Watchdog to issue notice to GSK on cancer vaccine ads

Watchdog to issue notice to GSK on cancer vaccine ads

New Delhi: India’s drugs regulator has put GlaxoSmithKline Plc’s (GSK) cervical cancer vaccine “awareness" advertisements under the scanner, following a similar move against emergency contraceptive commercials.

“We will issue a show-cause notice to GSK and also write to the state authorities about these ads. They (GSK) say the vaccine will be effective for cervical cancer. This kind of advertising is not allowed," said Surinder Singh, drugs controller general of India. “The ad can send a wrong message to the public also that by getting this vaccine the cancer can be prevented. And these vaccines are not cheap."

This comes as the ministry of health considers a suspension of advertisements by Cipla Ltd and Mankind Pharma for emergency contraceptives, as their approval was not notified in the official gazette.

“As per the Drugs and Cosmetics Act, no person can claim to prevent or cure diseases in Schedule J of the Act, which includes cancer," said Manoj Tongra, drugs inspector in Rajasthan. “GSK’s ad clearly claims that vaccination can prevent cervical cancer, so it doesn’t matter that they don’t name the vaccine."

Under the Drugs and Cosmetics Act, drugs sold under prescription cannot be advertised and this includes vaccines. India only allows advertisement of over-the-counter (OTC) drugs.

GSK denied that its ads contravened the rules. “In our opinion, such disease awareness programmes do not contravene any of the provisions of the Drugs and Cosmetics Act," said a GSK spokesperson. “We have not received any communication from DCGI on the subject. The public awareness campaign attempts to build awareness about this debilitating disease, cervical cancer."

Besides television ads on cervical cancer prevention, GSK also advertises in leading national dailies: “It’s true! Vaccination can now protect your daughter from cervical cancer," the ad says.

“We believe this will highlight to all women that cervical cancer is preventable by screening and vaccination," GSK said. “The campaign clearly states and encourages everyone to consult a gynaecologist/paediatrician."

In India, only two companies are currently selling cervical cancer vaccines—GSK and Merck Sharp and Dohme (MSD), an affiliate of Merck and Co. Inc. While MSD has also advertised cervical cancer drugs, these don’t claim that vaccination can prevent the cancer and are regarded as “awareness campaigns".

Pharma companies have been advertising on television and in print without naming their products, dubbing these as awareness campaigns.

Such exercises can be critical in helping with early diagnoses, said Aparna Thomas, director communications, Sanofi-Aventis India.

“Medical communication is usually targeted directly at the doctor. However, often pharmaceutical companies feel the need to help create disease awareness amongst people," Thomas said. “This can help in early diagnosis and in turn quicker recovery for patients."

She added that this must, however, fit in with the business’ overall objective to create awareness on health topics by building association of the corporate brand with specific therapeutic areas, as consumer advertising for prescription drugs is not permitted in India.