Plan to regulate nutraceutical industry in the works

The paper is being drafted by the Food Safety and Standards Authority of India (FSSAI) in collaboration with key stakeholders such as the drugs regulator Drugs Controller General of India (DCGI), leaders from the nutraceutical industry, and health ministry officials, the people cited above said on condition of anonymity. Once the draft is ready, it will be presented before the Union health ministry in a few months.

The move follows rising complaints from consumers as well as state and Union territory (UT) administrations against the quality of nutraceuticals being sold in India, and surveillance drives carried out by FSSAI that unearthed several instances of dubious practices.

Read This: Amid global concerns over India-made drugs, Govt plans an exports revamp

The draft paper seeks to define which category of nutraceuticals or health supplements would be regulated by FSSAI, and which ones by DCGI, the people added.

As part of the plan, nutritional supplements (hybrid of nutrition and pharmaceuticals) such as vitamin D, minerals, calcium, glucosamine, and amino acids will be considered drugs and be regulated by the DCGI. 

On the other hand, supplements derived from plant and animal-based sources such as herbal immunity booster paste chyawanprash, curcumin derived from turmeric, fatty acids, and omega-3 from fish oil, among others, will fall under the regulatory ambit of FSSAI.

The development assumes significance in light of companies selling products with pharmaceuticals formulation as nutraceuticals, after failing to get the nod from the drugs regulator. 

FSSAI's estimates put the market size of nutraceuticals at around $4 billion and growing at about 25% annually, making it a lucrative market.

Queries sent to the health ministry spokesperson remained unanswered till press time.

The roundabout way to nutraceuticals

"Products that claim disease risk reduction should be categorized under drugs, as food products should not have complexity and have proper labelling," said the second person cited above.

The third person said that nutraceuticals act as prophylactic (preventive) while pharmaceutical drugs act as therapeutic (cure of disease). "Right now, both FSSAI and drug regulator can give approvals to companies for nutraceutical products. So, most companies are taking permission as nutraceutical even though the product contains pharmaceutical formulations. They are not adding the required food substances such as wheat or rice or whey protein into the nutraceutical product," the third person said.

Good manufacturing practices (GMP) are very stringent for drugs compared to nutraceuticals. “Both drug and food regulator can give marketing licence to the companies, so these manufacturers seek permission from any one of us. So, when the drug regulator does not give permission to them considering strong GMP, these companies come for approval to FSSAI," the third person added

Therefore, the central government has constituted a high-level committee to examine the overlapping of nutraceuticals and drugs, to examine the GMP provisions, to examine the issue of spurious and substandard products etc.

The committee, chaired by health secretary Apurva Chandra, comprises members from various government departments including departments of pharmaceuticals, AYUSH, and food processing, DCGI, Directorate General of Health Services (DGHS), and industry stakeholders.

“The committee is still reviewing the issue and it is in preliminarily stage of consultation," said the second person.

After the committee’s inputs are received and incorporated, FSSAI will issue a draft notification and float the paper in public for feedback. 

To be sure, doctors suggest that health supplements should not be taken without medical supervision as they can cause more harm than good.

“Vitamin D, particularly, manufactured by pharma companies, is a pharmaceutical formulation. If consumed unsupervised, it can cause kidney failure and liver damage," said Dr Atul Gogia, senior consultant, internal medicine at Sir Ganga Ram Hospital in New Delhi. "Nowadays, youth are more attracted towards muscular body and gym, and they take protein supplements without any medical guidance, which is very harmful. We see a few patients who come to us with kidney failure and their history reveals consumption of nutraceuticals or health supplements."

Illegal activities 

Last year, FSSAI directed state and UT administrations to carry out a special enforcement drive to check the quality and safety of nutraceuticals or health supplement products within their jurisdictions, after receiving information and complaints about such products being sold in the market not conforming to the standards laid out by the food regulator. 

Also This | In a pickle: Why it’s time for Fssai to wake up and crack the whip

The authority also stated these products were marketed with false or misleading and exaggerated health claims or labels in contravention of the provisions of FSS (Advertisement & Claims) regulations, 2018.

“It seems problematic that certain companies are consistently violating safety standards, particularly in the nutraceutical sector," Sanjaya Mariwala, executive chairman and managing director of nutraceuticals company OmniActive Health Technologies, and president of the Association of Herbal and Nutraceutical Manufacturers of India said. “Some of these companies may be importing or selling products that are not considered safe. They could be marketing pharmaceuticals as nutraceuticals, which contributes to this issue."

At the same time, Mariwala suggested that only a small fraction of the industry may be responsible for these violations. "We need to focus on these companies and encourage them to change their behaviour for the benefit of consumers and industry at large," he said.

“FSSAI receives complaints from multiple channels such as consumers, food safety officers who conduct regular surveillance activities in the states/UTs and social media platform," one of the people cited earlier said. "It also verifies the reports of agencies like the National Anti-Doping Agency who pick up samples from the market for their own research." 

During a surveillance activity conducted between January 2023 and May 2024, around 402 samples were lifted, out of which reports of 382 samples were received by the authority. About 172 of these were found to be not conforming to the standards. Twenty-one companies were issued show cause notice, and 39 were given improvement notice. 

Also Read | India has one of the most stringent standards of maximum residue limits in the world: FSSAI

At the same time, another 53 samples were found sub-standard or misbranded, and prosecution was filed against four companies for selling unsafe nutraceuticals.

“FSSAI did a joint inspection along with state authorities based on a tipoff about illegal activities being done in Himachal Pradesh (Baddi), Haryana and Uttarakhand," the second person cited earlier said, adding that the surveillance drive is still ongoing. One firm was found to be manufacturing drugs and nutraceutical items in the same premises. Another firm with nutraceutical licence was manufacturing spurious drugs. 

North India is the manufacturing hub of nutraceuticals, especially states such as Himachal Pradesh, Haryana, Uttarakhand, and Uttar Pradesh.