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Bombay HC nod to sale of Sensodyne toothpaste

Says govt did not call it harmful, allows firm to petition FDA for categorisation

| Mumbai | Published: May 19, 2019 9:16:20 am
The counsel argued that “action of seizing of the product is completely disproportionate, specially when the Government Analyst Report reveal that the product is of standard quality”.

The Bombay High Court recently allowed GlaxoSmithKline Consumer Healthcare Limited to resume the sale of Sensodyne toothpaste in the market, which was put on hold last year by the state Food and Drug Administration (FDA) on the ground that it was being sold as a “cosmetic product”.

GlaxoSmithKline, the manufacturer of Sensodyne toothpaste, was served a notice by the Thane drug inspector on October 6, 2018. The notice had said that though the product was being sold as a cosmetic, its label read “repair and protect, clinically proven relief and daily protection for sensitive teeth”.

The notice added that it cannot be called a “cosmetic product”, as it contravenes the provisions of the Drugs and Cosmetics Act, 1940.

GlaxoSmithKline had subsequently challenged the notice in the Bombay High Court. In its petition, it had alleged that the entire stock of 80 batches, comprising seven variants of the product, was subjected to coercive action without necessary tests being conducted to ascertain if it was a cosmetic or a drug. It had also challenged the Constitutional validity of Section 17 C (c) of the Drugs and Cosmetic Act, which provides for misbranding a cosmetic.

During a hearing earlier this month, the counsel for the petitioner told the court that the product has been in the market for a considerable period of time and has been approved as being of standard quality. He further added that the state FDA has not stated that the product is “harmful and dangerous to the end consumer if consumed in the present form”.

The counsel argued that “action of seizing of the product is completely disproportionate, specially when the Government Analyst Report reveal that the product is of standard quality”.

Government pleader A B Vagyani, through an affidavit, took the stand that the toothpaste contains 5 per cent of potassium nitrate, which is anti-sensitising in nature and is used for the purpose of treatment, and therefore, the product is not a cosmetic but would fall in the category of a drug. Therefore, it is incumbent on the petitioner to obtain the drug licence.

Vagyani added that the matter is under investigation and the contravention by the petitioners can be determined only at the end of probe.

In its order, a Division Bench of Justice Ranjit More and Justice Bharati H Dangre said, “We direct release of the remaining stock of the petitioner to be sold in the market… We are passing the said interim order in light of the peculiar fact that it is not the case of the respondents that though being a ‘Drug’, the product is harmful to the public at large or to the consumer using the product.”

The bench added that as the state government would grant a post decisional hearing to the petitioners as far as categorisation of its product is concerned, the petitioners are permitted to make a fresh representation to the authorities on the state’s stand on categorising the product as a drug.

Maintaining that as the state has come up with a new stand and alleged that the toothpaste is not a cosmetic but a drug, the court said: “We therefore, permit the petitioner to prefer a representation within two weeks, giving the details of its product and for demonstrating why its product cannot be branded as drugs.”

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