Lok Sabha Question No. 2781 (UNSTARRED), answered on 2016-03-15
Subject: Violation of Manufacturing Norms
Ministry: CHEMICALS AND FERTILIZERS
Asked by: M. K. RAGHAVAN

## Government of India Ministry of Chemicals & Fertilizers Department of Pharmaceuticals

## LOK SABHA

## UNSTARRED QUESTION No.2781

## TO BE ANSWERED ON THE 15 th  MARCH, 2016

## Violation of Manufacturing Norms

## 2781.  SHRI M.K. RAGHAVAN

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

- (a)  whether  any  Indian  drug  manufacturing  pharmaceutical  companies  have been indicted by the USFDA for violating manufacturing norms ;
- (b)  if so, the details thereof along with the action taken against these pharmaceutical companies for reduction in export and bringing bad name to the country in international market; and
- (c)  whether  such  yardstick  is  applied  for  pharmaceutical  manufacturers  that supply medicine domestically and if so, the details thereof?

## ANSWER

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

- a)  &  (b)  M/s  Ranbaxy  USA,  Inc.  pleaded  guilty  in  the  US  District  Court  of Maryland in the year 2013 for manufacture and distribution of certain drugs not  in  conformity  with  the  Good  Manufacturing  Practices  (GMP)  regulation which is considered as adulterated drugs as per US law and agreed to pay USD 500 million. For export, Indian Pharmaceutical Companies are required to  comply  with  the  regulatory  provisions  of  the  importing  country.  However, drugs  for  export  are  required to be manufactured  under  the manufacturing license  granted by the State  Licensing  Authority.
- c) The  Drugs  &  Cosmetics  Act,  1940  provides  that  drugs  are  manufactured  under  a license  granted  by  the  concerned  State  Licensing  Authority  and  comply  with  the requirements of Good Manufacturing Practices as specified under Schedule M and conditions  of  the  manufacturing  License  granted  under  the  Drugs  &  Cosmetics Rules,  1945  for  the  purpose.  However,  government  has  taken  the  following measures to establish strict enforcement regime for stringent prosecution/penalties in cases  of  manufacture,  supply  and  sale  of  drugs  as  well  as  non-adherence  to  the quality norms prescribed:
1. 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 and setting of special Courts.

2. 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.
3. 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.
4. The  scheme  provides  for  suitably  rewarding  the  informers  for  providing concrete information to the regulatory authorities in respect of movement of spurious drugs.
5. 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.
6. The testing capacities of Central Drugs Testing Laboratories under CDSCO are being constantly strengthened to expedite testing of drug samples in the country.