State at liberty to conduct fresh testing of J&J baby powder manufactured at Mulund plant: HC

A division bench of Justice G S Patel and Justice S G Dige was hearing a plea filed by the company challenging the September 15, 2022 order issued by the government directing that the licence be cancelled. The state Food and Drugs Administration (FDA), on September 15, had cancelled the license and later, the company was instructed to recall the product from the market.

During a random inspection in December 2018, the FDA had taken samples of J&J’s talc-based baby powder from Pune and Nashik for quality check. The sample manufactured at the Mulund plant was declared “not of standard quality” in 2019.

The HC had allowed the company to continue manufacturing the baby powder though its licence had expired on December 15. However, it can only manufacture the products and not sell them, the court added. On Friday, Additional Government Pleader Milind More sought the matter to be adjourned, adding the officials concerned would reconsider the decision as per the court’s oral directions.

The bench said the matter pertained to pharmaceutical products and the courts were not regulators for the same.

The bench orally remarked: “This is a matter of concern for everyone, if there is a problem with any pharmaceutical company product, we want the regulator to act swiftly. We cannot act like a regulator…We are judging a 2022 order (by state government) basis notice and testing conducted in 2019. It is an impossible situation. The rules have been overtaken. We do not know what the brand new situation is regarding the products.”

The bench granted liberty to the state government to conduct fresh testing of samples based on the existing guidelines.

The court told the state government: “We are not asking you to act within one week of taking a sample. We are asking you to take action within one week of getting the result (of the test). We are saying it from the consumer point of view. In case of any adverse result, action will have to be taken as per the statute with utmost urgency. Because you have to see what product is released in market.”

After senior advocate Ravi Kadam representing the company said it is ready to get the product tested as many times while pleading the company be allowed to sell the accumulated stock, the bench refused the same and said it will be subject to further orders.

The court will hear the plea on Monday, January 9.