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Indian Regulatory Requirements (Unit:- 5):- Hand Written Notes


Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs.

Indian Regulatory Requirements Introduction Central Drug Standard Control Organization (CDSCO) State Drugs Control Organization Approval of New Drug Requirements for Import and Registration Central Drugs Testing Laboratory (CDTL) Certificate of Pharmaceutical Product (COPP) 5.8
• Questions

The Central Drug Standard Control Organization is licensing authority (regulatory agency) for the approval of new drugs proposed and amount of drugs to be imported.
Developing standard and regulatory measures for drugs linguistics and devices.
Laying down regulatory measure by amending acts and rules.
Regulating the market authorization of new drugs.
In its role on the regulator of imported drugs, the CDSCO works with:
The Drugs Technical Advisory Board and Drugs Consultative Committee.
The Central Drugs Laboratory undertaken testing of such drugs.

Long-Answer Questions:
1. Explain the details of CDSCO and give its functions.
2. Write about various Drug Regulatory agencies.
3. Write details about different Central Drugs Testing Laboratories available in India.
4. Write short note on State Licensing authorities.
5. Explain about Central Drugs Laboratory and its function.
6. What is RDTL and its function?
7. What is COPP and its importance?
8. What are general requirements for submission of application for issue of COPP?
9. What is the procedure for accepting the application for issue of COPP?
10. What are the documents required for applying grating on revalidation of COPP?
11. What are the regulatory requirements and approval procedures for new drugs?