DCGI asks GSK to withdraw promotional campaign
26 Dec 2009
The Drug Controller General of India (DCGI) has objected to the promotional advrertisement released by pharma major GlaxoSmithKline (GSK) and asked the company to withdraw the same with immediate effect.
The advertisement for Cervaric, the cervical cancer vaccine, violates the norms prescribed under the Drugs and Cosmetics Act 1940, the drug regulator notedin its show cause notice to the company asking it to withdraw the promotional campaign.
According to reports, the company has admitted that it has received the show cause notice from the DCGI regarding the cervical cancer disease awareness campaign.
The national health regulator has alleged that the campaign launched by the company for Cervarix has violated the Drugs and Cosmetics Act 1940 norms, under which no one (neither company or any institute) can make any claim regarding prevention and cure of certain diseases.
The regulator has asked the company to explain, within 10 days, the reasons for not withdrawing the licence issued to the company, which violated rules related to the Drugs and Cosmetics Act, which bans advertisement for prescription drugs (including vaccines).
The Act states that "no drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments..."
The Act also states that before launching any campaign, prior permission of the government is needed.
