Lok Sabha Question No. 3510 (UNSTARRED), answered on 2017-08-08
Subject: Quality Testing of Generic Medicines
Ministry: CHEMICALS AND FERTILIZERS
Asked by: RAKSHA NIKHIL KHADSE

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

## LOK SABHA

## UNSTARRED QUESTION No. 3510

## TO BE ANSWERED ON THE 8 th  August, 2017

## Quality Testing of Generic Medicines

3510. SHRIMATI RAKSHATAI KHADSE:

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

- (a) whether the Government has received report of patients facing the same problems after using generic medicines purchase from open market;
- (b) if so, the details thereof and the reaction of the Government thereto;
- (c)  whether  the  Government  has  established  any  mechanism  for  quality testing  of  drugs  before  its  sale  in  the  open  market  and  if  so,  the  details thereof; and
- (d) whether the Doctors across the country are not prescribing the generic medicines as the medicines available in the market are not efficacious and if so, the details thereof?

## ANSWER

## MINISTER OF STATE IN THE MINISTRY OF ROAD TRANSPORT AND HIGHWAYS; MINISTRY OF SHIPPING AND MINISTRY OF CHEMICALS AND FERTILIZERS (SHRI MANSUKH L. MANDAVIYA)

- (a) and (b):  As per the information received from Drug controller General of India no such report has been received.
- (c): Manufacturing  sale  and  distribution  of  Drugs  in  the  country  are 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. Licensees are  required  to  comply  with  all  the  conditions  of  license  and  follow  Good Manufacturing  Practices  (GMP)  to  ensure  that  the  drugs  manufactured  by them are safe and of standard quality. Recently, the Drugs and Cosmetics Rules have been amended

vide GSR No. 327(E) dated 03.04.2017, wherein there is now a requirement that the applicant shall submit the result of bioequivalence study referred to in Schedule Y of the Rule, along with the application for grant of a license of oral dosage form of drugs specified under category II and category IV of the biopharmaceutical  classification  system.  All  the  drugs  manufactured  in  the country, whether branded or generic are required to comply with the same standards as prescribed in the Drugs & Cosmetics Act, 1940 & Rules made thereunder. The State Licensing Authorities are empowered to take action in case of any violation of above requirements.

(d):  The  doctors  prescribe  medicines  based  on  their  wisdom  keeping  the best  interest  of  the  patients ' health  in  mind.  However,  the  Government  is taking various steps for encouraging use of generic medicines. The Medical Council  of  India  has  amended  the  Indian  Medical  Council  (Professional Conduct, Etiquette and Ethics) Regulations, 2002 on 08.10.2016 to provide a new  para  regarding  use  of  generic  names  of  drugs  in  prescription.  The Government is operating a  Scheme, ' Pradhan  Mantri  Bhartiya  Janaushadhi Pariyojna ' (PMBJP)  for  providing  quality  generic  medicines  at  affordable prices in the country. Various publicity media are being used to popularize the PMBJP and for creating awareness of generic medicines.

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