Maharashtra Food and Drug Administration has cancelled the drug sale and distribution licences of Cipla Pharma’s warehouse in Pune (Representative image)
The latest order was passed on Oct 1 by Assistant Commissioner (Drugs), Division 3, FDA Pune, after the department withdrew its earlier proceedings in compliance with the directions of high court, FDA said. It held the claims, wording and illustrations did not comply with statutory provisions and constituted an issue of misbranding under Drugs and Cosmetics Act, 1940. PTI You Can Also Check: Gold Rate in Mumbai | Silver Rate in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai | Mumbai AQI | Weather in Mumbai | Petrol Price in Mumbai | Diesel Price in Mumbai | CNG Price in Mumbai | LPG Price in Mumbai Stay updated with the latest Mumbai news.
MUMBAI: Maharashtra Food and Drug Administration (FDA) on Friday said it has cancelled the drug sale and distribution licences of Cipla Pharma & Life Sciences Ltd’s carrying and forwarding warehouse at Wadki in Pune over alleged violations, a decision the firm said was “disappointing”. The action was taken after completion of fresh proceedings in compliance with the directions of Bombay High Court, FDA said in a statement. FDA said the latest decision was not merely a repetition of its earlier action but an independent regulatory decision taken after completing the entire process afresh in accordance with the court’s directions. FDA said the packaging carried a human figure and depicted the medicine as providing relief from muscular pain. FDA commissioner Tukaram Mundhe said the latest proceedings had been completed while fully respecting court directions and following principles of natural justice, transparency, an opportunity of hearing and a reasoned decision. In a statement, Cipla said it maintains an unwavering commitment to quality and patient safety. We believe our Pune C&FA warehouse operates in compliance with distribution and storage protocols and digital record-keeping standards,” it said. “Cipla remains fully dedicated to ensuring uninterrupted access to safe, high-quality medicines for patients and healthcare providers,” the statement added.
One of the key issues involved Reactin Plus. FDA found the drug’s packaging carrying claims describing it as an analgesic and promoting its use for conditions including headache, muscular pain, backache, joint pain, sprain, body ache and toothache. It further listed deficiencies in storage and warehouse management. “We find the Maharashtra FDA’s decision regarding our Wadki C&FA in Pune disappointing. Cipla added it is reviewing the order and evaluating further options. Download the TOI App.
It follows an earlier FDA action taken against the facility on Aug 27 over alleged irregularities involving the packaging, storage, documentation and recall of Reactin Plus Tablets. The department issued a revised show-cause notice to the company on Sept 4, according to the statement. Cipla submitted its written reply on Sept 11 and was given a personal hearing on Sept 21.
The FDA had cited unauthorised claims on the packaging of the Schedule H prescription drug and several deficiencies at the warehouse. The licensing authority considered the company’s reply, submissions made during the hearing, inspection findings, available records and applicable legal provisions before passing the fresh order. High Court Pulls Up Tukaram Mundhe’s Food Safety Body
Earlier reporting noted: The drug sale and distribution licences of a Pune warehouse of Cipla Pharma and Life Sciences Ltd have been suspended by the Maharashtra Food and Drug Administration (FDA) over alleged misbranding and storage violations. Earlier reporting noted: READ | “Do You Feel You Are A Lord?