Revised Schedule M Deadline Extension Application Process

The CDSCO has now opened the portal for Revised Schedule M deadline extension application. Revised Schedule M deadline extension will be applicable only for small and medium scale businesses having a turnover of less than 250 crore. We have prepared a detailed guide on how to apply for Revised Schedule M deadline extension.

8 major changes introduced in Revised Schedule M

The Revised Schedule M introduces several key updates to align India’s pharmaceutical manufacturing standards with the global quality benchmarks. We have highlighted some significant changes introduced in Revised Schedule M in addition to the existing requirements.

1. Pharmaceutical quality system (PQS): Implementation of a robust system to manage and improve quality across all processes.
2. Product quality review (PQR): Thorough and regular reviews of product quality to ensure consistency and compliance.
3. Quality risk management (QRM): Identifying and mitigating risks that could impact pharmaceutical product quality.
4. Product recall systems: Having an effective and prompt product recall procedure in place.
5. Sample retention: Retaining small quantities of sample drugs from each batch for quality verification, if needed.
6. Qualification and validation: Ensuring pharma equipment, manufacturing processes, and systems meet required quality benchmarks.
7. Change control: Managing changes in materials, processes, and equipment.
8. Computerized storage systems: Maintaining a digital record of all documents and information for better traceability and accountability.

Indian pharma companies will have to mandatorily comply with the Revised Schedule M guidelines. However, the Revised Schedule M has various specifications and requirements. Moreover, signification additions have been made to the existing Schedule M guidelines. Extensive knowledge of the guidelines will be required to properly implement all the latest changes. However, as a pharma company, it is not possible to stay abreast of all the changes in Revised Schedule M guidelines. As India’s leading Revised Schedule M consultant, we will help you seamlessly implement Revised Schedule M guidelines in your pharma company. Get in touch with us to have your pharma manufacturing facility renovated as per updated guidelines at minimal expenditure with minimum operational disruption within the stipulated deadline.

G.S.R. 10 (E) notifying provision for Revised Schedule M deadline extension

As per G.S.R. 922(E), small and medium businesses with 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 the DTAB, the government has released a provision for Revised Schedule M deadline extension. A notification G.S.R. 10 (E), dated 4^th January 2025, was released. Notably, this notification is applicable only for small and medium scale businesses having a turnover of less than 250 crore.

The G.S.R. 10 (E) mentions the Revised Schedule M compliance deadline will be extended by 1 year. The deadline shall be extended till 31^st December, 2025. Notably, this deadline extension will be appliable only for small and medium scale manufacturers with turnover of or less than 250 crores. To seek the Revised Schedule M deadline extension, an application on Form A has to be sent to CDSCO. This Revised Schedule M deadline extension application along with the plan of upgradation has to be submitted within a period of 3 months from the date of publication of the notification. 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 application

For Revised Schedule M deadline extension application, manufacturers will be required to submit the Form A. The Form A requires manufacturer’s details along with license number and validity. Moreover, the total turnover for the year has to be mentioned. Additionally, whether the manufacturer holds WHO GMP, COPP etc. certifications has 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 the deadline extension application Form A. Finally, this form along with the plan for upgradation for compliance with Revised Schedule M guidelines has to be submitted to the CDSCO by 31^st March 2025.  

What steps should pharmaceutical manufacturers take for Revised Schedule M deadline extension application?

We have mentioned some steps pharmaceutical manufacturers can take to prepare for Revised Schedule M deadline extension application.

