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Revised Schedule M to streamline inspections & boost pharmaceutical standards: CDSCO official
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Shardul Nautiyal, Mumbai
April 26 , 2024
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The implementation of Revised Schedule M is set to revolutionize the pharma industry landscape by not only enhancing quality standards but also by streamlining regulatory processes, notably by minimizing duplicative inspections by various regulatory bodies of different countries, according to a senior Central Drugs Standard Control Organisation (CDSCO) official.
The cornerstone of the Revised Schedule M, as highlighted by CDSCO official, is its potential to streamline regulatory inspections and eliminate the redundancy of multiple assessments by different countries. This strategic move aims to significantly reduce administrative burdens and streamline the regulatory landscape for pharmaceutical manufacturers operating within India's borders.
“The Revised Schedule M's emphasis on efficiency and coherence in regulatory oversight is poised to unlock a host of benefits for both industry stakeholders and regulatory authorities. By harmonizing standards and reducing duplicity of work, the initiative not only enhances the ease of doing business but also fosters an environment conducive to innovation and growth,” the CDSCO official explained.
In addition to its regulatory streamlining objectives, the Revised Schedule M also embodies a commitment to elevating pharmaceutical quality standards to international levels. Through provisions such as the retesting of expired active pharmaceutical ingredients (APIs), annual Product Quality Review (PQR), and integration of Quality Risk Management (QRM) practices, the initiative aims to ensure that Indian pharmaceutical products meet global benchmarks for safety, efficacy, and quality.
Industry response to the implementation of the Revised Schedule M has been positive, with stakeholders applauding its potential to drive competitiveness and bolster trust in Indian pharmaceutical products worldwide. With a clear roadmap for compliance, larger companies are mandated to implement the changes within six months, while medium and small-scale enterprises are given a year to adapt, ensuring a smooth transition period.
As India reaffirms its commitment to excellence in pharmaceutical manufacturing and regulatory oversight, the implementation of the Revised Schedule M will foster innovation, enhancing regulatory efficiency, and ultimately safeguarding public health.
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