December 19, 2018 / 8:12 AM / a month ago

J&J says Indian drug regulators visited facilities, took talc samples

NEW DELHI (Reuters) - Indian drug authorities visited some of Johnson & Johnson’s (JNJ.N) facilities on Wednesday and took “tests and samples” of its talcum powder, the company said in a statement.

The visits came as regulators in India launched an investigation into J&J’s Baby Powder following a Reuters report last Friday that the firm knew for decades that cancer-causing asbestos could be found in the product.

The company told Reuters in a statement that the facilities were visited by the Central Drugs Standard Control Organization (CDSCO) and some state-based food and drug administrations (FDAs).

“Today, a few of our facilities were visited by the CDSCO and local FDA authorities and we are fully co-operating with them by providing tests and samples,” the J&J statement said.

“The characterization of these visits as ‘raids’ or ‘seizures’ is incorrect as has been reported in some instances,” it said. “The tests have been conducted in the regular way that the FDA collects samples.”

J&J added 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.

It also said Indian FDAs and the CDSCO have in the past confirmed that its products “comply with Indian standards and are free of asbestos”.

Quoting an industry source with knowledge of the matter, Reuters reported earlier in the day that drug inspectors had taken samples of Baby Powder from its Baddi factory in the northern Indian state of Himachal Pradesh.

A source at the CDSCO said its officials lifted samples for testing from nine Indian cities - Mumbai, Chennai, Kolkata, Ahmedabad, Hyderabad, Bengaluru, Indore, Chandigarh and Ghaziabad.

FILE PHOTO: A bottle of Johnson and Johnson Baby Powder is seen in a photo illustration taken in New York, February 24, 2016. REUTERS/Shannon Stapleton/Illustration/File Photo

J&J did not immediately specify how many manufacturing plants the company has in India.

A CDSCO spokeswoman did not respond to a request for comment.

Surendranath Sai, a regional drug officer in the southern state of Telangana, on Wednesday said he would instruct inspectors to collect samples there.

“On the basis of the news report, we are alerting staff to pick up samples. We will test them in a drug control lab here,” said Sai. “We will take action accordingly. Certainly we are worried because millions of babies may be affected.”

Earlier, the Times of India quoted an official source as saying 100 drug inspectors had been assigned to examine different manufacturing facilities, wholesalers and distributors linked to J&J India, starting early on Wednesday.

A health ministry spokeswoman declined to comment when contacted by Reuters. However, a senior official at the ministry said the report was worrying.

“We are concerned about it and will take action,” the official told Reuters, declining to be identified due to the matter’s sensitivity. The official did not elaborate on what kind of action the ministry could take.

A Reuters examination of company memos, internal reports and other confidential documents, as well as deposition and trial testimony, showed that from at least 1971 to the early 2000s, J&J’s raw talc and finished powders sometimes tested positive for small amounts of asbestos.

It also showed that company executives, mine managers, scientists, doctors and lawyers fretted over how to address the problem while failing to disclose it to regulators or the public.

FILE PHOTO: Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015. REUTERS/Lucas Jackson/File Photo

The documents also depicted successful efforts to influence U.S. regulators’ plans regarding limiting asbestos in cosmetic talc products and scientific research on talc’s health effects.

J&J said on Monday it planned to buy back up to $5 billion of its stock, after $40 billion was wiped from its market value following the Reuters report.

Reporting by Rahul Singh, Aditya Kalra and Krishna N. Das; Editing by Sanjeev Miglani, Christopher Cushing and Jan Harvey

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