Revised Schedule M: Govt sets deadline for pharma industry

Now, WHO-GMP standards have been seamlessly integrated into the revised Schedule M.


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Last Updated on December 31, 2023 by The Health Master

Revised Schedule M

In a significant move to elevate the quality management standards of Indian pharmaceutical manufacturers, the Health Ministry has unveiled a crucial initiative for the revised schedule M.

This entails a mandatory requirement for small-scale manufacturers to obtain their World Health Organization-Good Manufacturing Practices (WHO-GMP) certification within six months, while larger units have been granted a 12-month window to achieve the same.

Understanding GMP and Schedule M:

The cornerstone of this endeavor lies in the realm of good manufacturing practices (GMP), which encompasses indispensable standards that instill and uphold quality in products.

These standards cover a comprehensive array of elements, including materials, methods, machinery, processes, personnel, and the facility environment.

Originally integrated into Schedule M of the Drugs and Cosmetics Rules in 1988, the last revision took place in June 2005.

Now, WHO-GMP standards have been seamlessly integrated into the revised Schedule M.

Schedule M sets forth a meticulous framework of requisites concerning facility maintenance, personnel, manufacturing processes, control and safety testing, material storage and transport, written procedures and records, traceability, and more.

Addressing critical issues:

A senior official from the Health Ministry has revealed pivotal insights garnered from ongoing risk-based inspections. The observations underscored the urgency to reevaluating the existing GMP regulations and quality management systems adopted by pharmaceutical manufacturers.

Among the significant concerns identified were deficient documentation, insufficient process and analytical validations, the absence of self-assessment, a lack of quality failure investigation, and the scarcity of internal product quality reviews.

Other concerns encompassed the omission of testing for incoming raw materials, infrastructural inadequacies to thwart cross-contamination, dearth of professionally qualified staff, and flawed design of manufacturing and testing areas.

Revitalizing GMP Principles:

To keep pace with the dynamic landscape of manufacturing and quality assurance, a substantial overhaul of the GMP principles articulated in Schedule M became imperative.

In 2018, a preliminary draft notification was issued to modernize and harmonize Schedule M in line with international benchmarks.

Recognizing the pivotal role of the updated and revised GMP guidelines in upholding drug quality, the Government has resolved to finalize the draft rules.

The timeline extended to the industry is aimed at facilitating a seamless transition from the existing Schedule M to the revamped version.

Ensuring Compliance and Accountability:

It is worth noting that while WHO-GMP certification remains valid for a period of three years, any breach of compliance may result in the revocation of licenses and the imposition of monetary penalties, as asserted by the Ministry.

Noteworthy Changes with Revised Schedule M:

With the introduction of the revised Schedule M, a host of substantial alterations are on the horizon.

These encompass:

  • Introduction of the pharmaceutical quality system (PQS)
  • Implementation of quality risk management (QRM)
  • Initiation of product quality review (PQR)
  • Rigorous qualification and validation of equipment
  • Robust change control management
  • Inclusion of self-inspection
  • Establishment of a quality audit team
  • Implementation of supplier audit and approval processes
  • Rigorous stability studies aligned with recommended climate conditions
  • Validation of GMP-related computerized systems
  • Specific requirements for the manufacture of hazardous products

Impact on the Pharmaceutical Landscape:

Of the approximately 10,500 manufacturing units in the country, nearly 8,500 belong to the Micro, Small, and Medium Enterprises (MSME) category.

India stands as a prominent exporter of medicines to low- and middle-income countries, a feat necessitating WHO-GMP certification.

Presently, the country boasts about 2,000 MSME units with this coveted certification, attesting to the nation’s commitment to global pharmaceutical quality standards.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

Understanding GMP, cGMP, and WHO-GMP

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