Voices from the Industry: Challenges MSMEs Face in Meeting Schedule M Standards

Voices from the Industry: Challenges MSMEs Face in Meeting Schedule M Standards

India’s pharmaceutical industry has long been a cornerstone of global healthcare, and its MSME (Micro, Small, and Medium Enterprise) sector plays a critical role in this success. These small-scale manufacturers are responsible for a significant portion of the country’s drug production, especially affordable generic medicines. However, with the government’s move to align domestic standards with global best practices, MSME pharma companies now face the pressing challenge of complying with the revised Schedule M standards under the Drugs and Cosmetics Act. In this blog, we explore the unique challenges faced by MSMEs in achieving compliance and highlight the voices from the industry as they navigate these regulatory shifts.

What is Schedule M?

Schedule M outlines the Good Manufacturing Practices (GMP) required for the pharmaceutical manufacturing process. Its aim is to ensure product quality, safety, and efficacy. Recent revisions to Schedule M aim to bring India’s standards closer to those set by the World Health Organization (WHO), enabling Indian companies to compete more effectively in global markets. However, for smaller players in the industry, achieving compliance is not without its challenges.

Key Challenges Faced by MSME Pharma Companies

1. Financial Constraints

One of the most significant barriers for MSMEs is the high cost of upgrading facilities to meet the revised GMP standards. From infrastructure improvements to advanced equipment, the financial burden can be overwhelming for small companies operating on limited margins.
Industry Voice:
“Many of us lack the capital to implement the necessary changes. Without financial support or subsidies, compliance feels like an uphill battle,” says a spokesperson from an MSME association.

2. Technical Expertise

MSMEs often lack access to the technical expertise required to interpret and implement Schedule M regulations effectively. This knowledge gap can lead to delays and mistakes, further complicating the compliance process.
Industry Voice:
“Large companies have entire teams dedicated to regulatory affairs. For MSMEs, it’s often just one person juggling multiple roles,” notes an owner of a small-scale pharma unit.

3. Infrastructural Challenges

Many MSMEs operate from older facilities that are not designed to meet modern GMP requirements. Retrofitting these buildings to comply with the revised standards is both time-consuming and expensive.
Industry Voice:
“Our facilities were built decades ago. Bringing them up to current standards requires a complete overhaul, which is simply not feasible for many small players,” laments a factory manager from Gujarat.

4. Shortage of Skilled Labor

Compliance with Schedule M involves not just physical upgrades but also significant changes in operational procedures. Training existing staff or hiring skilled professionals poses another challenge for MSMEs.
Industry Voice:
“It’s difficult to find trained personnel in smaller towns where most MSMEs are located. Retaining skilled labor is an added challenge,” shares an HR manager of a medium-sized pharma company.

5. Regulatory Ambiguity

While the guidelines are well-intentioned, MSMEs often struggle with unclear or inconsistent communication from regulatory authorities. This creates confusion and delays in compliance efforts.
Industry Voice:
“Timely guidance from authorities would go a long way in helping us meet the standards,” suggests a consultant working with several MSME pharma companies.

Government Support: A Ray of Hope

Recognizing these challenges, the Indian government has extended the deadline for Schedule M compliance for MSMEs to December 31, 2025. Additionally, MSMEs are required to register with the Central Drugs Standard Control Organization (CDSCO) and submit upgrade plans to access this extension.

While this is a welcome move, industry stakeholders believe that further measures are necessary, such as:

• Subsidies or financial incentives for facility upgrades.

• Technical training programs for MSME staff.

• Simplified guidelines and better communication from regulatory bodies.

The Way Forward

Despite the challenges, many MSME pharma companies view the Schedule M compliance push as an opportunity to modernize their operations and improve their competitiveness in both domestic and international markets. By investing in upgrades and fostering collaboration between industry stakeholders and the government, these companies can overcome barriers and emerge stronger. As one optimistic industry leader put it: “This is a challenging time, but it’s also a transformative one. With the right support, MSMEs can rise to the occasion and contribute even more significantly to India’s pharmaceutical success story.”

Do you think MSME pharma companies are equipped to meet these challenges, or does the government need to step in further? Share your thoughts in the comments below!