What the new drug rules mean for quality control in Pharma: From lab to license

Global perception has long viewed India as the “pharmacy of the world”. The upcoming changes in the country’s regulations will reshape the drug manufacturing industry’s entire quality measurement, management, and enforcement lifecycle. In the country, both the new drug policies and the updates to Schedule M’s enforcement by the Central Drugs Standard Control Organization (CDSCO) are the drivers of this change. Furthermore, these policies embody a new era of industry compliance that moves away from mere checking policies towards instilling true quality assurance.

Waves of change for India’s expectations of quality control 

India’s pharmaceutical quality is fragmented without any form of cohesive structure. While larger exporters followed set international standards, many domestic manufacturers operated under vague, flexible guidelines far from adherence to standard industry norms. The new drug policies are crafted with the intention of clarifying durable guidelines pertaining to quality, safety, and overall efficacy. Moreover, the updated Schedule M incorporates and standardises Indian ancillary systems to global benchmarks, World Health Organization’s Good Manufacturing Practices (WHO-GMP) and FDA regulations and standards.

Quality control had formerly been regarded as the last line of defence, but the current structure has placed it at the core centre. Quality control now possesses distinct boundaries and functional tasks within the new frame. It is bound to a separate entity as a defined autonomous process with specific roles and responsibilities.

A new era of quality expectations

India’s pharmaceutical quality control, as is well known, operated historically under a broken regulatory framework. While large exporters followed international standards, countless domestic manufacturers operated under loose and flexible norms. Attempting to fix this, the new drug rules issued better-defined specifications regarding expectations for quality, safety, and efficacy. Revised Schedule M brings Indian practices into alignment with international benchmarks, including the World Health Organization’s Good Manufacturing Practices and standards of the United States Food and Drug Administration.

What sets this framework apart from others is that it is more descriptive in nature. The final step in the process no longer need to be quality control. It is now an active, autonomous service with defined processes, responsibilities, and hierarchy at the headquarters. This indicates the attempt of India not only to safeguard domestic health outcomes, but also to enhance its image globally as a dependable pharmaceutical provider.

Autonomy and infrastructure in quality control

Possibly the most remarkable modification is the newly defined mandate for an independent Quality Control (QC) department. Under the new regulations, QC must operate independently from production to mitigate any potential conflicts of interest. Previously, overlapping roles meant that stringent quality controls were often lost amid production pressures.

The revised rules also mandate specific infrastructure upgrades. Facilities must now include designated zones for microbiological testing, chemical analysis, and product stability monitoring. These spaces should prevent cross-contamination through controlled workflows, ventilation systems, and validated cleaning procedures. Such provisions ensure that testing environments remain uncompromised, supporting more accurate and reliable outcomes.

Emphasis on digital systems and data integrity

Another major focus of the new rules is on digital compliance. Manufacturers are now required to utilise verified electronic systems that include functionalities like audit trails, safe login access, and dependable data backup procedures. Such initiatives enhance transparency and traceability, simplifying the process for regulators to examine each phase of a drug’s progression.

Audit trails allow tracking of every modification to test data, thereby discouraging falsification or errors. Backup systems ensure records are protected and retrievable, even during technical failures. Additionally, all analytical methods and equipment used must be validated, reinforcing that quality control must be based on verified, reproducible science rather than assumptions.

Skilling the quality workforce

No regulatory reform can succeed without skilled personnel. The new drug rules place strong emphasis on building human capital in pharmaceutical quality control. Organizations are expected to employ staff with expertise in specialised areas such as microbiology, radioisotope testing, and analytical method validation.

In addition to routine quality checks, teams are now responsible for tasks such as Annual Product Quality Reviews and climate-based stability studies. This expands their role from operational support to strategic oversight. To meet these requirements, companies will need to invest in training, cross-functional learning, and partnerships with research institutions. A skilled and continuously updated workforce is vital for long-term regulatory compliance and scientific excellence.

Implications for domestic and global markets

While these rules introduce stricter expectations, they also open new opportunities. For companies that want to grow internationally, compliance with international quality standards provides a competitive advantage. The Indian Pharmaceutical Alliance has indicated that over 60 per cent of India’s pharmaceutical exports go to a highly regulated market, such as the: United States, European Union, and Japan.

Domestically, the reforms promise to boost consumer confidence. Instances of spurious or substandard drugs have occasionally marred public trust. A culture rooted in quality control can help rebuild that trust by ensuring that medicines are safe, effective, and reliable regardless of where they are manufactured or consumed.

As per data from the Press Information Bureau, India exported pharmaceuticals worth over 25 billion US dollars in the financial year 2023 to 2024. Enhanced quality frameworks can help grow this figure, making India not just the largest supplier by volume, but also among the most trusted globally.

Preparing for the transition

These policies will not get implemented without challenges. Small and medium-sized pharmaceutical companies, especially when they are supporting specifically local markets, may find significant challenges associated with their ability to fund the cost and complexities of upgrading new systems and training personnel to do it. However, this also presents a chance for collective solutions such as shared testing infrastructure, third-party quality service providers, and government-supported training programs. Public and private sector collaboration will be key to making quality accessible across the board.

The revised drug rules and Schedule M enforcement mark a significant evolution in India’s pharmaceutical regulation. This is more than an exercise in compliance; it is a roadmap to position India as a global leader in quality as well as volume. By prioritising integrity, infrastructure, digital systems, and skilled talent, the new framework ensures that every medicine produced is backed by science, scrutiny, and trust.

For stakeholders across the industry, the message is clear: the future of pharmaceutical excellence will not be inspected at the end. It must be designed, validated, and built in from the very beginning.