CDSCO is the Central Drug Authority of India functioning under Directorate General of Health Sevices (DGHS), Ministry of Health and Family Welfare. CDSCO is headed by Drug Counseller General of India (DCGI) and is DCGI is guided by Directorate Technical Advisory Board (DTAB) and Drug Consultative Committee (DCC). Major functions of CDSCO are; a. Approval of Clinical trials. b. Control manufacture, sale and distribution of drugs, LVPs, vaccines, blood products, sera. c. Import and registration. d. Approval of license for Drugs, medical devices and diagnostic kits. There are 8 divisions under CDSCO : 1. Bio-availability / Bio-equivalence ( BA / BE ). 2. Biologics - Vaccines, gene therapies and cellular therapies. 3. Clinical trials - evaluating medical, surgical or interventional behaviour. 4. Cosmetics. 5. DTAB and DCC - organise meetings of Drugs Technical Advisory Board and Drug Consultative Committee. 6. New drugs. 7. Import and Registration. 8. Medical Devices and Diagnostics CDSCO Organisation consists of ; 6 Zonal Offices, 4 Sub-zonal Offices, 13 Port Offices and 7 Laboratories. SUGAM Online Portal : Registration of clinical trial, Apply for License and Registration of new drug, medical devices and diagnostic kits.

1. Central Drugs Standard
Control Organization
(CDSCO)
By;
Dr. Archana. S. N
B.A.M.S, MD (Ayu), PGDYTD, (PGDCR)

2. ❖ Overview :
● Introduction - CDSCO, DCGI
● Importance and functions of CDSCO, responsibility of the state authority.
● Divisions of CDSCO
● Organizational chart
● Clinical trial approval process
● Drug approval process
● Cosmetics and medical devices approval
● SUGAM : Online portal
● Various CDSCO online portals.

3. ❖ INTRODUCTION :
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority
for discharging functions assigned to the Central Government under the Drugs and Cosmetics
Act. CDSCO functions under the Directorate General of Health Services (DGHS).
CDSCO serves parallel function to the European Medicines Agency of the European Union,
the PMDA of Japan, the Food and Drug Administration of the United States and the Medicine
and Healthcare products Regulatory Agency of the United Kingdom.
HEAD QUARTERS : New Delhi, India.
Ministry Responsible : Ministry of Health and Family Welfare.
Minister Responsible : Dr. Mansukh L. Mandaviya, Hon’ble Cabinet Minister
Dr. Bharati Pravin Pawar, Hon’ble Minister of State

4. ❖ Drug Controller General of India (DCGI) :
● In accordance with the provisions of the 2019 - CT rules, the Drug Controller General of
India (DCGI) heads CDSCO under Directorate General of Health Services (DGHS).
● Drug Controller General of India is responsible for approval of licenses of specified
categories of Drugs such as; blood and blood products, I. V. Fluids, Vaccine and Sera.
● As per the Drug and Cosmetics act - 1940, Drug and Cosmetics Rules - 1945, the DCGI is
advised by the Drug Technical Advisory Board (DTAB) and Drug Consultative Committee
(DCC).
● DCGI is commonly referred to as the Central Licensing Approval Authority (CLAA) in Indian
Regulations.
● Head of DCGI : Dr. Rajeev Singh Raghuvanshi.

5. ❖ Importance of CDSCO :
● WHO declares CDSCO as functional National Regulatory Authority (NRA).
● Under the Drugs and Cosmetics Act - 1940, approval of new drugs as well as
conducting clinical trials, putting down regulations for cosmetics and drugs are
implemented through this act.
● The aim of CDSCO is to be transparent, accountable as well as keep a uniformity in
the service it provides.
● With the state regulators, it takes the responsibility to grant licenses of categories of
specialized drugs which are critical like blood products, vaccines and Intravenous
fluids.

