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J&J baby powder sample fails quality test as per Mumbai FDA latest lab report

Shardul Nautiyal, Mumbai
Tuesday, December 6, 2022, 08:00 Hrs  [IST]

Johnson and Johnson (J&J) baby powder sample has again failed quality test as per the recent government analyst test report of Maharashtra Food and Drugs Administration (FDA) Laboratory in Mumbai.

The Maharashtra FDA report states that the sample tested does not comply with IS 5339: 2004 specification for the test pH which is above the prescribed limit at pH - 8.52. pH is a figure that represents potential hydrogen, and is the measure of acidity or alkalinity in any water-soluble substance. pH values are represented on a logarithmic scale with numbers 1 to 14 with 7 being a neutral point.

The Bombay High Court bench of Justices SV Gangapurwala and SG Chapalgaonkar had on November 16, 2022 directed the Maharashtra FDA to send fresh samples of J&J baby powder from its Mulund facility in Mumbai for testing.

The Central Drug Laboratory (CDL), Kolkata, test report had also found the powder containing higher pH levels than prescribed on the basis of which the Maharashtra FDA had on September 20, 2022 issued orders to immediately stop manufacturing and sale of the company's baby powder.

Following which, J&J had filed a petition at the Bombay High Court (HC) challenging two orders of the state government dated September 15 with reference to cancelling the license and the second order of September 20 to stop and manufacture baby powder.

The Bombay HC bench of Justices SV Gangapurwala and SG Chapalgaonkar, however, refused to give immediate relief on the matter and posted the matter for further hearing on December 6, 2022 to hear the Additional Government Pleader representing the Maharashtra government.

Voicing his concern in the larger public interest, Abhay Pandey, president, All Food and Drug Licence Holder Foundation (AFDLHF) has written to the Maharashtra FDA to add or club the pending cases related to baby powder with reference to writ petition number 984 of 2014 of Bombay HC filed by J&J with writ petition number 32004 of 2022 of Bombay HC to offer clarity in the case..


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