CDSCO and Phamacovigilance {Regulatory body in India}

The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.

Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.

In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.

1. CDSCO (India) and
Pharmacovigilance
An Overview of Regulations, Differences, and Requirements
SUBMITTED BY:
NEHA GUPTA
SUBMITTED TO:
SAQUIB TANWEER SIR
DEPARTMENT OF PHARMACY

2. TABLE OF CONTENT
Introduction
CDSCO Overview
D&C Act (Drugs and Cosmetics Act)
Schedule Y of D&C Act
Pharmacovigilance in India
CDSCO Pharmacovigilance Framework
Global Pharmacovigilance Practices
Differences Between Indian and Global Practices
Indian Pharmacovigilance Requirements
Future Directions and Improvements
Conclusion
2

3. Introduction
CDSCO (Central Drugs Standard Control Organization):
•The CDSCO is India's national regulatory body responsible for regulating
pharmaceuticals and medical devices. It ensures that drugs and medical
products are safe, effective, and of high quality.
Importance of Pharmacovigilance:
•Pharmacovigilance is crucial for monitoring the safety of drugs
post-marketing, identifying and assessing adverse drug reactions (ADRs), and
ensuring ongoing drug safety.
3

4. CDSCO Overview
Role
•Role and Functions: The CDSCO regulates the approval, manufacture, and
distribution of pharmaceuticals and medical devices in India. It ensures that
these products meet established standards of safety, efficacy, and quality.
Regulatory Authority
•National Authority: The CDSCO acts as the central regulatory authority in
India, overseeing all drug-related activities and ensuring compliance with legal
and regulatory requirements.
4

5. D&C Act (Drugs and Cosmetics Act)
Introduction
•Overview: The Drugs and Cosmetics Act, 1940, provides the legal
framework for the regulation of drugs and cosmetics in India. It ensures that
these products are safe and meet quality standards.
Key Provisions
•Important Sections: Key provisions of the Act relevant to drug regulation
and safety, including rules for drug approval, manufacturing practices, and
market surveillance.
5

6. Schedule Y of D&C Act Clinical Trials
•Requirements: Schedule Y outlines the requirements for conducting
clinical trials in India, including ethical considerations, protocol approvals,
and safety monitoring.
Good Clinical Practices
•Ethical Standards: Emphasizes the importance of ethical standards and
regulatory compliance in conducting clinical trials to ensure the protection
of trial participants and the integrity of data.
6

7. Pharmacovigilance in India
Pharmacovigilance: The science and activities related to the detection,
assessment, understanding, and prevention of adverse effects or any other
drug-related problems.
Importance
•Role in Safety: Pharmacovigilance plays a vital role in ensuring that drugs
remain safe and effective throughout their lifecycle, from development to
post-marketing.
7

8. CDSCO Pharmacovigilance Framework
Pharmacovigilance Programme of India (PVPI): An initiative by the CDSCO
to monitor and report adverse drug reactions (ADRs) and ensure drug safety
in India.
Reporting Systems
•ADR Monitoring: Systems and mechanisms for healthcare professionals and
consumers to report ADRs, contributing to the continuous monitoring of drug
safety.
8

9. Global Pharmacovigilance Practices
WHO and ICH Guidelines
•International Guidelines: Overview of global pharmacovigilance guidelines
provided by the World Health Organization (WHO) and the International
Council for Harmonisation (ICH).
Global Harmonization
•Alignment Efforts: Efforts to align Indian pharmacovigilance practices with
international standards to ensure consistent and effective drug safety
monitoring worldwide.
9

10. Differences Between Indian and Global
Practices
Regulatory Differences
•Key Differences: Highlighting the differences in regulatory approaches
between India and other countries, including variations in guidelines,
reporting systems, and compliance requirements.
Implementation Challenges
•Challenges: Discussing the challenges faced by India in adopting and
implementing global pharmacovigilance standards, such as resource
constraints and infrastructure limitations.
10

11. Indian Pharmacovigilance Requirements
Reporting Obligations
•Requirements: Detailed requirements for healthcare professionals and
pharmaceutical companies in India regarding the reporting of adverse drug
reactions and other safety issues.
Technological Integration
•Technology Use: The role of technology in enhancing pharmacovigilance
practices, including electronic reporting systems and databases for efficient
monitoring and analysis.
11

12. Future Directions and Improvements
Policy Enhancements
Proposed Changes: Discussing proposed policy changes aimed at
strengthening the pharmacovigilance framework in India, including updates
to regulations and guidelines.
Capacity Building
•Training Initiatives: Highlighting the importance of training and
development initiatives to build capacity among healthcare professionals and
regulatory personnel for better pharmacovigilance practices.
12

13. Reference
CDSCO, Ministry of Health & Family Welfare, Government of
India. CDSCO Website
Ministry of Health & Family Welfare, Government of India.
Drugs and Cosmetics Act
Schedule Y of the Drugs and Cosmetics Rules. Clinical Trial
Regulations
13

14. Company History/Timeline
Notable, relevant
event or
milestone from
this year
Notable, relevant
event or
milestone from
this year
Notable, relevant
event or
milestone from
this year
Notable, relevant
event or
milestone from
this year
05/02/1977 08/05/1980 09/25/1983 08/12/2018
14

15. About the Event
Flushing Meadows, New York
Venue
May 7, 2010
Date
Promote Innovation
Objective
15

16. About the Venue
Use this slide to o?er some details about the venue where the
event is being held.
Give an overview and provide critical
details such as capacity and available
amenities.
Address
Website
Main Contact Name
Phone number
Email
16

