A brief introductory presentation about National Drug Regulatory Authority of India for Indian Pharmaceuticals and Medical Devices i.e. CDSCO. By Pratibha Chaudhary, pursuing Mpharm DRA from Amity University.

1. z
(CDSCO)
presented by: -
PRATIBHA
M.PHARM DRA
Amity University
CENTRAL DRUGS
STANDARD
CONTROL
ORGANISATION

2. z
CONTENTS
 Introduction
 Major functions of CDSCO
 Organization chart
 Drug approval process
 Cosmetics
 SUGAM
 Pharm Facts

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INTRODUCTION
 The Central Drugs Standard Control Organization(CDSCO) is
the National Regulatory Authority (NRA) of India.
 The Drugs & Cosmetics Act,1940 and rules 1945 have
entrusted various responsibilities to central & state regulators
for regulation of drugs & cosmetics.
 It envisages uniform implementation of the provisions of the Act
& Rules made there under for ensuring the safety, rights and
well being of the patients by regulating the drugs and
cosmetics.

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CONTD..
 Under the Drugs and Cosmetics Act, CDSCO is responsible for
approval of Drugs, Conduct of Clinical Trials, laying down the
standards for Drugs, control over the quality of imported Drugs in
the country.
 Further CDSCO along with state regulators, is jointly responsible
for grant of licenses of certain specialized categories of critical
Drugs such as blood and blood products, I. V. Fluids, Vaccine and
Sera.
 Its headquarter is located at FDA Bhawan, Kotla Road, New
Delhi.

5. z
CONTD..
 Ministry responsible : Ministry of Family & Health
Welfare.
 Minister responsible : Dr. Harsh Vardhan
 Drug Controller General of India : Dr S Eswara
Reddy
 It has six zonal offices , seven sub zonal offices ,
thirteen Port offices and seven laboratories spread
across the country

9. z OBJECTIVES
 VISION : To protect and promote health in India.
 MISSION : To safeguard and enhance the public health by
assuring the safety , efficacy and quality of drugs ,
cosmetics and medical devices.

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FUNCTIONS
 The regulation of manufacture, sale and distribution of
Drugs.
 Approval of New Drugs.
 Clinical Trials in the country.
 Control over the quality of imported Drugs.
 Coordination of the activities of State Drug Control
Organizations.
 Meetings of Drugs Consultative Committee(DCC) and
Drugs Technical Advisory Board(DTAB).

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Contd..
 Laying down the standards of drugs.
 Testing of drugs by Central labs.
 Monitoring adverse drug reaction.
 Guidance on Technical matters.

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CENTRAL LICENSING AUTHORITY
 Approval of New drugs and clinical trials.
 Import registration and licensing & approving of blood banks,
LVPs, Vaccines, r-DNA products & medical devices.
 Amendments on D & C Act and Rules.
 Banning of drugs and cosmetics.
 Grant of Test license, Personal license.
 NOCs for Export Testing of New Drugs.
 Oversight and market surveillance.

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Zonal Offices
 Mumbai
 Kolkata
 Chennai
 Ghaziabad
 Ahmedabad
 Hyderabad
 These are involved in GMP audits and inspections of
manufacturing units of large volume parenteral , sera, vaccines,
and blood products.

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Sub-Zonal Offices
 Bengaluru
 Varanasi
 Goa
 Jammu
 Indore
 Guwahati
 Baddi
 These centers coordinate with State drug control authorities
under their jurisdiction for uniform standard of inspection and
enforcement.

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Central Drug Testing Laboratories
 Central Drug Laboratory, Kolkata
 Central Drug Testing Laboratory, Mumbai
 Central Drug Testing Laboratory, Chennai
 Central Drug Laboratory,Kasauli
 Regional Drug Testing Laboratory, Chandigarh
 Regional Drug Testing Laboratory, Guwahati
 Central Drug Testing Laboratory, Hyderabad

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Approval of New Drugs
 New drugs are permitted to be marketed in accordance with the
permission granted by DCGI after ensuring that these drugs are:
 Safe
 Effective
 Comply with requirement of schedule Y of D&C rules.
 Applicant are required to provide technical data in respect of
safety and efficacy before these could be permitted to marketed
in country.

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DRUG APPROVAL PROCESS

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COSMETICS
 Cosmetic division, CDSCO is responsible :
 For the Import of Cosmetics in India, the imported cosmetic
products required to be registered with CDSCO by giving
application in Form 42 to obtain registration certificate in Form 43.
 The Manufacturer himself/The Authorized agent/any other importer
can be an applicant for issuance of Registration certificate for
import of cosmetics into India.
 License will be granted within 6 months.

20. z CONTD…
 The following licenses are required for cosmetic products :
 License on Form 32 is issued for manufacturer/sale distribute
of cosmetics.
 License on form 32A is issued for loan license for
manufacture/sale distribute of cosmetics.(Form 31A)

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SUGAM – Online Licensing Portal
 An online licensing portal of CDSCO has been implemented on
January 2016 and has been named SUGAM to file application
for various services like Application submission, processing and
grant of permission for quick delivery of services.
 Sugam benefits
 Applicant can apply license under import and registration division
to CDSCO
 Track the status of application
 Answer back to raise queries
 Applicant can also upload essential documents for registration,
Import license and other related activities.

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Types of license can apply through
SUGAM portal
 Registration certificate – Form 41 for Drug, Medical Devices,
diagnostic kit.
 Import license – Form 10 for Drug, Medical devices,
diagnostic kit.
 Test licenses for clinical trial
 BE NOC for Clinical trial / to import or manufacture of new
drugs.
 Registration certificate for cosmetics.

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PHARM FACTS
 In INDIA, pharmaceutical market turnover reached Rs
129,015 crore(US$ 18.12 billion)in 2018,
 growing 9.4% year-on-year and exports revenue was
US$17.28 billion in FY18 and US$ 19.14 billion in FY19.
 Pharmaceutical export from India stood at US$ 17.27
billion in 2017-18, and is expected to grow by 30% to reach
US$ 20 billion by the year 2020.
 India is the largest provider of generic medicines globally.
 Hyderabad, Mumbai, Bangalore, and Ahmedabad are the
major Pharmaceutical hubs of India.

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THANK YOU