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Pioglitazone ban creates chaos for state DCs, patients, pharma cos, pharmacists and doctors

Nandita Vijay, Bengaluru
Saturday, June 29, 2013, 08:00 Hrs  [IST]

The sudden ban on diabetes drug pioglitazone by the union health ministry has caused chaos and confusion to one and all, including the state licensing authorities, patients, pharma companies, pharmacists and medical practitioners.

In Karnataka, there are two companies Biocon and Micro Labs which market this drug.

Pioglitazone has been reported to be safe with no adverse drug reactions reported so far. It is an important drugs in terms of regular revenues and many companies have been expanding their portfolio with this oral diabetic agent, according to a panel of pharma consultants who viewed the move to disallow pioglitazone as a pressure from a particular lobby.

Diabetologists from both government and corporate hospitals stated that pioglitazone is safe for type II diabetes and also reduces triglycerides and increase HDL levels.

However, there are reports from a couple of nursing homes where patients on pioglitazone reported to have developed lung congestion and required hospitalization. When patients were off the drug, there was relief. However, diabetologists said that this could be one in 1,000 cases reporting such a reaction and the drug was seen to be safe.

According to BR Srinath, senior vice president, Diabetes Task Force and Micro Critical Care, part of the Micro Labs Group, the US FDA has cleared pioglitazone. In fact, the global regulatory authority has gone a step ahead to allow a combination of pioglitazone with alogliptin. Now considering that the US does not allow combinations, this is to underscore the fact that pioglitazone is safe and is even being allowed to be in combination with another drug which no doubt proves its safety.

The manufacturers in India have to be given an opportunity to prove that the product is safe because it has been in the market for over a decade reporting no adverse drug reactions. Micro too has a formulation of pioglitazone known as ‘Tripride’ which was launched in 2004. The company will lose out its projected sales of Rs.60 crore for the fiscal 2013-14. In fact two divisions of Micro Labs : Caryson II and Diabetic Task Force were expected to generate Rs.12 crore and Rs.48 crore respectively for the year, said Srinath.

“This sudden ban without giving an opportunity to the companies will put nearly three million diabetics’ across the country into a serious problem. This may even cause a lot of deaths if patients have been forced to withdraw from this drug following the ban by the government. Pharma companies are now confused that when US has not banned the drug and approved combination of pioglitazone with alogliptin, the Indian government has banned it which comes as a surprise and shock. In India the market for pioglitazone is approx. Rs.700 crore which reinstates the importance of the drug for patients in the country,” Srinath stated.

Biocon manufactures pioglitazone in bulk and also has formulations: Piodart 15, Poiodart 30 and Piodart MF. “Pioglitazone is marketed globally and international regulators known to have high safety and compliance standards, continue to believe in the therapeutic advantages of this drug. But this decision is more critical for India as six per cent of the total diabetes patients here are on pioglitazone. With this decision, patients will now be compelled to use alternative therapy options which are eight to ten times times more expensive than pioglitazone and could reduce compliance rate in diabetes management. Our regulators need to review the decision and re-evaluate if the perceived risks of pioglitazone outweigh the pharmaco-economical benefits, especially in the socio-economic context of India,” said Rakesh Bamzai, president-marketing, Biocon.


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vijaykumar Jul 9, 2013 1:43 AM
Ever since 2001 I returned to India, I have been very successful in treating T2DM patients with Pioglitazone and combinations with Metformin and Glimiperide. I have about more than 2000 patients on this drug with good Glycemic control. None of the patients have had any side effects what so ever as I choose the drug judiciously. I am amazed in a country with largest Democratic Population, we are still ruled by the Babus who have no qualifications but pass orders like goons playing havoc with the patients suffering from the disease which is worst than Cancer! Pepsi-colas, KFC fried Chickens and Pizzas are more harmful. And what about Cigarettes which cause Bladder cancers more than 50% in Smokers are not banned and why the Tobacco company's' are licensed to manufacture to increase the incidence of all Cancers put together ?? Please I request the Government to give the Medical Fraternity a free hand to choose what is best for their Patients and it is they who are responsible for their
tushar sarkar Jul 3, 2013 12:18 AM
gov.shuld rethink about the ban of pioglitazone.

Guha Jul 1, 2013 11:37 PM
It is indeed very strange that the Indian Govt suddenly took this arbitrary decision without consulting diabetologists, RSSDI, ESI etc Obviously it is done under pressure or shall we say enticement from a wealthy pharma lobby. The past record of our Govt in matters of integrity leave no doubt. Poor Pio and poor Indian diabetics, this sinful Govt will force u take expensive alternatives so that they can fill their dirty pockets. No national studies or data, just do what they say. The Govt wants u to go to Quacks for treatment! Hai Ram!
Jayendra Shah Jun 30, 2013 12:12 PM
congrats Ms Nandita vijay. you have touch the nerve of the issue and highlights the dirty politics of concern companies. I firmly believe this can be happened in our country only. I firmly believe that this decision will give very very bad effects to the diabetic patients from lower class of the society by health and wealth both.
Dr B Bandyopadhyaya Jun 30, 2013 9:20 AM
withdrawl of pioglitazone is a welcome step. The giant pharma industries in USA have lot of influence on FDA UDA, not to ban the drug, Pio has adverse effects on heart. The data of patients" safety was supressed by pharma Giant, and the case is in the dept of justice in UDA. WE can manage patients of diabetes without pioglitazone.
Hariharan Jun 29, 2013 11:36 AM
Is there any authentic reports are there to ban PIOGLITAZONE and its combinations from India by overnight. Was there any calamity or serious of deaths had happened inspite of any warning given. If there are no such evidences how come our Govt. can ban this molecule without any prior intimation.
What are all the alternative arrangements made for the existing patients who are in the drug which they may not get it in the market right from day one. Many patients even donot know that they are taking this molecule as they are not very familiar to such pharmacological names.
Due to the discontinuation of this drug how they will manage their diabetic complications and even if they go to the doctors it is not easy to set the correct alternative theraphy within a stipulated time as diabetics is such a condition which needs lots of dose titrations till that time the patients will land into complications.
All these queries need to be addressed before taking such decision of banning the drug
vijay Jun 29, 2013 10:26 AM
Pioglitazone is good molecule why Indian govt. has banned dont know. The molecule is one of the best for type 2 diabetes.
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