Industry for simplified regulatory process


The Indian nutraceutical industry which is witnessing a growth of 18% is pressing for ingredient approval and simplified regulatory procedures.

Industry and the regulator for that industry always have a complex relationship. They need each other. In the absence of the industry the regulator has no job at all. And any good industry prefers a regulator for two reasons – for bringing in clarity on various complicated issues and controlling unscrupulous elements which would mostly be present at least in small numbers in any indus- try. But many a times their expectations do not match. While one wants more control, the other wishes for more freedom. As a result, they don’t like each other’s actions.

Food Safety and Standards Authority of India (FSSAI) and the NuFFooDS industry had been passing through the phase of similar complex relationship. The industry was dissatisfied about some decisions of FSSAI. One such issue was related to asking the industry to take prior approval for the products and the delays caused for launching products into the market, leading to unspecified losses to the industry.

The industry challenged the FSSAI advisory on the matter in court. The Mumbai High Court decision by majority on the product approval advisory, on June 30, came as a big relief to food business operators (FBOs), as they have been passing through an unclear regulatory process and practices. The Indian food and nutraceutical industry hailed the court order saying that it will boost the industry and will allow manufacturers to launch products without any hassles.

Hailing the decision, George Kuriakose, Vice-President, marketing, Bio-gen Extracts observed that the judgment comes as a huge relief to the nutraceutical industry. The industry can now go about its business without having to worry about impending threat of the Sword of Damocles hanging over its head.

P J Kunjachan, Chairman & Managing Director, Arjuna Natural Extracts opined that court order will mean greater industrial rowth and cumbersome free opera- tions and functioning for manufactur- ers in the nurtaceutical sector. Reacting to the development Bhavlal Borse, Local Business Line Manager, Food & Beverage Industry Performance Mate- rials, DKSH India, said “This is only temporary relief. And I don’t think this is permanent solution.”

One of the impacts of the court order will be “long established products will get a boost and will continue to be available in the country for the benefit of Indian population,” said Sandeep Gupta, Vice-Chairman, Nutraceutical Committee, Indian Drug Manufacturers’ Association (IDMA).|

According to BASF India, clarity and course of action is still missing. The conclusion that can be drawn is that nothing seems to be moving. As product approval and licencing are linked with each other, imports are being withheld and FSSAI’s silence on this matter is adding to the anxiety. There is no fate of pending product approval applications.

K Chandramouli, FSSAI Chairman, clarified on this point recently while inaugurating a conference on Indian Nutra and Health Food Industry organised by PHD Chamber of Commerce in New Delhi. “We have officially yet to receive the order from the court,” said Chandramouli. Responding to queries from the audience, he said if order is confirmed then FSSAI will have to go through regulation route. Every stakeholder will be involved in the process as FSSAI will be inviting suggestions from all stakeholders. There would be a task force of experts looking into them. It would be a transparent procedure. He reminded that even the FSSA Act was being discussed for eight years before it was enacted.

Making his point, Dr Vivek Srivastav, Chief Scientific Offiicer, Zeon Lifescience said “The discontinuing of the product approval system will allow unhindered manufacturing of nutraceuticals, market for which is expected to grow at a compound annual growth rate (CAGR) of 18%. Also, product-wise approval for proprietary food (nutraceuticals) will not be required and now cannot be demanded or enforced.”

“The high court order will encourage the nutraceutical industry as there was delay in the approval process. Regulation process should be much simplified and quick. So this judgement will help the manufacturer to launch the products, observed Dr H N Shivaprasad, Vice-Pres- ident, Research & Technical Affairs, Olive Lifesciences.

The industry, which is against the product approval system, is in favour of novel ingredient approval system. No industry person has a clear picture as how many applications related to product approval are still pending with FSSAI and how many have been cleared. “We were told that more than 25,000 applications are pending with them. This number is speculative as there is no clarity even on this issue,” opined George Kuriakose. While sharing his observations Dr Vivek Srivastav said, “I can just reply God knows! After March, 2013 there was no status update of application received at FSSAI. However, my supposition may put a supple figure of about 2,500 applications.”

However, BASF India says that prod- uct approval should be for Novel food only. In today’s scenario for example, mixing sugar, coffee and milk powder falls under the preview of product approval. None of the ingredients mentioned above are threat to food safety. Therefore, substances added to foods which are not for direct consumption as food, including those “meant for industrial use which is/are not for direct sales to consumers” and ingredients present in Indian market for human consumption from the regime of PFA doesn’t require product approval.
Says George Kuriakose, “We are of the firm belief that ingredient approvals would be the right way to address this issue for all the stakeholders involved. This would facilitate the manufactur- ers as they would have absolute clar- ity on the ingredients to be used and also on the ingredients to be avoided. Above all it would pave the way for an easier and more effective monitoring mechanism for FSSAI. To make the entire process more transparent, the list of approved ingredients could be uploaded on the FSSAI website.”

