INDIA. Mumbai: Food & Drugs Administration (FDA), Maharashtra has cancelled the product manufacturing license of Johnson’s Baby Powder manufactured by M/s Johnson & Johnson Private Limited located at Mulund in North East Mumbai.
The FDA, Maharashtra, drew the samples of Johnson’s Baby Powder at Pune and Nashik for quality check purposes.
The drawn samples of the Johnson’s Baby Powder were declared “Not of Standard Quality” by the Govt. Analyst: “The sample does not comply with IS 5339: 2004 (Second Revision Amendment No. 3) Specification for Skin powder for infants in the test pH.”
Pune
A sample was drawn by S K Jadhav, Drug Inspector, FDA, Pune Zone III, and it was forwarded to Govt Analyst, FDA, Mumbai vide letter No PZ3/RAG/FRM/118646/MH-MUM dated December 20, 2018.
The sample of baby powder (50 gms) drawn from Batch No: 83R80804 (Manufactured- October 2018, Expiry-September 2020) was taken for analysis on January 19, 2019. The sample was described as “White Amorphous Powder”.
The analyst considered the label’s description: Keeps baby’s skin comfortable and dry, Ingredients-talc, fragrance, sodium citrate, citric acid, No added phthalates, no added parabens, contains purified talc. Warning: For external use only, skin powder for infants.
Analysis report (No.NSQ/MUM/118646/2019 and dated December 11, 2019, issued by Milind M Kolhatkar, Govt Analyst, FDA Laboratory, Maharashtra, stated that the sample did not comply with IS 5339:2004 specification for skin Powder for infants ( Second Revision for the test pH.
Nashik
S S Deshmukh drew another sample, Drug Inspector, Nashik Zone I, and was sent to Govt Analyst vide letter No: NZ1 /TOP /FRM / l21402/MH-MUM dated June 27, 2019.
A sample of 50 gm powder was drawn from Batch No: B3R90301(Manufactured-May 2019, Expiry-April 2021). It was taken for analysis on July 05, 2019.
The sample was described as“White, free-flowing fine powder with characteristic mild fragrance”.
The analysis report (No NSQ/MUM/ 121402/2019) dated November 27, 2019, issued by Milind M Kolhatkar, Govt Analyst, stated that the sample does not comply with IS 5339-2004 (second revision, Amendment No 3) specification for skin powder for infants in the test pH.
The FDA issued a show cause notice to the firm under the Drugs & Cosmetics Act, 1940, and Rules there as to why action like suspension or cancellation of a manufacturing license or product manufacturing license should not be taken against it. FDA also issued instructions to recall the stock of the said product from the market.
The J & J did not accept the reports of the Govt Analyst and challenged the decision of the FDA to send the samples to the referral laboratory-Central Drugs Laboratory (CDL), Govt. of India, Kolkata, in court.
However, the Director CDL, Kolkata confirmed the report of the government, Analyst, FDA, Maharashtra issued a final, conclusive report stating that “The sample does not conform to IS5339: 2004 concerning the test for pH”, the FDA statement said.
In January 2020, a complaint was lodged with the FDA by Abhay Pandey, President of the All Food and Drug License Holders Foundation, about the alleged inferior quality of Johnson’s Baby Powder, demanding early action in the matter.
“Generally, when the pH of baby powder is above average, it indicates a mistake in the manufacturing process and impurity in an admixture element or ingredient during the manufacturing process. If the pH level in baby powder is above average, it can affect babies’ skin. Therefore, I request you to take this matter very seriously and conduct a fair investigation,” read Pandey’s letter.
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 public health, the FDA, Maharashtra, cancelled the manufacturing license of Johnson’s Baby Powder of M/s Johnson’s & Jonson’s Pvt. Ltd vides its order dated September 15, the FDA statement added.
The Transcontinental Times is still awaiting a response to an email it sent to Johnson & Johnson requesting more information.
Also Read: Mumbai Police Seize Drugs Worth Rs 1,403 Crore from Nalasopara
