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Nutraceuticals under drug regulation more beneficial; recommendations lack important aspects: Experts
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Gireesh Babu, New Delhi
November 18 , 2024
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Bringing in nutraceuticals under the purview of the drug regulator in the country would be beneficial to both the industry and the consumers, say experts.
Commenting on the recommendations by the eight-member inter-ministerial committee to review the regulatory purview of nutraceuticals, they said that the recommendations missed important aspects of coordination between the regulatory bodies and creation of awareness among the doctors and consumers.
Sumant Kumar Tiwari, joint director of the Jharkhand Drug Control Administration said that bringing in nutraceuticals under the drug regulation would help the segment to be covered under the insurance claims. At present, the insurance companies do not cover the claims on purchase of nutritional supplements or nutraceuticals since they are under the FSSAI license. If the nutrition comes under the therapeutic category, nutraceuticals will fall under the drugs category, and the chances are the insurance companies may reimburse the claims, which will be beneficial for both the manufacturers and consumers.
This is especially relevant considering the insurance penetration has gone up significantly through government schemes under Ayushman Bharat. India is expected to see the insurance penetration in the country going up in a decade. Insurance reimbursement for these products would be a huge support for the pharma sector, he added.
"Most of the nutraceutical companies are also pharma companies, so they have a larger advantage in this situation. People should also get the benefit of the price control, since the Central and the state governments are paying the premium for insurance. In larger perspective the industry should fall in line with the regulations and the government should also take steps to bring the nutraceuticals under the purview of drugs," said Tiwari.
Professor Bejon Kumar Misra, the founder of Patient Safety and Access Initiative of India Foundation (PSAIIF) and a member of the executive committee of the General Insurance Council, nominated by IRDAI, agreeing to the point, added that the need of the hour is that insurance companies should cover preventive healthcare and should have products which cover over-the-counter (OTC) products for healthcare and safety.
Commenting on the committee report, he said that the recommendation should have clearly stated that all the three regulators - FSSAI, CDSCO, and the Ministry of Ayush - should meet together once a month to discuss how they are approving which product.
"Health and safety of the citizens is paramount. In order to assure that, all the three regulators should be able to work together in a very transparent manner to ensure that all products which are brought into the marketplace does not compromise on the health and safety of the citizens," he opined. "There should be an umbrella body, which meets every month, exchanging notes on what each regulator has done. It is not a big rocket science," he added.
Creating awareness among the consumers and the doctors regarding nutraceuticals and health supplements is another aspect that is not mentioned in the recommendations.
"None of the members in the inter-ministerial committee, in their recommendations, have written about consumer awareness and education and its importance. Nowhere have they written that there should be a large amount of communication being given to the medical professionals, consumers, and retailers. All the stakeholders should be made aware," he added.
Today the consumer does not know which is a drug and which is a food. They are all packed in similar ways and even food has started coming in pills and capsules and liquid form. For a consumer, it all looks the same. The consumer is only relying on the prescription of the doctor, and the doctor is nowhere in the picture at present.
The medical practitioners regardless of the system of medicine, should be able to understand the standards and the implication on the health and safety of the consumer. If the regulator is developing some standards, that should get translated into simple, easy-to-understand language. Then only the consumer will be able to differentiate. Besides, even nutraceuticals - if they are used irrationally - can harm the health and safety of the consumer.
When it comes to the recommendations related to advertisements, the regulators are not even implementing what is already there in the law and just a recommendation for another body to monitor advertisements related to nutraceutical claims will only complicate things. The committee also failed to put punishment or penalty in place. If anybody violates the norms and standards, there should be serious deterrent action against them under the law.
An inter-ministerial committee formed by the Union health ministry has recommended amendments to the Food Safety and Standards Act, 2006 and regulations on nutraceuticals and health supplements, to shift regulation of certain items to the drug regulatory authority and bring in standards including the Good Manufacturing Practices (GMP) for health supplements and nutraceuticals.
The committee, formed earlier this year under the chairmanship of the then health secretary Apurva Chandra to look into the regulatory purview of nutraceuticals in the country, recommended that in terms vitamins, minerals and amino acid supplements, the mere combination including single use of nutrients specified in Schedule-I of Nutra regulation may not be regulated by Food Safety & Standards Authority of India (FSSAI).
Vitamin, minerals and amino acids added in food (as defined in the FSS Act 2006) (containing macronutrients such as protein, carbohydrate and fat providing significant calories), may be retained under the purview of FSSAI, but the formulations having vitamins, minerals and amino acids with dose and/or dosage formats and permitted excipients as defined in rule D&C Act shall be shifted under the purview of Central Drugs Standard Control Organisation (CDSCO), it recommended.
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