2026-03-05

Sunil Dubey, Managing Director, SOTAX India, in an interview with Pharma Industrial India, highlighted the company’s initiatives in India, including affordable quality machinery for small manufacturers, advanced R&D support for complex formulations and adoption of AI-driven automation to ensure safer and more reliable drug testing and compliance.

Q. Give us a brief about SOTAX.

Sunil Dubey: SOTAX is a wholly owned subsidiary of SOTAX Age from Basel, Switzerland. We are into tablet testing solutions, especially manufacturing entities like tablet dissolution testers, hardness testers and physical instruments.

Q. What are the new products that you have introduced this year at CPHI India 2025?

Sunil Dubey: As part of our initiatives, we have been strongly focusing on the Made in India vision over the past two years. This year, we launched a 14-station comparative dissolution system designed to support comparative dissolution studies, where innovator and generic tablets are evaluated side by side.

Given that India is predominantly a generic pharmaceutical market, such comparisons are critical during product development to ensure equivalence with innovator products. Our system, developed and deployed at SDTL and branded as SDTL, enables efficient and reliable comparative studies, helping manufacturers strengthen their development and quality evaluation processes.

Given that India is predominantly a generic pharmaceutical market, such comparisons are critical during product development to ensure equivalence with innovator products. Our system, developed and deployed at SDTL and branded as SDTL, enables efficient and reliable comparative studies, helping manufacturers strengthen their development and quality evaluation processes.

Q. Apart from that, what other USPs would you like to highlight compared to your other competitors?

Sunil Dubey: SOTAX is unique in its nature, because we are not only manufacturing, but we are also pharma services, where we basically help the customers in their method development as well. Usually, if you are a manufacturing company, you focus on instrument and machinery manufacturing. 

However, we have taken a step forward. We are not just manufacturing, but also helping in product development and technology transfers to our customers.

Q. Recently, we heard about reports on contamination, though there is a different case of component contamination. Can you just highlight, what are the common factors that are leading to contamination in India?

Sunil Dubey: The biggest challenge we see is the lack of awareness among small manufacturers. That was the core vision behind starting manufacturing in India—to ensure that smaller players have access to high-quality instruments and machinery.

In the absence of reliable quality equipment, testing is often overlooked or avoided. When testing is compromised, manufacturers have no clear visibility into whether the products being released into the market are truly effective or even meeting the required specifications. Our aim is to bridge this gap by enabling better quality practices through accessible, reliable technology.

We support these manufacturers by providing quality machines at highly affordable prices. Beyond this, we actively collaborate with the Central Drugs Standard Control Organisation (CDSCO) to conduct training programmes and pharma workshops aimed at building awareness around product testing, quality standards and GMP requirements. These sessions also educate manufacturers on how different types of machinery—not just SOTAX equipment, but industry-wide technologies—are used for various testing needs.

This holistic approach helps ensure that the products reaching the market, and ultimately patients, are safe, reliable and compliant with quality standards.

Q. So, are there any plans to venture into other segments as well?

Sunil Dubey: We also offer solutions for ophthalmic and topical formulations, with a strong specialisation in R&D services for non-oral, complex dosage forms. Our focus is on supporting biologics companies and non-OSD facilities in the development of advanced and complex formulations.

For instance, with the rise of personalised medicines—such as drug-loaded patches and implantable medical devices—there is a critical need to closely monitor how these complex dosage forms release or elute the drug over time. We help ensure that the rate of drug release aligns with the intended formulation design.

Through this expertise in non-oral and advanced dosage forms, we support innovation-driven development and contribute to India’s growing role as an emerging hub for pharmaceutical innovation.

Q. So, what role can your company play in this?

Sunil Dubey: We are dedicated to support all these new complex manufacturers, or biologics, with the type of technology they will require for the development of the product, for their innovation, not only with the technology, but with the know-how as well. That’s because we have a knowledge base and experience in doing this. So, we will provide the know-how as well to our customers.

Q. In the next few years, what new trends are you expecting to see?

Sunil Dubey: What we are clearly seeing now is a growing shift towards digital solutions across the industry. With AI becoming a major focus, companies are moving towards reduced physical testing and increased reliance on predictive models. The emphasis is on systems that can perform in line with these predictions, with results closely matching what customers anticipate through advanced analytical tools.

In parallel, AI-driven automation is emerging as a key industry trend. Like the rest of the sector, we are actively aligning our technologies and systems to be compatible with these advancements, ensuring we remain future-ready as digitalisation continues to reshape pharmaceutical development and testing.

Q. So, how is SOTAX adopting to that?

Sunil Dubey: SOTAX is one of the leaders in laboratory automation, with a dedicated automation arm focused on enabling the unattended operation of testing equipment with minimal to no human intervention. This capability has become a critical requirement, especially for complex formulations and products developed for oncology or other high-potency therapies.

By eliminating direct human involvement during testing, automation significantly reduces the risk of contamination, exposure, or variability, ensuring safer handling of sensitive drugs and more reliable results. This approach not only enhances product integrity, but also aligns with the industry’s growing emphasis on safety, precision and compliance.

In such cases, advanced technologies are essential, and this is where we bring our core expertise and focus.

Q. In the recent cough syrup contamination cases, where do you think the testing gaps may have occurred?

Sunil Dubey: I believe this happened due to a clear lack of testing and insufficient awareness of the importance of compliance and GLP practices in laboratories. Had these standards been properly followed, such a tragic situation—where so many children lost their lives—could have been avoided. It appears that while manufacturing may have been completed, adequate testing was either insufficient or not carried out at all. Otherwise, we could have immediately recognised that this is not ethylene glycol. This is something else. Some people skip that part.

Q. Don’t you think that there should be a regulation policy?

Sunil Dubey: The CDSCO is forcing everyone to adopt the policies. But then, you know, the competitions are also rising. The product pricings are basically getting affected. So, people also have to ensure they safeguard their margins. So, in that sense, all these business-minded manufacturers, they try to avoid some important activities and create this mess in the end.