Ensuring the safety and quality of food and pharmaceuticals is vital to public health. In 2023, 15% of food samples tested by FSSAI failed safety standards, highlighting the need for rigorous testing. Similarly, concerns like nitrosamine impurities and global recalls underscore the growing importance of regulatory compliance in the pharmaceutical sector. In an exclusive conversation, Dr. Saurabh Arora, Managing Director of Auriga Research, speaks with Dr. Asawari Savant from Elets News Network (ENN), to shed light on how India’s food and pharmaceutical safety landscape has evolved, the trends shaping this critical sector, and the pivotal role of testing labs like Auriga in ensuring consumer safety and trust. 

Auriga Research has over 30 years of experience in testing and product safety. How have you seen the landscape of food and pharmaceutical safety evolve in India, and what trends are currently shaping this sector?

In both food and pharmaceuticals, the entire regulatory framework has transformed. Initially, it was less stringent to enable the industry to grow and make the country self-sufficient in both sectors, transitioning us from an importer to a net exporter of these products. This meant that earlier, the Prevention of Food Adulteration Act was more focused on ensuring basic quality and preventing adulteration. However, now the Food Safety and Standards Act focuses on complete food safety regulations, including pesticides, heavy metals, microbiological concerns, and system-related aspects for the processing industry. Similarly, the Indian Pharmacopeia, which initially had very basic quality requirements, enabled the Indian pharmaceutical industry to grow rapidly and meet both domestic and global market demand.

Now, the Indian Pharmacopeia has transitioned to being on par with the British or United States Pharmacopeia, and the regulations are nearly at the same level. What we are seeing now in these sectors is an overall move towards harmonizing standards, so that the same quality and product are available in India, and our products can be easily exported and accepted by importing countries, as the same standards apply here and abroad.

With increasing demand for transparency and safety in pharmaceuticals and food products, what are some of the key testing practices that Auriga Research prioritizes to ensure high-quality and safe products for consumers?

We, as third-party labs, are at the forefront of any new regulations or demands. We can put in the capital expenditure and have the expertise to quickly establish new tests and facilities to meet upcoming regulations. This has been true over the decades. For example, in the early 2000s, the issue of heavy metals devastated the Nutra and Ayurvedic industry exports. Later, testing labs geared up to support the testing and export of grapes and other agricultural commodities. In the pharmaceutical sector, labs like ours have been at the forefront of establishing testing for nitrosamines and genotoxic impurities, helping the industry comply with these regulations. So, we are always on the lookout and working closely with the industry to establish new methods and regulations that challenge the industry, enabling the production and innovation of high-quality products.

How does Auriga Research support the healthcare industry, particularly in ensuring that pharmaceutical products meet regulatory standards and quality benchmarks?

Ensuring the safety and quality of pharmaceutical products is at the core of our services at Auriga. We work with the industry throughout the entire lifecycle, starting with R&D and product development. This includes testing ingredients, sourcing, and setting up new ingredients for R&D batches, pilot-scale batches, and technology transfer to manufacturing sites. We perform process validation studies, and area monitoring, and ensure the facilities are ready with water system validation and process validation. We also handle stability studies for products and release testing for APIs and drug products.

In addition to manufacturing, we work with procurement side organizations, such as government hospitals and agencies, to test the products they are purchasing to ensure they meet agreed quality standards. We also assist importers with pre-shipment inspection to ensure products meet the required standards before being shipped. This entire range of services helps ensure that product quality is up to the mark.

As a NABL-accredited lab, what role does Auriga Research play in supporting compliance with Indian and international safety standards for sectors like food, cosmetics, and environmental safety?

Through our NABL-accredited testing, inspection, and certification services, we ensure that products meet safety, quality, and functional tests for every product. For food products, we test for microbiological safety, the absence of pesticides, heavy metals, and naturally occurring toxins, ensuring the food is safe for consumption. In cosmetics, we test for BIS standards, and global standards, and check for microbiology, heavy metals, and other safety concerns. We also have dedicated facilities for testing environmental samples like water, wastewater, soil, and stack emissions.

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Given the rapid growth in sectors like herbal and nutraceutical products, what unique challenges and testing protocols does Auriga employ to ensure the safety and efficacy of these products?

Nutra and herbal products are challenging from a quality testing perspective. While safety testing for heavy metals, pesticides, microbiological pathogens, and other toxins is relatively well-defined, the challenge lies in quantifying and identifying the large number of ingredients in these products. We use techniques like chromatographic fingerprinting to ensure all claimed actives are present at the proper levels. We also quantify marker compounds in nutraceuticals and herbal products, ensuring the identity, purity, and efficacy of ingredients.

Environmental safety has become increasingly important, especially with its link to public health. How is Auriga Research adapting to this trend, and what kind of testing services do you provide to address environmental health concerns?

We are seeing increased concern regarding environmental safety. Three years ago, we acquired Alcatec Research Laboratory, which specialises in environmental testing and is approved by the Ministry of Environment and Forest. This acquisition allowed us to expand our service portfolio. We now provide testing for water, wastewater, soil samples, sludge, solid waste, stack emissions, air quality, and indoor air quality. We are supporting industries in their environmental safety efforts, as government regulations and industry awareness drive the demand for these services.

With heightened scrutiny on quality assurance, how does Auriga Research integrate advanced technologies and state-of-the-art infrastructure to provide accurate and reliable testing results across industries?

At Auriga, we prioritize innovation and the production of safe and efficacious products using skilled personnel and state-of-the-art infrastructure. We continually invest in new technology and infrastructure to ensure that we offer the most accurate and reliable testing. Recently, we doubled our capacities at our Baddi, Himachal Pradesh lab to meet increasing pharmaceutical testing demands. We have also added mass spectrometers to test for nitrosamines and genotoxic impurities. As new regulations emerge, we continue to invest in equipment and staff to ensure that we can help the industry comply.

As consumers become more health-conscious, how is Auriga Research responding to the demand for transparency in labelling and product content, especially in food and pharmaceutical testing?

As consumers become more health-conscious, labelling has gained importance. While pharmaceutical labelling has been consistent for years, food labelling has been evolving rapidly with new regulations. We offer testing to substantiate claims on labels, including nutritional profiles, and claims like vegan, GMO-free, preservative-free, and chemical-free. Additionally, we conduct clinical trials to substantiate claims like “joint health” benefits, providing evidence-based data to support these claims.

How do you see emerging global regulatory standards impacting the Indian market, and what role does Auriga Research play in helping local businesses meet these international benchmarks?

There is a trend toward harmonization with global standards, such as residue limits for veterinary drugs and the Indian Pharmacopeia aligning with USP and BP. As global standards evolve, new regulations and requirements emerge, and we are at the forefront, ensuring we invest in the equipment and methods to offer these services. By doing so, we help the Indian industry meet international benchmarks and maintain global competitiveness.

Looking to the future, what innovations or advancements do you anticipate in the product testing and safety sector, and how is Auriga Research preparing to lead or adapt to these changes?

We anticipate more harmonization and stringent standards in the future, with increased demand for testing as manufacturing in India grows. Consumer awareness will drive further transformation in the industry and accelerate demand for quality testing. To adapt to these changes, we are enhancing our capabilities, adding new labs and facilities, and integrating automation and AI into our processes to improve planning, predictions, and customer service.

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