Lok Sabha Question No. 2002 (UNSTARRED), answered on 2020-03-03
Subject: Quality Medicines to Animal Husbandry Sector
Ministry: FISHERIES, ANIMAL HUSBANDRY AND DAIRYING
Asked by: Darshana Vikram Jardosh

## GOVERNMENT OF INDIA MINISTRY OF FISHERIES, ANIMAL HUSBANDRY & DAIRYING DEPARTMENT OF ANIMAL HUSBANDRY & DAIRYING LOK SABHA UNSTARRED QUESTION NO. 2002 TO BE ANSWERED ON  3 RD  MARCH, 2020

## QUALITY MEDICINES TO ANIMAL HUSBANDRY SECTOR

## 2002.  SHRIMATI DARSHANA VIKRAM JARDOSH

## Will the Minister of FISHERIES, ANIMAL HUSBANDRY & DAIRYING मत्स्यपाऱन , पशुपाऱन और डेयरी मंत्री

be pleased to state:

- (a) whether  the  Ministry  has  proposed  to  formulate  a  concrete  policy  for  providing  quality medicines  to  animal  husbandry  sector  in  coordination  with  the  Department  of  Animal Husbandry;
- (b) if so, the details thereof;
- (c) whether the Ministry has proposed to formulate a concrete policy for enhancing research and developmental activities in animal husbandry sector;
- (d) whether the Government complies with international norms for providing quality medicines to animal husbandry sector; and
- (e) If not the concrete reasons therefor?

## ANSWER

## THE MINISTER OF STATE FOR FISHERIES, ANIMAL HUSBANDRY & DAIRYING (DR. SANJEEV KUMAR BALYAN)

- (a) and  (b)  Drugs,  including  veterinary  drugs,  are  regulated  under  the  provisions  of  Drugs  and Cosmetics Act, 1940 and Rules made there-under. Central Drug Standards Control Organization  (CDSCO)  under  Directorate  General  of  Health  Services,  Ministry  of  Health  & Family Welfare, Government of India is administering the Drugs and Cosmetics Act, 1940 and Rules made there-under. CDSCO issues license for manufacture, marketing and import of drugs including veterinary drugs.
- (c) The  Indian  Council  of  Agricultural  Research  (ICAR)  under  the  Department  of  Agricultural Research and Education (DARE), Ministry of Agriculture and Farmers Welfare, Government of India is mandated to work in the area of agricultural research and development including animal husbandry. ICAR has 19 Animal Science Institutes working in the area of livestock and poultry production  including  species  specific  institutes  carrying  out  research  in  various  species  for improvement in Animal Health Management and conservation of elite germ plasm for better progeny.

All  India Coordinated Research Projects (AICRP)/All India Network Project (AINP)/Outreach Programme (ORP)/Consortium Research Platform (CRP) are coordinated by ICAR for breed improvement and management of Animal Health through development of specific point of care diagnostics and vaccines including prophylactics.

- (d)  and(e)  As  per  information  received  from  the  Central  Drugs  Standard  Control  Organization (CDSCO), Government has taken the following regulatory measures to ensure quality of drugs 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.
- ii) 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.
- iii) States  /  UTs  have  been  requested  to  set  up  special  Courts  for  speedy  disposal  in  respect  of offences under Drugs and Cosmetics Act.
- iv) On 27/10/2017, the Drugs and Cosmetics Rules, 1945 were amended vide Gazette notification no.  G.S.R.  1337  (E)  making  it  mandatory  that  before  the  grant  of  manufacturing  license,  the manufacturing establishment is  to  be  inspected  jointly  by  the  Drug  Inspectors  of  the  Central Government and the State Governments.
- v) The  licensed  manufacturing  premises  shall  be  inspected  jointly  by  the  Drugs  Inspectors  of Central  Government  and  State  Government  to  verify  the  compliance  with  the  conditions  of license and the provisions of the Drugs & Cosmetics Act and Rules for not less than once in three years or as needed as per risk based approach.
- vi) On  10/04/2018,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended  vide  Gazette notification no. G.S.R. 360 (E), making it mandatory that the applicants shall submit evidence of stability, safety of excipients, etc. to the State Licensing Authority,for all drugs, before grant of product manufacturing license by the authority.