In a significant move aimed at empowering Micro, Small, and Medium Enterprises (MSMEs) in the pharma sector, the All-India Pharmaceutical Associations Consortium (AIPAC) has launched a series of initiatives focused on skill development and compliance with revised Schedule M guidelines.
These efforts are expected to transform the landscape of Indian pharma industry, which is heavily reliant on MSMEs for the production of high-quality and affordable medicines.
MSMEs often face financial and infrastructural limitations that hinder compliance and modernization. Many MSMEs lack awareness of evolving regulations and global standards. Limited access to advanced technologies can impede competitiveness.
To address these challenges, AIPAC plans to expand its training programs to cover emerging technologies and Industry 4.0 practices, increase outreach efforts to raise awareness among MSMEs about available resources and support and foster greater collaboration with international bodies to bring in best practices and technologies.
AIPAC’s vision and mission are a testament to its commitment to empowering MSMEs in India’s pharma sector. By focusing on skill development, regulatory alignment, and quality enhancement, AIPAC is paving the way for a more resilient, compliant, and globally competitive industry. As the consortium continues to expand its initiatives and collaborations, it promises to be a catalyst for sustainable growth and innovation in one of India’s most critical sectors.
Revised Schedule M: A call for compliance The Union Ministry of Health recently extended the deadline for implementing the revised Schedule M until December 31, 2025, providing much-needed relief to thousands of MSME pharma units across the country.
Originally mandated in December 2023, the revised guidelines required units with turnovers above Rs. 250 crore to comply within six months, while those below the threshold had a one-year timeline. The extension allows smaller manufacturers additional time to upgrade facilities and align with global quality standards.
To further support this transition, the Ministry issued a draft notification on January 4, 2025, enabling small and medium manufacturers with turnovers below Rs. 250 crore to seek timeline extensions. Applicants are required to submit detailed upgrade plans to the Central License Approving Authority within three months of the notification.
AIPAC’s role in empowering MSMEs Recognizing the critical role MSMEs play in India’s pharma ecosystem, AIPAC has stepped in to provide specialized training and coaching. The consortium’s initiatives aim to bridge the gap between MSMEs and regulatory bodies, enhancing compliance and fostering a culture of quality.
AIPAC recently organized its inaugural event at the Prestige Institute of Management and Research in Indore, drawing over 250 delegates. Themed “Symposium on Dissolution Science and Technology for QA, QC, R&D, and Regulatory Professionals of Pharma,” the programme equipped participants with cutting-edge knowledge in dissolution science and quality control.
Keynote speaker Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI), emphasized the importance of collaboration between MSMEs, regulators, and academia to ensure the production of quality and affordable medicines.
Future plans and collaborations Based on positive feedback, AIPAC has already scheduled upcoming events in February 2025 in Chandigarh and Bangalore. These events, organized in collaboration with the National Institute of Pharmaceutical Education and Research (NIPER) and the Federation of Pharma Entrepreneurs (FOPE), will focus on enhancing quality systems and production capabilities. Quarterly programmes across the nation are also planned, covering diverse topics aimed at empowering MSMEs.
The consortium’s maiden initiative saw participation from notable organizations like the Society for Pharmaceutical Dissolution Science (SPDS), Indian Drug Manufacturers’ Association (IDMA-MP), and Madhya Pradesh State Drugs and Pharmaceutical Manufacturers Association (MPSDMA). Industry stalwarts, including Dr. L. Ramaswamy, S. R. Vaidya, and Paresh Chawla, played pivotal roles in the programme’s success, alongside speakers who shared insights on regulatory compliance and advanced dissolution techniques.
Training to sharpen competitive edge Complementing AIPAC’s efforts, the Gujarat Food and Drug Control Administration (FDCA) has conducted extensive training programmes to equip manufacturers with the skills needed to implement the revised Schedule M. Over 2,000 manufacturers, primarily from the MSME category, have benefited from workshops held in Vadodara, Ahmedabad, and Gandhinagar. Collaborative efforts with the IDMA Gujarat Chapter and the CDSCO have further bolstered these initiatives.
