Cipla has strongly disputed the Maharashtra FDA's decision to cancel its drug sale and distribution licences for the C&F warehouse in Wadki, Pune, calling the action "disappointing" and "unfair." According to the company's statement to NDTV Profit, Cipla maintains that "our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards." The pharmaceutical giant is reviewing the order and evaluating further options while reiterating its "unwavering commitment to quality and patient safety." Cipla emphasized that it would "continue working to ensure uninterrupted access to safe, high-quality medicines for patients and healthcare providers."
India's apex drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), may consider a proposal to review the correct disposal of machinery from non-compliant or closed pharmaceutical units to stop potential diversion for manufacturing spurious or contraband drugs. This initiative comes after the Rajasthan drug control department raised the issue at a recent meeting of the Drugs Consultative Committee (DCC) on September 18. According to the minutes of the meeting reviewed by Business Standard, the DCC deliberated on the proposal and opined that even if some regulatory framework is created, its implementation seems to be poor.
The DCC has asked the drug controller, Rajasthan, to submit a detailed proposal covering identification, manufacture or supply, ownership, transfer, decommissioning and disposal of pharmaceutical machinery. As reported by Business Standard, the proposal will also have to include new monitoring mechanisms, resource implications and other aspects such as scrap monitoring after disposal. The step comes at a time when recommendations from the National Human Rights Commission (NHRC) to curb spurious and counterfeit medicines have been sent to the DCC. These recommendations include implementation of a centralised registration system for medicines sold in India, along with a portal to track their movement through supply chains in real time and dynamic QR codes for authentication.
The regulatory crackdown gained momentum with Maharashtra FDA revoking Cipla Pharma & Life Sciences Ltd's drug sale and distribution licences for its C&F warehouse in Wadki, Pune. According to the FDA statement, the Division 3 Assistant Commissioner (Drugs) issued the licence-cancellation order on October 1, following fresh regulatory review conducted in line with the Bombay High Court's directives. The latest order follows an earlier regulatory action against the facility on August 27, with the regulator citing alleged misbranding of Reactin Plus, storage deficiencies, record discrepancies and lapses in handling expired medicines. The Maharashtra FDA issued a revised show-cause notice on September 4, followed by Cipla's written response and a personal hearing before the final decision.
The regulatory measures come after Rajasthan saw several cases of distribution of spurious drugs in the last few months. According to reports from Business Standard, at least seven women died in Kota and Bikaner districts of Rajasthan due to complications caused by postpartum administration of spurious oxytocin injections. The state drug control department cancelled the licence of a Kota-based pharma distributor over the alleged sale of several batches of spurious oxytocin injections and other irregularities. In a separate case, the state drug control department also seized spurious and expired drugs worth ₹4 crore from a pharma warehouse in Haryana's Bhiwani in September 2026.
