New Delhi: Major drug makers, including Wockhardt Ltd, are under the scanner of the pharma regulator for allegedly launching combination drugs to treat diabetes and fungal infection without mandatory prior approval.
The Central Drug Standards Control Organization (CDSCO) is contemplating cancelling licenses of Wockhardt Ltd, Mascot Health Series Pvt. Ltd and Ambic Aayurchem Ltd for allegedly selling drugs without conducting safety trials, thereby risking the lives of patients.
A drug maker needs approval from the Drug Controller General of India (DCGI) before launching any product.
Mascot health and Wockhardt are being probed for launching and marketing an anti fungal Fixed Dose combination (FDC) -Itraconazole 100 mg and Terbinafine 250 mg tablets in the market without conducting any safety trials, two people aware of the matter said, requesting anonymity.
During the raids conducted by the officials from the Central and state authorities on Thursday, it was found that Haridwar based “Mascot was manufacturing the product without any approval from the central regulator," said one of the people cited above. The searches will continue on Friday.
Narendra Kukreja, managing director of Mascot Health, denied any such wrong doing. “We are manufacturing products for top notch companies and it is not possible that a product is being launched without taking approval from the regulator. The raids are being carried at our plant in Haridwar. This is a ploy to tarnish our image and am sure we will come out clean," he said. However, one of the persons cited above said that over 50 products from Kukreja’s manufacturing unit was found to be unregulated. Emails sent to Wochardt did not elicit any response till the time of press.
Significantly, these drugs are not sold anywhere in the world. Another such drug is anti diabetic FDC-Teneligptin Hydrobromide Hydrate 20 mg+Metformin Hcl 500 mg +Pioglitazone Hydrochloride 15 mg manufactured by Ambic Aayurchem in Roorkee. “Globally this combination is not approved. Its poses risk to the patients as clinical trials were not conducted and big companies are violating the rules," said a senior official in the health ministry.
A fixed dose combination contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form.
Ambic Aayurchem did not respond to the queries till the press time.
“The companies will be issued show cause notices and licenses will be cancelled for launching these drugs without approval. Legal action will be initiated against the companies," added the official from health ministry.