{"id":1313448,"date":"2026-08-31T09:15:35","date_gmt":"2026-08-31T03:45:35","guid":{"rendered":"https:\/\/trak.in\/stories\/?p=1313448"},"modified":"2026-08-31T09:15:48","modified_gmt":"2026-08-31T03:45:48","slug":"bombay-high-court-pulls-up-maharashtra-fda-over-cipla-licence-cancellation-order-withdrawn","status":"publish","type":"post","link":"https:\/\/trak.in\/stories\/bombay-high-court-pulls-up-maharashtra-fda-over-cipla-licence-cancellation-order-withdrawn\/","title":{"rendered":"Bombay High Court Pulls Up Maharashtra FDA Over Cipla Licence Cancellation, Order Withdrawn"},"content":{"rendered":"\n

<\/p>\n\n\n\n

FDA Cancels Cipla\u2019s Pune Licence<\/strong><\/p>\n\n\n\n

The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences\u2019 Carry and Forwarding facility at Wadki in Pune<\/strong>, after the Bombay High Court criticised the regulator\u2019s approach.<\/p>\n\n\n\n

\"\"<\/figure>\n\n\n\n

The FDA had cancelled the licences with effect from August 27, citing several regulatory irregularities linked to the packaging, storage and recall of Reactin Plus tablets<\/strong>, a Schedule H prescription medicine.<\/p>\n\n\n\n

The decision was challenged by Cipla before the Bombay High Court.<\/p>\n\n\n\n

Court Questions FDA\u2019s Procedure<\/strong><\/p>\n\n\n\n

During the hearing, a bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad strongly questioned the manner in which the FDA had proceeded against the company.<\/a><\/em><\/p>\n\n\n\n

The court observed that the regulator appeared to have acted against the principles of natural justice<\/strong> and questioned whether Cipla had been given a proper opportunity to present its case before such a significant action was taken.<\/p>\n\n\n\n

The judges also criticised the FDA for going \u201coverboard\u201d<\/strong> and behaving in a \u201chigh-handed\u201d manner.<\/p>\n\n\n\n

Hearing Was Scheduled on a Public Holiday<\/strong><\/p>\n\n\n\n

A major issue raised before the court was the timing of the hearing offered to Cipla.<\/p>\n\n\n\n

According to the company’s legal counsel, the FDA had emailed Cipla asking a representative to appear before the department on August 26<\/strong>, which was a public holiday.<\/p>\n\n\n\n

Cipla sought an adjournment because it could not arrange for a representative to appear that day. However, the FDA proceeded to issue the cancellation order on the same day.<\/p>\n\n\n\n

The court questioned why the regulator had scheduled the hearing on a holiday and then proceeded with the cancellation without granting the company an effective opportunity to respond.<\/p>\n\n\n\n

FDA Agrees to Withdraw the Order<\/strong><\/p>\n\n\n\n

Following the court’s criticism, the Maharashtra FDA agreed to withdraw the licence cancellation order forthwith<\/strong>.<\/p>\n\n\n\n

The regulator will instead issue Cipla a fresh show-cause notice<\/strong> and reconsider the matter after giving the company an opportunity to respond.<\/p>\n\n\n\n

A fresh, reasoned order will subsequently be passed based on the proceedings.<\/p>\n\n\n\n

This means the withdrawal does not necessarily end the regulatory dispute. The FDA retains the ability to take further action after following the required procedure.<\/p>\n\n\n\n

What Led to the Original Cancellation?<\/strong><\/p>\n\n\n\n

The FDA’s initial action followed an inspection of Cipla’s main warehouse at Wadki in June.<\/p>\n\n\n\n

Officials had flagged several issues involving Reactin Plus tablets<\/strong>, including unauthorised promotional text on the packaging.<\/p>\n\n\n\n

The drug is classified as a Schedule H prescription medicine, for which advertising and promotional claims are subject to regulatory restrictions.<\/p>\n\n\n\n

The FDA had also seized Reactin Plus stock worth around \u20b911.19 lakh<\/strong> and directed the company to recall the affected medicine from the market.<\/p>\n\n\n\n

Stock and Storage Irregularities Also Flagged<\/strong><\/p>\n\n\n\n

The regulator’s inspection identified additional issues concerning the warehouse and inventory records.<\/p>\n\n\n\n

