Revised Schedule M: A Strategic Opportunity for India’s Pharma Units
The pharmaceutical standards in India are changing, and the revised Schedule M is notified by Government of India as per the Drugs and Cosmetics Rules and is implemented by CDSCO as per DCGI (Drugs Controller General of India) is an indication of the emerging importance of quality, safety and global preparedness.
To small and mid-sized units of pharma, it is not only a regulatory change, but also a strategic chance to improve GMP systems and open new markets.
At Masuu Global Solutions, we know your way.
Our two stage GMP audit software will help and enable your facility to upgrade to the new Schedule M and also be in line with the WHO GMP standards, without being expensive or disrupting your operations.
The directive from the DCGI, signals an end to the current extension of timeline until December 31, 2025 for thousands of small and medium-sized pharmaceutical firms to comply with the Revised Schedule M rules, warning that “strict action” will be initiated against units that fail to meet the new quality mandates.
Why Masuu?
However, it is time to refer to the list of global expertise, local impact: 50+ compliance specialists, 150 regulatory scientists, 7 scientific advisory board members – most are former USFDA, MHRA, EMA, INVIMA, ANVISA, TGA, AIFA, and others.
- Excellent History: Successful audits of more than 450+ GXP assets in 35 countries, assisting their customers in achieving USFDA, EU, PIC/s and WHO GMP regulations.
- Strategic Support: We provide vendor audits, six-system audits, gap assessment, Revised Schedule M audit and off/on-site SME support – to meet your size and objectives.
Masuu’s Dual Audit Advantage
- Pre-Upgrade Audit: We evaluate your existing GMP system, detect areas of weaknesses, and show you upgraded, in practice, and staged improvements that are in line with the new Schedule M and WHO GMP.
- Post-Upgrade Audit -Free: After the changes are made, we re-audit your facility so that you are ready to submit to CDSCO / State inspection and WHO GMP certification – this is a part of our package. Plus, post-audit, we will guide in sending Response to CDSCO/DCA Audits for WHO GMP or GMP Certification audits which will be handled by Masuu at no additional cost.
Beyond Compliance: Open-Door Global opportunities.
Through compliance with the new GMP framework of Masuu, your facility will be eligible to:- Promote products to ROW and semi-regulated markets
- Respond to sourcing queries – directly or via Masuu’s global network of 500+ pharma clients
- Establish a long-term reputation with authorities, customers and suppliers.
- We will be onboarding on some MSME pharma units to our modified Schedule M + WHO GMP readiness program.
- Teamwork: regulatory upgrades into strategic advantage.