The government has banned three popular medicines1. Pioglitazone
2. Deanxit
3. Analgin
PIOGLITAZONE :
It is the widely prescribed anti-diabetes drug. Pioglitazone is a prescription drugof 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 2diabetes.
MECHANISM OF ACTION:
Pioglitazone selectively stimulates the nuclearreceptor peroxisome proliferator-activated receptor gamma. Itmodulates the transcription of the insulin-sensitivegenes involved in the control of glucose and lipidmetabolism in the muscle, adipose tissue, and the liver.
As a result,pioglitazone reduces insulin resistance in the liver and peripheraltissues; increases the expense of insulin-dependent glucose; decreaseswithdrawal 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 pioglitazonecan lead to fluid retention that precipitates or worsens congestive heartfailure among patients. While it's believed that it can cause increases therisk of bladdercancer.
2. DEANXIT
Deanxit is a combination of twopsychoactive agents (Flupenthixol and Melitracen ) which has antidepressantproperties. 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 treatmentof depression and anxiety.The pharmacologyof melitracen has not been properly investigated and is largely unknown, but itis likely to act in a similar manner to other Tricyclic antidepressants.Indeed, melitracen is reported to have imipramineand amitriptyline-likeeffects and efficacy against depression and anxiety, though with improved tolerabilityand a somewhat faster onset of action.Flupentixol acts as an antagonist at various dopamineserotonin (5-HT2),adrenaline (α1), and histamine (H1)receptors, without affecting the muscarinic acetylcholine receptors.Its antipsychotic effects are likely causedby D2 and/or 5-HT2A antagonism, whereas itsantidepressant effects at lower doses may be mediated by preferential D2/D3autoreceptorblockade, resulting in increased postsynaptic activation.
SIDE EFFECT:
Deanxit, is aharmful combination, which has been long banned even in Denmark, its country oforigin. anti-depressant deanxit—in the wake of health risks associated withthem
This decision comes in the wake of a strong stand by the government onsuspending marketing of all drugs prohibited for sale in other countries likethe US, the UK, EU and Australia.
3. ANALGIN :
Analgin®is a brand name for Metamizolesodium, a medication used to treat a variety of pains. Analgin®is referred to as an analgesicand an antipyretic. This means that it is designed as a painkiller and a feverreducer. Besides fever, Analgin® is used to treattoothache and headache. Other ailments include arthralgia, which involves painof the joints; neuralgia, which is pain in one or more nerves; and myositis,which concerns inflammationof the muscles.
SIDE EFFECT:
A side effect of the medication, however, causedmajor concern. Scientists discovered that the drug could heighten the risk ofagranulocytosis, a medical condition that involves a lowered white blood cellcount, 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 beendiscarded the world over on grounds of patient safety.
THE CASE HISTORY:
The ministry ofhealth and family welfare has suspended the manufacture and sale ofall three drugs under Section 26A of the Drugs and Cosmetics Act, 1940 withimmediate effect, While the ministry has been dilly-dallying on withdrawinganalgin and deanxitfor years now, despite pressure from a parliamentary panel, the decision on thediabetes drugpioglitazone has taken the industry completely by surprise.
The decision to ban pioglitazone and its combinations will hit the Rs 700-croremarket for such drugs and adversely impact a clutch of companies includingAbbott, Sun Pharma, USV, Lupin, Ranbaxy and Wockhardt.
Pioglitazone combination is a bigger market than plain pioglitazone itselfwhich is has posted a strong double-digit growth, with over 30 companiesmarketing the drug. The top-selling brands of posiglitazone include Pioz MF Gand 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 likeBaralgan and Novalgin (Sanofi Aventis), as most companies fearing a ban havealready pulled out from the market, industry experts said. The third drug, acombination of Flupenthixol and Melitracen sold as Deanxit (Lundbeck), Placida(Mankind), Franxit (Intas) and Restfull (Lupin) is facing a ban because deanxitis prohibited for sale in Denmark, its country of origin, and also, thecombination is not sold in major countries.
Under the Drugs and Cosmetic Rule 30-B, the import and marketing of any drugthe use of which is prohibited in the country of origin, is banned in India. Aparliamentary panel report on health earlier this year had rapped thegovernment for dilly-dallying on withdrawing deanxit and analgin, which are notsold in markets globally.
The family of 'glitazones', used for blood glucose lowering properties, hasbeen mired in controversy since the beginning, with many drugs under the classhaving already been banned globally, and in India. Three years back, anotherdrug from this family, rosiglitazone, marketed by a host of companies includingGSK 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 itmay cause or worsen heart failure, and its use for over a year may beassociated with an increased risk of bladder cancer.
Doctors here in India had said in a study last year that more robust data onuse of pioglitazone on Indian patients was needed. Till that time, the patientshould be adequately informed about this adverse effect and the drug should beused in as small a dose as possible, with carefulmonitoring and follow up. Earlier this month, the ministry had suspended saleof dextropropoxyphene, sold as Wockhardt's Proxyvon, a widely-used pain-killer.
REFERENCES
Wikipedia
Drug bank
Times of India