Thursday, 27 June 2013

Popular drugs banned by Govt of India recently



The government has banned three popular medicines
1. Pioglitazone
2. Deanxit
3. Analgin

PIOGLITAZONE :
It is the widely prescribed anti-diabetes drug. Pioglitazone is a prescription drug of the class thiazolidinedione (TZD) with hypoglycemic (antihyperglycemic, antidiabetic) action to treat diabetes. It is used to improve glucose control in adults over the age of 18 with type 2 diabetes. 

MECHANISM OF ACTION:
Pioglitazone selectively stimulates the nuclear receptor peroxisome proliferator-activated receptor gamma. It modulates the transcription of the insulin-sensitive genes involved in the control of glucose and lipid metabolism in the muscle, adipose tissue, and the liver.
 As a result, pioglitazone reduces insulin resistance in the liver and peripheral tissues; increases the expense of insulin-dependent glucose; decreases withdrawal of glucose from the liver; reduces quantity of glucose, insulin and glycated hemoglobin in the bloodstream.

SIDE EFFECTS:
According to some experts, the use of pioglitazone can lead to fluid retention that precipitates or worsens congestive heart failure among patients. While it's believed that it can cause increases the risk of bladder cancer

2. DEANXIT
 Deanxit is a combination of two psychoactive agents (Flupenthixol and Melitracen ) which has antidepressant properties. It is designed for short term usage only. It is produced by Lundbeck.

MECHANISM OF ACTION:
Deanxit is a combination of Flupenthixol and Melitracen.
 Melitracen  is a tricyclic antidepressant for the treatment of depression and anxiety. The pharmacology of melitracen has not been properly investigated and is largely unknown, but it is likely to act in a similar manner to other Tricyclic antidepressants. Indeed, melitracen is reported to have imipramine and amitriptyline-like effects and efficacy against depression and anxiety, though with improved tolerability and a somewhat faster onset of action.
Flupentixol acts as an antagonist at various dopamine serotonin (5-HT2), adrenaline (α1), and histamine (H1) receptors, without affecting the muscarinic acetylcholine receptors.
Its antipsychotic effects are likely caused by D2 and/or 5-HT2A antagonism, whereas its antidepressant effects at lower doses may be mediated by preferential D2/D3 autoreceptor blockade, resulting in increased postsynaptic activation.


SIDE EFFECT:
 Deanxit, is a harmful combination, which has been long banned even in Denmark, its country of origin. anti-depressant deanxit—in the wake of health risks associated with them
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.

3. ANALGIN :
Analgin® is a brand name for Metamizole sodium, a medication used to treat a variety of pains. Analgin® is referred to as an analgesic and an antipyretic. This means that it is designed as a painkiller and a fever reducer. Besides fever, Analgin® is used to treat toothache and headache. Other ailments include arthralgia, which involves pain of the joints; neuralgia, which is pain in one or more nerves; and myositis, which concerns inflammation of the muscles.

SIDE EFFECT:
A side effect of the medication, however, caused major concern. Scientists discovered that the drug could heighten the risk of agranulocytosis, a medical condition that involves a lowered white blood cell count, thus weakening the immune system's ability to fight diseases. In 1974, Sweden was the first country in the world to ban the drug, analgin has been discarded the world over on grounds of patient safety.


THE CASE HISTORY:

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, 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).

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.

REFERENCES
Wikipedia
Drug bank
Times of India