Govt proposes new rules for tighter oversight of antibiotics and diabetes drugs
The proposed amendments focus on introducing a new Schedule G, which is expected to list specific drugs under heightened regulatory scrutiny.
- Jul 15, 2024,
- Updated Jul 15, 2024 7:56 AM IST
The Indian government plans to introduce stricter regulations to ensure the safety and efficacy of commonly used drugs such as antibiotics and diabetes medications through proposed amendments to the Drugs and Cosmetics Rules, 1945.
The proposed amendments focus on introducing a new Schedule G, which is expected to list specific drugs under heightened regulatory scrutiny. The inclusion of drugs in this schedule will necessitate additional compliance measures and potentially stricter oversight.
Schedule G drugs include critical medications that play a pivotal role in public health, such as antibiotics like Ceftriaxone and Amoxicillin used to treat severe infections, vaccines crucial for preventing diseases like Tetanus and Hepatitis B, and life-saving drugs for chronic conditions such as insulin and metformin for diabetes management and hypertension. These drugs are vital for managing and controlling various health conditions, making their regulation critical to safeguarding patient health and well-being, according to government officials.
"These medicines are deemed essential due to their significant impact on treating diseases and improving patient outcomes. The proposed amendments seek to enhance the oversight and regulation of these drugs to ensure they meet stringent safety, efficacy, and quality standards," stated an official from the Ministry of Health and Family Welfare. "By explicitly incorporating Schedule G drugs into the regulatory framework, we aim to strengthen oversight mechanisms to uphold their safety and efficacy," the official added.
The draft rules, titled the Drugs Rules (Amendment), 2024, are now open for public feedback 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 these regulations. "These amendments will enable us to adopt best practices in regulatory governance, thereby enhancing public confidence in the quality of medicines available in the country," said the official.
The Indian government plans to introduce stricter regulations to ensure the safety and efficacy of commonly used drugs such as antibiotics and diabetes medications through proposed amendments to the Drugs and Cosmetics Rules, 1945.
The proposed amendments focus on introducing a new Schedule G, which is expected to list specific drugs under heightened regulatory scrutiny. The inclusion of drugs in this schedule will necessitate additional compliance measures and potentially stricter oversight.
Schedule G drugs include critical medications that play a pivotal role in public health, such as antibiotics like Ceftriaxone and Amoxicillin used to treat severe infections, vaccines crucial for preventing diseases like Tetanus and Hepatitis B, and life-saving drugs for chronic conditions such as insulin and metformin for diabetes management and hypertension. These drugs are vital for managing and controlling various health conditions, making their regulation critical to safeguarding patient health and well-being, according to government officials.
"These medicines are deemed essential due to their significant impact on treating diseases and improving patient outcomes. The proposed amendments seek to enhance the oversight and regulation of these drugs to ensure they meet stringent safety, efficacy, and quality standards," stated an official from the Ministry of Health and Family Welfare. "By explicitly incorporating Schedule G drugs into the regulatory framework, we aim to strengthen oversight mechanisms to uphold their safety and efficacy," the official added.
The draft rules, titled the Drugs Rules (Amendment), 2024, are now open for public feedback 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 these regulations. "These amendments will enable us to adopt best practices in regulatory governance, thereby enhancing public confidence in the quality of medicines available in the country," said the official.