Johnson & Johnson moves Bombay High Court against cancellation of license in Maharashtra

Johnson & Johnson Private Limited has approached the Bombay High Court challenging the cancellation of cosmetic manufacturing license of its baby powder facility in Maharashtra.

The petition filed through Nishith Desai advocates pointed out that the Joint Commissioner & Licensing Authority, Food and Drug Administration, Maharashtra issued an order on September 15 cancelling the company’s license, effective from December 15, 2022.

Five days later, the commissioner reviewed the order and directed the company to stop manufacture and sale of the baby powder manufactured at a facility in Mulund, Maharashtra with immediate effect on the ground that the baby powder did not conform to the statutory requirements.

An appeal was filed before the Minister of FDA which was rejected on October 19. The Minister also refused to stay the effect of the commissioner's order. 

Since there was no statutory appeal available before the company, it approached the High Court through a writ petition. 

During the hearing which took place on Wednesday, Senior Advocate Ravi Kadam, appearing for the company, sought a stay on the order till the petition is finally disposed of. 

Additional Government Pleader Jyoti Chavan sought for sometime to respond to the petition. The State was permitted to file its reply till November 9.

Kadam then asked for directions from the Court to examine the report of CDTL, Kolkata which was referred to in the FDA orders. 

This was permitted by a vacation bench of Justices NJ Jamadar and Sharmila Deshmukh and the matter was posted for hearing on November 10.

The petition stated that the order was passed by the Minister despite having provided stability reports and test reports of the latest batches of the talcum powder. 

The company had also allegedly assured that it would submit pH reports of the product. 

The order failed to refer to the alleged lab report on the basis which the orders under challenged came to be passed.

The petitioner also claimed that the orders by the FDA authorities referred to two samples of the powder submitted in 2018 and 2019. 

Importantly, in 2020, the Assistant Commissioner of FDA conducted an inspection and both batches were found to be within the specification limits of pH. Accordingly, the license, which was issued first in 1965, was renewed.

The petitioner also pleaded that there existed no rules through which the authorities could cancel or suspend cosmetic licenses. 

In light of this, the company sought quashing of the orders passed by the FDA authorities. 

[Read order]