Drug regulatory agencies play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products, including drugs, biologics, and medical devices. These agencies are responsible for establishing and enforcing regulations and guidelines that govern the development, testing, approval, manufacturing, labeling, marketing, and post-market surveillance of these products.

1. Welcome
ROLE OF DRUG REGULATORY AGENCIES
Dandeboina Sushma
B. Pharmacy
170/082023
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2. Contents
 Introduction
 Global drug regulatory agencies
 Drug regulatory agencies in India
 CDSCO
 Organization chart of CDSCO
 Goals
 Role of drug regulatory agencies
 Challenges
 Conclusion
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3. Introduction to Drug Regulatory Agencies
Definition:
Drug regulatory agencies are government organizations responsible for
overseeing and regulating the development, approval, manufacturing,
distribution, and post-market surveillance of pharmaceutical drugs and
medical products.
These agencies ensure that drugs are safe, effective, and of high quality
before they are made available to public.
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5. Global Drug Regulatory Agencies
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6. Drug regulatory agencies in India
Some of the key regulatory agencies in India are:
 Central Drug Standard Control Organization (CDSCO)
 National Pharmaceutical Pricing Authority(NPPA)
 Indian Council of Medical Research(ICMR)
 Indian Pharmacopoeia Commission(IPC)
 Directorate General of Health Services(DGHS)
 State Drug Regulatory Authorities
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7. Central Drug Standard Control Organization
CDSCO is the main regulatory body responsible for the approval,
regulation, and quality control of drugs , medical devices, and cosmetics
in India.
It operates under the Ministry of Health And Family Welfare
Functions:
• Monitoring adverse drug reactions
• Publication of Indian pharmacopoeia
• Approval of new drugs and clinical trials
• Testing of drugs by Central Labs
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8. Organization Chart of CDSCO
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9. Goals of drug regulatory agencies
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Goals
Consumer
Protection
Public
Safety
Innovation
Stability
and Trust
Efficiency
Risk
Management

10. Role of drug regulatory agencies
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Regulatory agencies has the responsibility to close down an on going trial in the case
there are serious breaches of good clinical practice
Post-marketing surveillance : After a drug is approved and on the market,
regulatory agencies continue to monitor its safety and effectiveness
Drug approval and regulation : Regulatory agencies review and assess applications
for new drugs , including their safety, efficacy, and quality data, before granting
approval for them to be marketed and distributed
Clinical trial oversight : Regulatory agencies oversee the design, conduct, and
reporting of clinical trials conducted during the drug development process

11. Role drug regulatory agencies
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Policy Development : These agencies develop and update regulations and guidelines
for various aspects of drug development, manufacturing, and distribution
Risk Assessment and Management: Regulatory agencies assess the potential risks
and benefits of new drugs, as well as any changes to existing drugs.
Public Communication: Regulatory agencies communicate important information
about drugs to healthcare professionals and the public.
International Collaboration: Many regulatory agencies collaborate with their
counterparts in other countries to harmonize regulatory standards and share information

12. Role of drug regulatory agencies
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 In Clinical Research (CR):
• Review and approval of clinical trial protocols to ensure scientific rigor and ethical
considerations.
• Oversight of ongoing clinical trials to ensure participant safety and data integrity.
• Evaluation of clinical trial results as part of the drug approval process.
• Guidance and regulation to maintain high standards of research conduct.
 In Pharmacovigilance (PV):
• Monitoring and analyzing adverse events and drug reactions to ensure patient safety.
• Issuing safety alerts, recalls, and warnings based on safety concerns.
• Assessing benefit-risk profiles of drugs throughout their lifecycle.
• Collaboration with international agencies to share safety information.

13. Challenges
• The major challenges of these regulatory agencies are:
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To promote public health and protect the public from harmful and dubious
drugs
To establish proper legalization covering all products with a medicinal claim
and all relevant pharmaceutical activities, whether carried out by the public or
the private sector
To increase worldwide regulatory growth to ensure safety of people

14. Conclusion
Drug regulatory agencies play crucial role in ensuring the safety, efficacy, and quality
of pharmaceutical products. They review and approve new drugs, monitor clinical trials,
establish guidelines for manufacturing practices and enforce regulations to protect public
health.
These agencies also facilitate drug registration, inspect manufacturing facilities, and
monitor adverse drug reactions to maintain a robust pharmaceutical industry and
safeguard patient wellbeing.
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15. Thank You!
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