Johnson & Johnson baby talc: Bombay High Court allows production despite expired licence

Mumbai: The Bombay High Court on Friday allowed Johnson & Johnson to continue manufacturing baby powder, the manufacturing licence for which expired on December 15. 

However, a division bench of Justices RD Dhanuka and Milind Sathaye continued the restraint on the company from selling the product. 

The court was hearing a petition filed by J&J challenging two orders of the state government – one dated Sept 15 by the Food and Drugs Administration (FDA) Joint Commissioner and Licensing Authority cancelling its licence with effect from Dec 15, 2022; and second order dated Sep 20 by the FDA Commissioner directing the company to immediately stop manufacturing and sale of baby powder.

Owing to the cancellation of the licence, the firm’s counsel Venkatesh Dhond requested the court to urgently hear the plea. However, due to paucity of time, the court kept the petition for hearing on Jan 3, 2023. 

Dhond also pointed out that they have not been able to sell their product despite two government approved laboratories stating that the samples met statutory requirements. The Central Drug Testing Laboratory (Western Zone) and FDA laboratory at Bandra-Kurla Complex submitted their reports stating that the firm’s Mulund facility adheres to the legal requirements on quality. 

Dhond said the restraint continues “only because of some erroneous report which they (government) obtained”. He also pointed out that the government had taken the samples in 2019 from their factory but were sent for testing only in 2020. 

When the court refused to allow sale of the product, Dhond said they may be protected as the revocation of their licence has come into effect. The bench continued the Dec 2 order, which allowed them to manufacture but not sell the product.