Bombay HC quashes FDA order against J&J baby talc

In a major relief for Johnson & Johnson, the Bombay High Court on Wednesday set aside the orders of Maharashtra’s Food and Drug Administration (FDA) department that had restrained the local unit of the US personal care and pharma major from manufacturing baby powder in its facility in Mumbai.

The court also quashed the orders of the state authority that had directed the company to recall the products from the market and has now permitted the company to sell its product manufactured at this facility. “The failure of FDA to act with utmost dispatch is contrary to the provision of the Drugs and Cosmetics Act,” observed a division bench of Justice GS Patel and Justice SG Dige in its oral order. “It is too late now to fall back on a single batch sample of 2018 not tested till 2019 and not acted on till 2022 to stop the manufacture of all batches of baby powder.”

The court also observed that “Public welfare and consumer protection is at the heart of the Drugs and Cosmetics Act and the delays are unreasonable”.

The detailed order was not available till press time Wednesday. In this case, the local subsidiary of the US pharmaceutical firm had challenged the state government’s decision to revoke its licence.