were being stored directly on the floor due to inadequate availability of pallets/racks. There was accumulation of dust on medicine stocks and deficiencies in cleanliness apart from the absence of a clearly designated area marked “Expiry – Not for Sale” for expired medicines.

Cipla in a statement said, “Cipla maintains an unwavering commitment to quality and patient safety, and we find the Maharashtra FDA’s decision regarding our Wadki C&FA in Pune disappointing. We believe our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards. We are reviewing the order and evaluating further options. Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers.”

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Other deficiencies related to signatures of authorized persons on duplicate copies of sales invoices and discrepancies between computer/SAP records. Earlier when the FDA had cancelled the carry and forwarding agent (CFA) drug sale license of the warehouse in Pune, Cipla Pharma had contested the Pune FDA order and in their statement had stated that FDA order had not alleged concerns related to safety quality or efficacy of their products and indicate patient safety issue. FDA officials said that the earlier proceedings were withdrawn in compliance with the directions of the High Court.

However a revised show-cause notice was issued on September 4, the organization submitted its written reply on September 11 and was given an opportunity for a personal hearing on September 21. FDA authorities said, “It is an independent regulatory decision taken afresh after completion of the prescribed process in accordance with the directions of the Bombay High Court.”

Anuradha Mascarenhas

Anuradha Mascarenhas is a Senior Editor at The Indian Express, based in Pune. With a career spanning three decades, she is one of the most respected voices in Indian journalism regarding healthcare, science and environment and research developments. She also takes a keen interest in covering women's issues . Professional Background Education: A gold medalist in Communication and Journalism from Savitribai Phule Pune University and a Master’s degree in Literature. Author: She authored the biography At The Wheel Of Research, which chronicles the life and work of Dr. Soumya Swaminathan, the former Chief Scientist at the WHO. Key Focus: She combines scientific accuracy with storytelling, translating complex medical research into compelling public and human-interest narratives. Awards and Recognition Anuradha has won several awards including the Press Council of India's national award for excellence in journalism under the gender based reporting category in 2019 and the Laadli Media award (gender sensitivity -2024). A recipient of the Lokmat journalism award (gender category-2022), she was also shortlisted for the RedInk awards for excellence in journalism-2021. Her debut book At The Wheel Of Research, an exclusive biography of Dr Soumya Swaminathan the inaugural chief scientist of World Health Organisation was also nominated in the Popular Choice Category of JK Paper AUTHER awards. She has also secured competitive fellowships including the Laadli Media Fellowship (2022), the Survivors Against TB – New Research in TB Media Fellowship (2023) and is part of the prestigious 2025 India Cohort of the WomenLift Health Leadership Journey.” Recent Notable Articles (Late 2025) 1. Cancer & Specialized Medical Care "Tata Memorial finds way to kill drug-resistant cancer cells" (Nov 26, 2025): Reporting on a breakthrough for triple-negative breast cancer, one of the most aggressive forms of the disease. Discipline, diet and purpose; How a 97-year-old professor defies ageing'' (Nov 15, 2025) Report about Prof Gururaj Mutalik, the first Head of Department at Pune's B J Government Medical College who at 97 credits his longevity to healthy habits and a strong sense of purpose. 2. Environmental Health (The "Breathless Pune" Series) Long-term exposure even to 'moderate' air leads to chronic heart, lung, kidney issues" (Nov 26, 2025): Part of an investigative series highlighting that even "safe" pollution levels are damaging to vital organs. "For every 10 µg/m3 increase in PM2.5 level, there was 6-8% jump in medicine sales" (Nov 23, 2025): Using commercial data to prove the direct link between air quality and respiratory illnesses in Pune. 3. Lifestyle & Wellness News "They didn't let cancer, diabetes and heart disease stop them from travelling" (Dec 22, 2025): A collaborative piece featuring survivors who share practical tips for traveling with chronic conditions. At 17, his BP shot up to 200/120 mmHG; Lancet study flags why child and teen hypertension doubled between 2000 and 2020'' (Nov 12,2025)--A report that focusses on 17-year-old-boy's hypertensive crisis and reflects the rising global trend of high blood pressure among children and adolescents. 4. Scientific Recognition & Infrastructure For promoting sci-comm, gender diversity: IUCAA woman prof highlighted in Nature" (Nov 25, 2025): Covering the global recognition of Indian women scientists in gender studies and physics. Pune researchers find a spiral galaxy like the Milky Way from early universe'' (December 3, 2025)- A report on how Indian researchers discovered a massive galaxy that existed when the universe was just 1.5 billion years old , one of the earliest to have been observed so far. Signature Beat: Health, Science & Women in Leadership Anuradha is known for her COVID-19 reportage, where she was one of the first journalists to provide detailed insights into the Covishield and Covaxin trials. She has a dedicated interest in gender diversity in health and science, often profiling women researchers who are breaking the "leaky pipeline" in STEM fields. Her writing style is scrupulous, often featuring interviews with top-tier scientists and health experts from various institutions. ... Read More

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