Last Updated on January 14, 2024 by The Health Master
Schedule M
Download Schedule M dated 28-12-2023, the link is given below the article: In a significant move towards enhancing compliance with quality standards, the Ministry of Health and Family Welfare (MoHFW) has recently unveiled revised rules under Schedule M of the Drugs and Cosmetics Rules, 1945.
These rules, encompassing good manufacturing practices (GMP) for pharmaceutical products, aim to reshape the landscape of pharmaceutical manufacturing in India.
Key Changes in the Revised Schedule M
The revised Schedule M brings forth several pivotal changes that are poised to redefine the pharmaceutical industry’s operational dynamics.
These changes include the incorporation of:
- Pharmaceutical quality system (PQS),
- Quality risk management (QRM),
- Product quality review (PQR),
- Qualification and validation of equipment, and
- The implementation of a computerized storage system.
The heart of this regulatory shift lies in the Government of India’s notification, G.S.R. 922(E) dated 28-12-2023.
This section highlights the key aspects of the proposed amendments, setting the stage for a detailed exploration of the changes in the Drugs Rules, 1945.
Rule 74 Amendment
One of the pivotal changes proposed in G.S.R. 922(E) pertains to Rule 74, specifically targeting clause (o).
The amendment replaces the existing reference to “Good Manufacturing Practices” with a broader scope, now encompassing “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”
Rule 76 Amendment
Continuing the trend, Rule 76 undergoes modifications in clause (8).
Similar to the changes in Rule 74, the words “Good Manufacturing Practices” are substituted with a more comprehensive term, now covering “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”
Rule 78 Amendment
Rule 78, too, sees an alteration in clause (p).
The amendment mirrors the changes in Rule 74 and Rule 76, expanding the scope to include “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.”
Government’s Notification and Consultation Process
The Central government, in collaboration with the Drugs Technical Advisory Board (DTAB), formally notified the amended rules under the Drugs (Amendment) Rules, 2023.
This move signifies a proactive step towards ensuring adherence to good manufacturing practices and establishing stringent requirements for premises, plant, and equipment concerning pharmaceutical products.
Implementation Timeline
As the amended Drugs (….. Amendment) Rules, 2023 come into force, a crucial aspect to consider is the timeline set for their implementation.
This timeline is categorized based on the turnover of pharmaceutical manufacturers, aiming to provide a structured approach to compliance.
Categorization Based on Turnover
Manufacturers are divided into two categories concerning their turnover – large manufacturers with a turnover exceeding 250 crores and small/medium manufacturers with a turnover equal to or less than 250 crores.
This categorization forms the basis for the timelines stipulated for compliance.
Timeline for Large Manufacturers
For large manufacturers falling in the category with a turnover greater than 250 crores, the implementation timeline is set at six months from the date of publication of the amended rules.
This relatively shorter timeframe emphasizes the urgency for these manufacturers to adapt to the new regulatory landscape swiftly.
Timeline for Small and Medium Manufacturers
On the other hand, small and medium manufacturers, encompassing those with a turnover of 250 crores or less, are granted a more extended timeline of twelve months from the date of publication of the rules.
This allows these manufacturers additional time for meticulous planning and execution of the necessary changes.
Evolution of GMP Standards
Introduced in 1988 under Schedule M, GMP standards encompass materials, methods, machines, processes, personnel, and facilities.
The revised rules mark the first amendment in the Drugs and Cosmetics Rules since June 2005, indicating a substantial evolution in the regulatory landscape.
13 Parts of Revised Schedule M
The revised Schedule M comprises 13 parts, each delineating GMP guidelines for specific requirements in the manufacturing of pharmaceutical drugs.
Notably, the updated rules introduce five new categories of drugs, expanding the regulatory framework to cover substances such as:
- Sex hormones, steroids, cytotoxic substances,
- Biological products,
- Radiopharmaceuticals,
- Phytopharmaceuticals, and
- Investigational pharmaceutical products for clinical trials.
Download Schedule M
Download Schedule M dated 28-12-2023
Gist of 31 Chapters on Schedule M
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