Lok Sabha Question No. 258 (UNSTARRED), answered on 2016-04-26
Subject: Spurious Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RAVINDRA VISHWANATH GAIKWAD

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

## UNSTARRED QUESTION No. 258

## TO BE ANSWERED ON THE 26 th  April, 2016

## Spurious Medicines

## 258. PROF. RAVINDRA VISHWANATH GAIKWAD:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government has conducted any investigation into the production  of  spurious  medicines  in  the  country  and  if  so,  the details thereof;
- (b) the  number  of  companies,  persons  or  institutions  found  guilty  of producing and distributing spurious medicines during the last three years; and
- (c) the concrete action taken/being taken/proposed to be taken by the Government to check this menace?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)

- (a) The manufacturing, sale and distribution of drugs in the country is regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules,  1945  made  thereunder  through  a  system  of  licensing  and inspection. License for manufacturing sale and distribution of drugs are granted by State Licensing Authorities appointed by respective State Governments. State Licensing Authorities are legally empowered  to  take  action  against  violations  of  any  provisions  of said Act.
- (b) As  per  the  Office  of  Drugs  Controller  General  (India),  information received  from  various  State/UTs  Drugs  Controllers  mentions  that 3648  raids  were  conducted  during  1 st April,  2015  to  31 st March, 2016. These cases were investigated and FIR, Prosecution, Suspension/Cancellation of licenses were done where found guilty.

- (c) The  Govt.  of  India  has  taken/taking  following  steps  to  check  the menace of spurious medicines and to ensure that safe, efficacious and quality of medicines are made available in the country:-
- (i) The Drugs and Cosmetics Act, 1940 was amended under Drugs  &  Cosmetics  (Amendment)  Act  2008  to  provide stringent penalties for manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable by setting of special Courts.
- (ii) The States / UTs were requested to set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy  disposal.  So  far,  22  States  have  already  set  up designated special Courts.
- (iii) A Whistle Blower Scheme was announced by the Government of India to encourage vigilant public participation  in  the  detection  of  movement  of  spurious drugs  in  the  country.  The  scheme  provides  for  suitably rewarding the informers for providing concrete information to  the  regulatory  authorities  in  respect  of  movement  of spurious  drugs.  The  details  of  policy  are  available  at  the website of CDSCO (www.cdsco.nic.in).
- (iv) Guidelines for taking action on samples of drugs declared spurious or not of standard quality in the light of enhanced penalties under the Drugs & Cosmetics (Amendment) Act, 2008  were  forwarded  to  the  State  Drugs  Controllers  for uniform implementation.
- (v) The inspectorate staffs have been instructed to keep a vigil and draw samples of drugs for test and analysis to monitor the quality of drugs moving in the country.
- (vi) The number of sanctioned posts in Central Drugs Standard Control  Organization  (CDSCO)  has  been  increased  from 111 in 2008 to 474 in 2016.
- (vii) The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened  to  expedite  testing  of  drug  samples  in  the country.

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