Nearly a month after issues regarding Johnson & Johnson’s baby powder were resolved in India, the US healthcare conglomerate has once again come under the scanner of Indian drug regulatory authorities for quality concerns with another of its childcare products. The Rajasthan Drugs Control Organisation, in March, flagged two batches of the company’s baby shampoo for failing tests to ascertain that they were of standard quality.
The Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulatory body, also plans to “examine” the matter closely. “We will monitor movement of such type of products in the market,” Drug Controller General of India Eswara Reddy told The Indian Express.
According to the Rajasthan drug regulator’s alert, the samples tested “contain harmful ingredients”. The samples belong to batches ‘BB58204’ and ‘BB58177’, which will expire in September 2021. The regulator has found formaldehyde in these samples, according to a statement by J&J.
“Particulars of the same declared as not of standard quality on test/analysis are given below for ensuring that the stocks of these drugs are not consumed anymore and appropriate safe guard to the consumers is provided by withdrawing the available stock and take action as per provisions of the Drugs and Cosmetics (D&C) Act 1940 and Rules made thereunder,” the Rajasthan drugs watchdog told drugs control officers in the notice.
The Act also empowers the state’s drugs control authorities to prosecute J&J, if they feel the need for such punitive action, said a senior government official.
“We do not accept the interim results given to us which mentioned samples to ‘contain harmful ingredients- identification positive for formaldehyde.’ The government did not disclose the test methods, details or any quantitative findings,” stated a J&J spokesperson.
“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 Act and D&C rules,” the spokesperson added.
J&J has contested the interim test results of the government analysis, claiming they were based on “unknown and unspecified methods”. The samples were drawn earlier this year, and the company “fully co-operated” during the process, the spokesperson said, adding that its application before the relevant authority is pending for re-testing of samples at the Central Drugs Laboratory.
“Johnson & Johnson is in full compliance with current Indian regulatory requirements and standards for manufacturing and testing of all our products,” the spokesperson stated.
J&J had earlier come under fire and global scrutiny for another product — its baby powder — following a December 2018 Reuters article stating the company had known “for decades” that the product contained cancer causing asbestos and that the firm kept this information from regulators and the public.
CDSCO, that month, seized samples of the product from J&J’s manufacturing plants in India to test for this ingredient. However, the regulator in February gave the company the green light to resume production of the product at its manufacturing plants in Baddi and Mulund after its tests reaffirmed that the products did not contain asbestos.