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Bombay HC reserves order Johnson & Johnson plea challenging FDA order

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| Photo Credit: Reuters

The Bombay High Court reserved its order on a petition filed by Johnson & Johnson challenging an order by the Maharashtra Food and Drug Administration for cancelling their licence to manufacture baby powder at a plant in Mumbai.

A Division Bench of Justices G.S. Patel and S.G. Dhige was hearing the petition filed by the company.

The petition mentioned, тАЬOn September 15, the Joint Commissioner and Licensing Authority, FDA, Maharashtra issued an order cancelling the companyтАЩs licence, effective from December 15, 2022. In December 2018, the FDA during a random inspector took samples of the baby powder and found it to be тАЬnot of standard quality.тАЭ The State had then revoked the licence citing public interest and in September 2022, cancelled it and directed the company to recall the stock of the powder from the market.

The Bench reserved the order on the plea and asked┬аunder which Rule could a manufacturer re-start production of a product.┬аThe court also told the State government to be vigilant with respect to a medicinal consumer product especially with big pharma companies because their production level is very high.

Senior advocate Ravi Kadam┬аappearing for the company, said┬аthat the Central Drug Testing Laboratory Kolkata is being considered as a gospel, which finds┬аthe productтАЩs pH level┬аwithin permissible limits.

In the last hearing, the court had suggested the State FDA to carry out┬аfresh testing of samples of baby powder and take swift action.┬аAnother Bench had opined that the company adhered to all legal requirements after receiving results of samples.┬а

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