Bombay High Court Pulls Up FDA Over Drug Sale Licence Revocation
The Bombay High Court took strong exception to the procedure followed by the Food and Drug Administration (FDA) in revoking the drug sale licence of a pharmaceutical unit, observing that the authority acted against the principles of natural justice.
A bench comprising Acting Chief Justice Ravindra Ghuge and Justice Gautam Ankhad was hearing a petition filed by Cipla Pharma and Life Sciences Limited challenging the FDA's August 27 order, which had cancelled licences for its carry and forwarding unit at Vadki in Pune.
The FDA had initiated action against the company over alleged unauthorised text on the packaging of its drug 'Rectin Plus', along with deficiencies in purchase-sale records and drug storage.
Senior counsel Abad Ponda, representing the company, submitted that the FDA's order raised no questions regarding the safety, quality, or efficacy of the products and did not involve any patient safety issue.
The court was informed that the FDA sent an email on August 26, a public holiday, directing the company to appear for a hearing on that very day. When the company requested an adjournment because no representative was available, the authority passed the revocation order without conducting a hearing.
Additional Government Pleader Priyabhushan Kakade, appearing for the FDA, argued that the company did not have a legal right to a hearing under the law.
The bench questioned the FDA's conduct in sending an email on a public holiday and expecting immediate attendance, pointing out that government authorities themselves frequently seek adjournments citing holidays. The court remarked that the authority had made a mistake and was acting beyond its limits, noting this was not the first instance of such conduct.
Following the bench's observations, the FDA informed the court that it would withdraw the revocation order and issue a fresh show-cause notice. The regulator stated that a final order would be passed only after considering the company's response. The court recorded the statement and disposed of the petition.
