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After years of deliberation whether nutraceuticals are a food or drug, the decision was taken to classify it as food. But as the nutraceutical landscape grows, with some products claiming therapeutic benefits — the nutra–pharma discussions have come up again.
Government representatives and experts are revisiting streamlining the regulatory framework. And a critical part of this discussion involves manufacturing — allowing a plant that produces pharmaceutical products, to make nutraceutical products, as well.
Industry-insiders explain that turning the regulatory clock back and disallowing nutraceuticals from being made at pharma production facilities would be contrary to global practice.
Decontamination rules
Pharma plants have cleaning and decontamination protocols in place, as they make multiple products, says Sanjaya Mariwala, Executive Chairman and Managing Director, OmniActive Health Technologies, and President of the Association of Herbal and Nutraceutical Manufacturers of India.
Drug-makers can make nutraceuticals in their plants (following cleaning protocols) — the reverse is not allowed, he clarifies, adding, it is the right approach. Responding to concerns that nutraceutical producers may claim pharma-level manufacturing standards (adhering to current Good Manufacturing Practices), Mariwala said, that should be seen as a positive. There are about a 1,000-odd nutraceutical producing plants in the country, he estimates
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Nutraceutical production is governed by the FSSAI rules says Mariwala, and companies exporting to regions including the US, for example, meet their regulatory requirements. He estimates the domestic nutraceuticals market at $6 billion.
The recent nutraceuticals/pharmaceuticals discussion traces back to a few industry practices, including possibly circumventing price control, says a regulatory veteran familiar with the details. For example, pharma producers of vitamins or mineral products may have shifted to the food classification, by reformulating their product to meet food standards and avoid price control, the expert observed. This is not illegal, but could impact the requirement of similar pharma products required to treat certain health issues, and that is a concern, the official added. Also, nutraceutical products are now available in convenient formats like capsules, tablets and syrups – usually seen with drugs.
The way forward is to tighten regulation, so products meeting the pharmaceutical definition (in terms of composition and percentage of active ingredient) and making therapeutic claims are regulated by the Drug Controller General of India; and those products meeting the food requirements are classified as nutraceuticals, the expert suggested.
Production facilities can make both products on a “campaign basis”, the expert added, where few days of the week are dedicated to making nutraceuticals and the rest for pharmaceuticals, after decontamination protocols are followed. That is the global practice, the industry-veteran said.
‘Allow both’
Anil Matai, Director General with the Organisation of Pharmaceutical Producers of India (OPPI) foresees “significant challenges” in implementing the proposed changes.
“Limiting manufacturing premises exclusively to drug production, as outlined in the revised Schedule M, could impact companies that produce both drugs and dietary supplements, affecting both domestic supply and exports. This is particularly important as India is poised for significant manufacturing opportunities, with global companies considering it a viable alternative to China. Ensuring our companies can meet their commitments is crucial for maintaining credibility,” he says.
Besides, “the investment required for establishing new, separate plants might not be feasible for many companies, potentially leading to a loss of revenue, he adds. The Indian pharmaceutical industry already aligns with global standards, such as US FDA and European Union regulations, “where facilities adhering to stringent drug manufacturing protocols are permitted to produce FDA-licenced dietary supplements,” Matai points out. “These protocols effectively prevent cross-contamination and ensure product safety,” he says.
“Safety and quality standards should continue to meet WHO GMP guidelines,” says Matai, adding that OPPI have submitted comments to the Government, advocating that “companies be allowed to manufacture both drugs and nutraceuticals/dietary supplements if they meet the revised Schedule M requirements for good manufacturing practices and premises, plant and equipment standards.”
The regulatory landscape is fragmented, says a recent Assocham report, and it “often leads to ambiguity and inconsistency in compliance requirements, hindering industry growth.” The requirement is, for a “unified regulatory framework that provided clarity and consistency in standards,” it points out.
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