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Bombay HC permits Johnson & Johnson to produce and sell its baby powder, quashes Maharashtra FDA ban

The Bombay High Court has set aside an order passed by the Maharashtra Food and Drug Administration (FDA) which had restricted Johnson & Johnson to manufacture, sell and distribute its baby powder.
The company had moved the High Court in September 2022 against the orders of the FDA revoking the company’s licence and asking it to stop manufacturing and sale of baby powder, terming the orders “stringent, unreasonable and unfair”.
The regulator had earlier claimed that tests on baby powder samples showed that the pH levels — determine whether a substance is acidic or alkaline in nature — were higher than the prescribed limit.
The FDA had collected the samples in November 201, and issued a show-cause notice to Johnson & Johnson in 2021. Subsequently, in September last year, the FDA cancelled the product’s licence.
A division bench of Justices Gautam Patel and S G Dige came down heavily on the state Food and Drug Administration (FDA) for its delay in carrying out tests on a sample of Johnson & Johnson’s baby powder seized in December 2018.
The HC bench noted that it does not seem reasonable to close down the whole manufacturing process when there is a slight deviation in one of the products. The bench, however, said that it is important to maintain standards of quality and safety for cosmetic products.
The HC in its order said the fresh tests on baby powder showed all batches of the product were compliant with the norms prescribed.

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