17. Event Schedule
9
am
Meet & Greet
10
am
First Speaker
11
am
Second Speaker
12
pm
Lunch
1
pm
Keynote Speaker
2
pm
Networking Seminar
3
pm
Wrap Up
4
pm
Closing Remarks
17

18. Marketing Strategy
Direct Mailers Email
•Introduce proposed strategy
•Organize your points by platform
Social
Media
LinkedIn Facebook
•Pinpoint the actions that led to these results.
•Consider advantages of each platform
Ads Banner Ads TV Ads
•Acknowledge weak points for each platform
•Include brief analysis of performance
18

19. Target Demographic
Where are the customers you want to
reach? This can yield insights into how
best to market to them. 
Geographic
Describe your ideal customer. Show
which demographic categories
influence your plan.
Demographic
What do you know about your target
audience's buying habits, media
consumption, or other behaviors? 
Behavioral
Describe your targets' interests, values,
and attitudes. These can be crucial details
as you plan your promotional campaigns.
Psychographic
19

20. Personal
What are the key identifying characteristics that make
this persona di?erent from your other personas (it’s
best to include multiple personas in your presentation)
Identifiers
What are some of the demographics this person fits
into? This can apply to a lot of things, including but not
limited to: age, race, income, gender, education level, or
location.
Demographics
Elaborate on this customer persona's life experience.
Education, work history, likes and dislikes... Include
anything that is relevant to your marketing e?orts.
Identifiers
20

21. •Basic Benefit
•Basic Benefit
•Basic Benefit
•Basic Benefit
•Basic Benefit
•Basic Benefit
Sponsorship
Silver: $1000
•Gold Benefit
•Gold Benefit
•Gold Benefit
•Gold Benefit
•Gold Benefit
•Gold Benefit
•
Gold: $5000
•Platinum Benefit
•Platinum Benefit
•Platinum Benefit
•Platinum Benefit
•Platinum Benefit
•Platinum Benefit
Platinum: $10000
21

22. Meet the Team
CTO
John Doe
Brief description of what this
person does for the company.
Relevant background
information or interesting tidbit.
CFO
James Doe
Brief description of what this
person does for the company.
Relevant background
information or interesting tidbit.
CEO
Jane Doe
Brief description of what this
person does for the company.
Relevant background
information or interesting tidbit.
22

23. Meet the Speakers
Position | Company
Jeralynn Doe
Briefly address bio and
achievements.
Relevant background
information or interesting
tidbit.
Position | Company
Jerome Doe
Briefly address bio and
achievements.
Relevant background
information or interesting
tidbit.
Position | Company
Jillian Doe
Briefly address bio and
achievements.
Relevant background
information or interesting
tidbit.
23

24. Keynote Speaker
Title of Speech/Program
Occupation
Give an extended bio on your keynote speaker. O?er a
bit of background, their credentials, and a preview of
what they will be speaking about.
John Doe
24

25. Event Sponsorship
25

26. Mini Portfolio
Use this slide to showcase some of your previous events. Add a point or two about their performance and
successes.
•Date
•Description
•Results
•Date
•Description
•Results
•Date
•Description
•Results
Big Successful Event Big Successful Event Big Successful Event
26

27. Event Budget
Total Budget $42,102
Venue 9,683
Marketing $6,315
Travel $4,210
Presenters $6,315
Catering $6,315
Décor $4,210
Public Relations $ 6,315
Sta? $5,052
20.91%
Venue
10.91%
Venue
13.64%
Venue
9.09%
Venue
13.64%
Venue
13.64%
Venue
9.09%
Venue
9.09%
Venue
27

28. Planning Process
Use images rather than trying to describe your subject.
Show, Don’t Tell
Cluttered presentations are distracting and ine?ective.
Simplicity is Key
One consistent tone helps your presentation flow.
Be Consistent
visuals
simplicity
consistency
28

29. Storytelling
Audiences respond well to stories. Look for a narrative thread behind your presentation
content and consider presenting your information beginning-to-end. Follow a situation to
its consequences or a problem to its solution.
Weave the thread throughout your presentation. This will help it feel cohesive and make it
easier to follow than a jumble of disjointed slides.
29

30. Eye Contact Improves Engagement
Know your audience
Tailor your slideshow to your audience’s
needs. Consider their level of familiarity
with the subject matter, industry jargon,
and background.
If you’re using language they are likely to
be unfamiliar with, o?er definitions so they
don’t feel lost.
Keep Your Core Message in Mind
You have a lot of knowledge to share.
Decide which points you most want your
audience to remember after they leave.
Write your presentation with those points in
mind, so your most important message is
clear and memorable.
30

31. Keep It Light
People don’t need you to read to them. Your text and
talking points should complement one another rather than
repeating.
Bullet Points are e?ective for presentations because they:
•Draw the eye
•Highlight the important information
•Break up your text
•Make it easier to read
31

32. Presentation
Divider
32

33. Presentation
Divider
33

34. Data at Glance
Series 1 Series 2
Category 1 Category 2 Category 3
5
4
3
2
1
0
34

35. Storyboard
35

36. Goals
Brief description of
this goal
Big Goal
Brief description of
this goal
Big Goal
Brief description of
this goal
Big Goal
Brief description of
this goal
Big Goal
What are you and your team hoping to achieve?
36

37. Contact
28
Website | www.company.com
Phone | [phone]
Email | [email protected]
Parting Thoughts
Leave your audience with a quick final thought that encapsulates you, your company, or this presentation.

38. Zoho Show
To create beautiful presentations, download Zoho Show from Play Store https://zoho.to/cy7
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