This site is intended for Healthcare professionals only.
×

Another trouble for J&J: CDSCO seize samples of baby products for testing


Another trouble for J&J: CDSCO seize samples of baby products for testing

The action by CDSCO has come at a time when the company is already embroiled in a controversy over its faulty hip implants. 

New Delhi: Following orders of Drug Controller General of India (DCGI), drug inspectors have seized samples of various baby products of Johnson and Johnson from wholesalers, retailers and distributors across the country on Friday, an official said. All the samples will be tested to see if they complied with all prescribed regulatory and manufacturing standards and also to check the presence of cancer-causing asbestos, the government official said.

“Around 100 samples of Johnson and Johnson’s baby shampoo, oil, soap, besides the baby powder have been lifted from wholesalers, retailers and distributors from across the country, which will be tested to see if these complied with all prescribed regulatory and manufacturing standards and to check the presence of asbestos,” the official said.

The collected samples will be tested at the Central Drug Testing Laboratory.

The regulator on Thursday ordered Johnson and Johnson to not use talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for production till further direction.

The inspectors collected samples of Johnson and Johnson’s baby powder from both the plants, amid reports that the product allegedly contained cancer-causing asbestos.

“We have prohibited the company from using any raw material, including talc, for the production of the Johnson and Johnson baby powder till further orders. The Baddi plant has around 82,000 kilograms of talc stored, while the Mulund unit has around 200 metric tonnes stored,” he said.

The company said on Wednesday they were “fully cooperating” with the CDSCO by providing tests and samples, and said Johnson & Johnson’s baby powder is asbestos-free and doesn’t cause cancer.

The CDSCO, under the Union Health Ministry, said more samples of all brands of all products of Johnson & Johnson talcum may be collected from wholesalers and distributors from some more locations for testing.

A team of 100 drug inspectors have been deployed for this purpose.

The effects of long-term unsafe asbestos exposure on human health are well documented. Asbestos fibres are easily inhaled and carry into the lower regions of the lung where it can cause fibrotic lung disease (asbestosis) and changes in the lining of the chest cavity (pleura).

These diseases can lead to reduced respiratory function and death, while long-term inhalation of asbestos fibre increases the risk of lung cancer and mesothelioma.

Some recent reports claimed that the American multinational pharmaceutical giant allegedly knew for decades about the presence of cancer-causing asbestos in their product.

The action by CDSCO has come at a time when the company is already embroiled in a controversy over its faulty hip implants.

The company Wednesday said they were “fully cooperating” with the CDSCO by providing tests and samples, and asserted that the characterisation of these visits as “raids or seizures was incorrect”.

“The tests have been conducted in the regular way in which the FDA collects samples,” the company spokesperson said, “we have scientific evidence to prove that our talcum powder is safe and beneficial for use.”

The company pointed out that in the past, authorities in India like the FDA and the CDSCO have confirmed that its products comply with Indian standards and are free of asbestos.

“We unequivocally stand by the safety of our products, which are fully compliant with regulatory standards and requirements in India. We will continue to work with the regulatory authorities,” the spokesperson had said.

Also Read: CDSCO tightens safety and labelling rules for ISOTRETINOIN, prescription of dermatologist mandatory

Spread the love


Source: PTI
0 comment(s) on Another trouble for J&J: CDSCO seize samples of baby products for testing

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted