Karnataka Health Minister Calls on Pharma Sector to Embrace New Standards

The Health and Family Welfare Minister of Karnataka, Dinesh Gundu Rao, has urged the pharmaceutical industry to adhere strictly to new regulations aimed at enhancing public health and the sector’s credibility. This call to action was made during a workshop organized by the Indian Pharmaceutical Association (IPA) Karnataka branch, in collaboration with the Karnataka Drugs and Pharmaceuticals Manufacturers’ Association (KDPMA), held on Saturday in Bengaluru.

Modernizing Good Manufacturing Practices

Minister Rao addressed key issues affecting the pharmaceutical landscape, highlighting the government’s initiative to modernize India’s Good Manufacturing Practices (GMP). The revised Schedule M of the Drugs and Cosmetics Act, 1945, aims to align Indian manufacturing standards with global benchmarks, including those set by the World Health Organization.

“The Government has notified the revised Schedule M to modernize India’s GMP in alignment with global standards,” said Rao. The updated guidelines, published in 2023, introduce comprehensive quality systems and emphasize efficiency, traceability, and improved training for personnel. Enhanced documentation practices, digital compliance, and stringent environmental controls are also key components of the revised standards.

Addressing Quality Concerns

Rao emphasized that these regulatory changes should be viewed as investments rather than burdens. He pointed out the ongoing issue of Not of Standard Quality (NSQ) drugs, which pose significant risks to public health. “I want to make it clear that there will be no tolerance against NSQ,” he stated. Recent surveillance data indicated that failures in quality adherence, inadequate testing, and lapses in documentation have contributed to the spread of NSQ products.

“Following the revised Schedule M is a must, and trained faculty and employees and regulation of NSQs are mandatory,”

said Dr. Umesh S, Additional Drug Controller, reinforcing the importance of compliance for the industry’s future. The minister’s remarks and the workshop’s focus on regulatory changes signal a pivotal shift in how the pharmaceutical sector in Karnataka will operate moving forward, as it seeks to enhance its global standing and ensure the safety of its products.

As the pharmaceutical industry adapts to these new regulations, stakeholders are encouraged to engage actively with the guidelines to foster a culture of quality and accountability. The health of the public and the integrity of the pharmaceutical sector depend on rigorous adherence to these standards.