In an apparent violation of Drugs and Cosmetics Act, 1940 and Drugs & Magical Remedies Act 1954, GlaxoSmithKline has released a two full page advertisement about cervical cancer vaccine in some of the prominent national newspapers. GSK had recently launched the controversial cervical cancer vaccine, Cervarix in the Indian market. GSK's ad comes even before the heat and dust raised over the efficacy of the cervical cancer vaccine is settled down.

According to published reports, Dr Diane Harper, one of the key researchers involved in the clinical trials of the vaccine, has openly admitted that it doesn't prevent cervical cancer. Dr Harper is reported to have stated that the vaccine will not decrease cervical cancer rates at all. Dr Harper also warned that the cervical cancer vaccine was being 'over-marketed' and that parents should be warned about the possible risk of severe side effects from the vaccine to young girls. She went on to even say that the vaccine itself is more dangerous than the cervical cancer it claims to prevent.

Legal experts are of the view that the GSK's advertisement is grossly in violation of the Drugs & Cosmetics Act. “It is clearly the violation of Schedule J Rule 106 of the Drugs and Cosmetics Act. For this kind of ad, the government has to issue a special notification. As far as I know, no such notification has been issued by the concerned government department,” said Manoj Tongra, a legal expert and a drug inspector.

Another legal expert in Drugs and Cosmetics Act said that without DCGI permission such advertisements cannot be launched by any company. It is gross violation of rules, he said.

The company has, however, conveniently withheld the brand name of its vaccine and has claimed that the advertisement is a public awareness initiative.

All this is happening at a time when the union health ministry is contemplating to impose a ban on the advertisements of morning-after pills like I-Pill and Unwanted 72 manufactured by prominent Indian companies on the ground that these advertisements are misleading the youth.

Meanwhile, an email query sent to the company seeking clarification on the ad campaign remained unanswered till the time of filing of this story.