Drug Regulatory Affairs (DRA)

A brief introduction to Drug Regulatory Affairs and Its Regulatory Authority.

1. Presentation on drug regulatory affairs By :– Siddharth Kumar Sahu M.Pharmacy

2. Contents – Introduction t o Drug Regulatory Affairs. Why & What Issue DRA Provide Assistant.? Role of Regulatory Affairs Expert. Regulatory Bodies. Implementing Authorities. Central Drug Standard Control Organization. Drug and Cosmetic Act. and other acts. 2

3. Drug regulatory affairs – It is the new profession which developed from the desire of the government to protect public health by controlling the safety and efficacy of the product in the area including:- Pharmaceuticals, Veterinary Medicines, Medical Devices, Pesticides, Agrochemical, Cosmetics, Complementary Medicines. 3

4. Drug regulatory affairs – It is a dynamic and challenging field in the pharmaceutical industry. It is an affair between the competent and an applicant (company) to manage life cycle of the products. In present regulatory scenario, company requires expert in regulatory activities to manage the product life cycle. RA experts are qualified professional to provide the right solution to the technical problems under the light of laws and regulations. 4

5. Drug regulatory affairs 5 Advocate (RA Expert)

6. Drug regulatory affairs Judge (The Competent Authority) Communication Gap Applicant (The Company) 6

7. Why drug regulatory affairs?? Drug development and in order to develop the most efficient and safe pharmaceutical products. The path of drug registration is laid down with good intended but can be complicated. Somebody who gather all relevant information in one umbrella to bring product in the market for sell. Helps to reduce number of development failures. 7

8. On What Issue DRA Department Provide Assistance??? 8 Licensing Registration Development Manufacturing Quality guidance Pricing Marketing …..& many more GMP GLP GCP Patent Copyright Trademark Pharma-covigilance

9. What Are The Documents Prepared And/ Maintained By DRA Departments?? Licence And Certificates Obtained By Drug Regulatory Authorities. e.g. Mfg. Licence, GMP, ISO Etc. Common Technical Documents (CTD/ eCTD ) Drug Master File, Clinical Trials Reports, BA/BE Report. Quality Audits And Reports. Application for obtaining patent, copyrights and trademark registration. ......& Many More 9

10. Roles of regulatory affairs experts Regulatory affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and market the drug. Throughout the development stages , the pharmaceutical company have to abide by an array of strict rules and guidelines in order to ensure the safety and efficacy of the drug in humans. 10

11. Roles of r.a. expert(cont.) It plays a critical role as the leading department to provide strategic advice on extremely difficult decision through the life of a drug. To keep working order to meet regulatory commitments within the health authorities. The Regulatory expert also ensures the maintenance of the marketing license and leads life cycle such as broadening and indication of the drug, change of formulation, changes in dosage etc. 11

12. Regulatory bodies – India – CDSCO (Central Drug Standard Control Organization) US – USFDA (United State Food And Drug Administration) http://www.fda.gov/ Europe – EMA (European Medicine Agency) http://www.ema.europa.eu Australia – TGA(Therapeutic Goods Administration) http://www.tga.gov.au/ United kingdom – MHRA (Medicine And Healthcare Regulatory Agency) http://www.mhra.gov.uk 12

13. Regulatory bodies – Ireland – IMB (Irish Medicine Board) http://www.imb.ie/ ICH – International Conference On Harmonization http://www.ich.org/ Japan – MHLW-PMDA (Medicines And Pharmaceutical Device Agency) http://www.pmda.go.jp 13

14. Implementing Authorities Central Government: Central Drugs Standard Control Organization(CDSCO) State Governments : State Drug Licensing Authorities 14

15. 15 (CENTRAL DRUG STANDARD CONTROL ORGANIZATION) (CDSCO)

16. CENTRAL DRUG STANDARD CONTROL ORGANIZATION 16 VISION TO PROTECT AND PROMOTE PUBLIC HEALTH IN INDIA MISSION TO SAFEGUARD AND ENHENCE THE PUBLIC HEALTH BY ASSURING THE SAFETY EFFICASY AND QUALITY..

17. 17

18. 18 Central Drug Standard Control Organization

19. CDSCO Offices Zonal Offices: Ghaziabad, Mumbai, Chennai, Kolkata, Ahmedabad and Hyderabad Sub Zonal Offices: Chandigarh, Bangalore, Goa and Jammu Port Offices: (13) Central Drugs Laboratories – 7 Kolkata, Mumbai, Chennai, Hyderabad, Chandigarh, Guwahati and Kasauli Other Labs: NIB, IVRI 19

20. Functions of CDSCO 20

21. Functions of State Licensing Authorities Licensing of Manufacturing Site. Licensing of Establishment for sale or distribution of Drugs. Approval of Drug Testing Laboratories. Monitoring of Quality of Drugs, Medical Devices and Cosmetics marketed. 21

22. Drug And Cosmetics Act & Rule 1940 & 1945

23. Drug And Cosmetics Act & rule Objective: To Ensure Safety, Efficacy And Quality Of – Drugs Biological products Medical Devices Cosmetics Veterinary Drugs. 23

24. What is regulated under the act & rule 24 Regulated Under The Act:- Manufacture Import Distribution Sale Regulated Under Rules New Drugs Exports Clinical Trials

25. Administration of Act 25

26. Introduction To D & C Act, 1940 Part I:- Contains: 5 Chapters 38 Sections 2 Schedules Part II:- Contains: 19 Parts 169 Rules Schedules A to Y 26

27. Standard of the drug and cosmetics Schedule To The Act:- First Schedule:- Name Of Book Under Ayurvedic , Unani and Siddha . Second Schedule:- Improved Drugs And By Drugs Manufactured, Stocked For Sale. Schedule To The Rules:- ( Some Important ) 27 schedule Rule for C Biological And Other Special Product By Special Provision C1 List Of Other Special Product F Operation Of The Blood Bank And Component, Vaccines

28. 28 Schedules Rule for H List Of Prescription Drug M GMP Requirements O Standard For Disinfectant Fluid P Life Period Of Drug R Standard For Mechanical Contraceptives T Requirements Of Factory Premises And Hygienic Condition Y Guidelines For Clinical Trials W Marketed Under Generic Names

29. Other Acts and Orders Drugs Price Control Order (DPCO): To ensure drugs are sold at the prescribed prices, offenders are being monitored. Shortage and non-availability of drugs brought to the notice of manufacturers. Drugs and Magic Remedies Act: To monitor false/misleading advertisements. Narcotic and Psychotropic Substances Act: To prevent Pharmaceutical abuse. 29

30. Thanks For Your Attention