Johnson & Johnson Private Limited has filed a petition with the Bombay High Court to appeal the Food and Drug Administration’s decision to revoke its licence to produce baby powder at its Mulund factory.
The state was given till November 9 to file an affidavit, and the case was assigned for hearing on November 10, 2022, by the vacation bench of Justices N. J. Jamadar and Sharmila U. Deshmukh.
A petition filed by the company challenging two orders of the state government—one dated September 15 cancelling the licence and the other dated September 20 ordering an immediate halt to production and sales of the company’s baby powder product—was heard by a vacation bench of Justices N.J. Jamadar and Sharmila Deshmukh.
The state Food and Drug Administration’s Joint Commissioner and Licensing Authority issued the instructions (FDA). The Central Drug Laboratory’s analysis, which revealed that the powder had a higher pH level than recommended, served as the basis for the government’s instructions.
Two samples, one from Pune and one from Nashik, were allegedly obtained for the purpose of testing, according to the plea. Both samples were discovered to have pH values greater than the allowed range. However, both of the batches from which the samples were taken were confirmed to be within the proper pH range during an FDA examination of the Mulundfacility. After that, the petition claims that their licence was renewed.
Since the orders stated that an appeal might be made before the Minister, the petitioner appealed before the Minister, Food and Drug Administration. The petition contends that there is no statutory provision for filing an appeal before the Minister.
According to the petition, the petitioners presented pH reports from 14 random batches of the JBP that were completed by an independent laboratory at the hearing of this appeal. According to the petition, the pH values obtained through testing are within the required pH range and fall within the same range as the petitioner’s pH report. According to the petition, this demonstrates that there is no problem with the product’s manufacturing.
The state’s administration was subsequently ordered by the court to make the report available to the company. The government was instructed to file its affidavit by the court when it posted the case for further hearing on November 10.
Kadam had requested a temporary ruling allowing the business to resume the production facility. Jyoti Chavan, a second government attorney, disagreed. The bench ruled that the corporation may request the temporary relief on the following hearing date, when the courts will have reopened after the Diwali holiday. The corporation claimed in their appeal that an impartial public testing laboratory examined 14 random batches from February, March, and September 2022 and determined that all of them were within the acceptable pH range.
The biggest Fast Moving Consumer Goods (FMCG) producer claimed that its Mulund factory has been producing baby powder for the past 57 years and that its licence was extended in January 2020. According to the market value of the commodities sold, the company further claimed that as a result of the licencerevocation, it lost Rs 2.5 crore every day.
It even offered to only release the powder for sale, if instructed, after samples from pertinent batches had undergone pH testing in front of the Maharashtra FDA officer at the Mulund factory.
The petitioner further argued that there were no regulations through which the authorities could revoke or suspend licences for cosmetic products. In light of this, the corporation requested that the FDA authorities’ instructions be set aside.
