regulatory requirnment and approval procedure for drugs and cosmetics, medical devices, biologicals and herbals and food & nutraceuticals in india

this presentation contains all the requirement procedure for drugs and others

1. REGULATORY REQUIRNMENTS AND APPROVAL PROCEDURE FOR DRUGS AND COSMETICS, MEDICAL DEVICES, BIOLOGICAL & HERBALS AND FOOD AND NUTRACEUTICALS IN INDIA PRESENTED BY : SANDEEP BANSAL M.PHARMACY 1 st yr ( DRA)

2. CONTENTS REGULATORY REQUIRNMENT FOR NEW DRUG APPROVAL PROCEDURE IN INDIA. The Central Drugs Standard Control Organization (CDSCO). State licensing authority. Functions of State licensing authority. Regulatory Provisions for the approval of Cosmetics in India. Medical Device Registration in India . Registration process for food & Neutraceutical in India. Regulatory Requirements for Herbal Medicines in India. References.

3. APPLICANT APLICATION TO ETHICAL COMITTEE IND application filing to CDSCO head quarters Detailed review by IND committee Recommendation to DCGI IND application approved Clinical trials started Application for new drug registration to CDSCO Review by DCGI Examination by new drug division REPORT OF ETHICAL COMITTEE LICENCE IS GRANTED IF POSITIVE WITH IN 12 WEEKS REFUSED TO GRANT LICENCE If not complete Flow chart

4. The Central Drugs Standard Control Organization (CDSCO) The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare and Government of India is the National Regulatory Authority (NRA) of India. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of l Drugs, Conduct of Clinical Trials in India. Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and also has six zonal offices, four sub zonal offices, thirteen Port offices and seven laboratories spread across the country.

5. State licensing authority:

6. Functions of state licensing authority Licensing of Manufacturing Site for Drugs including API and Finished Formulation . Licensing of Establishment for sale or distribution of Drugs. Approval of Drug Testing Laboratories. Monitoring of Quality of Drugs and Cosmetics marketed in the country. Recall of sub-standard drugs.

7. Regulatory Provisions for the approval of Cosmetics in India

8. The application is accompanied with following documents

9. Medical Device Registration in India

10. APPLICANT ONLINE SUBMISSION OF APPLICATION WITH REQUISITE DOCUMENTS AND FEES APPLICATION RECEIVED BY NODEL OFFICER APPLICATION FORWARDED TO REVIEWING OFFICER AFTER REVIIEW FORWARDED TO NODAL OFFICER AFTER REVIEW FORWARDED TO DDA ( department of drug administration FORWARDED TO LA APPROVAL QUERY If any deficiency in documents FLOW CHART OF MEDICAL DEVICES APPROVAL

11. The following documents are required to be submitted in the following manner and order for grant of license in form-28 for Manufacture of Medical Devices in India : - Covering letter. An Authorization letter. A duly filled form of 27. The requisite fees i.e. 7500 Rs. Approved manufacturing premises plan. Site master file. Device master file. List of devices for manufacturing. ISO 13485:2003 Certificate (if any) .  

12. Registration process for food & Neutraceutical in India

13. Documents required for application in fssai

14. Documents required with Form A6 :

15. Apply to state licensing authority for site registration in Form A Inspection in 30 days Rejection of application Approval of site Apply mfg license in FORM B A unique application number has been issued Queries/ response based inspection on premises Grant of license and mfg shall start the business Rejection of license 7 days 30 days 60 days 60 days Flow chart

16. Regulatory Requirements for Herbal Medicines in India

17. Continued…..

18. References Patel j, Parikh k, shah d. NEW DRUG APPROVAL PROCEDURE IN INDIA | PharmaTutor [Internet]. Pharmatutor.org. 2018 [cited 08 december 2018]. Available from: https://www.pharmatutor.org/articles/new-drug-approval-procedure-india . Welankiwar A. REVIEW: REGULATORY PROVISIONS REGARDING COSMETICS IN INDIA | PharmaTutor [Internet]. Pharmatutor.org. 2018 [cited 08 december 2018]. Available from: https://www.pharmatutor.org/articles/review-regulatory-provisions-regarding-cosmetics-in-india . India Medical Device Registration - CDSCO Approval [Internet]. Pacific Bridge Medical. 2018 [cited 9 december 2018]. Available from: https://www.pacificbridgemedical.com/regulatory-services/medical-device/product-registration/india/ Home | Ministry of AYUSH | GOI [Internet]. Ayush.gov.in. 2018 [cited 9 December 2018]. Available from: http://ayush.gov.in/

19. Reference continued… [Internet]. Cdsco.gov.in. 2018 [cited 09 december 2018]. Available from: https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/medical-device/Guidance1.pdf . . Us A, Mission F, Us C, Subscription M, Archive M, Policy P et al. Food Regulations—What is the Current Scenario in India? - Food Quality & Safety [Internet]. Food Quality & Safety. 2018 [cited 09 december 2018]. Available from: https://www.foodqualityandsafety.com/article/food-regulations-what-is-the-current-scenario-in-india-2/ . home [Internet]. Cdsco.gov.in. 2018 [cited 09 december 2018]. Available from: https://cdsco.gov.in/opencms/opencms/en/Home/ . [Internet]. Cdsco.nic.in. 2018 [cited 09 december 2018]. Available from: http://www.cdsco.nic.in/writereaddata/statefunction.pdf . Defined Term: State Licensing Authority [Internet]. Defined Term. 2018 [cited 09 december 2018]. Available from: https://definedterm.com/state_licensing_authority .