Role of drug regulatory agencies

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2

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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3

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5. Global Drug Regulatory Agencies 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6

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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7

8. Organization Chart of CDSCO 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Goals of drug regulatory agencies 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9 Goals Consumer Protection Public Safety Innovation Stability and Trust Efficiency Risk Management

10. Role of drug regulatory agencies . . 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10 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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11 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 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12 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 agenci es are: 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13   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 r egulatory 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. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 14

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