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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