Significant changes in Revised Schedule M guidelines have been introduced to safeguard patients and improve the Indian pharmaceutical industry’s reputation. These new guidelines are aimed at changing the way pharmaceuticals are manufactured in India. For further increasing accountability of pharmaceutical manufacturers, the Indian pharmaceutical regulatory body has revised and updated the Schedule M guidelines. Revised Schedule M aims to help realise the vision of establishing India as a global pharma manufacturing hub. In this blog, we have highlighted the key changes introduced in Schedule M guidelines.

What is Schedule M?

Schedule M is a part of Drugs and Cosmetics Act 1940. It specifies the Good Manufacturing Practices (GMP) for pharmaceuticals. The GMP is a regulatory benchmark. It regulates the pharmaceutical manufacturing process to ensure the highest quality pharmaceutical products are consistently manufactured. All pharmaceutical manufacturing units in India need to mandatorily comply with the Schedule M guidelines.

What is the need for the changes in Revised Schedule M?

The government revised the Schedule M guidelines to bring the Indian pharmaceutical regulations at par with global standards. Thus, drugs manufactured in India would be globally accepted. Novel fields, such as personalised medicine, advanced therapies, gene and stem cell therapies, have emerged in the healthcare sector. Hence, the pharmaceutical manufacturing processes and protocols have been rapidly evolving. With rapid advances in the pharmaceutical domain, new and updated pharmaceutical regulatory guidelines were required. These have fuelled the need for revision of the existing Indian pharmaceutical manufacturing regulatory guidelines. Hence, certain changes have been introduced in Schedule M guidelines.

In the Revised Schedule M, the government has placed special emphasis on manufacturing premises, plant, and equipment in addition to the existing GMP requirements. The Schedule M is aimed at safeguarding patients and improving Indian pharmaceutical products’ reputation globally. Schedule M compliance is mandatory for manufacturing pharmaceuticals in India.

Some of the changes in Revised Schedule M are as follows: introduction of product quality review (PQR), pharmaceutical quality system (PQS), quality risk management (QRM), qualification and validation of equipment, and computerised storage system for all products. Additionally, the manufacturers must market the drugs only after obtaining satisfactory quality test results. Furthermore, a small quantity of sample drugs from a batch should be stored in case the tests have to be repeated for quality verification.

Therefore, in the Revised Schedule M, special emphasis has been placed on qualification and validation of equipment, self-inspection, and risk management. The aim is to ensure high-quality, effective, and safe drugs are being manufactured in India.

What are the key changes in Revised Schedule M?

To bring the Indian pharmaceutical regulations at par with global standards, certain key changes have been introduced in the Revised Schedule M guidelines. Notably, the changes mainly include incorporation of additional requirements in addition to the existing GMP guidelines in Schedule M. Guidelines for premises, plant, and equipment for manufacturing pharmaceutical products are the additional requirements introduced. We have highlighted the key changes.

1. Qualification and validation of equipment

Qualification and validation of equipment involved in pharmaceutical manufacturing are required to prove GMP compliance. Moreover, proper documentation is required to comply with this Revised Schedule M requirement. Equipment qualification and validation documentation is used to demonstrate the following:

• Manufacturing process reliability and finished product quality:  The pharmaceutical manufacturing process will consistently produce pharmaceuticals that meet predetermined specifications and quality benchmarks.
• Construction and installation of facility, process, and equipment per design specifications: The manufacturing facility, process, and equipment have been constructed and installed as per the set design specifications.
• Compliance with Good Manufacturing Practices: The manufacturing facility, processes, equipment, and supporting utilities have been designed in accordance to good manufacturing practices (GMP) guidelines.
• Functionality of manufacturing facility, utilities, and equipment: The manufacturing facility, supporting utilities, and equipment will perform and function as intended.

2. Quality risk management

Quality risk management is a systematic approach for the management, review, and communication of risks associated with the pharmaceutical product’s quality. This Revised Schedule M requirement aims to guarantee:

• The degree of effort, formality, and documentation of the quality risk management process corresponds to the degree of risk
• The risk to quality has been evaluated using scientific knowledge and experience with the procedure.

Quality risk management can be performed in a proactive or retrospective manner. Its main aim is patient protection.

3. Pharmaceutical quality system

The manufacturer is responsible and accountable for the final product quality. It is the responsibility of the senior management to ensure the quality of the product. Moreover, the raw material suppliers, manufacturing personnel, and distributors are equally responsible for meeting the product quality target. The pharmaceutical quality system aims to guarantee the pharmaceuticals are safe for the intended purpose, meet license criteria, and will not endanger patients. It will protect patients from spurious substandard drugs.

4. Implementation of a computerized storage system

Revised Schedule M requires computerized storage system for recording data. Every modification to the recorded data must be documented. Prior entry, the person making the change, the date the changes was made, and other necessary details have to be recorded. Moreover, a backup system must be in place to ensure the records are never permanently lost as a result of system failure or breakdown. Additionally, set methods for guaranteeing data safety should be in place. Furthermore, safety measures are required to avoid accidental data omissions. Finally, controls should be in place to stop unauthorized users from accessing or altering the data.

5. Product quality review

Regular and periodic quality review of all pharmaceutical products have to be carried out. Product quality review should be performed at least once every year. These reviews are required to identify lapses and areas of improvement in the finished product. Additionally, the quality review process should also focus on raw material quality. Moreover, current manufacturing process should also be evaluated. Furthermore, findings and observations of previous quality reviews should be taken into consideration.

Revised schedule M deadline extension

As per G.S.R. 922(E), small and medium businesses having a turnover of less than 250 crore were expected to comply with the Revised Schedule M by 31^st December, 2024. However, several stakeholders requested CDSCO to extend this deadline. Hence, a draft notification G.S.R. 10 (E), dated 4^th January 2025, has been released.

The G.S.R. 10 (E) notifies extension of Revised Schedule M deadline 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.

How can Pharmadocx Consultants help you comply with changes in Revised Schedule M?

Significant changes in Schedule M guidelines have been introduced. Pharmaceutical manufacturers will be expected to comply with the new changes in Revised Schedule M. We at Pharmadocx Consultants have extensive knowledge of the Revised Schedule M guidelines, regulations, and requirements. We will:

1. Ensure compliance with all the clauses of Revised Schedule M.
2. Help you prepare all the documents required for compliance with Revised Schedule M.
3. Help you modify your manufacturing plant to comply with changes in Revised Schedule M.
4. Train your staff to equip them with the necessary knowledge of the Revised Schedule M guidelines.
5. Provide holistic support to help you avoid any regulatory sanctions.
6. Revamp your existing pharma manufacturing factory as per changes in Revised Schedule M at minimal expenditure with minimum operation disruption.

Ensuring compliance with the new changes in Revised Schedule M can be overwhelming.  We will leverage our expertise to help you ensure your pharma company complies with Revised Schedule M guidelines. Our team has been helping set up pharmaceutical manufacturing facilities since 2007. Simply call/Whatsapp on 9996859227 or email at [email protected] and we will make your pharmaceutical manufacturing plant Revised Schedule M compliant. Furthermore, we are now providing cost effective teleconsultation services to our clients located anywhere in India.