Pharma Industry Adopts Stringent Quality Standards with Revised Schedule M Implementation

According to the revised rules, manufacturers must take responsibility for ensuring the quality of pharmaceutical products, making them fit for their intended use, compliant with licence requirements, and free from risks to patient safety.

In a significant move to align with global pharmaceutical quality standards, the Union Health Ministry of India has officially notified the revised Schedule M norms for Good Manufacturing Practices (GMP) and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products.

The final notification, dated December 28, 2023, was published after more than five years of stakeholder consultation, with the rules officially coming into force on January 5, 2024, as per the Gazette of India.

The Fresh Changes

The extensive amendments replace the term 'Good Manufacturing Practices' (GMP) with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.'

According to the revised rules, manufacturers must take responsibility for ensuring the quality of pharmaceutical products, making them fit for their intended use, compliant with licence requirements, and free from risks to patient safety.

Further, the updated guidelines emphasise the importance of a well-designed and correctly implemented Pharmaceutical Quality System (PQS), incorporating GMP and Quality Risk Management (QRM).

Moreover, staff involvement and commitment at all levels, including senior management, suppliers, and distributors, are deemed essential for reliably achieving the quality objectives.

The new Schedule M mandates periodic management reviews involving senior management to identify opportunities for continual improvement in products, processes, and the overall system.

Unless justified otherwise, these reviews must be conducted at least annually. Workshops conducted by the Central Drugs Standard Control Organisation (CDSCO) across industry hubs highlighted the applicability of World Health Organisation (WHO) guidelines on water and HVAC systems under the revised Schedule M.

A crucial element introduced is the annual Product Quality Review (PQR) requirement, involving documentation and assessment of various aspects, including starting materials, critical in-process controls, finished product results, deviations, stability monitoring, and more.

The manufacturer must evaluate these results, and corrective and preventive actions must be undertaken promptly and effectively, following documented procedures.

To Recap

The Minister of Health and Family Welfare, Dr Mansukh Mandaviya, announced in July 2023 that Schedule M would be made compulsory for Micro, Small, and Medium Enterprises (MSMEs) in the pharma industry in a phased manner.

However, this announcement raised confusion, as Schedule M has been mandatory since 2005. Subsequently, the government clarified its intention to mandate the implementation of the revised Schedule M, the draft of which was published in October 2018.

To further streamline compliance, the government announced a timeline for drug manufacturers to adhere to GMP standards. Companies with an annual turnover of more than INR 250 Cr were given six months, starting from August 1st, 2023, to comply with the standards. Those with a turnover of less than INR 250 Cr were provided a one-year timeline.

In light of these developments, the health ministry emphasised the need for a technical agreement between involved parties, defining their responsibilities in producing the quality review. The authorised person responsible for final batch certification must ensure the quality review is performed accurately and promptly.

The revised Schedule M underscores the commitment to international quality standards and sets a framework for continuous improvement and accountability within the Indian pharmaceutical industry. As stakeholders adapt to the updated regulations, the industry is poised for enhanced product quality and global competitiveness.