Selling Unapproved FDC drugs: Wockhardt, two others under CDSCO scanner

New Delhi: The Central Drug Standards Control Organization (CDSCO) has put several pharma firms under its scanner for allegedly manufacturing and marketing FDC drugs for various ailments like diabetes and fungal infections without prior approval.

A fixed-dose combination (FDC) contains two or more drugs combined in a fixed ratio of doses, available in a single dosage form.

A recent report in Mint states that Wockhardt Limited, Mascot Health Series Pvt. Limited and Ambic Aayurchem Limited are among the companies under the scanner for selling drugs without carrying out proper safety trials.

According to the report, CDSCO is considering to cancel the silence of these firms for allegedly launching the drugs without conducting safety trials that could pose a great risk to the patients consuming them.

As per the Drugs and Cosmetics Rules, 1945 a drug maker needs approval from the Drug Controller General of India (DCGI) before launching any product.

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.The regulator has so far seized anti fungal Fixed Dose Combination (FDC) -Itraconazole 100 mg and Terbinafine 250 mg tablets manufactured by Mascot health in Haridwar and marketed by Wockhardt.

Denying ani such wrongdoing, Narendra Kukreja, managing director of Mascot Health, told Mint, “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.”However, one of the persons cited by the daily said that over 50 products from Kukreja’s manufacturing unit were found to be unregulated.

The regulator also seized tablets of anti diabetic combinations Teneligptin Hydrobromide Hydrate 20 mg+ Metformin Hcl 500 mg +Pioglitazone Hydrochloride 15 mg manufactured by Ambic Aayurchem in Roorkee.

A senior health ministry official told Mint, “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.

The official further added, “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.”