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‘Not able to sell, what next’: Chemist body asks Johnson and Johnson as FDA orders withdrawal of baby powder from market

Industry experts want the Drug Controller of India to intervene in the matter of J&J baby powder failing the quality test in the country.

September 19, 2022 / 06:12 PM IST
Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015.  REUTERS/Lucas Jackson  - RTS4S6Q

Bottles of Johnson & Johnson baby powder line a drugstore shelf in New York October 15, 2015. REUTERS/Lucas Jackson - RTS4S6Q

The All India Organization of Chemists and Druggists (AIOCD) has sought clarity from pharma giant Johnson and Johnson (J&J) on the existing stock of baby powder in the chemist shops of Maharashtra after state Food & Drugs Administration (FDA) ordered the company to withdraw the product from the market.

“We have asked the company what should we do with the available stock on the shelves in chemists’ shops, because we are not able to sell the goods. We await a response from the company,” Rajiv Singhal, General Secretary, AIOCD, told Moneycontrol.

When asked if there was an estimate on J&J’s baby powder stock availability with chemists, Singhal said, a very small portion ― less than 20 percent ― was sold over the counter in medical shops, adding that a significant chunk of the product is sold by FMCG shops.

Also read: Johnson & Johnson won’t take controversial baby powder off shelves in India

Maharashtra FDA has notified that J&J will not be able to manufacture or sell the talc-based baby powder in Maharashtra after it was found that the product has a pH value above the mandated limit.

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The industry body of chemists has written to its members in Maharashtra to abide by the decision of the state FDA. Singhal said the chemists’ shops won’t be selling the baby powder as it has been red-flagged by the FDA.

“We do regularised business. Since this is an order by Maharashtra FDA, we all are bound to follow this. We will abide by this decision. We have communicated to our association members in Maharashtra,” said Singhal.

Path ahead for J&J

A senior Maharashtra FDA official responsible for granting licence to pharma companies told Moneycontrol that J&J hasn’t yet replied to the state regulator on the notice sent.

When asked if the company can appeal against the notice, the officer, requesting anonymity, said the pharma giant has a three-month window to challenge the notice issued.

“If they wish to appeal, they can. They have 90 days of time to appeal in front of Sanjay Rathor, FDA Minister, Maharashtra. The minister may decide the fate of the appeal,” the officer said.

Also read: Dear Johnson & Johnson, are babies in India of a lesser god?

Govt intervention needed

Industry experts have demanded intervention by the Drug Controller of India (DCGI) in the matter of the J&J baby powder failing the quality test in India.

“India doesn’t have the concept of class action suit. There must be many cases here like in the US, where this product would have affected peoples’ lives. The company should be held accountable,” says Arvind Singhal, Chairman and MD of Technopak Advisors, a management consultancy firm.

Drug Controller General of India, VG Somani, refused to comment on this matter.

Maharashtra FDA’s action against J&J comes after the company decided to discontinue its talc-based baby powder globally in the face of lawsuits claiming it contains a cancer-causing substance, saying the company has no plan to take the product off the market in India.

“We will work with retailers to keep the product on the shelves until our supply of talc-based powder runs out,” a J&J spokesperson told Moneycontrol.

The Maharashtra FDA has asked J&J to recall the stocks of the powder that were found ‘Not of Standard Quality’. The FDA cited the fact that using the powder would affect the skin of new-born babies.

J&J has so far not issued any statement on the FDA cancelling the manufacturing license of Johnson’s Baby Powder at the Mulund plant in Mumbai after samples of the powder drawn at Pune and Nashik were declared ‘Not of Standard Quality’ by the government regulator.

 
Ayushman Kumar Covers health and pharma for MoneyControl.
first published: Sep 19, 2022 06:12 pm
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