India has transitioned from being dependent on pharmaceutical imports to being the “pharmacy of the world” in the last few decades. Although manufacturing capabilities and R&D achievements draw the most attention, the unsung hero behind the industry’s credibility and safety is the independent, NABL-accredited laboratories. These labs have assisted drug manufacturers in conforming production to local and international standards and have become critical partners for regulators to guarantee that public health is prioritised.

The Evolution of a Shared Ecosystem: From Regulation to Collaboration 

India’s pharmaceutical history has been uniquely influenced by its flexible regulatory approaches. Governing authority began with the establishment of the Indian Pharmacopoeia, which was created to set local drug standards as opposed to demanding adherence to strict, globally recognised standards, which could hinder growth. Importantly, in the Act that governed the establishment of the Drugs and Cosmetics Act, there were provisions whereby private laboratories were allowed to be designated as publicly certified testing laboratories for the pharmaceutical industry.

This foresight resulted in a co-regulatory model whereby every manufacturer did not need to invest in expensive in-house quality control capabilities and could rely on third-party laboratories for key tests. This meant small and medium-sized manufacturers could enter the ecosystem without the burden of incurring the massive cost of building a fully functional laboratory. In several cases, the capitalisation to build sophisticated testing capabilities (often including metal analysis tested with an ICP by mass spectrometry) could be more expensive than purchasing an entire manufacturing facility. Instead, these labs were able to share their use of solely accredited labs. This was taken into consideration, and there was still able to operate and do well by enabling full compliance with safety standards.

Infrastructure, Innovation, and Immediate Response

The pharmaceutical sector is subject to rapidly evolving standards, particularly in the areas of residual solvents, nitrosamine impurities, and genotoxic contaminants. Independent laboratories, however, have acted as first responders to those changes, often adapting faster than manufacturers on their own. Independent labs can act quickly to incorporate new testing protocols and approaches, ensuring that the pharmaceutical sector is compliant with little interruption to production timelines.

In addition to compliance, a robust testing infrastructure fundamentally strengthens factors influencing brand reputation. Testing certifications from NABL-accredited labs act as essential quality standards for regulators, procurement organisations and consumers alike for products that cross borders between geographies and reach global markets. Both importers and international agencies get assurance from the testing languages to maintain India’s reputation as a source of safe and effective drugs.

The laboratories also add to domestic safety net mechanisms. Many government procurement agencies that do not have any in-house testing will depend solely on third-party labs to confirm the quality of medicines they will distribute. Thus, independent labs are not only partners to manufacturers. They are also enablers of public health assurance. 

Capacity Building and Knowledge Hubs for the Industry

Another neglected but important role of testing labs is the education of talent. Independent testing laboratories act as entry points for many quality assurance and quality control professionals who are early in their careers. The variety of instruments, methods, and pharmaceutical products they are exposed to while working with testing clubs forms an agile, seasoned workforce. Many of these individuals have gone on to lead quality organisations in large pharmaceutical organisations based on the rigour and standards taught in independent testing labs.

Furthermore, they evolve into knowledge centres for collective experience from working with multiple formulation, regulatory or analytical considerations. They often play a role as consultants that extend beyond routine testing to help manufacturers fix complex quality problems, validate new processes, or comply with continually evolving international standards. Their technical capacity, with a foundation in hands-on operations, provides manufacturers with a partner they can rely upon to sustain excellence in drug production.

Read more: Govt Funds ₹330 Cr AI-Healthcare CoE by IIT Delhi & AIIMS Under ‘Make AI Work for India’ Initiative

Recognising the Unseen Pillars of Drug Safety

In India’s pharmaceutical industry, independent testing laboratories are often the hidden backbone of compliance and innovation. They have built an ecosystem with manufacturers and regulators via collaborative frameworks, which have leveraged capital requirements while maximising safety and quality assurance.

They have a multi-faceted impact. They provide leading-edge infrastructure, develop a talented labour pool, speed up response to changing regulations, and maintain the standards that preserve brand trust globally. As India rises as a global pharmaceutical force, the roles of these non-recognised players should not be seen as ancillary to drug safety and trust in the public, but rather as an integral part of it.

Views expressed by: Dr. Saurabh Arora, Managing Director, Auriga 

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