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Question

Which of the following is not a function of Central Drugs Standard Control Organization?

Regulating the prices of essential medicines.


A

Approval of new drugs

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B

Approval for conducting clinical trials

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C

Regulatory control over the import of drugs

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D

Regulating the prices of essential medicines.

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Solution

The correct option is D

Regulating the prices of essential medicines.


Recently, clinical trials conducted at academic institutions were given exemption from taking the hitherto mandatory permission from the Drug Controller General of India (DCGI).

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act.

Major functions of CDSCO: 1. Regulatory control over the import of drugs, approval of new drugs and clinical trials,

The once booming clinical trials in India came under the Supreme Court scrutiny in 2013, after at least 370 deaths were attributed to Serious Adverse Events (SEAs) during such trials.

In September 2013, the apex court ruled that no new clinical trials be permitted until the regulatory mechanism was reformed.

The National Pharmaceutical Pricing Authority (NPPA) is a government regulatory agency that controls the prices of pharmaceutical drugs in India


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