The CDSCO looks to give show case notices along with cancelling their licenses for the offence. These companies were apparently selling combination drugs to treat diabetes and fungal infections without the required approval.
The Central Drug Standards Control Organisation (CDSCO) has put Wockhardt Limited, Mascot Health Series Pvt. Limited and Ambic Aayurchem Limited under the scanner for selling drugs without carrying out proper safety trials.
According to a Mint report, CDSCO is contemplating cancelling their licenses for the offence. These companies were apparently selling combination drugs to treat diabetes and fungal infections without the required approval.
An official who spoke to the paper said that the authorities had conducted raids on Mascot and found that it was manufacturing the product without the prior approval from the regulator.
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.
Narendra Kukreja, managing director of Mascot Health, denied any such wrong doing, calling it a ploy to tarnish the image of the company. However, another official stated they found over 50 unregulated products in Mascot’s plant in Haridwar.
Combination drugs are drugs that are sold with two drugs packaged in a single dose in a specific ratio. Similarly, another drug is the anti-diabetic diabetic FDC-Teneligptin Hydrobromide Hydrate 20 mg+Metformin Hcl 500 mg +Pioglitazone Hydrochloride 15 mg manufactured by Ambic Aayurchem. Such a combination is not allowed by global standards.