Hotline: 1800 102 2007
X
Search Business Opportunities
Mar, 17 2018

CDSCO Curbs Drug Firms For Unapproved Medicine Dealings

The firms are also involved in manufacturing "many" other FDCs which are not approved by DCGI.

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,"

Comment
image
Related opportunities
  • Gyms and Fitness Centres
    About Us: VIVAFIT concept is to provide health and well-being in a..
    Locations looking for expansion New Delhi
    Establishment year 2017
    Franchising Launch Date 2017
    Investment size Rs. 30lac - 50lac
    Space required 1500
    Franchise Outlets -NA-
    Franchise Type Unit
    Headquater New Delhi New Delhi
  • Bars, Pubs & Lounge
    About Us: House Of Mandarin offers delicious dining, takeout and delivery..
    Locations looking for expansion Maharashtra
    Establishment year 2000
    Franchising Launch Date 2018
    Investment size Rs. 2 Cr. - 5 Cr
    Space required 2500
    Franchise Outlets -NA-
    Franchise Type Unit
    Headquater Mumbai Maharashtra
  • Bike Maintanance & Repair Services
    About Us: EXPERT AUTO CARE SERVICE is a Bhavnagar, Gujarat, India based..
    Locations looking for expansion Gujarat
    Establishment year 2016
    Franchising Launch Date 2017
    Investment size Rs. 5lac - 10lac
    Space required 350
    Franchise Outlets -NA-
    Franchise Type Unit, Multiunit
    Headquater Bhavnagar Gujarat
  • Quick Service Restaurants
    About: Go Italia is a casual dining Italian cuisine restaurant with..
    Locations looking for expansion Karnataka
    Establishment year 2013
    Franchising Launch Date 2017
    Investment size Rs. 10lac - 20lac
    Space required 300
    Franchise Outlets -NA-
    Franchise Type Unit
    Headquater Bangalore Karnataka
Insta-Subscribe to
Entrepreneur
Magazine
For hassle free instant subscription, just give your number and email id and our customer care agent will get in touch with you
OR Click here to Subscribe Online
Daily Updates
Submit your email address to receive the latest updates on news & host of opportunities