Even as Gujarat Food and Drugs Control Administration and Maharashtra FDA have banned GlaxoSmithKline’s Crocin Quik, AP Drugs Control Administration is yet to take any stringent action. The drug is marketed by GSK Asia and is manufactured by the Bangalore-based Remidex Pharma Pvt Ltd. GSK is marketing the drug as a proprietary and patented medicine licensed from Karnataka.
R Ranga Rao, director, AP Drugs Control Administration, told Pharmabiz that the department has made some observations based on which the department has felt that there had been minor errors in labeling.
“As the drug is not toxic, the State drugs departments need not ban the product and only the licensing authority should take a decision on banning or directing the manufacturer to recall the drugs from the market,” added Rao.
Rao further stated that AP DCA had already written a letter to the Karnataka drugs director advising necessary action. He did not comment on the effect of the film coating and the coloring agents.
S Vijaya Kumar, the drugs inspector of Eluru, West Godavari District, Andhra Pradesh who seized the samples (tablets) of Crocin Quik in May, 2005 in Eluru region of AP has written to the manufacturer, Remidex to recall the product and also has written a letter to the director, Office Of the Director General, Drugs and Copy Right, Drugs Control Administration, Hyderabad on September 26, 2005 following a letter on June 26, 2005.
In the letter the drugs inspector has asked the department to direct the manufacturer, Remidex Pharma to recall the tablets and ban the drug as done by the Gujarat Commissioner in September, 2005.
The office of the director general, DCA, Hyderabad, on the contrary (based on its observations) issued a letter to Remidex Pharma and informed that action of calling back of the stocks and return of the same to the manufacturer is unwanted at this stage.
Vijaya Kumar told Pharmabiz that there has been a clear violation in labeling as the label claims ‘advanced formula’ and ‘fast acting’. There is also no clarity on the claims made in the label about the presence of sodium content (173 mg). The AP DCA laboratory, which took the samples for testing has not analysed the sodium content in the drug. There has been a violation of the rule 96 of the Drugs and Cosmetics Rules 1945 and the same contravenes the section 17 (b) of The Drugs and Cosmetics Act 1940 and the said case is under investigation.
According to sources, certain loopholes such as not testing the sodium content in the drug at the AP DCA lab and issuing of letter to Remidex that it need not recall the stocks, and the view that only licensing authority will take any action on either banning the drug or recalling the stocks and not the State drug departments as two other State drugs departments have done indicate possibility of a vested interest somewhere.