Johnson & Johnson baby powder: Bombay HC seeks FDA's opinion after clear Lab reports

Johnson & Johnson baby powder: Bombay HC seeks FDA's opinion after clear Lab reports

On Friday, the Bombay High Court's division bench of Justices SV Gangapurwala and SG Chapalgaonkar made a preliminary finding that Johnson & Johnson baby powder manufactured at the company's Mulund facility in Maharashtra meets legal quality standards. The court ordered that copies of the reports be given to the petitioner and scheduled a hearing for December 6, 2022. The bench was hearing the company's petition against the FDA's cancellation of its licence to manufacture baby powder at its Mulund factory.

The Court made the following observations after reviewing the reports:

·         The FDA laboratory at Bandra-Kurla Complex reported that the sample met the statutory requirement;

·         The Intratech Laboratory (private lab) reported that the reading was not stable as per the procedure; and

·         The Central Drug Testing Laboratory, Western Zone reported that the sample met the requirements.

Before passing any order, the Court stated that it will hear what Additional Government Pleader Milind More has to say. The Court denied Kadam's request and maintained that the company would not be allowed to sell or distribute its baby powder until the next hearing date.

On December 6, the case will be heard again.

JJB's licence was revoked on September 15 by Maharashtra's apex drug regulatory body on the grounds that a batch of the powder tested at the Central Drugs Testing Laboratory had a slightly higher pH than prescribed. Later, the company was also told to recall their stocks. The FDA conducted a random check on J&J's powder in Pune and Nashik in December 2018, sparking an investigation.

The petitioner argued that there was no statutory requirement for the licence to be suspended or cancelled if a batch was found to be of poor quality.

The FDA has suspended or cancelled licences for 27 cosmetic products and 84 drug products in the last three years, but no licence has been suspended or cancelled, according to the petition.

According to the petition, this demonstrates that the FDA acted illegally as "the proceedings were clearly motivated, vindictive, deliberate, discriminatory, with intent to harm and cause irreparable damage to the reputation and goodwill of the Petitioner. Thus, the Petitioner has been denied equal treatment".


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