Consumer health top priority, cancellation of J&J’s baby powder license justified: Maharashtra to HC
The government had revoked the licence citing ‘public interest' and following a report from Food and Drug Administration (FDA), the apex drug regulating body of Maharashtra, which found that the sample of baby powder manufactured at the company’s Mulund plant was ‘not of standard quality’.
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On September 15, the FDA cancelled the licence and later the company was also instructed to recall the stock of the said product from the market. (Photographer: Justin Sullivan/Getty Images)THE MAHARASHTRA government on Thursday informed the Bombay High Court that it decided to cancel the baby powder manufacturing licence of the Johnson and Johnson Pvt Ltd as the “health and welfare of the consumer is most important”.
The government had revoked the licence citing ‘public interest’ and following a report from Food and Drug Administration (FDA), the apex drug regulating body of Maharashtra, which found that the sample of baby powder manufactured at the company’s Mulund plant was ‘not of standard quality’.
On September 15, the FDA cancelled the licence and later the company was also instructed to recall the stock of the said product from the market.
In December 2018, the FDA during a random inspection took 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’. 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 company under the Drugs and Cosmetics Act-1940 and Rules. But it challenged the result and demanded a retest, which was then referred to the Central Drug Testing Laboratory (CDTL), Kolkata.
The state government in its reply to the plea by the company challenging the government order claimed that it will be “a gross failure” on its part if it fails to enforce the provisions under the Drugs and Cosmetics Act and Rules under it stipulating safeguards for the health of people.
The affidavit filed through Ashok Rathod, Assistant Commissioner of FDA, said that the petitioner without assuring the quality of their baby powder till its final use, cannot manufacture it for sale according to the rules and regulations.
The FDA official said that samples of the talc-based powder sent for testing were reported as “not of standard quality” and the said finding was upheld by the CDTL, Kolkata, which said that the pH values impact the health of the consumers at large.
A division bench of Justice S V Gangapurwala and Justice S G Dige asked the state government whether it had tested more samples from the same batch of baby powder under challenge in the plea or whether they belonged to any other batch.
After additional government pleader Milind More representing the state sought time to respond to the query, the court posted further hearing in the matter to November 14.
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