PUNE: Hours after the Bombay High Court accused the Maharashtra Food and Drugs Administration (FDA) of going “overboard” and acting in a “high-handed” manner, the regulator on Saturday withdrew its order cancelling the drug sale licence of Cipla Pharma and Life Sciences Ltd’s carrying and forwarding (C&F) facility at Wadki in Pune.
As no company representative was available on the holiday, Cipla sought an adjournment. Additional government pleader P P Kakade, appearing for the FDA, argued that the law did not give the company a right to a hearing. The bench questioned the regulator’s decision to schedule the hearing on a public holiday and then proceed with the cancellation after the company sought more time. The court also questioned whether it was fair and transparent for the FDA to ask the company to send a representative for a hearing on a public holiday. It noted that government departments themselves often seek adjournments on the ground that they cannot work on holidays. The FDA subsequently informed the court that it was withdrawing the cancellation order and would initiate the process afresh.
The regulator had cancelled the drug sale licence of Cipla’s C&F facility with effect from August 26 over alleged irregularities relating to the packaging, storage and recall of Reactin Plus tablets. Senior counsel Aabad Ponda, appearing for Cipla, told the bench that the FDA had directed the company to appear for a hearing on August 27 — a public holiday declared by the Maharashtra government.
The FDA told the court that it would withdraw the cancellation order with immediate effect, issue a fresh show-cause notice to Cipla and, after considering the company’s response, pass a reasoned order. The FDA, however, proceeded to cancel the licence the same day without granting the company a hearing, Ponda said. Ponda told the bench that the court had given the regulator the option of withdrawing the order or having the court decide the matter.
Cipla challenged the action before the High Court.
