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Drugs And Clinical Trials Rules, 2019
Consider the following statements regarding the Drugs and Clinical Trials Rules, 2019:
- In the New Drugs and Clinical Trials Rules, 2019, the time for approving applications for drugs manufactured in India has been reduced to 60 and 120 days for those developed outside the country.
- The Nodal Ministry for implementing the rule is Ministry of Health & Family Welfare.
- As per the new rule, the requirement of a local clinical trial may be waived off for approval of a new drug if it is approved and marketed in any of the countries EU, UK, Australia, Japan and US.
- The new rule imposes restrictions to launch Orphan Drugs in India.
Select the correct answer using the codes given below:
A |
1 and 2
|
|
B |
2 and 4
|
|
C |
2 and 3
|
|
D |
1, 2, 3 and 4
|
Your Ans is
Right ans is B
Your Answer Is Correct
Your Answer Is Wrong
Explanation :
- On 26th March, 2019, the Government notified the New Drugs and Clinical Trials Rules, 2019, reducing the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country.
- The new rules give regulatory freedom to launch Orphan Drugs and not to restrict it.
Source: CSC May 2019
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