LATEST TREND OF PHARMACEUTICAL AND MEDICAL DEVICE REGULATION AND

INTERNATIONAL COOPERATION

Dr. S. Eswara Reddy

Drugs Controller General (I)

CDSCO

9/4/2018 1

Goal of Indian Drug Regulators

To built trust and confidence in public mind on quality of

Medical Products

To have predictable, transparent and efficient regulatory

system

To ensure accessibility, availability and affordability of

Medical products

To hormonise Indian drugs regulations with International

standards to the extent feasible

To promote innovation by providing regulatory support

Ease of doing business

9/4/2018 2

Submission of Formulation Development Data

Excipients Compatibility and Toxicity data

Stability data of API and Finished product

Process Validation /Analytical Method validation data

Mandatory submission of BA/BA data for drugs of Class II

and IV

All the applicants obtaining new drugs permission are

mandated to have a pharmacovigilance system in place.

Joint Inspection of manufacturing facilities.

Enhanced Capacities of Drugs Testing Laboratories

Conducting Risk Based Inspections

Measures taken to further improve

Quality

Transparency CDSCO established Public Relation Office: Single Window

System

To address public grievances,

To facilitate innovators,

To aid and advise start up companies,

To provide clarifications on drug regulations, and

No prior appointment required

Video Conference with innovators on regulatory

requirements.

Online Applications, Review, Communications with applicant

and approvals

In house timelines for processing of various applications

prescribed9/4/2018 4

Public Relations Office

Ground Floor, CDSCO, HQ,

FDA Bhawan, Kotla Road, New Delhi-110002

Email: startupinnov@cdsco.nic.in

Toll Free No. 1800 11 1454

Applications Processed in Month of July-2018

Jul-18

Type of

Applications

Total

received

Disposed Under

Process &

taken on

priority

%age

Disposal

Pending cases 215 156 59 72.56

Clarification 133 133 0 100.00

Sugam portal issue 48 41 7 85.42

Information on D & C

Act

17 17 0 100.00

Misc. 10 7 3 70.00

Minor error 7 7 0 100.00

Innovator/Start up 5 5 0 100.00

Complaints 1 1 0 100.00

Total 436 367 69 84.17

Graphical status of applications for March to June data

Enforcement

An Intelligence cell has been created at CDSCO HQ in

March 2018. the major functions of the cell are:

To gather information on the contraventions under the

Act and Rules,

To carry out surprise raids, and

To investigate international quality complaints received

from foreign regulatory agencies,

Raids have been conducted on regular basis.

Actions are being taken on the offenders.

9/4/2018 8

Ease of Doing Business Perpetual validity of various licenses

Established a common forum of Indian drugs/

pharmaceutical manufacturers to address their issues

Waiver of requirements of export NOC from port offices

Delegation of powers of CDSCO to state authorities for

grant of NOC for export purpose.

Increased Validity of COPP

Single window grievance address mechanism

FAQs posted on website. 9/4/2018 9

E- governance1. SUGAM portal an egovernance initiate of CDSCO has

been launched in November 2015.

2. On an average 40000 applications are received annually.

3. Majority of the services rendered by CDSCO are now

online.

4. A separate portal for Medical Devices has been launched

in late 2017.

5. Pharmaceutical manufacturers Data Management

6. The national portal SUGAM is further proposed to be

extended to all the states which then will become single

platform for all drugs regulatory services in the country.

9/4/2018

1) Waiver of local clinical trials for drugs approved by

identified countries

2) Application process timelines is 30 days, deemed

approved

3) Pre and post submission meetings

4) Separate provisions for approval of Orphan drugs

5) Accreditation of investigator and clinical trial sites

6) Separate provision for academic clinical trial.

7) Provisions for Post trial access as per

recommendation of Investigator and EC

8) Manufacture of Unapproved New Drug for Treatment

of Patients in Government Hospital and Government

Medical Institution

New Drugs and Clinical Trials Rules

Medical Device Rules 2017 have become madeeffective from 01st January 2018.

Harmonized inline with the practices being followed inthe developed countries across the globe.

Online Submission of applications

Risk based Classification (Class – A, B, C and D)

Low Risk devices (A& B) are regulated by States,Audit by Notified bodies

High Risk Devices (C&D) are regulated by CDSCO

Standards are well defined

Devices approved in Japan, Wavier of ClinicalInvestigations

Separate regulations for IVD

Perpetual validity of licenses

Medical Devices Regulations

International co-operation

CDSCO has signed MoU on cooperation in the field of

regulation of pharmaceuticals with Japan,

Russia, Sweden, Brazil, UK, Afghanistan, Indonesia and

USFDA.

CDSCO has been actively participating at various

multilateral fora. These include:

WHO, ICDRA, ICMRA, ICH, AHWP, etc.

Also exploring the possibility of CDSCO becoming a

PIC/S member.

SEARN for SEARO region9/4/2018 13

Way forward

Regulation of the following emerging areas:

Regenerative Medicine/Gene Therapies

Nutraceuticals

Radiopharmaceuticals

Medical Devices

9/4/2018 14

15

Thank You