Drug Regulatory
Agencies of World and Laboratories of India
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1
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WHO
Established- 7th April 1948
WHO
Headquarter- Geneva, Switzerland
Current
Director General of WHO- Margret Chan
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2
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WADA-
World Anti Doping Agency
WADA
Established- 10 November 1999
WHO
Headquarter- Montreal, Canada
President
of WADA- Craig Reedie
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3
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USFDA
formed in 1906
Current
commissioner of USFDA- Robert Califf
Headquarter
of USFDA- Maryland
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4
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CDSCO-
Central Drugs Standard Control Organization (India)
CDSCO
Heahquarter- New Delhi
Head –
Health minister (J.P.Nadda)
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5
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Health
minister of India- J.P.Nadda
Present
Drug controller General of India (DCGI)-G.N. Singh
Zonal offices of CDSCO – Four (Mumbai,
Kolkata, Chennai, and Ghaziabad)
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6
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Drug
Regulatory Agencies of Different Countries:
1.
USA- Food
and Drug Administration (FDA)
2.
UK-
Medicines and Healthcare Products Regulatory Agency (MHRA)
3.
Australia- Therapeutic Goods Administration (TGA)
4.
India-
Central Drug Standard Control Organization (CDSCO)
5.
Canada-
Health Canada
6.
Europe-
European Medicines Agency (EMEA)
7.
New Zealand- Medsafe - Medicines and Medical Devices Safety Authority
8.
China-
State Food and Drug Administration
9.
Japan-
Ministry of Health, Labour & Welfare(MHLW)
10. Singapore- Centre for Pharmaceutical Administration
Health Sciences Authority
11. Brazil- Agencia Nacional de Vigilonica
Sanitaria (ANVISA)
12. South
Africa- Medicines Control Council
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7
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Central
Food Laboratory in India- Four
a.
Food research and standardization laboratory- Gaziabaad
b.
Central food laboratory- Kolkata
(both lab. Come Under supervision of Director general
of health services )
c.
Central food laboratory- Pune
d.
Central food laboratory- Mysore
(both
lab. come under supervision of CSIR and Govt. of INDIA)
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8
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Different
Laboratory location of India
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1.
Central Drug Laboratory- Kolkata
2.
Central Research Institute- Kasauli
3.
Veterinary Research Institute- Izatnagar or Mukteshwar
4.
Central Pharmacopeial Laboratory (for condom)- Ghaziabad
5.
Pasteur Institute of India (check sample of oral
poliomyelitis)- Conoor
6.
Enterovirus Research Institute, Haffkine Institute Compound
(check sample of oral poliomyelitis)- Mumbai
7.
Laboratory of Serological and Chemical examiner to the
Government of India (VDRL sample checking)- Kolkata
8.
Central Drug Testing Laboratory (for intra uterine
device and falope rings)- Thane
9.
National Institute of Biologicals- Noida
10. Homeopathic Pharmacopeial
Laboratory- Ghaziabad
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9
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Committee
Apointment:
1.
Central License Approving Authority- Drug Controller (india)
2.
Drug Consultative Committee- Constituted by Central Government
3.
Director of Central Drug Laboratory appointed by
Central Government
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10
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Some Important
Abbreviations:
1. IND- Investigational
New Drug Application
2. ANDA- Abbreviated New
Drug Application
3. NDA- New Drug
Application
4. BLA- Biologic License
Application
5. CTA- Clinical Trial
Authorization
6. CTX- Clinical Trials
Exemption
7. WIPO-World
Intellectual Property Organization
8. ICH-International
Conference on Harmonization
9. WTO- World Trade
Organization
10. CDSCO- Central Drugs Standard
Control Organization
11. WADA- World Anti Doping Agency
12. PETA- People for ethical treatment
to Animal
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Monday, 13 February 2017
Important General Awareness-1 for NIPER EXAM-2017
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