The Drug Controller General of India (DCGI) has issued a show-cause notice to GlaxoSmithKline Pharmaceuticals (GSK) for launching an advertisement campaign in the national media on cervical cancer vaccine Cervarix.
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).
“We have issued a showcause notice to GSK for the advertisement campaign,” confirmed a health ministry official. GSK officials could not be contacted for comments.
Under Rule 106 and Schedule J of the Drugs and Cosmetics Act, 1940, drug companies cannot advertise any prescription drugs. Though GSK’s advertisement campaign did not mention Cervarix, it said vaccination could prevent cervical cancer. Apart from Cervarix - which had sales of $182 million globally in 2008 — Merck and Co markets its version, Gradasil, in the Indian market since last year.
Cervical cancer or cancer of the uterine cervix, is the most common type of cancer affecting women in India after breast cancer and causes over 74,000 deaths annually in the country. According to WHO estimates, over 130,000 Indian women are diagnosed with cervical cancer annually. The global market for cervical vaccine is estimated at more than $10 billion. Infection of the human papilloma virus (HPV) is believed to be the reason for cervical cancer and approximately 80 per cent of women get one or more types of virus by the age of 50. Vaccination is advised for females aged between 9 to 26 years.
