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Setback to JnJ baby Powder: DCGI issues show cause notice for violating drug law


Setback to JnJ baby Powder: DCGI issues show cause notice for violating drug law

The notice issued to J&J quotes, “Publication of such advertisement has the potential to mislead the general public which is against the public interest.”

New Delhi: In a major setback, global skincare and health player Johnson & Johnson (J&J) has been furnished a show cause notice by the Drugs Controller General of India (DCGI) on account of allegedly violating the drug law by using government test report to advertise and boost its talcum powder.

According to a recent media report in TOI, J&J widely promulgated its talcum powder as “asbestos-free” after it got clearance from the regulator, advertising the said clearance and thereby sparking another controversy.

The probe initiated amid reports that J&J’s baby powder allegedly contains cancer-causing asbestos. The Government of India conducted sample tests following the allegations and the company was barred from using raw material, mainly talc, for the baby powder at its plants in India.

Following the orders of Drug Controller General of India (DCGI), drug inspectors had seized samples of various baby products of Johnson and Johnson from wholesalers, retailers and distributors across the country. All the samples were tested to see if they complied with all prescribed regulatory and manufacturing standards and also to check the presence of cancer-causing asbestos.

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

However, no asbestos was found in the baby powder manufactured in J&J’s Baddi and Mulund plants. The samples collected from these plants were tested at a government lab in Chandigarh. The drug regulators gave a clean chit, allowing J&J to resume the production of its baby powder at these facilities. The advertisement came in the wake of the permission conferred by the drug regulator to restart production.

Also Read: J&J passes asbestos test, allowed to make baby powder in India

Within a span of seven days, the company placed different advertisements re-establishing its well-known baby powder as “pure, safe & gentle”. The advertisements were backed by the proclamation that government lab tests confirmed that the talcum powder was asbestos-free.

 TOI quotes the Ad as stating, “Laboratory testing, commissioned by the Indian government, has again confirmed that there is no asbestos in our talc. This conclusion reinforces the findings of decades of independent tests by universities, research labs and government regulators around the world that have consistently found that our talc is safe.”

However, Section -29 of the Drugs & Cosmetics Act, 1940 prohibits use of “any report of a test or analysis made by the Central Drugs Laboratory or by a government analyst, or any extract from such report, for the purpose of advertising any drug [or cosmetic]”.

“Any violation of this clause is punishable along with a penalty,” an official told TOI.

“Publication of any advertisement on the basis of test report of government analyst is not permissible under Section 29 of the of Drugs and Cosmetics Act, 1940,” quotes the show cause notice. “Publication of such advertisement has the potential to mislead the general public which is against the public interest,” the notice added.

The company has been asked to explain, “why appropriate action as provided under the Drugs and Cosmetics Act, 1940 be not initiated” against it for violation of the law.

The company has been given seven days time to respond to the show cause notice, failing which it will attract action by the regulator. However, J&J refused to comment on the matter.

The company’s baby powder is one of the most recognised foreign brands in India and holds around 13% of the Rs 700 crore talcum powder market. Other baby products in the market include the new Himalaya Baby and Dove Baby line.

J&J’s consumer segment in India also includes other baby care products such as soap, lotion and shampoo. The company owns brands like Neutrogena, Tylenol, Splenda, Aveeno, and Band-Aid.

Also Read: After damaging Reuters report, J&J doubles down on talc safety message



Source: with inputs
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