Impact of Ban on Manufacturing of Food in Pharma Units: A Plea from SPIC

SPIC emphasizes that until recently, the manufacturing of food or nutraceuticals in a pharma unit was a legally sanctioned process.

The Health Master

March 8, 2024

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Last Updated on March 19, 2024 by The Health Master

Manufacturing of Food

The SME Pharma Industries Confederation (SPIC) is raising concerns over the recent decision by the Central government to ban the manufacturing of food or nutraceutical products in pharma units.

This move has far-reaching consequences, impacting the investments and operations of at least 5,000 entrepreneurs across the country.

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Understanding the Regulatory Shift

In a letter addressed to Prime Minister Narendra Modi, SPIC highlights the regulatory shift that has led to this predicament.

The drug regulator has taken a firm stance, asserting that manufacturing facilities approved for drugs should not be utilized for any other product manufacturing.

This decision has particularly affected 58 units in Himachal Pradesh, which hold dual licenses for both drugs and food manufacturing.

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Historical Legitimacy

SPIC emphasizes that until recently, the manufacturing of food or nutraceuticals in a pharma unit was a legally sanctioned process.

The Drug Consultative Committee (DCC), established under Subsection 7 of the Drugs and Cosmetics Act 1940, had approved the manufacture of food in pharma units after meticulous deliberations in its 37th meeting in 2007.

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Global Alignment and Viability

Drawing parallels with regulatory norms in the Western World, including the USFDA, TGA, EU, MCC, and MHRA, SPIC notes that nutraceuticals are recognized as dietary supplements.

This alignment allowed for the viability of such units even in developed countries, fostering entrepreneurship.

Recent Regulatory Challenges

However, during recent Risk-Based Inspections (RBI) of pharma units, the Central Drugs Standard Control Organization (CDSCO) has taken a strict stance against the manufacturing of food in these facilities.

Pharma units were directed to surrender their Food Safety and Standards Authority of India (FSSAI) licenses immediately if they wished to continue pharma manufacturing.

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DCGI’s Directive and NHRC’s Concerns

The Drugs Controller General (India) (DCGI), Dr. Rajeev Singh Rahuvanshi, referencing a case by the National Human Rights Commission (NHRC), directed the Himachal Pradesh State Drugs Controlling Authority to inspect units with dual licenses.

This was in response to allegations of manufacturing spurious or unlicensed drugs disguised as nutraceuticals.

SPIC’s Argument and the Current Scenario

SPIC argues that even in the latest Schedule M, effective from January 2025, although the manufacture of any other category is prohibited, there are provisions to manufacture an entirely different category of active drugs in the same unit on a campaign basis.

Nutraceuticals, similar to non-Beta Lactam/Hormonal drugs, pose no risks of contamination when produced in the general section of a unit with mandatory precautions.

“At least 5,000 entrepreneurs across the country are demoralized because their investment and sustenance are jeopardized for no fault of theirs,” says Jagdeep Singh, Secretary-General, SPIC, in the letter to the Prime Minister.

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Call for Action

The Confederation urges that unless an authority superior to the DCC, finding grounds for a change, the provision to manufacture food in pharma units should not be terminated by a notification.

SPIC requests the withdrawal of the prohibition on food manufacturing in pharma units, emphasizing the adverse impact on entrepreneurship, investments, and exports.

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