A day after the drug sale licences of Cipla Pharma &amp; Life Sciences Ltd’s Carry and Forwarding (C&amp;F) facility at Wadki in Pune was cancelled, citing serious irregularities linked to Reactin Plus tablets, the Maharashtra Food and Drug Administration (FDA) withdrew its order after the Bombay High Court rapped the regulator for going “overboard” and acting in a “high-handed” manner.&nbsp;A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad while hearing the case in which Cipla challenged FDA's action said the regulator had followed an improper procedure and acted against the “principles of natural justice”.&nbsp;"You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue," the high court said.&nbsp;<h2>Why had FDA cancelled Cipla's sales licence?</h2>&nbsp;According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines.&nbsp;The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine.&nbsp;The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication.&nbsp;Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations. &nbsp;

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad while hearing the case in which Cipla challenged FDA's action said the regulator had followed an improper procedure and acted against the “principles of natural justice”.

A day after the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) facility at Wadki in Pune was cancelled, citing serious irregularities linked to Reactin Plus tablets, the Maharashtra Food and Drug Administration (FDA) withdrew its order after the Bombay High Court rapped the regulator for going “overboard” and acting in a “high-handed” manner. A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad while hearing the case in which Cipla challenged FDA's action said the regulator had followed an improper procedure and acted against the “principles of natural justice”. "You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. You have wronged, and now you have to resolve the issue," the high court said. Why had FDA cancelled Cipla's sales licence? According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines. The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine. The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication. Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations.

A bench of Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad while hearing the case in which Cipla challenged FDA's action said the regulator had followed an improper procedure and acted against the “principles of natural justice”.

'You are going overboard': HC raps FDA over Cipla Pune licence cancellation

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma &amp; Life Sciences Ltd’s Carry and Forwarding (C&amp;F) facility at Wadki in Pune, citing serious irregularities linked to Reactin Plus tablets. According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines.<h2>Reactin Plus packaging violation</h2>The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine.The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication.<h2>Medicines worth ₹11.19 lakh seized</h2>Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations.&nbsp;Also Read: <a href="https://www.wionews.com/defence-pulse/javelin-missile-explained-how-india-s-new-anti-tank-weapon-uses-fire-and-forget-technology-to-hit-armoured-targets-1787925604825">Javelin missile explained: How India's new anti-tank weapon uses 'fire-and-forget' technology to hit armoured targets</a><h2>FDA flags storage and distribution lapses</h2>A subsequent inspection of Cipla’s C&amp;F operations revealed several additional irregularities involving the storage and distribution of medicines. The FDA found discrepancies between physical stock and computerised inventory records. Inspectors also identified gaps in purchase and sales records and alleged non-compliance with directions issued for the recall of medicines. The inspection further found medicines stored directly on the floor, along with inadequate pallet and rack facilities at the facility. The FDA also flagged shortcomings in the maintenance of records and procedures for dealing with expired medicines.<h2>Show-cause notice issued to company</h2>Before cancelling the licences, the FDA issued a show-cause notice to the company concerning the alleged violations. The regulator examined Cipla’s response before proceeding with the cancellation under the applicable provisions of the Drugs and Cosmetics Act and Drugs Rules. The licence cancellation came into effect on August 27, according to FDA officials.

Maharashtra FDA cancels Cipla’s Pune C&F drug sale licences over Reactin Plus packaging violations, stock discrepancies, storage lapses and recall issues

The Maharashtra Food and Drug Administration (FDA) has cancelled the drug sale licences of Cipla Pharma & Life Sciences Ltd’s Carry and Forwarding (C&F) facility at Wadki in Pune, citing serious irregularities linked to Reactin Plus tablets. According to FDA officials, the licences were cancelled with effect from August 27 following inspections that revealed violations related to the storage, distribution and packaging of medicines. Reactin Plus packaging violation The action followed an inspection of the company’s main warehouse in June. During the inspection, FDA officials found unauthorised promotional wording on the packaging of Reactin Plus, which is classified as a Schedule H prescription medicine. The words “analgesic and antipyretic” were printed on the packaging, according to the FDA. The regulator said such promotional information on a prescription medicine could encourage consumers to use the drug without consulting a doctor, potentially increasing the risk of self-medication. Medicines worth ₹11.19 lakh seized Following the inspection, the FDA seized Reactin Plus stock valued at ₹11.19 lakh and directed the company to recall the medicine from the market. The regulator cited provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, while taking action over the packaging violations. Also Read: Javelin missile explained: How India's new anti-tank weapon uses 'fire-and-forget' technology to hit armoured targets FDA flags storage and distribution lapses A subsequent inspection of Cipla’s C&F operations revealed several additional irregularities involving the storage and distribution of medicines. The FDA found discrepancies between physical stock and computerised inventory records. Inspectors also identified gaps in purchase and sales records and alleged non-compliance with directions issued for the recall of medicines. The inspection further found medicines stored directly on the floor, along with inadequate pallet and rack facilities at the facility. The FDA also flagged shortcomings in the maintenance of records and procedures for dealing with expired medicines. Show-cause notice issued to company Before cancelling the licences, the FDA issued a show-cause notice to the company concerning the alleged violations. The regulator examined Cipla’s response before proceeding with the cancellation under the applicable provisions of the Drugs and Cosmetics Act and Drugs Rules. The licence cancellation came into effect on August 27, according to FDA officials.

Maharashtra FDA cancels Cipla’s Pune C&amp;F drug licences after Reactin Plus packaging, storage, stock records and recall violations were found

Maharashtra FDA cancels Cipla facility drug licences over Reactin Plus irregularities

cipla-pharma

Cipla Pharma, News on Cipla Pharma, stories on Cipla Pharma, articles on Cipla Pharma, Cipla Pharma stories at Wion, Cipla Pharma news, Cipla Pharma latest news

cipla pharma

'You are going overboard': HC raps FDA over Cipla Pune licence cancellation

Cipla faces FDA action as Reactin Plus violations lead to licence cancellation