The multinational drug company GlaxoSmithKline (GSK), which had run an advertisement blitzkrieg in several national newspapers in the country on cervical cancer vaccine late last year in gross violation of Drugs and Cosmetics Act, 1940 and Drugs and Magical Remedies Act 1954, has been completely absolved of any irregularities by the drug controller general of India (DCGI) Dr Surinder Singh, it is learnt.
The drug authorities, who at one time had threatened to take stringent action against the erring company including withdrawal of licenses issued to the GSK's cervical cancer vaccine Cervarix, all of a sudden found the company not guilty of committing any irregularities to initiate any action, industry sources said.
Sources said that the DCGI's decision to absolve GSK came after the company made a detailed presentation to the DCGI in which the company gave an assurance to completely withdraw the advertisements regarding the cervical cancer vaccine.
During November-December last year, the GSK had launched a no-holds-barred advertisement in the media on the pretext of creating public awareness on cervical caner. After creating a fear-psychosis among the parents about dangers of cervical cancer, the full-page ads advocated that vaccination can now prevent cervical cancer long before it happens. Though the GSK had claimed that the advertisements were launched in public interest to instill awareness on the dangers of cervical cancer, the real intention of the company was there for everybody to see as it had some time back launched the controversial cervical cancer vaccine Cervarix in the Indian market.
As the advertisements became controversial, the GSK gave an assurance to the DCGI and unilaterally withdrew the ads. But, the DCGI issued a show cause notice to the GSK in December last year, asking it to explain within 10 days the reasons for such an ad in the media. In the show cause notice, the DCGI had said that the GSK has violated Rule 106, Schedule J of the Drugs and Cosmetics Act, 1940 under which the drug company cannot advertise any drugs. For launching the advertisements, the companies need to take prior permission from the DCGI and in the GSK's case, no such permission was given by the DCGI. Besides, for this kind of ads, the government has to issue a special notification.
Though the GSK had replied to the DCGI show cause, DCGI is learnt to have found the GSK's reply unsatisfactory and issued another notice to the GSK, asking it to further clarify the reply.
The company made a detailed presentation to the DCGI in this regard recently and got a clean chit.
