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the Indian pharma Micro, Small, and Medium Enterprises (MSMEs) are gearing up to implement the Revised Schedule M by January 2025. These enterprises, forming the backbone of Indian pharma manufacturing sector, have demonstrated a proactive approach to adopting the new standards aimed at enhancing drug quality and safety.
“MSMEs are now more focused on ensuring compliance with the Revised Schedule M. They are investing in Pharmaceutical Quality Systems (PQS), Quality Risk Management (QRM), and state-of-the-art computerized storage systems to meet global standards,” stated Dr. H.G. Koshia, Commissioner of Gujarat Food and Drug Control Administration (FDCA).
He was speaking at a workshop on ‘Vendor Validation and Audit as per Revised Schedule M Guidelines,’ organized in Ahmedabad by the CDSCO in collaboration with FDCA Gujarat and the Indian Drug Manufacturers Association (IDMA).
This workshop was a milestone event, emphasizing the importance of aligning with international regulatory frameworks. It included sessions led by regulatory and industry experts, focusing on validation processes, GMP compliance, and best practices for operational excellence.
Dr. Koshia also highlighted MSMEs’ commitment to strengthening supply chain quality and their readiness to adopt technological advancements. “These efforts reflect the industry’s determination to produce high-quality drugs that not only serve the domestic market but also reinforce India’s position as a global pharmaceutical leader,” he said.
Why Revised Schedule M is critical?
The Revised Schedule M, notified by the Union Health Ministry on December 28, 2023, comes after more than five years of deliberation and drafting. The updates are aimed at closing critical gaps in India’s pharmaceutical regulatory system, a move necessitated by international scrutiny following a series of high-profile incidents.
Over the last few years, the Indian pharma industry has faced severe criticism after contaminated medicines exported from India were linked to the deaths of children in Gambia and Uzbekistan. These incidents damaged the reputation of the sector, which has long been hailed as the “pharmacy of the world” for its large-scale production of affordable generic medicines.
To restore trust and prevent such tragedies, the Revised Schedule M mandates a series of stringent guidelines aligned with global GMP standards. These include:
Modernized facilities: Upgrades to manufacturing plants to ensure cleanliness, prevent cross-contamination, and improve overall hygiene.
Equipment validation: Ensuring all equipment is qualified and maintained to meet rigorous production standards.
Environmental controls: Enhanced focus on air, water, and waste management to align with global environmental standards.
Regular Product Quality Reviews (PQR): Ongoing assessments to ensure drugs meet specifications throughout their lifecycle.
Pharmaceutical Quality Systems (PQS): Establishing robust systems to monitor and maintain consistent drug quality.
The government has set January 2025 as the compliance deadline for MSMEs, giving them time to upgrade facilities, implement new processes, and align with these critical standards.
Government and regulatory initiatives
To support the smooth implementation of the Revised Schedule M, the government and regulatory bodies have undertaken several initiatives:
Training programmes
The Gujarat FDCA has launched extensive training sessions for 150 regulatory officers, focusing on the key aspects of Schedule M. These programs, announced during the National cGMP Day celebrations on October 10, 2024, aim to equip officers with the knowledge and tools required to oversee compliance.
Collaborative workshops
Events like the Ahmedabad workshop, organized by CDSCO and IDMA, serve as platforms for knowledge exchange and collaboration. Industry experts provide actionable insights into aligning with the updated guidelines, while regulators outline their expectations and support mechanisms.
Financial support
Various state governments, along with central agencies, are exploring incentives and financial assistance for MSMEs to help them invest in the required infrastructure upgrades.
Technological integration
Regulatory authorities are encouraging the adoption of advanced technologies like computerized monitoring and storage systems. These innovations aim to enhance traceability and minimize risks in the supply chain.
State-level leadership
Gujarat, producing over 30 per cent of India’s pharmaceutical output, is leading the way. The FDCA has set a benchmark for other states by initiating regulatory reforms and enforcement mechanisms.
Dr. Koshia emphasized, “Gujarat is demonstrating a model approach by training officers, working closely with manufacturers, and ensuring the state’s pharmaceutical industry aligns with global benchmarks.”
Challenges and way ahead
While the Revised Schedule M represents a significant step forward, the road to full compliance is fraught with challenges. MSMEs, which often operate on limited budgets, will need substantial support to meet the new requirements. Additionally, ensuring uniform implementation across India’s vast pharmaceutical landscape will require sustained regulatory oversight and industry cooperation.
The success of the Revised Schedule M hinges on a co-ordinated effort involving manufacturers, regulators, and policymakers. As the January 2025 deadline approaches, the focus must remain on fostering a culture of quality and accountability within the industry.
A transformative opportunity
The Revised Schedule M is more than a regulatory update—it is a transformative opportunity to elevate India’s pharmaceutical industry to global standards. By stepping up to this challenge, MSMEs are not only safeguarding public health but also ensuring India retains its position as a trusted pharmaceutical powerhouse.
The revised standards aim to enhance quality control measures, proper documentation, and IT support, thus ensuring the production of high-quality medicines in India and for the global market, opine experts
The proposed Revised Schedule M guidelines will have provisions for a comprehensive system towards prompt and effective drug recall. It will have provisions to inform the licensing authority about the product or drug recall
Currently, there is no provision to inform the licensing authority about the drug recall. The proposed guidelines have also provisioned to report product deterioration, faulty manufacturing and serious quality problems to the Licensing Authority (LA) on a timely basis.
Under the proposed Revised Schedule M guidelines, pharma companies are supposed to set up pharmacovigilance (PV) cells to qualify for World Health Organisation-Good Manufacturing Practices (WHO-GMP) standards.
This will enable pharma companies to collect, process and report adverse drug reactions (ADRs) emerging from the use of the drug manufactured or marketed by the respective company in the country.
Schedule-M prescribes requirements to the manufacturing plants of pharmaceutical companies for maintenance, manufacturing, control and safety testing, storage and transport material, written procedures and records, and traceability among others.
The drug exporting pharmaceutical companies by setting up a PV cell will be accountable to fulfil its legal tasks in relation to PV, to monitor the safety of medicinal products and to detect any change to their risk-benefit balance.
The new version of Schedule-M is designed to ensure compliance to standards of drugs, promote exports, promote innovation and also to build trust and confidence on the quality of drugs manufactured and sold.
With proactive efforts from MSMEs and robust support from regulatory bodies, the industry is on track to achieve its vision of producing safe, effective, and high-quality medicines for both domestic and global markets.
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