Wednesday, December 6, 2023

Johnson & Johnson moves Bombay High Court against Maharashtra government cancelling manufacturing licence for its baby powder

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A writ petition has been filed in the Bombay High Court, challenging the Maharashtra government’s decision to cancel the cosmetic manufacturing licence of Johnson & Johnson Private Limited for manufacture and sale of baby powder at its Mulund factory.

Filed by Advocate Nishith Desai, the plea contended that the Joint Commissioner & Licensing Authority, Food and Drug Administration, Maharashtra, had issued an order on September 15 cancelling the company’s licence, effective from December 15 this year.   

The order was reviewed by the Commissioner after five days, who directed the company to stop manufacturing and selling of the baby powder at a facility in Mulund with immediate effect on the ground that the baby powder did not conform to the statutory requirements.

The company then filed an appeal before the Minister of FDA, who rejected it on October 19 and even refused to stay the Commissioner’s order.

Johnson & Johnson then filed a writ petition in the High Court.

On October 26, the Vacation Bench of Justice N.J. Jamadar and Justice Sharmila Deshmukh directed the state government to file an affidavit on the matter by November 9, after Additional Government Pleader Jyoti Chavan sought time to respond to the petition.

Representing Johnson & Johnson, Senior Advocate Ravi Kadam sought a stay on the order till the petition was finally disposed of.

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

The High Court gave him permission and fixed November 10 as the next date of hearing.

As per the petitioner, the order was passed by the FDA Minister, despite having provided stability reports and test reports of the latest batches of talcum powder. The company had also assured that it would submit pH reports of the product.

Kadam said the government order failed to refer to the alleged lab report on the basis of which the orders under challenge came to be passed.

He further claimed that the orders by FDA authorities referred to two samples of the powder submitted in 2018 and 2019.

As per the Counsel, the Assistant Commissioner of FDA had conducted an inspection in 2020 and found both batches of the talcum powder to be within the specification limits of pH. The Commissioner then renewed the licence, which was issued first in 1965.

The petition sought quashing of the orders passed by the FDA authorities on the basis of the fact that no rules existed, by way of which, the authorities could cancel or suspend cosmetic licences.

(Case title: Johnson and Johnson Pvt. Ltd. vs State of Maharashtra and Ors)

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