'Cosmetic' Or 'Drug': Bombay HC Allows Sale Of Sensodyne Toothpaste Put On Hold By State FDA [Read Order]

A division bench of Justice RV More and Justice BH Dangre was hearing a writ petition filed by GlaxoSmithKline challenging the notices issued by Thane Drug Inspector and the subsequent decision to restrain the company from disposing off stock left in their possession.

Case Background

The Drug Inspector, Thane, issued notice to the petitioner on October 6, 2018, informing the company that although Sensodyne is categorized as a 'cosmetic', its label bears a statement - "Repair and Protect, Clinically Proven Relief and Daily Protection for sensitive teeth".

The show-cause notice proceeds to state that in terms of Section 3(aaa) of the Drugs and Cosmetics Act, 1940, the term "Cosmetics" means any article intended to be rubbed, poured, sprinkled, spread on or introduced into or otherwise applied to human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering appearance and includes any article intended for use as a component of cosmetic.

Therefore, it was alleged that the statement of labels of the product of the petitioner contravenes the provisions of Section 18(a)(ii) read with Section 17­C(c) of the Act. The company was asked to show cause as to why action should not be taken for contravening the aforesaid provisions of the Act. The petitioners submitted their explanation but the respondents continued to issue the notices in Form No.15 against the petitioners.

The JMFC, Bhiwandi, heard an application filed by respondents and considered Sensodyne as a drug. He directed the Drug Inspector to seize the product and keep it within the premises of the petitioner company.

Submissions

Senior Counsel Janak Dwarkadas appeared on behalf of GlaxoSmithKline and argued that the petitioner's product has been in the market for a considerably long time and is approved as of standard quality. He submitted that it is not the case of the respondents that their product is harmful and dangerous to the consumer. Further, the action of seizing of the product is completely disproportionate especially when the Government Analyst Report reveals that the product is of standard quality. He, therefore, questioned the coercive steps initiated by the respondents in relation to the product and submitted that the product has a shelf life and an expiry date and even though orders were passed in October 2018, till date no action has been taken, rendering the product useless on its scheduled expiry date.

Government Pleader AB Vagyani submitted an affidavit filed by the Joint Commissioner (Konkan Division) Food and Drug Administration, Thane. In the affidavit, it is stated that Sensodyne contains 5% potassium nitrate, which is anti-sensitizing in nature and bears the properties of decreasing the excitability of the intra-dental nerve action, which is indicative of the fact that the product is used for the purpose of treatment and therefore, it is not a 'cosmetic' but would fall within the meaning of 'Drug' and therefore, it is incumbent on the petitioners to obtain the Drug Licence.

Order

The court noted that the show-cause notice issued to the petitioners merely alleged contravention of the provisions of Section 18a(ii) which deals with any cosmetic which is not of standard quality or is misbranded or adulterated or spurious.

"However, in the affidavit, respondents have come up with a totally new stand and has alleged that the product manufactured and sold by the Petitioners is not a 'cosmetic' but 'Drug'," the court said.

Thus, the court permitted the petitioner to make a representation before the JMFC, Bhiwandi, giving details of its product and for demonstrating why its product cannot be branded as 'drugs'.

Finally, the bench observed -

"Till date, the respondents have not carried out any testing and have merely imposed restriction on the petitioner not to dispose of the stock on a specious ground that it is 'misbranded' cosmetic. The respondents are entitled to take appropriate action if the product of the petitioner is found to be a drug and not cosmetic ….

However, at present, interest of justice would be served if the respondents are directed to retain samples of the 7 (seven) variants of the product 'Sensodyne' toothpaste, which are the subject matter of the restraint orders under section 22 (1) (c) and we direct release of the remaining stock of the petitioner to be sold in the market."

The court clarified that the said release of the product is subject to the final outcome of the petition.

Read the Order Here