Bombay High Court Asks Authorities To Supply Lab Report To Johnson and Johnson In Baby Powder Case

The Johnson and Johnson Private Limited has approached the Bombay High Court challenging the cancellation of its licence by Food and Drug Administration (FDA) for manufacturing of baby powder at its Mulund factory.

The vacation bench of Justice N. J. Jamadar and Justice Sharmila U. Deshmukh on October 26 directed the state to file an affidavit by November 9 and listed the matter on November 10 2022.

The court also directed the authorities to give a copy of the report of Central Drug Testing Laboratory, Kolkata to the company.

The petition states that the Joint Commissioner and Licencing Authority, FDA had issued an order cancelling the licence, effective December 15, 2022.

However, five days later, the Joint Commissioner issued another order directing the company to immediately stop manufacture of JBP at its Mulund facility as well as stop sale of the powder from this facility, according to the petition.

The licence was cancelled 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, according to the petition.

According to the petition, two samples, one from Pune, and one from Nashik were collected for the purpose of the testing. Both samples were found to have higher pH than the specified range.

However, when the FDA conducted inspection at the Mulund facility, both the batches from which the samples were obtained were found to be within the correct range of pH. After this their licence was renewed, according to the petition.

The petitioner appealed before the Minister, Food And Drug Administration as the orders provided that appeal can be filed before the Minister. However, there is no statutory provision for filing appeal before the Minister, the petition argues.

During the hearing of this appeal, the petitioners submitted pH reports of 14 random batches of the JBP conducted by an independent laboratory, according to the petition. The pH levels from the testing is in the same range as the pH report of the petitioner and within the prescribed pH value, the petition states. This shows that there is no issue in the manufacture of the product, the petition claims.

The petition contends that there is 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 petition contends that the orders under challenge are 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 are within the required pH range.

The petition claimed that the petitioner has not received the copy of the CDL report which is relied on in the order for the cancellation of licence and stopping of manufacture of baby powder at Mulund facility. The pH can vary based on other factors unconnected to the quality of the product, such as improper handling of the sample, the petition contends.

The petition prays for a writ of certiorari calling for papers and proceedings pertaining to the orders and to quash the same. The petition also prays for an interim order restraining the respondents from acting on the impugned orders.

Case title – Johnson and Johnson Pvt. Ltd. v. State of Maharashtra and Ors.