Cdsco ppt

Central Drug Standard Control Organisation
(CDSCO)
1
Presented by:
Nikhat Parveen

OVERVIEW
 Introduction: CDSCO
 Functions of CDSCO
 Organisational Chart
 Clinical Trial process
 Drug approval process
 Cosmetics & Medical devices approval
 SUGAM: Online portal
 Recent advances in CDSCO
 Summary
 References
2

INTRODUCTION:
 The Central Drugs Standard Control
Organization (CDSCO) is the national regulatory
body for Indian pharmaceuticals and medical devices.
 It 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 Medicines and Healthcare products
Regulatory Agency of the United Kingdom.
 Headquarters: New Delhi, India
 Ministry responsible: Ministry of Health and Family
Welfare.
 Minister responsible: Harsh Vardhan.(1) 3

DRUG CONTROLLER GENERAL OF INDIA
 Within the CDSCO, the Drug Controller General Of
India (DCGI), regulates pharmaceutical and medical
devices, under the gamut of Ministry of Health and
Family Welfare.
 He/She is responsible for approval of new drugs,
medical devices, and Clinical Trial to be conducted
in India
 The DCGI is advised by the Drug Technical
Advisory Board (DTAB) and the Drug Consultative
Committee (DCC).
 DCGI: Dr. S. Eswara Reddy(1)
4

ORGANISATIONAL CHART OF CDSCO
6
(3)

CLINICAL TRIAL 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.
 To determine the maximum tolerated dose in humans, adverse
reactions, etc. on healthy human volunteers, Phase I clinical trials
are conducted. The therapeutic uses and effective dose ranges are
determined in Phase II trials in 10-12 patients at each dose level.
The confirmatory trials (Phase III) are conducted to generate data
regarding the efficacy and safety of the drug in ~ 100 patients (in
3-4 centers) to confirm efficacy and safety claims. Phase III trials
should be conducted on a minimum of 500 patients spread across
10-15 centers. (4) 7

 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. (4)
8

 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 filing in Form
44 also submitting the data as given in schedule Y of
D & C act 1940 and 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. (4)
10

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 category 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
a notification in 2014, the targeted timeline for cosmetics regulatory
approval process is 90 days. (5) 11

 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 Regulation has
been 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 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. (5)
12

RECENT ADVANCES IN CDSCO
 To improve ease of doing business, CDSCO increases the
validity of the WHO GMP certificate to three years. Earlier it
was valid for two years, said DCGI, Eswara Reddy during the
6th annual International Exhibition of Pharma and Healthcare.
 The protocol for clinical trial approvals has also been changed
by setting the timeline of approval at 45 days. Once approval
does not come within this timeline, the protocol would deemed
to be approved.
 56th DCC held on 01st June 2019, DCC after deliberation
opined that New Drugs and Clinical Trials Rules, 2019 for
mandating inspections of BA/BE study centres by officers
authorized by State Licensing Authorities.
 82nd DTAB held on 02.04.2019, examine the Safety and
Efficacy of unapproved FDCs which were licensed by State
Licensing Authorities without due approval of DCG(I). (6) 13

 After examining 418 applications of FDCs, the Kokate
Committee has found 324 FDCs as irrational, after evaluating
all the data submitted and available information, 28 FDCs as
rational, 2 FDCs which require further generation of data and
4 FDCs which require further deliberation. It was also
observed that 60 FDCs have already been either prohibited (48
FDCs) or have been already declared as rational (11 FDCs), or
fall under sub-judice category (1 FDC) by the Kokate
Committee which were placed in the list of these 418
applications of FDCs inadvertently. Therefore, the Kokate
Committee did not make any recommendations on these 60
applications of FDCs.
 Minutes of IND Committee meeting held on 15.03.2019 and
again held on 10.06.2019 on the Clinical trial with Rabimab of
M/s Cadila Healthcare Limited. (6)
14

SUGAM: ONLINE PORTAL
 An online licensing portal of CDSCO has been implemented
on January 2016 and has been named “SUGAM” 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.
 Answer back to the raised queries.
 Applicant can also upload essential documents for
Registration, import license & other related activities. (7)
15

SUMMARY
 CDSCO is main regulatory body for Indian
pharmaceuticals, medical devices and clinical trial.
 Head office is located in New Delhi, and functioning
under the control of DCGI, under ministry of MoHFW.
 There are 6 zonal offices, 3 sub-zonal and 6 laboratories
are under CDSCO, to perform the GMP audits &
inspection in manufacturing units, uniform standard of
inspection and enforcement and 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.
16

REFERENCES
1. https://en.wikipedia.org/wiki/Central_Drugs_Standard_Contr
ol_Organization
2. https://cdsco.gov.in/opencms/opencms/en/About-
us/Functions/
3. https://cdsco.gov.in/opencms/export/system/modules/CDSC
O.WEB/resources/pdf/Introduction/org.pdf
4. https://sites.google.com/site/athonycrastopharmaceuticals/dru
g-a
5. https://morulaa.com/registration-services-in-india-cdsco/
6. https://cdsco.gov.in/opencms/opencms/en/Committees/
7. https://morulaa.com/cdsco/sugam-online-portal-a-brief-
overview/
17

Cdsco ppt

More Related Content

What's hot (20)

Similar to Cdsco ppt (20)

Recently uploaded (20)

Cdsco ppt