CDSCO- CENTRAL DRUG STANDARD CONTROL ORGANISATION

CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO)

1. CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO ) Presented by: Pawar Anil keshav M- Pharm (1 st year) 2019-2020 Guided by: Mr.V.C G urumukhi 1 Dept. of quality assurance R.C P atel institute of pharmaceutical education and research, shirpur

2. CONTENTS Introduction O r g ani z a t i o n Cha r t Major function of CDSCO Drug approval process Clinical trials process Cosmetics Medical devices SUGAM – online licensing portal References 2

3. INTRODUCTION Th e Central drug standard and control organization (CDSCO ) is the main r egu l a t o r y body of india f o r r egu l a t i o n o f phar m aceu t i c al, me d i c al d e vices and C l i n i c al T ria l s . CDSCO is the Central D rug A uthority for discharging function assigned to the Central Government under the Drug and cosmetics Act. Head office of CDSCO is located in NEW DELHI Functioning under the control of Directorate General of Health Services, ministry of health and family welfare, Government of India. 3

4. Minsitry responsible for : Ministry of health and family welfare. Minster responsible for: harsh vardhan Vision To protect and promote health in I ndia. Mission To safeguard and enhance the public health by assuring the safety, efficacy, and quality of drugs, cosmetics and medical devices. 4

5. Drugs Controller General of India [DCGI] He/she is a responsible for approval of New Drugs , Medical devices and Clinical Trails to be conducted in India. He is appointed by the central government under the State drug control organization will be functioning . The DCGI ( Drug C ontroller G eneral of I ndia ) is advised by the Drug Technical Advisory Board {DTAB } and the Drug Consultative Committe {DCC}. 5

6. O r g ani z a t i o n Cha r t Head quater Zonal office(6 ) Sub- zonal office(3 ) Port/airport office(9) Laboratories (6) New drugs import GMP audit Coordination with states GMP Audit Coordination with sates Import export Testing of drug sample Validation of test protocol 6

7. 7 Zonal offices Thes e a r e i n v o l v ed i n G M P aud i ts and i nsp e cti on o f manu f ac tur i n g u n its o f l a r g e v o l ume pa r e nt al , se r a, v acci n e and b l oo d p r oducts. Sub-zonal offices These centre co-ordinate with state drug control authorities under their jurisdiction for uniform standard of inspection.

8. 8 Port/airport office Laboratories

9. Major function of CDSCO Regulatory control over the import of drugs , approval of new drug and clinical trial It control meeting of Drug consultative committee (DCC). it give certain licences as central licence & state licence approving authority is exercised by the CDSCO headquarters. 9

10. 10 Approval of new drug and clinical trials. Banning of drug and cosmetics. Grant of test licence , personal licence Import registration , licensing and approving of blood banks,vaccines , medical devices. Central Licensing authority

11. 11 Licensing of manufacturing site for drug including API and finished product. It give Approval of drug testing laboratories. Monitoring of quality of drug and cosmetics marketed in the country Licensing of establishment for sale or disturbance of drug. Recall of sub-standard drugs. State Licensing authority

12. 12 Drug approval process A pplicant Application to ethical committee Report of ethical committee If positive IND application filling to CDSCO Headquarter Examination by new drug division Detailed review by IND committee Recommendation to DCGI IND application approved Clinical trials started Application for new drug registration to CDSCO Review by DCGI License is granted If complete Reflux to grant license If not complete

13. 13 Clinical trials process Schedule Y of drug and cosmetics act explain the guidelines for grant of permission for conducting clinical trials in india. The protocol for such trials are examined by the office of DCGI before the permission are granted. Office of DCGI also give grant permission for conducting bioequivalence studies. Registration of clinical trials has been made mandatory with centralised clinical trials. Drug cosmetics rule are being amended to make mandatory the registration of clinical research organisation. Drug and cosmetics act is proposed to be amended to include a separate chapter on clinical trials.

14. 14 For import of cosmetics in india required to be registered with central drugs standard control organisation (CDSCO) by giving application in Form 42 to obtain registration certificate in Form 43. The manufactured person / the authorised agent can be an applicant for issuance of registration certificate for import of cosmetics into india. License will granted within 6 months. Cosmetics

15. 15 MEDICAL DEVIC E S A n y i n s tr u me n t, appa r a tu s , imp l eme n t mach i ne , ap p l i ance, i m p la n t, i n vit r o r ea g e n t use d f or treatment . The import ,export , manufacturing of medical devices regulated under drug and cosmetics act &rule The risk based classification for medical devices ranging from : Class A low risk ( thermometer, tongue depressor) Class B low moderate risk ( suction equipment, hypodermic needle) Class C high moderate risk ( bone fixation plate) Class D high risk ( heart valves, ) 16

16. 16 An online licensing portal of CDSCO to file application for various services like application submission, processing and grant of permission for quick delivery of services. SUGAM Benefits: Applicant can apply license under import and registration division to CDSCO. Track the status of application through online. Answer back to raised queries. Applicant can also upload essential documents for registration , import license and other related activities. SUGAM – online licensing portal

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18. 18 Registration certificate – Form 41 for drug Registration certificate – Form 41 for medical device Registration certificate – Form 41 for diagnostic kit I mport license- form 10 for drug Import license- form 10 for medical device Import license- form 10 for diagnostic kit Test license for clinical trails Registration certificate for cosmetics. Type of license can apply through SUGAM portal

19. 19 http :// w.w.w.cdscoonline.gov.in / w.w.w cdsco.nic.in https:// www.researchgate.net/publication/301637817_ DRUG_REGULATORY_AGENCIES_IN_INDIA_USA_EUROPE_AND_JAPAN-A_REVIEW https://ijdra.com/index.php/journal/article/download/186/103 E:\cdsco\cdsco guildlines.pdf https :// mohfw.gov.in/sites/default/files/Medical%20Device%20Rules%2C%202017.pdf https:// rgcb.res.in/documents/Schedule-Y.pdf https://en.m.wikipedia.org/wiki/Drug_Controller_General_of_India External links: Official Central Drugs Standard Control Organization Website for sugam portal . Official Central Drugs Standard Control Organization Website . REFERENCES :

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