HC seeks reply from state on J&J’s opposition to stop manufacturing of baby talc

The company also challenged the FDA minister’s October order wherein its appeal against the license cancellation order was rejected. The court has asked the state to file an affidavit in reply to the petition and posted hearing of the petition to November 10

Mumbai The Bombay high court, on Wednesday, directed the state government to make provide a copy of the test report by the Central Drug Testing Laboratory, Kolkata, to Johnson and Johnson Pvt Ltd. While hearing the company’s petition challenging the August 2022 decision of the state government through the Food and Drug Administration (FDA) whereby the license to manufacture talcum powder at its Mulund unit was cancelled.

HC seeks reply from state on J&J’s opposition to stop manufacturing of baby talc

The company also challenged the FDA minister’s October order wherein its appeal against the license cancellation order was rejected. The court has asked the state to file an affidavit in reply to the petition and posted hearing of the petition to November 10.

The vacation bench of justice N J Jamadar and justice Gauri Godse, while hearing the petition of J&J Co Ltd, was informed by senior advocate Ravi Kadam that the company had its manufacturing license for baby powder renewed in 2020 after the authority had verified that it was conforming to the stipulated norms. However, manufacturing came to a halt at its Mulund unit in September ’22 after FDA had its licence cancelled due to pH level being beyond the 5.5-8 range.

Kadam submitted that the sample in which the pH levels were found to be 8.5 was of a 2018 batch and if the same was found in later batches as well, the license should not have been removed in 2020. However, the license had been renewed for five years. The company was suffering a loss of ₹2.5 cr per day. Kadam also submitted that it was not provided with the lab report.

The court was also informed that the company had undertaken tests of random samples of the product after receiving the intimation from FDA and the samples were found to have pH levels in the normal range.