By Raju Vernekar
Mumbai, Nov 17:
The Bombay High Court has permitted Johnson & Johnson Private Limited to manufacture baby powder at its Mulund facility in North East Mumbai and has ordered the fresh testing of samples. But the sale or distribution of the baby powder will not be permitted for the time being.
On Wednesday while hearing the petition filed by Johnson and Johnson, challenging the cancellation of cosmetic manufacturing license of its baby powder facility by Food and Drug Administration, Maharashtra, a division bench comprising Justices S V Gangapurwala and S G Dige, directed the FDA to send fresh samples of the baby powder from its Mulund plant to three laboratories for testing.
During an earlier hearing, the Court had called for the re-examination of samples of baby powder manufactured by Johnson & Johnson in government or government-approved labs.
Accordingly Additional Government Pleader Milind More submitted a list of laboratories to the court. From the list, the parties selected- the Central Drugs Standard Control Organisation (CDSCO), Western Zone, Mumbai, FDA laboratory at Bandra-Kurla Complex and Intertek Laboratory, a private laboratory in Mumbai.
The Court in its order clarified that the samples will be collected from the manufacturing facility by the FDA officer in the presence of a representative of the petitioner company, within 3 days from Wednesday and will be sent to the laboratory within 3 days thereafter. The court stated that laboratories should send test report within a week from the date on which the sample is received.
The bench permitted Johnson & Johnson to manufacture the baby powder at its own risk, but affirmed the order of the FDA that no sale of the product or handing it over to the distributor for sale would be permitted.
The FDA, Maharashtra had drawn and tested samples in Pune and Nashik in 2019 and the Govt. Analyst had declared that “the samples do not comply with IS 5339: 2004 (Second Revision Amendment No. 3) specification for Skin powder for infants in the test pH.”
Subsequently the FDA referred the samples to the CDSCO, West zone. The CDSCO confirmed the report of Govt. Analyst and issued a final report stating that “the sample does not conform to IS5339: 2004 concerning the test for pH”.
The FDA issued a show cause notice to the firm under Drugs & Cosmetics Act, 1940, as to why action like suspension or cancellation of a manufacturing license or product manufacturing license should not be taken against it. The FDA also issued instructions to recall the stock of the said product from the market.
“The product Johnson’s Baby Powder is popularly used in newborn babies. The sample declared “Not of Standard in pH and the use of the product may affect the health of the skin of the newborn babies”. In the interest of the public health at large, the FDA, Maharashtra cancels the manufacturing license of the Johnson’s Baby Powder, the FDA stated in its order dated September 15.
The company claimed that the FDA Joint Commissioner issued an order on September 15 cancelling its licence, effective from December 15. However after 5 days, the commissioner reviewed the order and directed the company to stop manufacture and sale of the baby powder manufactured at a facility in Mulund, with immediate effect.
