Bombay HC pulls up Maharashtra FDA over Cadila drug ban, says powers must be used judiciously

The Bombay High Court has pulled up the Maharashtra Food and Drug Administration (FDA) over its action against pharmaceutical company Cadila Pharmaceuticals, questioning the manner in which the regulator exercised its powers while restricting the sale and distribution of medicines worth around Rs2.45 crore. The case relates to Cadila’s Aciloc range of medicinesand concerns raised by the FDA over similarities in the branding and packaging of different variants.

What triggered the FDA action?

The dispute followed FDA inspections conducted on 9 and 10 Julyat Cadila-linked carrying and forwarding agent warehouses in Pune, Nagpur and Bhiwandi. The regulator raised concerns over four products — Aciloc 150, Aciloc 300, Aciloc 150 Plus and Aciloc 300 Plus. The FDA’s concern was that while Aciloc 150 and Aciloc 300 contain ranitidine, the “Plus” variants contain famotidine, a different active pharmaceutical ingredient.

However, the branding and packaging of the products were considered sufficiently similar by the regulator to potentially cause confusion among doctors, pharmacists or patients. The FDA subsequently restricted the sale and distribution of the affected stock and also directed that the products be recalled from the market. The value of the stock covered by the stop-sale action was approximately Rs2.45 crore.

Why did Cadila approach the court?

Cadila challenged the FDA's action before the Bombay High Court, arguing that the regulator had taken the drastic step without first giving the company an opportunity to explain its position. During the hearing, the court questioned whether the FDA could take such action first and hear the pharmaceutical company later. The bench stressed that regulatory powers, even when exercised in the interest of public health, must be used judiciously and with due process.

Following the court's intervention, the FDA agreed to revoke the earlier orders, issue show-cause notices to Cadila, hear the company's response and subsequently pass a reasoned order. The court's intervention does notamount to a clean chit for Cadila. The FDA can still take action after completing the required procedure. The case comes amid Maharashtra FDA Commissioner Tukaram Mundhe's intensified enforcement drive, and could add to the wider debate over whether aggressive regulatory action is being balanced with procedural safeguards.