6. ❖ Functions of CDSCO :
The major functions of CDSCO are; Regulatory control over the import of drugs, approval of new drugs and
clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB),
approval of certain licenses as Central License Approving Authority (CLAA) is exercised by the CDSCO
headquarters.
1. Approval of new drugs and clinical trials.
2. Import Registration and Licensing.
3. Licensing of Blood banks, LVPS, Vaccines, Pie-DNA products, medical devices and diagnostic agents.
4. Amendment to Drug and Cosmetic Act and Rules.
5. Banning of drugs and cosmetics.
6. Grant to Test license, Personal License, NOC’S for export.
7. Testing of drugs by Central Laboratories.
8. Publication of Indian Pharmacopoeia.
9. Monitoring adverse drug reactions.
10. Guidance on a technical matter.

7. ❖ Responsibility of the State authority :
● Regulating manufacture, sales and distribution of drugs.
● Approving drug formulations for manufacture.
● Overseeing the manufacturing process for drugs manufactured by respective state
units and those marketed in the state.
● Licensing drug testing laboratories in the state.
● Carrying out pre and post licensing inspections.

8. ❖ Divisions of CDSCO :
There are 8 divisions under CDSCO;
1. Bio-availability / Bio-equivalence ( BA / BE ).
2. Biologics - Vaccines, gene therapies and cellular therapies.
3. Clinical trials - evaluating medical, surgical or interventional behaviour.
4. Cosmetics.
5. DTAB and DCC - organise meetings of Drugs Technical Advisory Board and Drug
Consultative Committee.
6. New drugs.
7. Import and Registration.
8. Medical Devices and Diagnostics.

9. ❖ ORGANIZATIONAL CHART :
4

10. ● Inspection of manufacturing units
of Large Volume Parentrals
(LVPs), Sera, Vaccine & blood
products.
Under their jurisdiction for
uniform standard of inspection &
enforcement.

11. ❖ Clinical Trial Approval Process :
● An application to conduct clinical trials in India should be submitted along with the data of chemistry,
manufacturing, control and animal studies to DCGI.
● The date regarding the trial protocol, investigator's brochures and informed consent documents should also be
attached.
● A copy of the application must be submitted to the ethical committee and the clinical trials are conducted only
after approval of DCGI and ethical committee.
● If the new drug substance is not marketed in any other country. The new drug registration (using form 44 along
with full pre- clinical and clinical testing information) is applied after the completion of clinical trials.
● The comprehensive information on the marketing status of the drug in other countries is also required other
than the information on safety and efficacy.
● The information regarding the prescription, samples and testing protocols, product monograph, labels, and
cartons must also be submitted. The application can be reviewed in a range of about 12-18 months.
● After the NDA approval, when a company is allowed to distribute and market the product, it is considered to be
in Phase IV trials, in which new uses or new populations, long- term effects, etc. are explored.

12. Functions
❖ New Drug Approval Process :

13. ● When a company in India wants to manufacture/ import a new drug it has to apply
to seek permission from the licensing authority (DCGI) by filling in Form 44 also
submitting the data as given in schedule Y of D&C Act 1940 and D&C Rules 1945.
● Applicants are required to provide technical data in respect of safety and efficacy
before these could be permitted to be marketed in country.
● Definitions of new drug also includes fixed dose combination which are required to
be marketed for the 1st time in country.

14. ❖ COSMETICS & MEDICAL DEVICES APPROVAL :
● For the import of cosmetics into India, the cosmetic products need to be registered with
the licensing authority as defined under Rule 21 of Drugs & Cosmetic Rules.
● The regulatory application needs to be submitted in Form 42 along with Soft copies of the
information about the brands, products and manufacturer, product specification and
testing protocol to receive the cosmetics registration certificate in Form 43.
● The Cosmetics that are supposed to be imported are categorized into Brands. These
brands are divided into 4 main categories namely; Skin products, Hair and scalp products,
nail and cuticle products and Oral hygiene products.
● License will be granted within 6 months by CDSCO. However, as per circular dated
30-5-2014, the targeted timeline for cosmetics regulatory approval process is 90 days.

