One of the country's most trusted pharmaceutical institutions, Cipla, recently faced a turbulent period after the Maharashtra Food and Drug Administration took strict regulatory action against its operations. The state drug regulator cancelled the sales license for the company's facility located in Pune, triggering a legal battle that eventually reached the judiciary. The Bombay High Court intervened strongly in the matter, rebuking the regulatory body and directing it to retract the cancellation order, which ultimately brought substantial relief to the firm.
A division bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad pulled up the regulatory authorities during the hearings, stating that the action taken against the facility violated the basic principles of natural justice and crossed arbitrary boundaries. Following the strict judicial observations, the drug regulator agreed to immediately withdraw the order that scrapped the license and confirmed that a fresh show-cause notice would be issued to the company. A reasoned order will be passed subsequently after following due procedure.
The controversy centers around the storage and distribution warehouse of Cipla Pharma and Life Sciences Limited situated in Wadki, Pune. The regulatory body had initially revoked the drug sales license for this storage facility effective August 27. The punitive measure was initiated over allegations of serious irregularities linked to the packaging, storage practices, and the failure to recall a specific medication batch from the market, prompting severe scrutiny from state inspectors.
Challenging the decision promptly, the company approached the court through legal representation. Senior advocate Abad Ponda, appearing for the firm, informed the bench that the regulatory authority had sent an email on August 26 directing company representatives to appear for a hearing on the very same day. He pointed out that August 26 was a public holiday, making it impossible for any representative to attend, and noted that the company had formally requested an adjournment, which was disregarded when the order was passed regardless.
Defending the department, additional government pleader P. P. Kakade argued that the governing laws do not strictly mandate an opportunity of hearing for the company in such matters. This argument drew sharp questioning from the bench, which asked why the department bothered emailing the company to send a representative in the first place, particularly on a day declared as a public holiday by the government. The high court observed that while the regulator performs commendable work, it cannot overstep legal boundaries, adding that mistakes were made which needed rectification.
Earlier inspections by the Maharashtra FDA at the Pune unit had uncovered multiple alarming shortcomings concerning storage and record maintenance. Officers found pharmaceutical products scattered directly on the warehouse floor without adequate pallet or rack infrastructure to keep them off the ground. Furthermore, a wide discrepancy was detected between the inventory recorded in the computer systems and the physical stock present inside the godown, alongside incomplete purchase, sales, and expired drug records.
A key trigger for the dispute involved packaging claims regarding the product Reactin Plus. The regulator flagged claims printed on the packaging of this Schedule H drug suggesting specific therapeutic uses for pain and fever management, which authorities deemed inconsistent with regulatory norms. Officials had seized stock valued at over eleven lakh rupees and instructed the company to recall the tablets from circulation. The failure to satisfactorily execute this recall ultimately culminated in the drastic step of license revocation, which the high court has now brought under judicial review.
