This decision comes in the wake of a strong stand by the government on suspending marketing of all drugs prohibited for sale in other countries like the US, the UK, EU and Australia.
The ministry of health and family welfare has suspended the manufacture and sale of all three drugs under Section 26A of the Drugs and Cosmetics Act, 1940 with immediate effect, through a notification issued on June 18, informed sources told TOI. While the ministry has been dilly-dallying on withdrawing analgin and deanxit for years now, despite pressure from a parliamentary panel, the decision on the diabetes drug pioglitazone has taken the industry completely by surprise.
The decision to ban pioglitazone and its combinations will hit the Rs 700-crore market for such drugs and adversely impact a clutch of companies including Abbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.
Pioglitazone combination is a bigger market than plain pioglitazone itself which is has posted a strong double-digit growth, with over 30 companies marketing the drug. The top-selling brands of posiglitazone include Pioz MF G and Pioz (USV), Gemer P (Sun Pharma), Tribet (Abbott), Tripride (Micro Labs) and Gluconorm PG (Lupin). (See chart)
Popular pain-reliever analgin is a relatively small market with brands like Baralgan and Novalgin (Sanofi Aventis), as most companies fearing a ban have already pulled out from the market, industry experts said. The third drug, a combination of Flupenthixol and Melitracen sold as Deanxit (Lundbeck), Placida (Mankind), Franxit (Intas) and Restfull (Lupin) is facing a ban because deanxit is prohibited for sale in Denmark, its country of origin, and also, the combination is not sold in major countries.
Under the Drugs and Cosmetic Rule 30-B, the import and marketing of any drug the use of which is prohibited in the country of origin, is banned in India. A parliamentary panel report on health earlier this year had rapped the government for dilly-dallying on withdrawing deanxit and analgin, which are not sold in markets globally.
The family of 'glitazones', used for blood glucose lowering properties, has been mired in controversy since the beginning, with many drugs under the class having already been banned globally, and in India. Three years back, another drug from this family, rosiglitazone, marketed by a host of companies including GSK India was banned, following a decision taken in Europe.
In the case of pioglitazone too, France has already taken it off the shelves, while in the US it is sold with a boxed warning. The warning emphasizes that it may cause or worsen heart failure, and its use for over a year may be associated with an increased risk of bladder cancer.
Doctors here in India had said in a study last year that more robust data on use of pioglitazone on Indian patients was needed. Till that time, the patient should be adequately informed about this adverse effect and the drug should be used in as small a dose as possible, with careful monitoring and follow up. Earlier this month, the ministry had suspended sale of dextropropoxyphene, sold as Wockhardt's Proxyvon, a widely-used pain-killer.