15. ● Earlier, manufacturers could sell medical devices in India without any jurisdictions. Since
2006, medical devices entering India must be in compliance with the Indian Medical
Device Regulations set by the CDSCO.
● Registration Certificate in Form-41 and Import License in Form-10 are required under the
regulation of Drugs and Cosmetics Act - 1940, for marketing of imported medical devices.
● Medical devices which undergo regulatory approval process include spinal needles,
cochlear implants, annuloplasty rings, tracheostomy tubes, syringes and needle, dental
implants, surgical sealants, heart valves, cardiac stents, orthopedic implants, endotracheal
tubes, and catheters.
● The time period for Registration is generally 6-9 months, post the submission of complete
and accurate regulatory dossier (a compilation and array of documents regarding the safety,
efficacy, and quality information of a medical product) and fees. Registration is valid for 3
years and renewal applications (re- registration) need to be submitted 6 months in
advance of expiry of the registration certificate.

16. ❖ SUGAM: ONLINE PORTAL
"SUGAM" (acronym for Suraksha, Gunavatta and Manakta) portal launched in
November 2015 by the Ministry of Health and Family Welfare is an online licensing portal
of CDSCO. This online portal got implemented on January 2016, to file applications for
various services like Application submission, Processing and Grant of permission for quick
delivery of services.
➤ SUGAM BENEFITS :
● Applicant can apply for license under import & registration division to CDSCO.
● Track the status of submitted application.
● Answers back to the raised queries.
● Applicant can also upload essential documents for Registration, import license &
other related activities.

17. ● Registration certificate : FORM 41 - for drug, medical device and
diagnostic kit.
● Import license : FORM 10 - for drug, medical device and
diagnostic kit.
● Test license for Clinical Trials
● Registration certificate for cosmetics.
★ Type of License applied through SUGAM portal :

18. ● CDSCO and State Licensing Authorities (SLAs) are going to have all activities
online. Application for any purpose to be made online and obtaining of
license/ permission/ certificate are done through online only.
● CDSCO has developed following online portals :
a. www.cdscoonline.gov.in — for Drugs and Cosmetics
b. www.cdscomdonline.gov.in — for medical devices (for State and Central)
c. www.sugamlabs.gov.in — for the laboratories under CDSCO
d. www.statedrugs.gov.in — for National State portal for Licensing
❖ Various CDSCO Online portals :

19. ❖ SUMMARY :
● CDSCO is main regulatory body for Indian pharmaceuticals, medical devices
and clinical trials. Head office is located in New Delhi, and functioning under the
control of DCGI, under ministry of MoHFW.
● There are 6 zonal offices, 4 sub-zonal offices, 13 port offices and 7 laboratories
which work under CDSCO, to perform the GMP audits & inspection in manufacturing
units, uniform standard of inspection and enforcement, quality control of drugs &
cosmetics in the country respectively.
● Clinical trial approval, drug approval, cosmetics and medical devices approval all
are done with the permission granted by DCGI after ensuring that all submitted
documents are accurate and complete.
● CDSCO plans to open an international office in Beijing, China.

20. ❖ REFERENCES :
1. https://cdsco.gov.in
2. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadAler
tsFiles/Guidance_for_New_Drug_Approval-23july2.pdf
3. https://cdscoonline.gov.in
4. https://byjus.com/free-ias-prep/central-drugs-standard-control-organization/
5. https://unacademy.com/content/upsc/study-material/polity/a-clear-explanation
-of-the-functions-of-the-central-drug-standard-control-organisation/
6. https://en.wikipedia.org/wiki/Central_Drugs_Standard_Control_Organisation
7. https://optimizeias.com/cdsco-2/
8. https://www.idma-assn.org/pdf/Workshop_on_e-Governance_Initiatives_of_C
DSCO.pdf
9. https://www.clevernotes.in/awards-organisations/central-drugs-standard-contr
ol-organisation-cdsco-upsc-342628