|
|
|
You can get e-magazine links on WhatsApp. Click here
|
|
|
|
|
|
India’s policy needs execution, not mere formulation
|
|
Tuesday, 05 May, 2026, 15 : 00 PM [IST]
|
|
Sanjaya Mariwala
|
Nutraceuticals are no longer sitting on the edges of the wellness space. They have, over time, found their way into how people think about staying healthy day to day. This hasn’t happened suddenly. With lifestyle diseases becoming more common, people living longer, and treatment costs continuing to rise, there is a visible shift towards prevention. That is also reflected in the numbers—the global market has already crossed $500 billion and continues to grow steadily. What is equally notable is that regulators in several markets have adapted to this shift. The debate is no longer about whether such products should exist, but how they should be governed without constraining growth.
India’s regulatory framework, while established, has not evolved at the same pace.
The 2016 regulations from FSSAI came in when the space was still quite scattered. They helped bring some order by putting categories in place, setting basic norms around composition, and clearly spelling out what would not be allowed. That framework served its purpose at the time. Now, however, its limitations have become more visible.
The system still depends heavily on defined ingredient lists. Products that fit within these lists tend to move through approvals without much difficulty. Those that do not, even when backed by scientific evidence, often face longer period for the approval.
At the same time, a more fundamental issue remains unresolved. Many nutraceutical products sit between food products and pharmaceuticals. This makes classification less straightforward, with different regulatory interpretations coming into play depending on how a product is positioned. This lack of clarity continues to slow down decision-making.
There have been attempts to address this. Changes in the framework and the evolving role of CDSCO were meant to bring more clarity to classification and approvals. But these changes have largely stayed at the policy level. On the ground, the expected improvement in timelines and consistency is still not visible.
This is where the gap between policy and execution becomes evident.
Product development timelines are shaped as much by regulatory pathways as by science. Formulations are often aligned to what is likely to be accepted rather than what may be optimal. Clinical research, which should ideally act as a differentiator, becomes a longer-term bet with uncertain returns. In practice, several manufacturers operate with separate strategies for domestic and export markets, which is neither efficient nor sustainable.
Alongside this, structural challenges are becoming harder to ignore. Fragmented ITC (HS) classification creates inconsistencies in trade treatment. Regulatory barriers in markets such as the US and EU make entry more demanding, particularly for smaller companies. Access to shared scientific validation platforms is still limited, which restricts the ability to build globally accepted evidence.
There is also the question of quality and scale.
A large part of the industry is made up of MSMEs, many of whom operate with limited access to advanced testing, certification, and validation infrastructure. This results in uneven quality standards across the sector. It also affects credibility, both in domestic markets and in exports, where compliance expectations are significantly higher.
The Governments’ support for R&D in nutraceuticals is not in question. Allocations have been made and intent is evident. The problem lies in infrastructure and implementation. The availability of credible testing facilities has remained a challenge, especially for those organisations that cannot afford to establish such a facility due to their size. On the other hand, the speed of establishing infrastructure from funds set aside has been inadequate. As a result, the expectation for science-backed products are not matched by the supporting systems.
A look at the other developed markets offers some perspective.
The United States has taken a relatively flexible approach, placing responsibility on manufacturers while relying on post-market enforcement. The European Union, on the other hand, follows a more structured route, particularly when it comes to health claims, where scientific substantiation is tightly scrutinised. Japan and Australia have adopted differentiated pathways that link regulatory requirements to product risk and claim intensity. These approaches vary, but they are built on a clear recognition of nutraceuticals as a separate category.
India is still moving towards that level of clarity.
The next phase does not require a new framework. It requires the existing one to work more effectively.
Clarity on claims is a starting point. Not all claims carry the same weight, yet they are often treated similarly. A clearer distinction between claim types, linked to corresponding levels of evidence, would reduce ambiguity and give the industry a more predictable path.
A credible certification system will also be important in building trust, especially in global markets. The introduction of an official Nutra Mark for Indian nutraceuticals can help create a recognisable standard around quality and traceability. The pharmaceutical sector built its reputation over time through consistent compliance. Nutraceuticals will need to move in a similar direction if they are to gain wider acceptance.
Regulatory stewardship also needs attention. There is a need for clearer ownership between FSSAI and CDSCO to reduce overlap and improve confidence within the industry.
There is a case for building a stronger evidence base to support policy decisions. The Ministry of Food Processing Industries (MoFPI) may consider commissioning a national-level study that looks at the sector end-to-end. This should cover value chain mapping, export potential across key markets such as the US, EU, UK, ASEAN, and Africa, and gaps in policy as well as HS classification. It should also assess MSME capabilities, investment needs, and the state of R&D and clinical validation infrastructure. A clearer understanding of employment and rural income impact can help shape more targeted interventions, including PLI and fiscal incentives.
However, export opportunity should be handled much more strategically. With several Free Trade Agreements going towards their implementation phase, nutraceuticals are likely to emerge as a key area to export from.
It is imperative to establish capabilities collectively. Regional centres of excellence could aid in industrial innovation, creation of primary processing facilities, collecting regional information on crops, and establishing a centralised database for the industry.
This also brings into perspective the importance of coordination among the regulatory landscape. A more coordinated effort from government, regulation agencies, industry players, and academics could lead to increased synergy and reduced fragmentation. It is at such a juncture that the establishment of a national council for regulation and quality systems can prove to be quite beneficial.
The direction is not unclear. The gap lies in how consistently it is executed.
The challenges are already visible and the measures outlined here address them directly. Greater clarity can reduce approval delays. Better infrastructure can improve access to scientific validation. Stronger certification can build trust in global markets.
India has the capability to be more than just a participant in this space. But that will depend less on new policies, and more on how effectively the existing ones are put into practice.
(The author is executive chairman and managing director, OmniActive Health Technologies Ltd)
|
|
|
|
|
|
|
|
|
|