On Wednesday, the Bombay High Court's division bench allowed Johnson & Johnson Private Limited to manufacture baby powder at its Mulund facility in Maharashtra but prohibited the sale or distribution of the baby powder for the time being. The Court was hearing a petition filed by Johnson & Johnson's Nishith Desai & Associates challenging the cancellation of its cosmetic manufacturing licence for its Maharashtra baby powder facility.

A division bench of Justices SV Gangapurwala and SG Dige directed the FDA to collect the samples for testing from the company within three days and send them to labs within the next three days. The labs would then have seven days to complete the testing.

On September 15, the apex drug regulating body of Maharashtra canceled the licence on the grounds that a batch of the powder tested at the Central Drugs Testing Laboratory had a slightly higher pH than prescribed. Later, the company was also told to recall its stocks. Johnson and Johnson, represented by Senior Advocates Ravi Kadam and Birendra Saraf, contended that the challenged orders were disproportionate because they were based solely on the testing of one sample, one batch of the product when multiple test reports showed that the same batches, as well as other batches from the Mulund facility, were within the required pH range.

The petition stated that on September 15, the Joint Commissioner and Licensing Authority, FDA, of Maharashtra issued an order canceling the company's licence, effective December 15, 2022. Five days later, the commissioner reviewed the order and directed the company to immediately cease production and sale of the baby powder manufactured at a facility in Mulund, Maharashtra.

Furthermore, the Court directed the parties to choose three laboratories in order to reduce the margin of error in the results. "We will direct that samples be sent to 2-3 labs. We do not want any margin of error. We will not send the sample to just one", the Court said.

The three laboratories agreed upon by the parties are: 

• Central Drug Testing Laboratory, Western Zone
• FDA laboratory at Bandra-Kurla Complex, Maharashtra
• Intratech Laboratory (private lab)

On Monday, the court ordered the FDA to submit a list of labs today.

The sample manufactured at the Mulund plant had been 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) specifications for skin powder for infants in the test pH."

Later, the company was served with a show-cause notice under the 1940 Drugs and Cosmetics Act and Rules. However, it challenged the outcome and requested a retest, which was referred to the Central Drug Testing Laboratory (CDTL) in Kolkata. In its response, the state government told the high court that the decision was made because "the health and welfare of the consumer is most important." The state government claimed that failing to enforce the provisions of the Drugs and Cosmetics Act and Rules requiring safeguards for people's health would be a "gross failure" on its part.