Revised schedule M is being mandatorily implemented in India. Thus, all pharmaceutical manufacturing units in India need to strictly comply with the Schedule M guidelines. Notably, the focus of Schedule M is the production of highest quality pharmaceuticals in India. As per G.S.R. 922(E), small and medium businesses having a turnover of less than 250 crore were expected to comply with revised schedule M by 31^st December, 2024. However, several stakeholders requested CDSCO to extend this deadline for small and medium scale businesses. Upon consultation with Drugs Technical Advisory Board (DTAB), the government has released a provision for revised schedule M deadline extension. Hence, a draft notification G.S.R. 10 (E), dated 4^th January 2025, extending the revised schedule M compliance deadline has been released. Notably, this notification is applicable only for small and medium scale businesses having a turnover of less than 250 crore.

Revised schedule M deadline extension for small and medium scale pharmaceutical manufacturers

What is the revised schedule M?

New frontiers, such as advanced therapies, personalised medicine, gene and stem cell therapies, have emerged in the healthcare sector. Thus, the pharmaceutical manufacturing processes have been rapidly evolving. With the rapid changes in the pharmaceutical domain, new and updated regulatory guidelines are required. These have fuelled the need for revision in the existing Indian pharmaceutical manufacturing regulatory guidelines. The principles and concepts of the existing Schedule M regulatory guidelines had to be changed. The government aimed to revise the Schedule M to bring the Indian pharmaceutical regulations at par with global standards. Thus, drugs manufactured in India would be globally accepted. This will fulfil the vision of establishing India as a global pharma manufacturing hub.

Significant changes have been made in the Schedule M guidelines to safeguard patients and improve the Indian pharmaceutical industry’s reputation. For further increasing the accountability of pharmaceutical manufacturers, the Indian pharmaceutical regulatory body has revised and updated the Schedule M. Notably, the changes mainly include incorporation of additional requirements in addition to the existing GMP guidelines. The Revised Schedule M has placed special focus on risk management, qualification, and validation of equipment. Guidelines for premises, plant, and equipment for manufacturing pharmaceutical products have been introduced along with GMP guidelines in the revised Schedule M. Additionally, the provision for self-inspection has been increased. Thus, by effectively implementing Revised Schedule M guidelines, high-quality, effective, and safe drugs will be manufactured in India.

Major aspects incorporated in the revised schedule M

• Product quality review
• Pharmaceutical quality system
• Quality risk management
• Computerized storage system
• Change control management
• Complaint and product recall procedure
• Qualification and validation of equipment

Pharmaceutical quality systems and product quality review have been placed at the core of the revised schedule M. Furthermore, the manufacturers are required to market the drugs only after obtaining satisfactory quality test results. Additionally, a small quantity of sample drugs from a batch should be stored in case the tests have to be repeated for quality verification.

Excellence in pharmaceutical product quality and enhanced patient safety will be possible with the strict enforcement of revised schedule M. Hence, the Indian pharma regulatory body is mandatorily enforcing the revised schedule M. However, the revised schedule M has various specifications and requirements. Extensive knowledge of the guidelines will be required to properly implement the guidelines. Thus, taking the help of a consultant for revised schedule M implementation, will be beneficial.

G.S.R. 10 (E) draft notification: Revised schedule M deadline extension

The G.S.R. 10 (E) notifies revised schedule M deadline extension by 1 year. Notably, this deadline extension will be appliable only for small and medium scale manufacturers with turnover of or less than 250 crores. The revised schedule M implementation deadline shall be extended till 31^st December, 2025.

To seek the revised schedule M deadline extension, an application in Form A has to be sent to CDSCO. This application along with the plan of upgradation from the date of publication has to be submitted within a period of three months. For these manufacturers, the deadline for revised schedule M implementation shall be extended till 31^st December, 2025.

Form A for revised schedule M deadline extension

To seek the revised schedule M deadline extension, manufacturers will be required to submit Form A. The Form A requires manufacturer and license details. Additionally, whether the manufacturer holds WHO GMP, COPP etc. certifications have to be mentioned.

Furthermore, the manufacturers will be expected to perform a self-audit of their facility. They will have to identify all gaps and non-compliance with revised schedule M. Then, the manufacturers will be expected to fill in their self-audit findings and other details on Form A. Finally, this form along with the plan for upgradation for compliance with revised schedule M has to submitted to the CDSCO by 31^st March 2025.

Pharmadocx Consultants for revised schedule M implementation

Self-assessment and audit of manufacturing facility to identify revised schedule M non-conformities can be cumbersome. Additionally, gap analysis and presenting a detailed plan for upgradation to ensure revised schedule M compliance are mammoth tasks. Fret not! Our team will be more than happy to help you.

The Pharmadocx Consultants team has extensive knowledge of the revised schedule M guidelines, regulations, and requirements. We are India’s premier consultant for revised schedule M implementation and compliance. Our team of experts will provide holistic support to help you avoid any regulatory sanctions. We will leverage our rich experience and in-depth expertise in this field to help you. With our support, you can rest assured compliance with all the clauses of the revised schedule M guidelines. Moreover, we will help renovate your existing pharma factory as per the revised guidelines. Our team of experts will completely modify your factory within the deadline so that you do not face legal consequences. We will revamp your factory as per updated guidelines at minimal expenditure with minimum operational disruption within the stipulated deadline. Furthermore, our team will provide all the support required to fill Form A for revised schedule M deadline extension.

How can Pharmadocx Consultants help?

1. Regulatory compliance: We will help you ensure that your manufacturing facility meets Revised Schedule M and WHO-GMP regulatory standards. Moreover, we guarantee compliance with all the clauses of Schedule M. Additionally, we will provide a detailed checklist for your easy reference.
2. Modification of plant: We will help you modify your manufacturing plant to comply with the new Schedule M guidelines and specifications.
3. Staff training: As a consultant for Revised Schedule M, we will train your staff to equip them with the necessary knowledge of the revised guidelines. Our comprehensive training will make your technical staff adept at handling manufacturing facility inspections and audits.
4. Mock audit: Our team will conduct thorough mock audits at your manufacturing facility. We not only identify the shortcomings but also provide corrective actionable next steps. We will work relentlessly to make your manufacturing facility audit ready.
5. Document preparation support: Our team will help you prepare all the documents required for compliance with Schedule M.

Furthermore, we are now providing cost effective teleconsultation services to our clients. Our team will provide complete guidance and teleconsultation services at minimal charges. If you send us your factory layout, equipment, and document, we will provide a detailed gap analysis. You can avail our revised schedule M implementation teleconsultation services from anywhere in India. We will help you fill in the Form A within the deadline so that you can seek revised schedule M deadline extension in a hassle-free manner. Drop an email at [email protected] or call/Whatsapp on 9996859227 for any assistance related to revised schedule M implementation.