J&J receives order to cease use of raw material in manufacture of Baby Powder
Indias drugs regulator has ordered Johnson Johnson to stop manufacturing its Baby Powder using raw materials in two of its Indian factories until test results prove they are free of asbestos, a senior official said on Thursday
NEW DELHI - India’s drugs regulator has ordered Johnson & Johnson to stop manufacturing its Baby Powder using raw materials in two of its Indian factories until test results prove they are free of asbestos, a senior official said on Thursday.
The official at the Central Drugs Standard Control Organization (CDSCO), who declined to be named citing the sensitivity of the matter, said a written order had been sent to the U.S. Company ask them to stop the use of “huge quantities” of raw materials stocked in its plants in northern and western India.
The company said on Wednesday that Indian drug authorities visited some of its facilities and took “tests and samples” of its talcum powder. It also said that the safety of its cosmetic talc was based on a long history of safe use and decades of research and clinical evidence by independent researchers and scientific review boards across the world.
The CDSCO also collected samples of the company’s baby shampoo and soap products as a matter of routine, the official said. “Whenever inspectors feel there is contamination in one thing they also take samples of other products from the same company,” the official said.
The visits came as the CDSCO and state-based food and drug administrations launched an investigation into J&J’s Baby Powder following a Reuter’s report last Friday that the firm knew for decades that cancer-causing asbestos could be found in the product. J&J has described the Reuters article as “one-sided, false and inflammatory”.
The company told Reuters that it is in full compliance with the current Indian regulatory requirements for the manufacturing and testing of its talc.
“All talc in India is sourced and exclusively sold in India and surrounding markets including Sri Lanka, Bangladesh, Nepal, Bhutan, Maldives and fully meets the regulatory standards of the Government of India,” the company send an emailed statement.
J&J also explain the talc routinely tested by both suppliers and in independent labs to ensure that it is free of asbestos.
Asked if the order meant the company would have to stop producing its ubiquitous Baby Powder in India for now, the official at the drugs regulator said that was “the inference you have to take” at least as far as the stores of raw materials were concerned.
“We have told them until this investigation concludes; you should not use the raw material. Test results will take time,” the official said.
“Testing for asbestos is not a routine procedure. It might be in traces. It will require us to develop a method and all those things,” the official said.