The story so far: A crisis of confidence assails the Indian spice export industry. At least five countries — including Singapore, Hong Kong and the U.S. — have announced an investigation into possible contamination of spice mixes sold by top Indian brands, MDH and Everest. The complaints cite the presence of ethylene oxide, a toxic chemical used as a food stabiliser, beyond permissible limits. The Spices Board of India in response has initiated mandatory testing of products shipped abroad and is reportedly working with exporters to identify the root cause of contamination. The international scrutiny has also stirred a demand for the Food Safety and Standards Authority of India to ensure stringent quality checks on spices and curry powders sold in domestic markets.

The incident isn’t isolated. Controversies have engulfed protein drinks, fruit juices, health drinks and imported Nestle baby products, drawing attention to regulatory lapses and heightening health concerns. “Consumers are increasingly questioning the safety and quality of trusted brands, and wonder what the food regulator in India is doing,” notes Simi T.B., who works with CUTS International, a global advocacy group for consumer welfare.

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The domino first shook on April 5, when Hong Kong’s Centre for Food Safety suspended the sale of three MDH spice blends (Masala curry powder, Sambhar masala and curry powder masala) and an Everest fish curry masala. The spice mixes contained high levels of ethylene oxide, the regulator said, and advised consumers against purchasing these products. Days later, Singapore ordered a recall of the Everest spice mix, stating: “Ethylene oxide is a pesticide that is not authorised for use in food,” adding that the pesticide makes the spices unfit for human consumption and posing a cancer risk if exposed for too long. 

The U.S. Food and Drug Administration (FDA), which has previously rejected food and spice imports from India, told Reuters that it is “aware of the reports and is gathering additional information about the situation”. 

Regulatory bodies in Maldives, Australia and Bangladesh have announced similar plans. “We are working with international counterparts to understand the issue…and to determine if further action is required in Australia,” said Food Standards Australia New Zealand in a statement. Maldives’s FDA in a statement on X said it has suspended the sale of spices produced by Everest and MDH. Bangladesh is gathering information on companies importing the possibly contaminated products into Bangladesh and plans to carry out examinations “if necessary”, an official told The Business Standard. 

The spice mixes flagged in question are manufactured by Everest and MDH, major players in India’s spice export industry. The top three importers of India’s curry powders and mixtures, in the fiscal year 2022-23, include the U.S. (₹196.2 crore), U.A.E (₹170.6 crore) and U.K. (₹124.9 crore); followed by Saudi Arabia, Australia, Bangladesh, Oman, Canada, Qatar and Nigeria, as per provisional data by the Indian Spices Board. Overall, China, U.S. U.A.E, Bangladesh and Thailand are the top importers of all spcies and spice mixes originating from India.

What are the health concerns?

MDH and Everest’s spice mixes allegedly contain high levels of a prohibited pesticide called ethylene oxide (ETO). ETO is a colourless, flammable, and in many ways, a remarkable gas that was originally intended for sterilising medical devices. It is used as a chemical in industrial settings, agriculture, and as a sterilising agent in food products, including spices, dried vegetables and other commodities. The chemical lends life to the spice industry: it reduces microbial contamination, and in turn, extends products’ shelf life and makes their storage safe.   

This process is not always airtight. The improper and excessive use of ETO may leave behind residues, causing toxic and even carcinogenic compounds to form, thus contaminating the product. One such compound is ethylene glycol, an ingredient found in Indian-made cough syrups which were linked to the deaths of more than 300 children in Cameroon, Gambia, Indonesia and Uzbekistan. Long-term exposure to ethylene oxide is associated with cancers including lymphoma and leukaemia, some evidence shows.

The European Food Safety Authority (EFSA) has banned the use of ETO and earlier flagged ETO contamination in Indian spices. A recent EFSA report also showed carcinogenic chemicals were found in 527 products (including herbs and spices) linked to India between September 2020 and April 2024. Possible reasons for ETO traces found in excess included the use of non-approved pesticides and processing techniques aimed to reduce microbiological contamination. They were “found to lead to not approved residues unsanitary processing techniques (e.g. ethylene oxide in guar gum and curry powder from India)”.  

MDH has called allegations over ETO contamination “baseless and unsubstantiated”. “We reassure our buyers and consumers that we do not use ethylene oxide at any stage of storing, processing, or packing our spices,” the company said in a statement. It added that neither the Spices Board nor the FSSAI have received communication or test reports from Singapore or Hong Kong authorities. 

Have the U.S. authorities rejected Indian spices before?

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How has India responded?

The Spices Board, tasked with developing, promoting and regulating the export of spices and spice products, operates under the Ministry of Commerce and Industry. On April 25 it announced a slew of corrective measures – including initiating mandatory testing of consignments shipped to Singapore and Hong Kong, and gathering technical details and analytical reports from the relevant food and drug agencies. also reportedly working with exporters whose consignments have been recalled getting to the root of the issue and “propose corrective measures”. “Thorough inspections at exporter facilities are also underway to ensure adherence with regulatory standards,” they said.  

A circular dated April 30 contains guidelines to exporters on preventing ETO contamination, prepared “after detailed discussions with the Indian spice industry”. Measures include voluntary testing of ETO during raw and final stages; ETO treated products to be stored separately; to “identify ETO as a hazard and incorporate critical control points in hazard analysis”. Exporters are also “encouraged to use alternate methods” such as steam sterilization or irradiation. The Spices Board issued a similar advisory in September 2021, after the EU flagged the presence of ETO in spices exported from India.  

