Bombay HC seeks state govt’s reply to plea by J&J against licence cancellation – The Indian Express

The state had revoked the licence citing ‘public interest’ and the Food and Drug Administration (FDA) held that the sample of baby powder manufactured at the Mulund plant was declared ‘not of standard quality’. The FDA on September 15 said the apex drug regulating body of Maharashtra, cancelled the licence and later the company was also instructed to recall the stock of the said product from the market, the FDA said in its order on Thursday.

In December 2018, the state FDA during a random inspection took samples of J&J’s talc-based baby powder from Pune and Nashik for quality check. The sample of baby powder manufactured at the Mulund plant was declared ‘not of standard quality’. The result of the test that came in 2019 concluded: “The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) specification for skin powder for infants in the test pH.”

Later, a show-cause notice was served to the firm under Drugs and Cosmetics Act-1940 and Rules. But the firm challenged the result and demanded a retest, which was then referred to the CDTL, Kolkata. A vacation bench of Justice N J Jamadar and Justice Sharmila U Deshmukh was hearing a plea by the company challenging cancellation of the licence.

The firm informed the bench that state FDA Minister Sanjay Rathod on October 19 rejected the appeal by the company and refused to stay the effect of the authority’s order. As there was no further statutory remedy available before the company, it prompted it to approach the HC with a writ petition. Till final disposal of the plea, Kadam, as an urgent relief, sought stay on the order, stating that the authority and the minister had passed the orders despite the company having submitted stability reports, test reports of latest batches of the talcum powder and assurances that it would submit pH reports of the product.

The petitioner claimed that the authority’s order failed to refer to the CDTL report based on which it had made the decision.

It said that the FDA order referred to two samples of the powder submitted in 2018 and 2019, however the FDA Assistant Commissioner in 2020 found the said samples were within specific limits of pH value and even renewed the licence which was first issued in 1965. It said the 2020 report and other internal findings of the company were sent to FDA and retesting of samples was sought through CDTL; however, no clarity on the same was given by the authority.

The company also said show-cause notices by the FDA did not refer to CDTL’s report and and during personal hearing before authority, it was merely told the said report had found the powder sample did not conform to the requirements.