The Drugs Controller General of India has ordered Johnson and Johnson not to use talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for any production till further directions
New Delhi: The Drugs Controller General of India (DCGI) has ordered Johnson and Johnson (J&J) not to use talc raw material from its Mulund plant in Mumbai and Baddi unit in Himachal Pradesh for any production till further directions. On the directions of the Central Drugs Standard Control Organization (CDSCO), drug inspectors collected samples of Johnson and Johnson’s baby powder from both plants on Wednesday, amid reports that the product allegedly contained cancer-causing asbestos.
Besides, over 100 samples were collected from wholesalers, retailers and distributors across the country, which will be tested to see if these complied with all prescribed regulatory and manufacturing standards, and also for the presence of asbestos.
A CDSCO official said according to the protocol, the manufacturer was “supposed to test for absence of asbestos" for all batches of talc raw material procured. “It is learnt that the manufacturer is not testing for absence of asbestos for all batches of talc raw material procured and testing them randomly."
“We have prohibited the company from using any raw material, including talc, for production of Johnson and Johnson baby powder till further orders. The Baddi plant has around 82,000 kilogram of talc stored, while the Mulund unit has around 200 metric tonnes," he said.
The collected samples will be tested at the central drug testing Laboratory. The company said on Wednesday they were “fully cooperating" with the CDSCO by providing tests and samples, and that Johnson & Johnson’s baby powder was asbestos-free and did not cause cancer.
The CDSCO said over the next four to five days, drug inspectors will collect samples of all brands of Johnson & Johnson talcum powder from wholesalers and distributors from 12-15 locations across the country for testing. “Samples of raw material as well as finished products from retail stores were also being collected," said the official quoted above.
A team of 100 drug inspectors have been deployed for the purpose.
The effects of long-term exposure of unsafe asbestos on human health are well documented. Asbestos fibres are easily inhaled and carried into the lower regions of the lung, where those 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 fibres also increases the risk of lung cancer and mesothelioma.
The company Wednesday said it was “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 that the FDA collects samples," the company spokesperson said, adding, “we have scientific evidence to prove that our talcum powder is safe and beneficial for use."
The company said in the past, authorities in India, including the FDA and the CDSCO, had confirmed that its products complied with Indian standards and were free of asbestos. “We unequivocally stand by the safety of our products, are fully compliant with regulatory standards and requirement in India and will continue to work with regulatory authorities," the spokesperson had said.