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Experts hail proposed draft Schedule M guidelines placing emphasis on stability testing
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Shardul Nautiyal, Mumbai
January 02 , 2024
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Experts have hailed the proposed draft Schedule M guidelines placing significant emphasis on stability testing compared to the existing Schedule M. This marks a commendable stride in aligning with global standards towards upgrading MSMEs to WHO- GMP standards.
However, it has also been recommended referencing the latest WHO 2018 guideline to standardize practices across the industry with India lacking a specific stability testing guideline.
The proposed Schedule M guidelines also emphasize on the need for a post-finalization inspection checklist, akin to the one issued after the implementation of the existing Schedule M in 2005, with a reasonable emphasis on stability testing operations. Recognizing India's established system of third-party manufacturing, it has also been proposed to include remarks on the distinct responsibilities of manufacturers and marketers concerning stability testing.
However, it has been argued that the absence of stability chambers in Part XIII: Requirements of Plant and Equipment, which calls for rectification to align with industry norms. The proposed Schedule M guidelines draft refers to national, World Health Organisation (WHO), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines in various sections, but lacks mention of stability testing guidelines, highlighting the need for a comprehensive document.
The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of pharmaceuticals and develop ICH guidelines. Since its inception in 1990, ICH has gradually evolved, to respond to increasingly global developments in the pharmaceutical sector and these ICH guidelines are applied by a growing number of regulatory authorities. ICH's mission is to achieve greater harmonisation worldwide to ensure that safe, effective and high-quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards. Since its announcement of organisational changes in October 2015, ICH has grown as an organisation and now includes 21 Members and 37 Observers.
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 etc. The revised GMP guidelines have come at a relevant time when India is reinforcing itself as the global pharmaceutical manufacturing hub.
The need for revision of Schedule-M, good manufacturing practices (GMP) requirements is being done keeping in mind current changes in the concept of quality of drugs, convergence of Indian standards with global standards, and technological advancements in manufacturing and testing of drugs.
The Government of India (GoI) had notified draft Schedule M on October 5, 2018 and had made a series of meetings with all drug manufacturers associations and other stakeholders. It is now under active consideration of the ministry of health and family welfare (MoHFW), Government of India (GoI).
Larger companies with a turnover of over Rs. 250 crore have been asked to implement the changes within 6-months, while medium and small-scale enterprises with turnover of less than Rs. 250 crore have been asked to do so within one year. The new version of Schedule-M is being 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.
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