Q. Consider the following statements:
Statement-I: India has faced difficulties in recalling drugs from the market that fail quality tests.
Statement II: The Drugs Controller General of India (DCGI) lacks the legal power to make rules that are binding and have the force of law.
Which one of the following is correct in respect of the above statements?

[A] Both Statement-I and Statement-II are correct and Statement-II is the correct explanation for Statement-I

[B] Both Statement-I and Statement-II are correct and Statement-II is not the correct explanation for Statement-I

[C] Statement-I is correct but Statement-II is incorrect

[D] Statement-I is incorrect but Statement-II is correct

Answer: A
Notes:

Explanation –

Statement I is correct. India has struggled with effectively recalling drugs that fail quality tests due to the lack of a robust, legally binding recall system. This has been a significant issue in the Indian pharmaceutical regulatory framework.

Statement II is correct. While the DCGI can propose guidelines and policies, it lacks the authority to enforce these as binding laws. Only the Ministry of Health or the Drug Regulation Section of the Ministry can initiate the process to create binding rules or legislation. This limitation is a major reason why India lacks a mandatory recall law, despite the DCGI’s initiatives.

Hence, the Statement-I describes the problem of ineffective drug recalls, and Statement-II provides the reason for this issue.

Source: The Hindu

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