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DCGI open to revoking of ban on pioglitazone based on scientific evidence

Joseph Alexander, New Delhi
Tuesday, July 2, 2013, 08:00 Hrs  [IST]

The Government is open to re-examine the case of anti-diabetes drug pioglitazone and revoke the ban if strong scientific evidences emerge in support of its safety and efficacy, Drug Controller General of India (DCGI) Dr G N Singh informed.
However, he defended the ban of the drug as per the existing system and adverse reactions, and strongly refuted the allegations that it was banned to help some other brands.
“It is not a closed case. We are open-minded in the case of pioglitazone, unlike in the case of the two other banned drugs-- analgin and deanxit. Science is progressing and we are willing to re-examine the ban if the companies concerned or the scientific community come up with scientific evidence to prove its safety and efficacy,” Dr Singh told Pharmabiz.

While indicating that it was kind of 'suspension' of manufacturing more than the blanket ban, the DCGI said the decision to ban drug was taken as per the existing norms. “The Health Ministry had made a written commitment before the Parliamentary panel that any drug banned in more regulated countries would be banned in India also immediately. Pioglitazone is banned in developed countries like Germany and France,” he said.
Apart from this, there were also cases of adverse reports about this anti-diabetes drug under the pharmacovigilance programme in India, further strengthening the case for a ban now, the regulator revealed.
The ban of pioglitazone had raised a storm with the industry leaders questioning the step and there were also allegations that it was banned to help some other existing brands. However, the DCGI strongly denied such allegations as 'totally baseless'.
Pioglitazone is one of the commonly-prescribed medicines. As many as 300 brands are available as single drug as well as in combinations with other drugs such as metformin and glimepiride. The sudden ban had raised protests from the industry which claimed that it was available in most of the countries across the globe.


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ganesan v Jul 28, 2013 7:55 PM
what is the current status of ban. You are aware lakhs of endusers closely awaiting for release of pioglitazone products

vinod sehgal Jul 26, 2013 10:27 AM
If pioglitazone will remain banned then what is the substitute for Gemer P1 or such other tablets for the persons using these tablets from many more years.
Gopinath Sunil Jul 6, 2013 3:11 AM
It has been very depressing to note that the DCGI is resorting to such high handed action based on the 'ban' in Germany and France; and not the medical information rich and research strong US and UK. In the US where I am practising as an endocrinologist, pioglitazone and rosiglitazones are still being used very widely. I have been using these drugs for the past 15+ years and have not seen any increase in cancer; in fact have seen reduction in cancer and heart problems. It is clear that this action by the government has been made to appease the financial interests of other multinationals who want to let diabetes progress unrelentlessly in unsuspecting Indians, so that they can sell their stents, their kidney failure medications and send more patients to cancer specialists. What a shame!! The medical community and the public should stand up in protest.
pg dinesh Jul 6, 2013 2:24 AM
Why cigerets and alcohol not banning in India? Is it not harmful to human body.? Is pioglitazone more dangerous than the other two? Pioglitazone is one of the cost effective medicine for diabetes treatment .It's adverse effects are minimum compared to the benefit it offers to diabetes patients

Pramod Agarwal Jul 5, 2013 2:34 PM
Pioglitazone is being used since last 12-15 years all across the globe. It is one of the best drugs against insulin resistance.
Thousands of t2dm pts. are well controlled with this drug. These are patients who cannot afford the costly gliptins. Before creating a PHOBIA in the media the authorities should have thought a thousand times. The declared a ban and says we shall consider if strong evidence come in favour.
1.How many bladder cancers are on record in India in the last 15 yrs?
2.Of them how many are diabetics?
3.Of the diabetic pts. How many are on pio and since how long?
4.Above all when pio. Is featured in all recommendations - ADA. CDA, AACE, EASD, INDIAN GUIDELINES then WHY? ? ?
Dr.Pramod Agarwal, Berhampur, Odisha

Naveen Jain Jul 5, 2013 12:21 PM
Our health officials should relook into the available safety data and critically analyzed the benefit Vs risk on this well clinically experienced molecule. However, it should be allowed with label warning and preacutions (on possible risk). This is wonderful molecule has demonstrated god efficacy when glycemic control is not possible with metformin and sulphonylureas.
Dr Lalit Badrakia MD Jul 5, 2013 1:09 AM
Dear Sir,
Pioglitazone is still approved by usa fda with box warning not to be used in heart failure. It is also marketed in europen union with contra indication as in usa. Only germany & france have baned.
Thanking you,
Dr Lalit Badrakia MD
Suvodip De Jul 4, 2013 10:00 PM
It is a good news for the patients of T2DM.
Dr Ajit Sinha Jul 4, 2013 6:27 AM
In fact this happening to help the companies which sell 'Gliptins' which very few patients are able to afford. Pioglitazone still features in 2013 treatment algorithm of ADA, ACE, ACCE, EASD.

Mr DCGI must be informed that this June 7th only, most of the 26-member advisory US FDA panel voted to loosen the restrictions which were placed Rosiglitazone in 2010 because of concerns it might raise the risk of heart attacks and death from CV causes.
Dr George T John Jul 3, 2013 11:02 PM
pioglitazone is a good, effective, low cost OHA , which can be added to other drugs for smooth control of diabetes.We have reasonable good experience with this drug and the side effect,the fluid retention, can be minimized using low dose,avoiding in high risk patient using diuretic . Comparing the number of patients using it and the benefit it offered , the banning is criminal.The risk of bladder carcinoma is minimal.FDA has not yet banned it, then how can our ''''expert'' ban it with out proper study and consultation
Dr,George T john
Harish B P Jul 3, 2013 9:28 PM
ITs good. It does not have side effects from 2 years. I am taking from 2 years, 15mg/day. (now ,, 15/500 otsira ,, 1-0-1 dosage ,, from 1 month)
Jayendra Shah Jul 3, 2013 9:14 PM
Govt. must re think on the issue apart of business it is very difficult for patients to switch over on other brands.
dr vandana kumari Jul 3, 2013 5:55 PM
Many drugs has rare but serious side effects,used with cautious .cost is very important for Indian people. Cost effect ratio is very important
Dr Parag Shah Jul 3, 2013 3:49 PM
Ban should be revoked as soon as possible. Many studys in combination with other drug combinations have been done. It is beneficial in indian patient to control blood sugar.For safety concern dose restriction can be the ideal option but withdrwaing is totally baseless and that to without any medical evidence.
Dr Parag Shah Jul 3, 2013 3:48 PM
Ban should be revoked as soon as possible. Many studys in combination with other drug combinations have been done. It is beneficial in indian patient to control blood sugar.For safety concern dose restriction can be the ideal option but withdrwaing is totally baseless and that to without any medical evidence.
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