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With reference to the Clinical trials, consider the following statements:
- Central Drugs Standard Control Organization (CDSCO) regulates the new drug approval process.
- Drug Controller General of India (DCGI) is the authority to give regulatory permissions for the conduct of clinical trials.
Which of the statements given above is/are correct?
- a)1 only
- b)2 only
- c)Both 1 and 2
- d)Neither 1 nor 2
Correct answer is option 'C'. Can you explain this answer?
Most Upvoted Answer
With reference to the Clinical trials, consider the following statemen...
The correct answer is option 'C' - Both 1 and 2.
1. Central Drugs Standard Control Organization (CDSCO) regulates the new drug approval process:
- CDSCO is the regulatory body in India responsible for the approval and regulation of drugs, medical devices, and cosmetics. It operates under the guidance of the Ministry of Health and Family Welfare.
- CDSCO is responsible for ensuring the safety, efficacy, and quality of drugs and related products in the country.
- It formulates guidelines and regulations for the conduct of clinical trials and monitors their compliance.
- CDSCO has the authority to grant approvals for new drugs, including the approval of clinical trial protocols and the import and manufacture of investigational drugs.
2. Drug Controller General of India (DCGI) is the authority to give regulatory permissions for the conduct of clinical trials:
- DCGI is the head of CDSCO and is responsible for overseeing the approval and regulation of drugs in India.
- DCGI is the authority that grants regulatory permissions for the conduct of clinical trials in the country.
- Before a clinical trial can be conducted, the sponsor or investigator must obtain approval from the DCGI.
- The DCGI reviews the clinical trial protocol, study design, and other relevant documents to ensure that the trial meets ethical and regulatory standards.
- Once satisfied with the proposed trial, the DCGI grants permission for the trial to proceed.
In summary, both statements are correct. CDSCO is responsible for regulating the new drug approval process, while the DCGI, as the head of CDSCO, is the authority that grants regulatory permissions for the conduct of clinical trials.
1. Central Drugs Standard Control Organization (CDSCO) regulates the new drug approval process:
- CDSCO is the regulatory body in India responsible for the approval and regulation of drugs, medical devices, and cosmetics. It operates under the guidance of the Ministry of Health and Family Welfare.
- CDSCO is responsible for ensuring the safety, efficacy, and quality of drugs and related products in the country.
- It formulates guidelines and regulations for the conduct of clinical trials and monitors their compliance.
- CDSCO has the authority to grant approvals for new drugs, including the approval of clinical trial protocols and the import and manufacture of investigational drugs.
2. Drug Controller General of India (DCGI) is the authority to give regulatory permissions for the conduct of clinical trials:
- DCGI is the head of CDSCO and is responsible for overseeing the approval and regulation of drugs in India.
- DCGI is the authority that grants regulatory permissions for the conduct of clinical trials in the country.
- Before a clinical trial can be conducted, the sponsor or investigator must obtain approval from the DCGI.
- The DCGI reviews the clinical trial protocol, study design, and other relevant documents to ensure that the trial meets ethical and regulatory standards.
- Once satisfied with the proposed trial, the DCGI grants permission for the trial to proceed.
In summary, both statements are correct. CDSCO is responsible for regulating the new drug approval process, while the DCGI, as the head of CDSCO, is the authority that grants regulatory permissions for the conduct of clinical trials.
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With reference to the Clinical trials, consider the following statements: Central Drugs Standard Control Organization (CDSCO) regulates the new drug approval process. Drug Controller General of India (DCGI) is the authority to give regulatory permissions for the conduct of clinical trials.Which of the statements given above is/are correct?a)1 onlyb)2 onlyc)Both 1 and 2d)Neither 1 nor 2Correct answer is option 'C'. Can you explain this answer?
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