Sharing the views, Bhavlal Borse said, “It’s important to have ingredient approval than product approval. But at the same time, they must refer CODEX and amend list of approved ingredients, before asking manufacturer or importers to apply for approval of anything and everything.”

Strongly supporting the views of the nutraceutical industry on ingredient approval, Dr H N Shivaprasad said, “FSSAI should consider the ingredient approval. If it is a known ingredient, the procedure should be made simpler. Like other countries, FSSAI also should consider GRAS (Generally Recognized As Safe), well known food ingredients, traditional usage, food usage, process involved etc. in approving the ingredients. This will simplify the procedure and manufacturer will use known and safe in- gredients for their products. If new ingredients need to be approved, it should follow the same regulation as USFDA, new dietary ingredient regulation. Or FSSAI should release the list of pre-approved ingredients based on well-established usage.”

Dr Muhammed Majeed suggested that FSSAI may consider following the best modus operandi implemented globally for ingredient approval rather than just product approval. Echoing similar thoughts George Kuriakose of Bio- gen Extracts said that FSSAI should go in for ingredient approval as is being done in the mature markets and to be in harmony with the rest of the world on this issue. They could consider granting GRAS status for ap- proved ingredients as is being done in the US.

Health or food supplement are meant for human consumption and bring wellness to human health but their safety establishment is utmost important. This is very obvious to say if ingredients are safe and their safety study is well established, the end product will remain safe unless negative interaction of ingredients doesn’t cause adverse effect and likelihood negligible in case of food products. Thus, Dr Vivek Srivastav, observed “it becomes mandatory to predefine the safety of ingredients at pre-clinical, clinical and regulatory point of view. In a nut shell, food regulatory authority should approve ingredient, considering all facets to approve a safety of ingredient and should be ingredient safety approval system.”

Vijay Uttarwar, CEO, Naturell (India), observed “In my opinion product safety is very important at the same time implementation has to be logical and practical. We believe approval of raw material is essential, and if approved raw material is used in the formulation then special approval for the product should not be required.”

However, K Chandramouli, Chairman, FSSAI, had given his opinion on the issue about a year back in the interview given to the first issue of this magazine. “The product approval is for ensuring that products, which are processed, which are newly manufactured, for which there is no history, no standards, they must pass through certain mechanism,” Chandramouli had then said. He had added further, ingredients are common to any product. What makes one product different from other is the additive. Standards were not stand alone. FSSAI was making standards for consumers’ safety since at the end of the day it was the consumer who was important.

Moving away from the fact that FSSAI is in favour of product approval, BASF India says, FSSAI is keen on ingredient approval by pointing out that if we see the draft ‘Frequently Asked Questions’ on product approval issued by the FSSAI it was very clearly mentioned that “If the premix or intermediary products contain ingredients or additives which are not specified or do not have standards in the FSS regulation, these require product approval. Also amount of vitamins and minerals as per Recommended Daily Allowance (RDA) are permissible and all applications with these above RDA will be rejected. These respective statements clearly indicate that FSSAI is in the favour of ingredient approval.

Piyush Rathi, Chief Marketing Officer of Advanced Enzyme Technologies, which has already received two product approvals and awaiting approvals for its eight products, said, “I think both Product Approval and Ingredient Approval are required. FSSAI has already defined the categories under the Indian Food Code. They can use same categories and designate which ones need Product Approval and for which ones Ingredient Approval is sufficient.”

Supporting the view of European Pharmacopoeia, Dr S N Singh, Managing Director, Biovet, noted that India should view the ingredient needed with the quality and formulations with safety, efficacy for man and animals. In today’s world, when everyone are focusing on ‘one health – one world’ concept, it is most important to go to the standard approved by national and international bodies.

“Our Industry needs established regulation and policies inclusive of innovation and not just mere regulations. Human health is the right and moral responsibility under service of healthcare set up and India is striving passionately to be innovative in its care and approach to its population health and safety thereby fostering “Quality of Life”. In this regard government and industry need to devise and evaluate smart regulatory strategies. It should be an inclusive and bottom up journey to build innovative growth strategy for industry. New government is in place and industries have high hopes to revamp the food and nutraceutical industry which is poised to grow and shine on the global map. We must use the inherent talent, resources for development of emerging sector,“ concludes Sandeep Gupta.

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