Revolutionizing Pharma Safety: Proposed Revised Schedule M Guidelines to Enhance Drug Recall and Pharmacovigilance

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In a significant stride toward bolstering pharmaceutical safety standards, the proposed Revised Schedule M guidelines are set to usher in a comprehensive system for prompt and effective drug recall. Dr. S Eswara Reddy, Joint Drugs Controller at the Central Drugs Standard Control Organisation (CDSCO), revealed that these guidelines will introduce provisions for notifying the licensing authority about product recalls, a crucial aspect currently lacking in the existing framework.

Presently, the absence of a Schedule M provision to inform the licensing authority about drug recalls poses a challenge to the pharmaceutical industry. The forthcoming guidelines aim to bridge this gap by mandating the reporting of product deterioration, faulty manufacturing, and serious quality issues to the Licensing Authority (LA) in a timely manner.

Dr. Reddy emphasized that, under the proposed guidelines, pharmaceutical companies must establish pharmacovigilance (PV) cells to meet the stringent standards of the World Health Organisation-Good Manufacturing Practices (WHO-GMP). This proactive approach will empower companies to collect, process, and report adverse drug reactions (ADRs) arising from the use of their manufactured or marketed drugs in the country.

Schedule-M, which outlines requirements for pharmaceutical manufacturing plants, covers aspects such as maintenance, manufacturing control, safety testing, storage, transport, and traceability. By implementing a PV cell, drug-exporting pharmaceutical companies will not only fulfill their legal obligations related to PV but also monitor the safety of medicinal products, ensuring a vigilant approach to changes in their risk-benefit balance.

The revised Schedule-M is strategically crafted to promote compliance with drug standards, facilitate exports, encourage innovation, and instill trust in the quality of manufactured drugs. The Union health ministry, in a proactive move on August 2, 2023, granted a grace period of 12 months for small manufacturers and 6 months for larger units to obtain WHO-GMP certification.

Acknowledging the critical role of stakeholders, the Government of India, after notifying the draft Schedule M on October 5, 2018, engaged in a series of meetings with drug manufacturers’ associations. Larger companies, boasting turnovers exceeding Rs. 250 crore, are mandated to implement changes within 6 months, while medium and small-scale enterprises with turnovers below Rs. 250 crore have been given a one-year timeline.

The emphasis on Adverse Drug Reactions (ADRs) in the guidelines is crucial, considering its status as a leading cause of morbidity and mortality globally. The overarching goal is to monitor medicine safety effectively, mitigating the consequences of ADRs on the healthcare system, including increased therapy costs and prolonged hospitalizations. As the pharmaceutical industry evolves to meet these stringent standards, the proposed changes mark a pivotal moment in ensuring drug safety and building a robust healthcare ecosystem.

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