Manufacture Baby Powder At ‘own Risk’ Hc Tells J&j, Legal News, ET LegalWorld – Legal Firms

MUMBAI: Bombay high court on Wednesday in an interim relief to Johnson and Johnson Pvt Ltd which is fighting a bar placed by the FDA, permitted it to manufacture its baby powder at the Mulund plant in Maharashtra at the company’s “own risk,”.

The company said it would not offer the product then for sale or distribution till the next hearing, which the HC accepted. In September the state Food and Drug Administration (FDA) passed an order to stop manufacturer and sale of Johnson’s baby powder at the Mulund facility after finding a 2018 sample had pH levels beyond permissible limits.

The high court also directed that re-examination of samples of Johnson and Johnson’s baby powder at two government and a private laboratory and said the assessment be completed within two weeks. A bench of Justices A V Gangapurwala S G Dige directed FDA, the top drug regulating body of Maharashtra, to collect baby powder samples and submit them to two government laboratories and one private lab for the re-testing. The HC was hearing the company’s plea challenging the government order that cancelled its baby powder manufacturing licence for the Mulund plant in Mumbai.

J&J had challenged the order of minister for Food and Drug Administration (FDA) Sanjay Rathod upholding the September FDA order stopping production and sale of baby powder from the Mulund plant. The HC will hear the plea next on November 30.

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