J&J says re-test of baby shampoo samples pending at CDL

After the recall of Johnson and Johnson’s faulty hip implants and concerns involving its baby powder and possible links to cancer, the company now faces trouble with its baby shampoo after the Rajasthan Drugs Control Organisation found it to be “not of standard quality” as it contained “harmful” ingredients.

Responding to the findings, J&J said that it had contested the interim test results of the Government analysis that were based on “unknown and unspecified methods.” Further, it added, “the application before the relevant authority is pending for re-testing of samples at Central Drugs Laboratory.”

On the alleged presence of formaldehyde in the shampoo, J&J said, “this is concerning especially when there is no prescribed test method or requirement for testing Formaldehyde in shampoo under the applicable standards. We have confirmed to the Indian authorities that we do not add Formaldehyde as an ingredient in our shampoo nor does Johnson’s baby shampoo contain any ingredient that can release formaldehyde over time. Our products are safe to use and conform to all applicable standard under the D&C (Drugs and Cosmetics) Act and D&C rules.”

Former Maharashtra Food and Drug Administration Commissioner Mahesh Zagade told Business Line that greater clarity would dawn on the findings once the Central Drugs Laboratory report comes out. However, he said, there have been instances when the company had been hauled up over issues like asbestos in its baby powder or its baby oil being largely liquid paraffin. And this, despite claiming to be adhering to international standards, he said.

J&J, however, said that it “unequivocally” stood by its products, adding that they were safe and that their assurance process was amongst the most rigorous in the world, “meeting or exceeding the safety standards in every country where our products are sold.”

Pointing out that they were in “full compliance” with current Indian regulatory requirements and standards for manufacturing and testing of products, the company said that they had cooperated with the authorities when earlier this year, representatives of the Drug Controller in Jaipur, Rajasthan drew samples of Johnson’s Baby Shampoo for testing. “We do not accept the interim results given to us which mentioned samples ‘contain harmful ingredients- identification positive for formaldehyde.’ The government did not disclose the test methods, details or any quantitative findings,” the company added.

Zagade explained that the Central drug authority too would be following this development, directing that more samples of the same batch be tested. Formaldehyde is said to be carcinogenic, he said. Used as a preservative to prolong the shelf-life of products, formaldehyde recently hit the headlines when traces were found in fish.

jyothi.datta@thehindu.co.in

COMMENT NOW