CDSCO Regulatory Authority.pdf
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The Central Drug Standard Control Organization (CDSCO) is India's regulatory authority for pharmaceuticals, cosmetics, and medical devices, headquartered in New Delhi. It oversees drug approvals, clinical trials, and monitoring through the Drugs Controller General of India (DCGI), who is advised by the Drug Technical Advisory Board and Drug Consultative Committee. The CDSCO also manages various zonal and testing laboratories to ensure compliance with health regulations and safety standards.
![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 DCGI the State drug control organization will be
functioning.
The DCGI is advised by the Drug Technical Advisory Board {DTAB} and the Drug Consultative
Committed {DCC}.](https://image.slidesharecdn.com/cdscoregulatoryauthority-230329082013-b3210bd0-230508164413-0d7195eb/85/CDSCO-Regulatory-Authority-pdf-3-320.jpg)
CDSCO Regulatory Authority.pdf
- 1. CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO) SUBMITTED BY: RAHUL PAL, PRACHI PANDEY SUBMITTED TO: ARSH CHANANA M. PHARM (PHARMACEUTICS) DEPARTMENT OF PHARMACEUTICS, NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY JAIPUR, RAJASTHAN
- 2. CENTRAL DRUG STANDARD CONTROL ORGANIZATION (CDSCO) The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. I. Headquarters: New Delhi, India. II. Organization executive: Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI) It functions under the control of Directorate General of Health Services, ministry of health and family welfare Government of India. Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices and is positioning within the Ministry of Health and Family Welfare. The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
- 3. 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 DCGI the State drug control organization will be functioning. The DCGI is advised by the Drug Technical Advisory Board {DTAB} and the Drug Consultative Committed {DCC}.
- 5. ORGANIZATION UNDER CDSCO 1. Zonal offices I. Mumbai, Kolkata, Chennai, Ghaziabad, Ahmedabad, Hyderabad II. These are involved in GMP audits and inspection of manufacturing units of large volume parental, sera, vaccine and blood products 2. Sub-zonal office:- I Chandigarh II Jammu III Bangalore I. These centre co-ordinate with state drug control authorities under their jurisdiction for uniform standard of inspection and enforcement. 3. Central Drugs Testing Laboratories I. Central Drug Laboratory, Kolkata II. Central Drug Testing Laboratory, Mumbai III. Central Drug Testing Laboratory, Chennai IV. Central Drug Laboratory, Kasauli V. Regional Drug Testing Laboratory, Guwahati VI. Regional Drug Testing Laboratory, Chandigarh
- 6. FUNCTIONS OF CDSCO IN CENTRE I. Approval of new drugs and clinical trials. II. Import Registration and Licensing. III. Licensing of Blood Banks, LVPs, Vaccines, r-DNA products and some Medical devices and Diagnostic agents. IV. Amendment to D&C Act and Rules. V. Participation in WHO GMP certification schemes.
- 7. FUNCTIONS OF CDSCO IN CENTRE VI. Banning of drugs and cosmetics. VII. Grant to test license, personal license, NOC’s for export. VIII. Testing of drugs by Central Labs. IX. Publication of Indian Pharmacopoeia. X. Monitoring adverse drug reactions. XI. Guidance on Technical matters.
- 10. FUNCTION OF STATE LICENSING AUTHORITIES I. Licensing of drug testing laboratories. II. Approval of drug formulation for manufacture. III. Monitoring of quality of Drugs and cosmetics, manufactured by respective state and those marketed in the state. IV. Investigation and prosecution in respect of contravention in respect of contravention of legal provisions. V. Administrative actions. VI. Pre- and post- licensing inspection. VII.Recall of sub-standard drugs.
- 11. APPROVAL FOR NEW DRUGS I. New drugs are permitted to be marketed in country in accordance with the permission granted by DCGI after ensuring that these drugs are II. Safe, Effective and Comply with requirement of schedule Y of the Drug and Cosmetic rules. III. Applicants are required to provide technical data in respect of safety and efficacy before these could be permitted to be marketed in country. IV. Definition of new drug also includes fixed dose combination which are required to be marketed for the first time in country
- 12. CLINICAL TRIALS I. Schedule Y of drugs and cosmetics act explain the guideline for grant of permission for conducting clinical trials in India. II. The protocol for such trials are examined by the office of DCGI before the permission are granted. III. Office of DCGI also grants permission for conducting bioequivalence studies. IV. Registration of clinical trials has been made mandatory with centralized clinical trial registry of ICMR with effect from 15th 2009. V. Drug and Cosmetic rules are being amended to make mandatory the registration of clinical research organizations. VI. Drug and Cosmetic act is proposed to be amended to include a separate chapter on clinical trials.
- 13. 1. Medical Devices Any instrument, device, apparatus, implement machine, appliances, implants, in vitro reagents used for treatment. The import, export, manufacturing of medical devices is regulated under D&C act and rule. 2. The risk based classification: Class A: Low risk thermometer Class B: Moderate risk hypodermic needle Class C: High moderate risk bone fixation plate Class D: High risk Heart valves