CDSCO Curbs Drug Firms For Unapproved Medicine Dealings

India’s apex drug regulator is considering action like cancelling the licences and even legal action several pharmaceutical firms, including listed firms like Wockhardt for making and marketing certain combination medicines to treat ailments like fungal infections and diabetes without its approval.

Reportedly drug makers have not proven their safety and effectiveness to the regulator and could pose great risk to the patients consuming them, said a senior health ministry official.

Over 70 fixed dose combination (FDC) medicine brands marketed by 16 pharma companies have been seized in an ongoing raid of two drug manufacturing facilities, according to another official who spoke to ET on condition of anonymity.

These medicines are not supposed to be marketed in the country as they are not approved by the Central Drugs Standard Control Organisation (CDSCO), as per the Drugs and Cosmetics Rules, 1945. Yet, these companies have managed to secure licences to market them from State Licencing Authorities in Uttarakhand, according to the regulator's note about the raid.

Wockhardt confirmed that it was marketing the product, but that Mascot had informed it that the manufacturer has a valid Food and Drug Administration licence from October 2015.

It is not clear when these medicines were launched and how widely they are used, as there is no market data available on them.

The regulator has so far seized Rs.3 lakh worth of an anti-fungal combination of itraconazole 100 mg and terbinafine 250 mg manufactured in Haridwar by Mascot Health Series and marketed by Wockhardt under the brand name ‘Itrawok-T’ and Bestchem Formulations under the brand name ‘Betawin-IT’.

Out of 118 products manufactured by Mascot, 73 are not approved by the Drug Controller General of India (DCGI), according to the note.

The regulator also seized one lakh tablets of anti-diabetic combination teneligliptin hydrobromide hydrate 20mg + metformin hydrochloride 500 mg + piloglitazone hydrochloride 15 mg manufactured by Ambic Aayurchem in Roorkee. This drug is marketed by Ambic under the brand name 'Tennyl Trio'.

The firms are also involved in manufacturing "many" other FDCs which are not approved by DCGI, according to the note.

The Parliamentary Standing Committee in its 59th report on the functioning of CDSCO noted that State Licencing Authorities have issued manufacturing licences for a "very large" number of FDCs without prior clearance from the apex regulator.

CDSCO's note stated, "This has resulted in the availability of many FDCs in the market which have not been tested for efficacy and safety. This can put patients at risk,"