Cdsco

central drug standard control organisation

1. SMS Medical College, Jaipur CENTRAL DRUG STANDARD CONTROL ORGANISATION (CDSCO) Dr.Jaya Dadhich Department of Pharmacology

2. Why ? PG questions As a pharmacologist New Drug development/trials Ethical commitee Sugam portal P vPi

3. Overview Website view About CDSCO Vision and mission Strategies

4. The Central Drugs Standard Control Organisation (CDSCO) under Directorate General of Health Services,Ministry of Health & Family Welfare,Government of India is the National Regulatory Authority (NRA) of India. Its headquarter is located at FDA Bhawan , Kotla Road, New Delhi 110002 and also has six zonal offices,seven sub zonal offices,thirteen Port offices and seven laboratories spread across the country.

5. Vision: To Protect and Promote public health in India. Mission: To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.

6. Values To achieve the mission and mandate of the CDSCO we will strive to act with transparency, accountability, punctuality, courtesy, openness, responsiveness, professionalism, impartiality, consistency, integrity and truthfulness

7. Strategies Initiate in framing of rules, regulations and guidance documents to match the contemporary issues in compliance with the requirements of Drugs & Cosmetics Act 1940 and Rules 1945. Facilitate in Uniform implementation of the provisions of the Drugs & Cosmetics Act 1940 and Rules 1945. Function as Central license Approving Authority under the provisions of Drugs and Cosmetics Act 1940 and Rules 1945. Collaboration with other similar International agencies. Providing training to the Indian regulatory personnel

8. Functions

9. Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

10. Function of State Licensing Authorities Licensing of drug testing laboratories. Approval of drug formulation for manufacture. Monitoring of quality of Drugs and cosmetics, manufactured by respective state and those marketed in the state.

11. BA/BE

12. Bioavailability (BA) :  Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation. Bioequivalence (BE):  Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.

13. The office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhawan , New Delhi has been receiving applications from applicants requesting for the approval to carry out BA/BE studies with various pharmaceutical dosage formulations on Indian subjects

14. Biologics

15. Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, to ensure the protection of the rights, safety and well-being of human subjects involved in a clinical trial for reviewing and approving the protocol the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards.

16. DTAB /DCC This division deals with organizing and convening meetings of ‘Drugs Technical Advisory Board (DTAB)’ and ‘Drugs Consultative Committee (DCC)’. The recommendations of DTAB and DCC on the matters rose out of administration of the Drugs and Cosmetics Act and Rules thereunder shall be done by amending the relevant particulars of the Drugs and Cosmetics Act and Rules thereunder .

17. Approval For New Drugs New drugs are permitted to be marketed in country in accordance with the permission granted by DCGI after ensuring that these drugs are Safe Effective Comply with requirement of schedule Y of the Drug and Cosmetic rules.

18. Applicants are required to provide technical data in respect of safety and efficacy before these could be permitted to be marketed in country. Definition of new drug also includes fixed dose combination which are required to be marketed for the 1 st time in country.

19. Subsequent new drug application can be made for the following cases: Bulk Drug already approved in the country (approved within 4 years). New drug (Formulation) already approved in the country (approved within 4 years). A drug already approved and proposed to be marketed with new indication. A drug already approved and proposed to be marketed as a ‘New Dosage Form/ New Route of Administration’. A drug already approved and proposed to be marketed as a ‘Modified release dosage form’. A drug already approved and proposed to be marketed with additional strength

20. Drug alert lists

21. PRO-public relation office 1.  Acting as 'Single Window' for disposal of grievances of Stakeholders. 2.  Provide information to the innovators regarding regulatory requirements for commercialisation of their products 3.  Provide clarifications pertaining to Drugs & Cosmetics Act, 1940 and Rules made there under. 4.  Guide and assist to handhold investors in various phases of business life cycle as per existing focus on "Invest India/ Make in India".

22. Thank you