Bombay High Court pulls up FDA for 'high-handed' cancellation of Cipla drug licences

The Bombay High Court on Saturday pulled up the Maharashtra Food and Drug Administration (FDA) for going overboard and high-handedly by cancelling the wholesale drug sale licences of Cipla Pharma & Life Sciences Limited [Cipla Pharma and Life Sciences v. State of Maharashtra & Ors]

A division bench of acting Chief Justice Ravindra V Ghuge and Justice Gautam A Ankhad reprimanded the regulatory body for its hasty conduct.

Cipla approached the Court after the FDA cancelled its wholesale drug licences governing operations at its primary distribution hub in Wadki, Pune.

The pharmaceutical firm highlighted in its petition that the warehouse services around 180 customers and distributes over 4,30,000 units of medicines monthly across Maharashtra.

“Notice of hearing was given on August 26 on a state holiday and your office was not open. How is it appropriate, fair and transparent? This is what we keep on telling you. You are doing a laudable job, an appreciable job, but working overboard. And this is not the first time this has happened,” Chief Justice Ghuge said. 

After the Court's strong remarks, the State government pleader told the bench that the cancellation order would be withdrawn immediately. 

The authority confirmed that a fresh notice will be served on the company before September 4.

The legal dispute stemmed from inspections conducted at the Wadki facility of Cipla in June and August.

FDA officials alleged that therer were packaging and artwork irregularities involving the drug 'Reactin Plus'.

The department issued a show-cause notice on August 13, to which Cipla submitted a detailed reply on August 25.  

The FDA then summoned company representatives for a personal hearing on August 26, which was a State holiday.

When Cipla deputed an administrative employee solely to deliver a written request for adjournment, the authority handed over the final cancellation order instead.  

The Court today stressed on the necessity of procedural fairness.

"As you normally say, that justice must not only be done, but must appear to be done. Show us that you had given them sufficient time for hearing. You have followed a wrong procedure and set it aside. We are giving you a chance. You have done something high-handedly," the Bench remarked.  

Justice Ankhad also questioned the legal validity of the decision.

"How is your order sustainable considering violation of natural justice?" he asked. 

The Court recorded the FDA's statement that it will withdrawing the decision.

The High Court advised the department not to conduct hearings on public holidays unless faced with a dire emergency.

With these directions, it disposed of the petition.

Senior advocate Aabad Ponda with advocate Ranjeet Sangle appeared for Cipla.

Government pleader PP Kakade appeared for FDA.