Sakina Tashrifwala
Published on: October 28, 2022 at 19:57 IST
Johnson & Johnson Private Limited has petitioned the Bombay High Court to challenge the Food and Drug Administration’s (FDA) cancellation of its licence to manufacture baby powder at its Mulund factory.
On October 26, the vacation bench of Justice N J Jamadar and Justice Sharmila U. Deshmukh directed the state to file an affidavit by November 9 and scheduled the case for November 10, 2022.
The court also ordered the authorities to provide the company with a copy of the report of the Central Drug Testing Laboratory in Kolkata.
According to the petition, the FDA’s Joint Commissioner and Licensing Authority issued an order cancelling the licence on December 15, 2022.
According to the petition, the Joint Commissioner issued another order five days later directing the company to immediately stop manufacturing JBP at its Mulund facility as well as selling the powder from this facility.
According to the petition, the licence was revoked because a batch of the powder was found to have a slightly higher pH than prescribed during testing at the Central Drugs Testing Laboratory.
According to the petition, two samples were collected for testing, one from Pune and one from Nashik. Both samples were found to have pH levels that were higher than the specified range.
When the FDA conducted an inspection at the Mulund facility, however, both batches from which the samples were obtained were found to be within the proper pH range.
According to the petition, their licence was renewed as a result of this.
The petitioner filed an appeal with the Minister of Food and Drug Administration, as the orders stated that an appeal could be filed with the Minister.
However, the petition claims that there is no statutory provision for filing an appeal with the Minister.
According to the petition, the petitioners submitted pH reports of 14 random batches of JBP conducted by an independent laboratory during the hearing of this appeal.
According to the petition, the pH levels from the testing are in the same range as the petitioner’s pH report and within the prescribed pH value. According to the petition, this demonstrates that there is no problem with the product’s manufacturing.
According to the petition, there is no statutory requirement that the licence be suspended or cancelled if a batch is 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 legal wrongdoing on the part of the FDA.
“The proceedings were clearly motivated, vindictive, deliberate, and discriminatory, with the intent to harm and cause irreparable harm to the Petitioner’s reputation and goodwill. As a result, the Petitioner was denied equal treatment”.
According to the petition, the FDA orders are based on a provision of law that no longer exists and ignore mitigating facts in favour of the petitioner.
Furthermore, the orders are arbitrary and violate natural justice principles.
The petition states that Rule 143 of the Drugs and Cosmetic Rules, which dealt with the suspension or cancellation of a licence, ceased to exist upon the notification of the Cosmetic Rules on December 15, 2020.
The petition claims that the challenged orders are disproportionate because they were based solely on testing of one sample, one batch of the product, when multiple test reports show 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 had not received a copy of the CDL report, which was cited in the order cancelling the licence and prohibiting the manufacture of baby powder at the Mulund facility.
The pH can vary due to factors unrelated to product quality, such as improper sample handling, according to the petition.
The petition requests a writ of certiorari to obtain papers and proceedings pertaining to the orders and to vacate them.
The petition also requests an interim order preventing the respondents from acting on the contested orders.