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DCGI's Policy Initiatives UPSC NOTE

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  Earlier this year, the Drugs Controller General of India (DCGI) under the Ministry of Health announced initiatives on: Recall guidelines ...

 

  • Earlier this year, the Drugs Controller General of India (DCGI) under the Ministry of Health announced initiatives on:

    • Recall guidelines

    • Good distribution practices

    • Use of similar brand names by pharmaceutical companies

  • These measures aim to improve public health by:

    • Removing drugs that fail testing

    • Regulating the storage and distribution of drugs

  • Preventing confusion from similar brand names, reducing prescription errors

Limitations of the Measures:

  • The initiatives lack the force of law or are poorly implemented.

  • For decades, vague guidelines have been repackaged as concrete reforms.

  • The Parliamentary Standing Committee (PSC) in its 59th report (2012) raised issues about:

    • Lack of recall guidelines

    • Poor storage standards for drugs

    • Confusing drug brand names

  • These issues were flagged decades earlier:

  • 1976: Lack of recall guidelines noted by the Drugs Consultative Committee (DCC)

  • 1974: Supreme Court flagged drug storage standards in Swantraj & Ors vs State of Maharashtra

  • 2001: Similar brand names highlighted by the Supreme Court in Cadila Healthcare vs Cadila Pharmaceuticals

  • The PSC's 59th report created pressure on the Ministry to take action.

  • The PSC published an "Action Taken Report" criticizing the Ministry for lack of reforms.

  • DCGI announced recall guidelines in 2012, 2017, and 2023, but lacks the legal power to enforce them.

  • Only the Ministry of Health has the constitutional power to make binding rules.

Good Distribution Practices (GDP):

  • A proposal to adopt WHO’s GDP guidelines was rejected in 2013 due to difficulty in implementation.

  • In 2019, after a drug storage scandal, the DCC resolved to make GDP guidelines mandatory.

  • The government is still delaying binding GDP regulations through repeated consultations.

Confusing Brand Names:

  • Despite court and PSC warnings, the issue remains unresolved.



  • In 2019, the government introduced a self-declaration rule for pharmaceutical companies instead of making the regulator responsible for vetting brand names.

  • Following public outcry, the NHRC intervened in 2023, and the Directorate General of Health Services asked the Registrar of Trademarks to prevent confusing brand names.

  • The Ministry’s leadership failure and frequent turnover of joint secretaries without domain expertise have stalled effective drug regulation reforms.

  • Stakeholders in the pharmaceutical industry often use consultations to delay necessary actions.

  • Direct intervention from the Prime Minister's Office is required to break the bureaucratic loop and ensure effective drug regulation reforms.

Parliamentary Committee

  • A Parliamentary Committee is a panel of MPs that is appointed or elected by the House or nominated by the Speaker/Chairman.

  • The committee works under the direction of the Speaker/chairman and it presents its report to the House or to the Speaker/chairman.

  • Parliamentary Committees have their origins in the British Parliament.

  • They draw their authority from Article 105 and Article 118.

  • Article 105 deals with the privileges of MPs.

  • Article 118 gives Parliament authority to make rules to regulate its procedure and conduct of business.

  • India’s Parliament has multiple types of committees. They can be differentiated on the basis of their work, their membership and the length of their tenure.

  • However, broadly there are two types of Parliamentary Committees– Standing Committees and Ad Hoc Committees.

  • The Standing Committees are permanent (constituted every year or periodically) and work on a continuous basis.

  • While the Ad Hoc Committees are temporary and cease to exist on completion of the task assigned to them.

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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: DCGI's Policy Initiatives UPSC NOTE
DCGI's Policy Initiatives UPSC NOTE
Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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