Lok Sabha Question No. 787 (UNSTARRED), answered on 2018-12-14
Subject: Anti-Diabetes Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: P. C. MOHAN

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

## LOK SABHA UNSTARRED QUESTION NO. 787 TO BE ANSWERED ON 14 TH DECEMBER, 2018

## ANTI - DIABETES MEDICINES

## 787. SHRI P.C. MOHAN:

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

- (a) whether the Government is aware about a report on the adverse drug reactions associated with the use of a new class of anti - diabetes medicines (SGLT - 2 inhibitors) in India;
- (b) if so, the details thereof and the ction taken against this;
- (c) whether the Drug Controller of India has given the permission to market this medicine in India and if so, the details thereof;
- (d) whether the Ministry is having any details of these medicines being used and its adverse effects reported in Karnataka and if so, the details thereof; and
- (e) the steps taken by the Government to create awareness among millions ofdiabetic patients in the country against the usage of SGLT - 2?

## ANSWER THE MIN ISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. ANUPRIYA PATEL )

- (a)& (b): Yes.  Central  Drugs  Standard  Control  Organisation  (CDSCO)  notified by  the concerned  company about  a  Health  Canada  communication  to  all  Sodium - Glucose  Co transporter 2 (SGLT2) inhibitor Marketing Authorization Holders regarding a Summary Safe Review (SSR) on the potential risk of pancreas inflammation (acute and chronic).

United StateFood & Drugs Administration (USFDA) in its Drug Safety Communications (DSC) stated that cases of rare but serious infection of the genitals a around the genitals have been reported with use of SGLT2 inhibitors. This serious rare in called ne crotizing fasciitis of the perineum, is also referred to as Fournier gangrene. USF examining addition of a new warning about the risk to the prescribing information of all inhibitors and to the patient Medication Guide.

The issue was deliberated in the 48th Subject Expert Committee (SEC)'s meeting held on 27.09.2018 in CDSCO.

The committee noted that both the health authorities (Health Canada & USFDA) had no issued  any  label  changes  or  restriction  in  SGLT - 2  inhibitors.  The  c ommittee,  inter - alia, recommended close monitoring for any new information /development with regard to the use SGLT - 2 inhibitors.

Indian Pharmacopoeia Commission (IPC) through Pharmacovigilance Programme of India (PvPI) keeps watch on patter n of Adverse Drug Reaction (ADR) induced by SGLT - 2 inhibitors.

(c): CDSCO  has  given  permission  to  Import/market  formulation  of  following  SGLT -2 inhibitors:  Canagliflozin,  Dapagliflozin  &  Empagliflozin  including  FDC  like  Canaglifloz Metformin, Dapagliflozin  +  Metformin,  Empagliflozin  +  Metformin  &  Empagliflozin  + Linagliptin.

(d) & (e): The adverse effects in respect of SGLT - 2 inhibitors reported under Pharmacovigilance Programme of India (PvPI) from Karnataka is annexed.

the

These drugs are marketed in many countries like the USA, Canada, European Union, etc As opined by the SEC mentioned in part (a) & (b) above, none of the Health Authorities either banned or issued any label change or advisory against the use of these drugs.

## Annexure

|   S.NO | SGLT - 2 Inhibitor   |   No. of Reports | Adverse Effects                                                                                                                              |
|--------|----------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
|      1 | Canagliflozin        |                3 | Renal impairment, Diabetic ketoacidosis, Encephalopathy Muscular weakness Urinary tract infection                                            |
|      2 | Dapagliflozin        |                4 | Epigastric discomfort, Dyspepsia, Burning sensation mucosal Genital infection, Urinary tract infection, Ketoacidosis Ketoacidosis Glycosuria |
|      3 | Empagliflozin        |                3 | Balanoposthitis Urinary tract infection Urinary tract infection                                                                              |