Bombay HC Directs Re-Testing Of Johnson & Johnson Baby Powder, Allows Company To Resume Manufacture But No Sale Or Distribution For Now

The court directed FDA to collect the samples for testing in front of an authorised person from the company within three days and send them for testing to labs within the next three days. The labs would have to complete testing within seven days thereafter.

However, the company has undertaken not to sell or distribute the product.

A division bench of Justice S V Gangapurwala and Justice S G Dige passed the interim order in the company's petition challenging the cancellation of its licence by FDA for manufacturing of baby powder at its Mulund factory.

The licence was cancelled by the apex drug regulating 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 started in December 2018, after a random check by the FDA on J&J's powder in Pune and Nashik.

Johnson and Johnson represented by Senior advocates Ravi Kadam and Birendra Saraf contented that the orders under challenge were disproportionate as they were passed relying only on testing of one sample, 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 petition stated.

The petition 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, the State.

After senior advocate Ravi Kadam, for the company, said that the said case was before a jurisdiction not governed by the Bombay High Court, the bench inquired why there were so many matters taking place against the company.

Kadam submitted that the Maharashtra FDA minister had not issued a show-cause notice to the company and did not consider the supporting material submitted by the company before passing the order and only relied on the CDTL report, which was not proper.

"You (company) have grievances against the minister, but if there is no reconsideration then we will send it back to him. We do not want that, but we want to have fresh samples tested," the bench said.

Case Title: Johnson & Johnson Pvt. Ltd. Versus State of Maharashtra & Ors.

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