Lok Sabha Question No. 3307 (UNSTARRED), answered on 2020-03-13
Subject: Banning Cheap Anti-Diabetic Drug
Ministry: HEALTH AND FAMILY WELFARE
Asked by: K. Shanmuga Sundaram

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

LOK SABHA UNSTARRED QUESTION NO. 3307 TO BE ANSWERED ON 13 TH MARCH, 2020

## BANNING CHEAP ANTI - DIABETIC DRUG

## 3307. SHRI SHANMUGA SUNDARAM K.:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a) whether the Government has banned the anti - diabetic drug Pioglitazone which is cheaper and is widely used by the poor and middle class patients in the country;
- (b) if so, the details thereof and the reasons therefor;
- (c) whether the Government has undertaken any scientific study to ascertain the risk of cancer caused by Pioglitazone, if so, the details thereof and if not, the reasons therefor
- (d) whether t he Government has received any specific complaint from any research organizatio or reputed hospitals, if so, the details thereof and action taken thereon; and
- (e) whether the Government is having any detailed report of the adverse effects of this drug FDA (Federal Drug Administration) of USA, if so, the details thereof?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR C HOUBEY)

- (a) & (b): In light of reported risk of bladder cancer associated with the use of piogl and restriction imposed  on marketing of pioglitazone by other  countries, the manufactu sale, sale and distribution of the drug Pioglitazone and formulations containing Pioglitazone for human was suspended vide gazette notification GSR 379 (E) dated 18.06.2013.

Subsequently, the Drugs Technical Advisory Board (DTAB) recommended for revocation of  the  said  suspension  subject  to  some  co nditions.  After  examination,  the  Government  vide gazette  notification  GSR  No.  520  (E)  dated  31.07.2013  revoked  the  suspension  of manufacturing and sale of the drug subject to the condition that the manufacturer shall the following on their pack age insert and promotional literature of the drug: -

- a) The drug should not be used as first line of therapy for diabetes.
- b) The manufacturer should clearly mention following box warning in bold red.

'Advice for healthcare professionals:

- Patients with active bl adder cancer or with a history of bladder cancer, and those wi uninvestigated haematuria, should not receive pioglitazone.
- Prescribers should review the safety and efficacy of pioglitazone in individuals af -6 months of treatment to ensure that only patients who are deriving benefit continue to be treated.  Pioglitazone  should  be  stopped  in  patients  who  do  not  respond  adequatel treatment (e.g., reduction in glycosylated haemoglobin, HbA1c).
- Before starting pioglitazone, the following known risk fac tors for development of bladder cancer  should  be  assessed  in  individuals:  age,  current  or  past  history  of  sm exposure to some occupational or chemotherapy agents such as cyclophosphamide, o previous irradiation of the pelvic region.
- Use  in  elderly  p atients  should  be  considered  carefully  before  and  during  treatmen because the risk of bladder cancer increases with age. Elderly patients should star lowest possible dose and be regularly monitored because of the risks of bladder c and heart failure associated with pioglitazone.'

(c): No  such  study  was  undertaken  by  the  Central  Drugs  Standard  Control  Organisatio (CDSCO) and the recommendation for suspension, as mentioned above, was based on reported risks and restriction imposed by other c ountries.

(d): A complaint was received from one of the Diabetic Care Centres. The complaint wa examined and replied accordingly.

(e): As per the safety announcement dated 12.12.2016 by the Food & Drug Administration o the United States of America available on their website, pioglitazone may be associated with increased risk in urinary bladder cancer. However, the drug is marketed in USA with war about the risk.

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