The Maharashtra Food and Drug Administration (FDA) has reinstated the drug sale licence for Cipla Pharma & Life Sciences Limited’s Pune unit. This decision comes after the Bombay High Court criticized the FDA for its previous cancellation of the licence, describing the regulator’s actions as ‘overboard’ and ‘high-handed.’ The court’s reprimand prompted the FDA to reverse its earlier order on Saturday.
What happened in the court? The FDA was represented by Additional Government Pleader P P Kakade, who argued that the law does not grant the company a right to a hearing. “You (FDA) are doing a laudable and appreciative job, but now you are going overboard. This is not the first time this is happening. “If the court does the same thing, will it be fair? The government refuses or seeks adjournments claiming they cannot work on holidays; then how has the state’s department passed an order like this on a public holiday,” the bench questioned.
Senior counsel Aabad Ponda, representing Cipla, told the bench on Saturday that the FDA had emailed the company asking its representatives to appear before the department for a hearing on August 26, which was a public holiday. The bench, however, disagreed with the submission and questioned why the department had emailed the drug company asking it to send a representative for a hearing, particularly when August 26 was a holiday declared by the state government.
You have wronged, and now you have to resolve the issue,” the high court said. The High Court also questioned whether it was “fair and transparent” for the FDA to email the company and ask it to send a representative for a hearing on the very same day.