The public disquiet about safety standards has floated into domestic markets. More than seven in 10 Indians are worried about the quality and safety of the spices they consume, according to a recent Local Circles survey that documented responses from 12,300 people across 293 districts. Almost 36% of them “had no confidence” that the FSSAI had the capacity or willingness to uphold its mandate.

The FSSAI has directed state regulators to collect samples of major spice brands, including MDH and Everest, to test for the presence of ETO. The body also plans to carry out a nationwide surveillance in 2024-25, “for fruit and vegetables, salmonella in fish products, spice and culinary herbs, fortified rice and milk and milk products”, according to a Union Health Ministry statement. The samples tested so far don’t paint a promising picture. In the last three years, nearly one-fourth of samples tested failed regulatory standards, the FSSAI said in its latest release. The body has reportedly tested over four lack samples in the current fiscal year, but the final data is still being collected. 

Activists have called for stringent safety checks of curry powders and spices; to detect and control the use of ETO in food products; and ensure proper implementation of regulatory norms. A recent CUTS report also recommended regularly updating food safety standards to align with global practices, and improving information flow to food industries to that they better comply with regulations.

What does the incident say about food safety in India?

Despite stringent food laws in place, the recent controversies “collectively underscore the persistent nature of food safety challenges across various sectors of the food industry”, notes Ms. Simi.

One challenge is operational: India’s diverse food landscape, the lack of standardised recordkeeping and intentional food fraud may prevent manufacturers from efficiently tracing ingredients and assessing potential risks. Other challenges are operational. “Many companies struggle to trace ingredients, especially raw agricultural commodities, due to the lack of standardised recordkeeping and intentional food fraud. This prevents manufacturers from assessing potential risks, compromising the safety of the entire food supply chain. Traceability is particularly challenging for small and medium sized businesses with limited resources. 

Some are logistic barriers. At least 10 States/Union Territories lack government or private notified food testing labs, as mandated under the FSS Act. These labs are distributed unevenly across regions; have insufficient number of food safety officers; and were found to operate ineffectively due to resource contraints, showed the FSSAI Annual Report of 2021-22. The absent accountability and consequences often mean enforcement agencies fail to penalise unscrupulous food operators, which fuels the issue, experts say. For samples found sub-standard, the maximum penalty is of up to ₹5 lakh. Under Section 59 of the FSS Act, food businesses found guilty of selling, storing or manufacturing sub-standard foods can be penalised with a ₹3 lakh penalty and a three-month jail term. 

FSSAI’s operations often lack transparency, which “hinders efforts to meet safety standards”, build accountability and trust, adds Ms. Simi. The regulator conducted another pan-India testing of spices two years ago, results of which were never put out in the public domain. Surveys that flagged contamination in products like milk and jaggery “have not resulted in positively addressing the rampant practice of adulteration”.

The malodor of mistrust thickens around FSSAI., revealing a growing appetite stricter regulatory measures and transparency in food production and safety industry standards. Ms. Simi adds, “There should be a commitment to proactive monitoring and enforcement, rather than reactive responses to individual incidents.”

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Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.
| Photo Credit: Reuters

The United States Food and Drug Administration (U.S. FDA) has issued a warning letter to Natco Pharma over quality concerns with the drugmaker’s Kothur manufacturing facility near Hyderabad.

The regulator’s action, which follows an inspection and issue of eight observations in October, is unlikely to impact supplies or existing revenues from the facility, Natco said in a filing. However, it added that the move may result in delay or withholding of pending product approvals from the site.

Without detailing the contents of the April 8 warning letter, the company said it would respond within the stipulated timelines and work closely with the FDA to address the concerns in a timely manner so as to ensure sustained compliance. Natco said it also remains committed to being compliant with current good manufacturing practices (CGMP) and ensuring it supplies high-quality products to its customers and patients globally.

In October, the company had said its Kothur manufacturing facility had undergone a routine CGMP inspection from October 9-18 at the end of which the U.S. FDA has issued eight observations. Natco Pharma had said at the time that it was confident of addressing all the observations within the stipulated time and working with the U.S. FDA to close them at the earliest.

The plant produces formulations and makes oral and solid dosages, including dry powder, cytotoxic and noncytotoxic orals and cytotoxic injectables, according to the company’s website.

Representational image only.
| Photo Credit: The Hindu

Biocon Limited on October 18 said the U.S. health regulator has classified as ‘official action indicated’ for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection.

The OAI (Official Action Indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Limited said in a regulatory filing.

“Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Limited, has received a communication from the U.S. Food and Drug Administration (FDA) pursuant to its July 2023 GMP inspection at its insulins manufacturing facility at Johor, Malaysia,” a company spokesperson said in the filing.

The USFDA has “determined the inspection classification as ‘OAI’ (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility”, the spokesperson added.

As per the USFDA, OAI implies that the regulator may withhold approval of any pending product applications or supplements filed from such facility till the outstanding observations related to non-compliance of manufacturing norms laid down by it.

The spokesperson said the company has submitted a comprehensive corrective and Preventive Action (CAPA) plan to the USFDA in response to observations from the July inspection and believe it is on track to complete all actions as committed.

“The company will continue to engage with the agency to understand any outstanding concerns and work closely to address them expeditiously. We do not believe that this will have a material impact on the manufacturing and distribution of the company’s commercial products for the U.S. market,” the spokesperson said.