Bombay High Court Seeks FDA's Stand After Two Of Three Laboratories Find Johnson & Johnson Baby Powder Complies With Statutory Requirement

A third laboratory found that the pH level for the sample was unstable.

A division bench of Justice S V Gangapurwala and Justice S G Dige directed copies of the reports to be given to the petitioner and posted the matter for hearing on December 6, 2022. The bench was hearing the company's petition against cancellation of its licence by the Food and Drug Administration (FDA) to manufacture baby powder at its Mulund factory.

Senior Advocate appearing for Johnson said that since samples met the statutory requirement, the company must be permitted to sell the product. But the bench said it would take a decision after hearing the government on December 6.

By an earlier order, the High Court allowed J&J to re-start manufacturing baby powder at their Mulund unit while simultaneously directing the FDA to re-test four samples, at two government and one private laboratory. Back then the company had undertaken not to sell or distribute the product.

The FDA laboratory at Bandra-Kurla Complex and Central Drug Testing Laboratory, Western Zone found the sample to be within the permissible limit of 5-8 pH level, the court noted. However, Intratech Laboratory, the private laboratory opined the pH reading was unstable.

Background

JJB's licence was cancelled by the apex drug regulatory body of Maharashtra on September 15 on the ground that a batch of the powder was found to be of slightly higher pH than prescribed on testing at the Central Drugs Testing Laboratory. The company was later also told to recall their stocks.

Investigations had started in December 2018, after a random check by the FDA on J&J's powder in Pune and Nashik.

J&J represented by Senior advocate Birendra Saraf had contended that the orders under challenge were disproportionate as they were passed relying only on testing of one sample, on one batch of the product when there are multiple test reports showing that the same batch as well as other batches from the Mulund facility were within the required pH range.

They submitted pH reports of 14 random batches of the JBP conducted by an independent laboratory. The pH levels of all these samples were within the prescribed pH value.

The petitioner contended that there was no statutory requirement that the licence should be suspended or cancelled in case a batch is not found to be of standard quality.

In the past three years, 27 cosmetic products and 84 drug products were declared to be not of standard quality, however, no licence has been suspended or cancelled by the FDA, the petition states.

According to the petition, this shows legal mala fides on the part of the FDA 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".

The petition states that the FDA orders are based on a provision of law that is no longer in existence and ignores mitigating facts in favour of the petitioner. Further, the orders are arbitrary and violate principles of natural justice.

Rule 143 of the Drugs and Cosmetic Rules dealing with suspension or cancellation of a licence ceased to exist upon the notification of the Cosmetic Rules on 15th December 2020, the petition states.

The court initially had directed the FDA to hand over a copy of the CDL report which was relied on for the cancellation of licence. The pH levels vary based on other factors unconnected to the quality of the product, such as improper handling of the sample, J&J claimed.

Additional Government Pleader Milind More for the FDA informed the court that another such case was found against the company in Delhi. Even there the statutory requirements were not met.