Delhi HC stays DCGI order cancelling Sensodyne licence for GSK contractor

In a big relief to GlaxoSmithKline (GSK), the Delhi High Court has stayed the Drug Controller General of India’s (DCGI) decision to cancel its licence held by Global Health Care Products (GHCP) for manufacturing of Sensodyne toothpaste in India. The Sensodyne products are being marketed by GlaxoSmithKline (GSK) Asia in India.

The licence granted to GHCP for the manufacture of cosmetic products – Sensodyne Rapid Relief and Fresh Gel variants — was cancelled by DCGI for alleged flouting of norms under the Drugs and Cosmetics Act and other rules.

Justice Yashwant Varma, while staying the March 5 order of cancellation, noted that the product itself had been in circulation not just in India but across the world since 1969. “It not the case of DGCI that the product otherwise posed a health risk. Their action appears to be based solely upon what is described to be a misleading claim about the efficacy of the product. That decision in turn rests on a report of the CCPA which has been assailed by the petitioner before the NCDRC. The matter requires consideration,” the order stated.

However, the bench asked the company to “ensure that no statements or advertisements which may appear in periodicals or any web portal shall fall foul of the labelling as approved by the authority concerned”.

Senior counsel Kapil Sibal, appearing for GHCP, argued that under the Cosmetic Rules 2020, the licencing authority had no power to cancel a licence. He further said that the labels for the product were changed with effect from December 2020 and had also been duly approved by the competent statutory authorities, therefore, the drastic action of cancellation of licence would not sustain.

GHCP counsel Ajay Bhargava said that the claims made for the Sensodyne range of toothpaste “are truthful and well-substantiated. No claim has been made which could mislead the consumers as to the nature, quality, or benefits of Sensodyne range of toothpaste including Rapid Relief and Fresh Gel toothpaste.” Their action is completely contrary to the principles of natural justice had resulted in a violation of its fundamental rights, the counsel said, adding that the impugned order was passed without any application of mind by the SLA.

Central Consumer Protection Authority (CCPA) had on February 9 asked GHCP to discontinue within seven days all the advertisements and label claims for the Rapid Relief and Fresh Gel variants of Sensodyne for flouting norms. The ads showed dentists outside India endorsing the Sensodyne Products. CCPA had also directed the Director General (Investigation) to submit a report after investigating the claims like “Recommended by dentists worldwide”, “world’s no.1 sensitivity toothpaste” and “clinically proven relief, works in 60 seconds”.

Even DCGI had opined that the claims made in the ads were not permitted under the Drugs and Cosmetics Act 1940, and Cosmetic Rules 2020. Parallelly, the DCGI directed the Assistant Drugs Controller and Licensing Authority, Silvassa (SLA), to take action against Sensodyne, which was launched in 2012. On the advice of DCGI, the SLA had on March 5 cancelled the licence.