Lok Sabha Question No. 1777 (UNSTARRED), answered on 2016-11-25
Subject: Impact of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: PRABHAS KUMAR SINGH

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

## LOK SABHA UNSTARRED QUESTION NO. 1777 TO BE ANSWERED ON 25 TH NOVEMBER, 2016

## IMPACT OF DRUGS

## 1777. DR. PRABHAS KUMAR SINGH:

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

- (a) whether the Government has undertaken any study to assess the impact of drugs/pharmaceuticals used in the country that are banned in other countries;
- (b) if so, the name and number of drugs banned since 2014;
- (c) if not, the reasons therefor; and
- (d) the other measures taken by the Government to ban of such drugs in the country?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI FAGGAN SINGH KULASTE)

(a) to (d): A drugbanned / restricted in one country may continue to be marketed in oth countries as the respective Governments examine the usage, doses, indications permitted along with the overall risk - benefit ratio and take decisions on the continued marketing of any drug in that country. In India, safety issues concerning drug formulations are, as and wh assessed  in  consultation  with  the  experts.  Safety  and  efficacy  issues  relating  to  cert which have been banned in some countries have been exami ned and some of these have been allowed for continued marketing subject to stipulated condition/restrictions. These includ

- I. Nimesulide: - The  manufacture,  sale  and  distribution  of  Nimesulide  formulation  fo human use in children below 12 years of age has b eenprohibited 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 18.06.2013. Subsequently, the ban was revoked subject t o the condition that manufacturers  will  be  required  to  mention  the  following  on  their  package  insert promotional literature of the drug: -

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

- III.Pioglitazone: -The manufacture for sale, sale and distribution of the drug Pioglitazone formulations  containing  Pioglitazone  for  human  use  was  initially  suspended  w. 18.06.2013. Subsequently,  the  suspension  was  revoked  subject  to  the  condition  that manufacturer shall mention on the package insert and promotional literature of the dr following: -
- a) The drug should not be used as first line of therapy for diabetes.
- b)  T he  manufacturer  should  clearly  mention  the  following  box  warning  in  bold  re 'Advice for healthcare professionals:
- I.  Patients  with  active  bladder  cancer  or  with  a  history  of  bladder  cancer,  and  th uninvestigated haematuria, should not receive pio glitazone.
- c)  Prescribers  should  review  the  safety  and  efficacy  of  pioglitazone  in  individuals  a -6 months of treatment to ensure that only patients who are deriving benefit continue to be Pioglitazone  should  be  stopped  in  patients  who  do  n ot  respond  adequately  to  treatment  (e.g. reduction in glycosylated haemoglobin, HbA1c).
- d)  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; exposure to some occupational or chemotherapy agents such as cyclophosphamide; or previous irradiatio the pelvic region.
- e) Use in elderly patients should be considered carefully before and during treatment bec risk of bladder cancer increases with age. Elderly patients should start on the lowest poss dose  and  be  regularly  monitored  because  of  the  risks  of  bladder  cancer  and  heart  f associated with pioglitazone.'