What are the key features of Revised Schedule M for manufacturing companies?

Ministry of Health and Family Welfare, Government of India, issued a notification regarding the implementation of revised Schedule-M 2024 by all pharmaceutical formulation companies in India. 

The initial gazette notification was published on 09th October 2018, and then objections and suggestions were sought by the department. On the basis of public objections and suggestions, the Central government decided to implement the Revised Schedule M. 

The following rules are further amended in the Drugs Rules, 1945,:-

1. Short Title and Commencement- These rules will be called Drugs(…. Amendment)Rules, 2023. These rules will be in force from the date of their publication in the gazette notification (05.01.2024) for larger than 250 crore annually turnover companies after six months of the publication date and for less than 250 crore annual turnover companies it will be effective from after twelve months of the publication (05.01.2024)
2. Now, in the Drugs Rules, 1945, rule 74, “Good Manufacturing Practice” will be replaced by the word “Good Manufacturing Practices and Requirements of Premises, Plant,  and Equipment for Pharmaceutical Products”.
3. In the principal rules, in rule 76 (clause 8) for the words “Good Manufacturing Practices”, the words “Good
   Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products” shall
   be substituted.
4. In the principal rules, in rule 78 (clause p) for the words “Good Manufacturing Practices”, the words “Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products” shall be substituted.
5. In the principal Rules (Drugs Rules, 1945), for Schedule M, the following Schedule shall be substituted:-
   • Schedule M [See rules 71, 74, 76, and 78]-GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND
     EQUIPMENT FOR PHARMACEUTICAL PRODUCTS.
   • Every license holder shall have to evolve appropriate methodology, system, and procedures which should be neatly documented and maintained for inspection, to achieve the objective of revised Schedule M, manufacturing premised can not used for any other activity other than manufacturing of permitted drugs. 

Part I of Schedule M:

Good Manufacturing Practices for Pharmaceutical Products: Main Principles

1. Pharmaceutical Quality System (PQS)
2. Quality Risk Management (QRM) 
3. Good manufacturing practices for pharmaceutical products
4. Sanitation and hygiene
5. Qualification and validation
6. Complaints and adverse reaction
7. Product recalls
8. Change control 
9. Production under loan license or contract and contract analysis and other activities
10. Self-inspection, quality audits, and suppliers’ audits and approval
11. Personnel
12. Premises
13. Equipment 
14. Materials 
15. Reference Standards
16. Waste materials 
17. Documentation
18. Good practices in production
19. Good practices in quality control 
20. Computerized systems

Site Master File- As per revised Schedule M:

Each license holder shall prepare a succinct document with the title of Site Master File (SMF). It shall contain some specific and factual information about the Good Manufacturing Practices at pharmaceutical manufacturing facilities related to production. It must contain the following information;-

1. General information
2. Personnel
3. Premises
4. Equipment
5. Sanitation
6. Documentation
7. Production
8. Quality Assurance and Control
9. Manufacture under loan licence and licensee
10. Distribution, complaints, and product recall
11. Self-inspection
12. Export of drugs

The document Site Master File will contain detailed information about all the above-mentioned points. 

References:

Health Ministry revises pharma manufacturing rules under Schedule M-[Business Standard]