Gujarat, a pharma hub with over 1,081 WHO-GMP units and 140 US FDA-approved facilities, has taken proactive steps to ensure compliance with international standards. Dr. H. G. Koshia, Commissioner of Gujarat FDCA, underscored the urgency of adopting revised norms to maintain India’s reputation as the “Pharmacy of the World.”
Revised Schedule M: Key Provisions The updated Schedule M, notified in October 2018 and revised subsequently, expands the definition of “Good Manufacturing Practices” to include “Requirements of premises, plant and equipment for pharmaceutical products.” The key features include:
Batch record review and stability studies: Emphasis on comprehensive documentation to ensure consistent product quality.
Computerized systems: Incorporation of advanced technology to enhance operational efficiency and data integrity.
Annual Product Quality Review (PQR): A systematic evaluation of product quality to identify improvement areas.
Quality Risk Management (QRM): Adoption of proactive risk assessment and mitigation strategies.
These provisions aim to align India’s pharma manufacturing practices with global standards, thereby boosting exports and building trust in the quality of Indian medicines.
Industry support and global impact The pharma industry has widely welcomed the revised norms, viewing them as a step towards enhancing India’s global competitiveness. With approximately 8,500 MSMEs contributing significantly to the sector, compliance with WHO-GMP certification is crucial for accessing low- and middle-income markets that demand stringent quality standards.
Support from organizations like the United States Pharmacopeia (USP), Indian Pharmacopoeia (IP), and global leaders in dissolution testing such as SOTAX underscores the collaborative spirit driving these initiatives. Subsidized delegate fees for training programmes further reflect the industry’s commitment to inclusivity.
Building a sustainable future The CDSCO has been at the forefront of regulatory training, conducting 23 residential programmes over the past year. These sessions have trained over 1,100 regulators, focusing on risk-based inspections, new therapies, and Industry 4.0 technologies. By fostering a quality culture, these efforts are paving the way for sustainable growth in the pharma sector.
As India’s pharmaceutical industry continues to evolve, initiatives like those spearheaded by AIPAC and Gujarat FDCA are vital for ensuring compliance, quality, and innovation. By empowering MSMEs through skill development and regulatory alignment, these programmes not only enhance the sector’s global standing but also reaffirm India’s commitment to providing affordable, high-quality medicines to millions worldwide.
The road ahead promises collaborative growth, driven by a shared vision of excellence in pharma manufacturing. With the revised Schedule M serving as a blueprint for the future, the industry is poised to achieve new milestones in quality, compliance, and innovation.
AIPAC: The way ahead The AIPAC is a pioneering initiative aimed at bridging the gap between MSMEs in the pharma sector and regulatory authorities such as the CDSCO and State Food and Drug Administrations (FDAs). With over 15 national pharmaceutical associations under its umbrella, AIPAC’s mission is to empower MSMEs by providing affordable, specialized training that enhances compliance, quality standards, and overall industry competitiveness.
AIPAC envisions a future where MSMEs in the pharma industry thrive as global leaders in quality, innovation, and affordability. By fostering collaboration between regulatory bodies, industry experts, and academia, AIPAC aims to create a robust ecosystem that supports MSMEs in meeting international standards while maintaining their role as essential medicine providers to domestic and global markets.
AIPAC’s mission is centred on the following objectives like Skill Development and Training, offering specialized training programs to MSMEs to enhance their technical expertise in areas such as Good Manufacturing Practices (GMP), regulatory compliance, and advanced manufacturing techniques.
It is posed to act as a bridge between MSMEs and regulatory authorities to ensure seamless communication, understanding, and compliance with evolving regulations. It will support MSMEs in adopting best practices for drug manufacturing, thereby improving the quality and safety of pharma products. It will ensure that MSMEs can access high-quality training and resources at affordable rates, fostering equitable growth within the sector. It will represent the interests of MSMEs in policy discussions to ensure that regulatory frameworks are conducive to their growth and sustainability.
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