These included discrepancies between physical and computerised stock records, gaps in purchase and sale records and concerns regarding compliance with directions related to the recall of medicines.<\/p>\n\n\n\n

Inspectors also reportedly found medicines stored directly on the floor, along with inadequate arrangements involving pallets and racks.<\/p>\n\n\n\n

The FDA further raised concerns about procedures and records relating to expired medicines.<\/p>\n\n\n\n

Cipla Says There Is No Patient Safety Issue<\/strong><\/p>\n\n\n\n

Cipla had maintained that the regulatory action did not allege any concerns about the safety, quality or efficacy of its products<\/strong>.<\/p>\n\n\n\n

The company also said that the matter was under judicial consideration and therefore declined to comment extensively on the proceedings.<\/p>\n\n\n\n

This distinction is important because the dispute centres on regulatory compliance, packaging, storage and recall procedures rather than an allegation that the medicine itself was unsafe for patients.<\/p>\n\n\n\n

Why the Court\u2019s Intervention Matters<\/strong><\/p>\n\n\n\n

The case highlights the importance of following due process even when regulatory authorities identify potential violations.<\/p>\n\n\n\n

Drug regulators have significant powers to inspect pharmaceutical facilities and take action when companies allegedly breach rules. However, companies must also be given a meaningful opportunity to respond before major punitive measures are imposed.<\/p>\n\n\n\n

The High Court’s intervention has therefore shifted the immediate focus from the alleged violations to the procedure followed by the FDA<\/strong> while cancelling Cipla’s licences.<\/p>\n\n\n\n

Fresh Proceedings Likely<\/strong><\/p>\n\n\n\n

With the cancellation order withdrawn, the FDA is expected to begin the process again by issuing a fresh show-cause notice.<\/p>\n\n\n\n

Cipla will then have an opportunity to respond to the allegations before the regulator decides what action, if any, should follow.<\/p>\n\n\n\n

The outcome could determine whether the FDA ultimately imposes restrictions on the Pune facility or concludes the matter after considering the company’s response.<\/p>\n\n\n\n

A Regulatory Dispute, Not a Product Safety Recall<\/strong><\/p>\n\n\n\n

For consumers, the most important distinction is that the licence dispute does not establish that Reactin Plus was unsafe or ineffective.<\/p>\n\n\n\n

The FDA’s concerns relate to regulatory compliance involving packaging, storage, stock records and recall procedures.<\/p>\n\n\n\n

The Bombay High Court’s intervention has now ensured that the next stage of the dispute will take place through a fresh regulatory process, with Cipla given another opportunity to defend its position.<\/p>\n\n\n\n

Summary<\/strong><\/p>\n\n\n\n

The Maharashtra FDA has withdrawn its order cancelling Cipla Pharma & Life Sciences\u2019 Pune drug sale licences after the Bombay High Court criticised the regulator for going \u201coverboard\u201d and violating principles of natural justice. The FDA had cited packaging, storage, stock-record and recall-related violations involving Reactin Plus. A fresh show-cause notice will now be issued before any further decision.<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA Cancels Cipla\u2019s Pune Licence The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences\u2019 Carry and Forwarding facility at Wadki in Pune, after the Bombay High Court criticised the regulator\u2019s approach. The FDA had cancelled the licences with effect from August 27, […]<\/p>\n","protected":false},"author":30,"featured_media":1313449,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[21],"tags":[10502,6990,10503],"class_list":["post-1313448","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business","tag-cipla","tag-fda","tag-tukaram"],"acf":[],"yoast_head":"\nBombay High Court Pulls Up Maharashtra FDA Over Cipla Licence Cancellation, Order Withdrawn - Trak.in - Indian Business of Tech, Mobile & Startups<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/trak.in\/stories\/bombay-high-court-pulls-up-maharashtra-fda-over-cipla-licence-cancellation-order-withdrawn\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bombay High Court Pulls Up Maharashtra FDA Over Cipla Licence Cancellation, Order Withdrawn - Trak.in - Indian Business of Tech, Mobile & Startups\" \/>\n<meta property=\"og:description\" content=\"FDA Cancels Cipla\u2019s Pune Licence The Maharashtra Food and Drug Administration (FDA) has withdrawn its order cancelling the drug sale licences of Cipla Pharma & Life Sciences\u2019 Carry and Forwarding facility at Wadki in Pune, after the Bombay High Court criticised the regulator\u2019s approach. 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