1. Conduct a thorough gap analysis: Pharma manufacturers will be expected to perform an in-depth gap analysis. They will have to perform a self-audit of their pharma manufacturing facility. Pharma companies will have to assess their current practices, plant, infrastructure, equipment against the updated requirements mentioned in Revised Schedule M guidelines. Then, they will have to identify gaps and areas of non-compliance needing improvement.
2. Document preparation: After performing the gap analysis, pharma manufacturers will have to document areas of non-compliance needing improvement.
3. Plan for upgradation: Pharma companies will have to prepare a detailed plan for upgradation of their facility to ensure compliance with all the clauses of Revised Schedule M guidelines. The plan should mention actionable steps for each point identified during gap analysis. Furthermore, this plan should be properly documented, as this has to be submitted along with the Revised Schedule M deadline extension application.
4. Upgrade infrastructure: Pharma companies will have to start upgrading the manufacturing facility, infrastructure, equipment, HVAC systems, and utilities to meet new guidelines.
5. Implement a robust Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS): Develop a robust QRM system to identify, assess, and mitigate risks in pharmaceutical manufacturing and quality control. Implement a PQS to manage and improve quality across all operations.
6. Train Employees: Impart trainings and conduct workshops on the Revised Schedule M guidelines to ensure the staff understands and follows the updated guidelines.

Gap analysis for Revised Schedule M deadline extension application

A detailed gap analysis is a vital step in Revised Schedule M deadline extension application. Gap analysis is a systematic process of identifying the differences between current practices and the desired standards or requirements. In the context of complying with the Revised Schedule M guidelines, the gap analysis process will involve the following steps:

1. Assessment of current practices: Review the existing manufacturing processes, facilities, equipment, systems, and documentation.
2. Identify gaps: Compare current practices and infrastructure against the updated Schedule M requirements to pinpoint areas of non-compliance and shortcomings.
3. Prioritize actions: Rank the identified gaps and areas of non-compliance based on their impact on compliance and product quality.
4. Develop an action plan: Create a detailed plan or strategy to address each gap, including timelines, resources, and responsibilities. This plan has to be submitted along with the Revised Schedule M deadline extension application form.

How can Pharmadocx Consultants help with Revised Schedule M deadline extension application?

To apply for Revised Schedule M deadline extension, small and medium scale pharma companies will have to submit an application on Form A. For Revised Schedule M deadline extension application, pharma companies are expected to carryout certain steps. First, a self-assessment and audit of the manufacturing facility has to be performed to identify Revised Schedule M non-conformities. After performing an in-depth gap analysis, a detailed plan has to be formulated for upgradation to ensure Revised Schedule M compliance. Furthermore, a justification has to be provided for seeking the deadline extension. Hence, applying for Revised Schedule M deadline extension is cumbersome and requires industry and regulatory knowledge.

The Pharmadocx Consultants team will be more than happy to help you with the Revised Schedule M deadline extension application. We have extensive knowledge of the Revised Schedule M guidelines, regulations, and latest updates.

Revised Schedule M Form A application support

We provide holistic Form A application support to our clients to help them easily seek the deadline extension. We will:

• Perform detailed gap analysis: We will thoroughly asses your facility, equipment, and processes to identify areas of shortcomings and non-compliance with Revised Schedule M guidelines. Our team will perform section-wise gap analysis covering plant, equipment, lab equipment, HVAC system, utilities, technical staff, and documentation as required by Form A.
• Develop a plan/strategy: Based on our gap analysis findings, we will develop a thorough plan/strategy for upgradation of your pharma facility. Our upgradation plan will be prepared section wise as required by the Form A.
• Prepare a justification: Form A demands a proper justification for seeking deadline extension. We will prepare the justification on your behalf that has to be attached along with the application.
• Prepare and compile documents: Multiple supporting documents have to be submitted along with the deadline extension application. We prepare all the files required for the plant, equipment, lab equipment, HVAC system, utilities, and technical staff. Furthermore, we will compile all the documents as required by the guidelines.
• Submit the application on Form A: Submitting the application on Form A seeking the Revised Schedule M deadline extension can be tricky. We will provide support and guidance for submitting the application. Additionally, if required, our team will fill out and submit the application on Form A on your behalf.

Furthermore, we have recently launched cost-effective teleconsultation services for our clients. If you send us your factory layout, equipment, and documents, we will prepare a detailed gap analysis for you. Our team will provide complete guidance and teleconsultation services at minimal charges. Email at [email protected] or call/Whatsapp on 9996859227 so that we can help you submit the Revised Schedule M deadline extension application in a hassle-free manner.