Government proposes new rules for tighter oversight of antibiotics and diabetes drugs

The Indian government plans to introduce stricter regulations to ensure the safety and effectiveness of commonly used medicines such as antibiotics and diabetes medications through proposed amendments to the Drugs and Cosmetics Rules, 1945.

The proposed changes focus on introducing a new Schedule G, which is to list specific medicines that are subject to heightened regulatory scrutiny. Including medicines on this Schedule will require additional compliance measures and potentially more stringent oversight.

Schedule G drugs include critical drugs that play a key role in public health, such as antibiotics like ceftriaxone and amoxicillin, used to treat severe infections, vaccines that are key to preventing diseases like tetanus and hepatitis B, and life-saving drugs for chronic diseases, such as insulin and metformin, used to treat diabetes and high blood pressure. These drugs are essential for treating and controlling a variety of conditions, making their regulation crucial to protecting the health and well-being of patients, according to government officials.

“These drugs are considered essential because of their significant impact on disease management and improved patient outcomes. The proposed changes aim to strengthen oversight and regulation of these drugs to ensure they meet rigorous standards of safety, efficacy and quality,” a Ministry of Health and Human Services official said. “By explicitly including Schedule G drugs in the regulatory framework, we aim to strengthen oversight mechanisms to maintain their safety and efficacy,” the official added.

The draft rules, titled Drugs Rules (Amendment), 2024, are now open for public comments and objections for a period of 45 days. The government has encouraged stakeholders, including pharmaceutical companies, healthcare providers and the general public, to contribute their insights to help shape the rules. “These amendments will enable us to adopt best practices in regulatory governance, thereby increasing public confidence in the quality of medicines available in the country,” the official said.