Companies must adhere to WHO standard manufacturing practices || Say union minister

New Delhi: Union Health Minister Mansukh Mandaviya announced on Wednesday that pharmaceutical companies with an annual turnover exceeding ₹250 crore will be required to implement Good Manufacturing Practices (GMP) within six months. Companies with a turnover of less than ₹250 crore will have a 12-month timeline for adoption.

Failure to adhere to these timelines could lead to penalties in accordance with the law, Minister Mandaviya emphasized.

He noted that the draft of Schedule M of the Drugs and Cosmetics Act, prepared in 2018, has now been sanctioned and put into action.

India houses approximately 10,500 manufacturing units, with around 8,500 classified as MSMEs (Micro, Small, and Medium Enterprises).

India, a significant exporter of medicines to Low and Middle-Income Countries (LMICs), is mandated to hold WHO GMP certification. The nation currently boasts around 2,000 MSME units with WHO GMP certification.

Mandaviya remarked, "The pharmaceutical manufacturing and quality sector has made significant strides over the last 15-20 years. Our comprehension of the field has expanded due to advancements in Pharmaceutical and Manufacturing Sciences. The connection between manufacturing and product quality has been solidified."

The existing Schedule M under the Drugs Rules, 1945 outlines various facility requirements and regulations for personnel, manufacturing, control, safety testing, storage, transport, written procedures, records, traceability, and more.

The incorporation of GMP into Schedule M dates back to 1988, with the most recent amendment occurring in 2018.

"The majority of drug manufacturers have not properly implemented Schedule M (of the Drugs and Cosmetics Act)," Mandaviya noted.

The health ministry also underlined that ongoing risk-based inspections have highlighted the necessity to review the current GMP regulations and quality management systems employed by pharmaceutical manufacturers.

A recent inspection of 162 units and 14 public testing labs revealed major concerns including inadequate documentation, insufficient process and analytical validations, lack of quality failure investigation, absence of internal product quality reviews, and flawed design of manufacturing and testing spaces.

"To align with the swiftly evolving manufacturing and quality landscape, it was imperative to revisit and revise the principles and concepts of GMP outlined in the current Schedule M," the ministry stated.

The revised Schedule M will introduce key changes aimed at enhancing unit capabilities. These changes include the implementation of a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), Product Quality Review (PQR), equipment qualification and validation, change control management, self-inspection and quality audit teams, supplier audits and approval, stability studies in recommended climate conditions, validation of GMP-related computerized systems, and specific requirements for manufacturing hazardous, biological, radiopharmaceutical, and phytopharmaceutical products.

These adjustments are expected to address issues related to documentation, failure investigation, and qualified personnel, fostering the establishment of robust quality management systems within companies and ensuring the production of globally accepted quality medicines, the ministry concluded.

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