CDSCOVivekanandan.S,

I M.Pharmacy

Regulatory Affairs

JSS College of Pharmacy, Ooty

contents

• Introduction

• Major functions of CDSCO

• Organisation chart

• Drug approval process

• Clinical trial process

• Three tier review process

• Cosmetics

• Medical devices approval

• Biologics

• Recalls in India

• Recent happenings in CDSCO

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 has six zonal offices, four sub-zonal offices, thirteen port offices and

seven laboratories under its control.

• Ministry responsible: Ministry of Family & Health Welfare.

• Minster responsible : Mr. Jagat Prakash Nadda

• Drug Controller General of India: Dr.G.N.Singh

•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

• The responsibility entrusted to the CDSCO is enormous, considering the fact

that the Indian pharmaceutical industry is currently worth over Rs.1200

billion with a growth rate of 12% for new drugs and 20% for biologicals over

the last five years, which is the highest in the world.

• It is also the third-largest producer of generic drugs in terms of volume and

14th in terms of value.

• India is the second-largest producer of certain generic drugs such as

ciprofloxacin, ranitidine, simvastatin, I-ephedrine and chloroquine.

Pharma Fact-INDIA

• Currently there are 10,500 manufacturing units and over 3,000 pharma

companies in India

• India has been accredited with approximately 1360 CEPs, more than 950

TGA formulations and 600 sites approved by USFDA which is largest in a

single country outside USA.

• 6 out of top 20 generic companies are from India.

• Globally more than 90 per cent of formulations approvals for anti-retroviral ,

anti-tubercular ARV & anti-malarial ( pre-qualified) have been WHO granted

to India.

• India is among the top six producers of pharmaceuticals in the world.

Major functions of CDSCO

• 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 licences as Central

Licence Approving Authority is exercised by the CDSCO headquarters.

Central Licensing Authority

• Approval of new drugs and clinical trials

• Import Registration and Licensing & approving of Blood Banks, LVPs,

Vaccines, r-DNA products & some Medical Devices(CLAA scheme)

• Amendment to 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 through Inspectorate of Centre Over and

above the State Authority.

State Licensing Authority

• Licensing of Manufacturing Site for Drugs including API and Finished

Formulation

• Licensing of Establishment for sale or distribution of Drugs

• Approval of Drug Testing Laboratories

• Monitoring of Quality of Drugs and Cosmetics marketed in the country

• Investigation and prosecution in respect of contravention of legal provision

• Recall of sub-standard drugs

Drug approval process

• 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 Drugs and

Cosmetics Act 1940 and Rules 1945

• New drug substance discovered in India – start from Phase I

Phase III should involve 500 patients , 10-15 centres

• New drug substance discovered in other countries –Phase I data need to

submit along with application to Licensing Authority

• Phase III should involve 100 patients , 3-4 centres

Clinical trial process

• In the past, the regulatory path for clinical trials was fairly simple with a

single tier approval process involving review at the Central Drugs Standard

Control Organization (CDSCO) office only. Approval timelines ranged

between 8 and 12 weeks

• In March 2011, CDSCO office constituted 12 New Drug Advisory

Committees (NDACs)

• Presently, these committees are named as “Subject Expert Committees

(SECs).”

Three tier review process

• February 2013, a three-tier

review process has been

implemented, wherein each

clinical trial application is

being referred for review to the

Technical and Apex Committee

Cosmetics

• Cosmetics Division, Central Drugs Standard Control Organization (CDSCO)

is responsible

• For the Import of Cosmetics in India, the imported cosmetic products are

required to be registered with Central Drugs Standards Control Organization

by giving application in Form 42 to obtain Registration certificate in Form 43

• The Manufacturer himself/The Authorized Agent of the Manufacturer/The

Subsidiary of the Manufacturer/any other importer can be an applicant for

issuance of Registration certificate for import of cosmetics into India

• License will be granted within 6months

• Fee of 250$ to be paid

• The following licenses are required for cosmetic product manufacturing &

market in India according to Drug and Cosmetics Act, 1940.

• License on form 32 is issued for manufacture/ sale distribute of cosmetics.

(Form no 31)

• License on form 32-A is issued for loan license for manufacture/ sale

distribute of cosmetics. (Form no. 31-A)

• SLA will give license to manufacture cosmetics

• Fee of 2500 to be paid.

Medical devices approval (till dec,2017)

Medical device rules, 2016

• On 17,October.2016 the union health ministry of India published the new

medical device rules draft., which will be effective from Jan1, 2018

• The risk based classification for medical devices ranging from

Class A low risk (Thermometer, Tongue depressor)

Class B low moderate risk (suction equipment, hypodermic needle)

Class C high moderate risk(ventilator, bone fixation plate)

Class D high risk (heart valves, AICD)

Biologics

Requirements for manufacturer:

• NOC for form 29

• Test License

• Post Approval Changes

• Marketing Authorization

• Clinical Trail Permission (Phase 1, 2 & 3)

& GCT

Requirements for importer:

• Registration

• Import License

• Marketing Authorization

• Clinical Trail Permission (Phase 1, 2 & 3)

& GCT

SUGAM –Online licensing portal

• An online licensing portal of CDCSO 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 CDCSO

• Track the status of application

• Answer back to raised queries

• Applicant can also upload essential documents for registration, Import license

and other related activities

• SUGAM –Challenges

• There is no provision to upload files greater than 10MB file size

• Documents need to be split as per each report. Generally companies have

information in one single report. For example, Bio-compatibility used to be

one topic earlier now it needs to be split into cytotoxicity testing, acute

toxicity etc…

• There is no provision to upload multiple different files for one heading.

Companies can only combine them as one PDF giving the possibility of

information getting misplaced.

• Types of license can apply through SUGAM portal

• Registration certificate – Form 41 for Drug

• Registration certificate – Form 41 for Medical device

• Registration certificate – Form 41 for Diagnostic kit

• Import license – Form 10 for Drug

• Import license – Form 10 for Medical device

• Import license – Form 10 for Diagnostic kit

• Test license for clinical trial

• BE NOC for clinical trial / to import or manufacture of new drug

• Registration certificate for cosmetics

• Obtaining permission to conduct GCT will be filed online through SUGAM

effected from October 2016

Recalls in India

• Recall is an action taken to withdraw/remove the drugs from distribution or

use including corrective action for which deficiencies are reported in quality,

efficacy or safety.

RECALL TYPES

VOLUNTARY RECALL

Recent happenings in CDSCO

• 51ST DCC meeting: DI as DCO, 1:200 for sale outlets, 1:50 for manufacturing

units

• Vaccine regulatory system , maturity level of 4, maximum as per WHO

• 77th DTAB meeting : Plan to extend time period of import of drugs for

personal use

• Planned to include several steroids under Schedule H like Beclomethasone,

Dexamethasone

• FDC hearing

References

• www.cdsco.nic.in/

• https://www.cdscoonline.gov.in/

• http://www.pharmainfo.net/reviews/new-drug-approval-process-regulatory-view

• Regulatory environment for clinical research: Recent past and expected future

• http://www.morulaa.com/cdsco/process-cosmetics-registration-india/

• https://www.emergogroup.com/services/india/india-medical-device-registration

• http://www.morulaa.com/cdsco/regulatory-india-medical-device-rules/

• https://cliniexperts.com/india-regulatory-services/biologicals/

• http://www.cdsco.nic.in/writereaddata/Guidlines%20on%20Recall.pdf