Understanding opportunities and challenges for SMEs after breather on Schedule M deadline
Akshansh Chaudhary, Executive Director & Chief Technical Officer, Venus Remedies highlights the challenges SMEs face and how they must focus on filling the leftover gaps, which deterred them from abiding by the guidelines last year
The much-awaited extension for the implementation of guidelines under Schedule M is finally here. In a notification issued earlier this month, The Union Health Ministry has granted a one-year extension to small and medium-sized pharmaceutical companies to upgrade their facilities as per the revised Schedule M of the Drugs and Cosmetic Act. However, this breather comes with a condition–SMEs will have to register with the Central Drug Standards Control Organization (CDSCO) and submit their upgradation plans within three months. Post registration, these companies will be able to avail a 12-month extension until December 31, 2025. While the spin-off in Schedule M deadline has prompted mixed reactions from the manufacturers and industry experts, SMEs now will have to focus on filling the leftover gaps, which deterred them from abiding by the guidelines last year.
Known as ‘Pharmacy of the developing world’, India is home to around 10,500 pharmaceutical units. Out of this, 8,500 units belong to the SME sector, of which only 2,000 SME units currently hold WHO-GMP certification—a validation to ensure that the products are produced and controlled to meet quality standards as per the guidelines of WHO. Lately, India’s image as a pharmaceutical hub has been jeopardised due to several incidents of drug adulteration globally as well as back home. To monitor this, the government has implemented several new GMP norms to ensure that quality standards are met at par with international standards.
Challenges for SMEs
Experts believe the extension will prevent many units from closure due to non-compliance and provide them with additional time to upgrade. However, SMEs do face several unique challenges in abiding by Schedule M compliance. Many lack proficiency in conducting detailed gap analyses to identify areas requiring improvement. Additionally, these companies often need insights into how similar organisations are addressing compliance challenges to guide their efforts.
Another critical hurdle is the reluctance to share their current compliance status with authorities due to concerns over exposing their vulnerabilities. This hesitancy can delay necessary upgrades and create a disconnect between regulatory bodies and smaller manufacturers.
Solutions to back SMEs
To combat the challenges, the government should constitute expert panels or third-party consultants to assist SMEs in conducting comprehensive gap analyses without fear of penalties. Creating platforms where smaller companies can learn from the practices of peers through anonymised case studies and fostering a non-penal collaborative environment where open communication by companies that are sharing their status will be provided with guidance and support, rather than punitive action will further streamline the processes for SMEs. Additionally, organising small-group workshops where SMEs can openly discuss challenges and solutions while fostering mutual learning in a non-judgmental setting can back SMEs in the longer run. The government should also consider providing low interest loans to address the financial constraints faced by SMEs during infrastructure upgrades required for compliance with regulatory standards.
Compliance a commitment
At Venus Remedies, our approach to compliance with the revised Schedule M guidelines was systematic and aligned with our commitment to international standards. Since Schedule M reflects principles similar to EU GMP, which forms the core of our operational framework, our preparedness was already integrated into our routine processes.
We conducted a comprehensive mapping of the revised Schedule M requirements against EU GMP standards, identifying any areas for improvement. This ensured consistency across all compliance frameworks. As most of the required systems were already in place, we focused on updating Standard Operating Procedures (SOPs) and fine-tuning our processes to align with the revised guidelines. To foster a compliance-driven culture, we organised targeted training sessions, ensuring our teams were well-versed in both the revised guidelines and their practical implementation. We also conducted internal audits to assess our readiness which simulated the official inspection. These exercises helped us identify and rectify minor gaps, reinforcing our preparedness. Our seamless transition under the revised Schedule M reflects our proactive approach to regulatory requirements and our dedication to maintaining global compliance standards.
Embracing a compliance-drive culture
Proactively building systems to address future regulatory challenges while maintaining operational efficiency and competitiveness is an ongoing process at Venus Remedies. As a compliance-first organisation, we ensure that regulatory adherence is embedded in every aspect of our operations. We utilise software tools and visual dashboards to track compliance requirements across our GMP environment. These tools provide real-time visibility, allowing us to identify and address gaps promptly. Understanding the criticality of compliances, we are developing a comprehensive repository of all applicable laws and guidelines that are linked to our SOPs and QMS. This system will enable us to actively monitor global regulatory updates and make timely adjustments to our processes. To enhance operational efficiency, we are investing in automated quality control systems and AI-driven data analytics, ensuring precision and compliance at every stage of production.
A compliance-driven culture serves as a bedrock for any pharma company and we ensure that our team is consistently trained and updated on global regulatory expectations, fostering a culture of preparedness and innovation.
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