Lok Sabha Question No. 1489 (UNSTARRED), answered on 2016-03-04
Subject: Banned Medicine
Ministry: HEALTH AND FAMILY WELFARE
Asked by: BHAVANA GAWALI (PATIL), KRUPAL BALAJI TUMANE

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

## LOK SABHA UNSTARRED QUESTIO N NO. 1489 TO BE ANSWERED ON 4 TH MARCH, 2016

## BANNED MEDICINE

## 1489. SHRIMATI BHAVANA PUNDALIKRAO GAWALI PATIL: SHRI KRUPAL BALAJI TUMANE:

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

- (a) whether many medicines which are banned in developed countries are freely sold in Indi

(b) if so, the details of such medicines which are banned in f oreign countries and freely available in India; and

(c) the steps taken/being taken by the Government to strictly implement to ban such med along with the outcome thereof?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI JAGAT PRAKASH NADDA)

(a) to (c):   A drug banned / restricted in one country may continue to be marketed countries as the respective Governments examine the usage, doses, indications permitted along with the overall risk - benefit ratio and take decisions o n the continued marketing of any drug  in  that  country.    In  India,  safety  issues  concerning  drug  formulations  are,  as  a noted, assessed in consultation with the Expert Committees / Drugs Technical Advisory B (DTAB).  Based  on  the  recommendations  o f the  Expert  Committees  /  DTAB,  the  Central Government prohibits manufacture, sale and distribution of such drugs in the country. So Central Government has prohibited the manufacture, sale and distribution of 94 drugs. and efficacy issues r lating to certain drugs which have been banned in some countries hav been examined in consultation with the DTAB/Experts. Some of these have been allowed f continued marketing subject to stipulated condition/restrictions.  These include :

- (i) Nimesulide: - The manufacture, sale and distribution of Nimesulide formulation for huma use in children below 12 years of age has been prohibited in the country.
- (ii) Analgin: - The manufacture for sale, sale and distribution of Analgin and its formula containing Analgin for human use was initially suspended in the country w.e.f. 18.06.20 Subsequently, DTAB examined the issue of suspension of manufacture and sale of the sa drug on 25.11.2013 in its 65 th meeting and on the basis of the recommendations of the D TAB, the ban was revoked subject to the condition that manufacturers will be required to m the following on their package insert and promotional literature of the drug: -

'The drug is indicated for severe pain and pain due to tumour and also for br inging down temperature in refractory cases when other antipyretics fail to do so'.

(iii)    Pioglitazone: -The manufacture for sale, sale and distribution of the drug Pioglitaz and formulations containing Pioglitazone for human was initially suspended w.e.f. 18.06.2013.    Subsequently,  DTAB,  after  examination,  recommended  for  revocation  of  th suspension  of  the  manufacture  and  sale  of  the  drug  subject  to  certain  condition accordingly, the suspension was revoked subject to the condition that the manu facturer shall mention on the package insert and promotional literature of the drug the following: -

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

'Advice for healthcare professionals:

- I. Patients  with  active  bladder  cancer  or  with  a  history  of  bladder  cancer,  and  thos uninvestigated haematuria, should not receive pioglitazone.
2. II.Prescribers should review the safety and efficacy of pioglitazone in individ uals after 3 -6 months of treatment to ensure that only patients who are deriving benefit continue treated.  Pioglitazone  should  be  stopped  in  patients  who  do  not  respond  adequatel treatment (e.g. reduction in glycosylated haemoglobin, HbA1c).
3. III.Before starting pioglitazone, the following known risk factors for development of b cancer should be assessed in individuals: age; current or past history of smoking; e to  some  occupational  or  chemotherapy  agents  such  as  cyclophosphamide;  or  previ ous irradiation of the pelvic region.
- IV. Use in elderly patients should be considered carefully before and during treatment b therisk  of  bladder  cancer  increases  with  age.  Elderly  patients  should  start  on  the possible dose and be regularly monitored because of the risks of bladder cancer and failure associated with pioglitazone.'

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