The Unapproved Fixed-Dose Combination Drugs in India: A Public Health Concern

By Staff Writer

November 25, 2023

The Ongoing Issue of Unapproved Fixed-Dose Combination Drugs in India

The regulation of medicines in India, a responsibility shared between the central government and individual states, has been a source of friction and calls for reform. One area of notable concern has been the regulation of Fixed-Dose Combination drugs (FDCs), specifically antibiotic FDCs. Despite regulatory initiatives since 2007, hundreds of unapproved antibiotic FDC formulations remained on the Indian market, Accounting for over 700 million of the 4.5 billion standard units sold in 2020. This issue extends beyond India’s borders, contributing to the global concern of increasing antimicrobial resistance.

The Impact on Public Health and Global Concerns

India’s vast sales of centrally unapproved FDCs pose a significant public health concern. This concern escalates when considering the context of increasing antimicrobial resistance. In 2020, 41.5% of the 4.5 billion standard units of antibiotic FDCs sold were attributed to combinations listed as ‘not recommended’ by WHO. The limited progress in controlling these FDCs is a result of weak, convoluted, and inefficient regulatory enforcement.

Recommendations and Further Steps

Regular surveillance of the market, informed regulatory enforcement, and antimicrobial stewardship are recommended. Criminal proceedings should be considered against manufacturers of the formulations marketed without a record of prior Central Drugs Standard Control Organisation (CDSCO) approval. The prescription of only well-evidenced FDCs, such as those listed in National List of Essential Medicines (NLEM), would reduce the use of FDCs and facilitate antimicrobial stewardship. Further research is needed on the control measures and trends in sales of FDCs in other therapeutic areas.

Reference url

Recent Posts

implantable glucose device
         

T1 Diabetes Care with an Implantable Glucose Device

🚀 Are we on the brink of a diabetes breakthrough?

A newly developed implantable glucose device from MIT could revolutionize diabetes management, providing an autonomous solution to prevent life-threatening hypoglycemic episodes. This innovative device combines continuous glucose monitoring with responsive hormone delivery, potentially transforming patient care by reducing the need for constant oversight.

Curious about how this technology could reshape diabetes outcomes and healthcare economics? Dive into the full article for a closer look!

#SyenzaNews #HealthTech #HealthEconomics #Innovation

federated learning governance
      

Federated Learning Governance in Healthcare: A Framework for Ethical and Effective Implementation

🔍 Have you considered how federated learning governance can revolutionize healthcare data collaboration?

In our latest article, we explore the critical principles of federated learning governance, emphasizing its role in managing decentralized health data while protecting patient privacy and improving research quality. Learn about the actionable strategies healthcare organizations can implement to navigate the unique challenges that come with this innovative approach.

Dive deeper into the world of federated learning in healthcare and unlock its potential for ethical and effective data use!

#SyenzaNews #AIinHealthcare #DigitalHealth

Cecolin 9 HPV vaccine
        

Cecolin 9 HPV Vaccine: A Game Changer for Cervical Cancer Prevention in China

🌍 Did you know that China has just achieved a historic milestone in the fight against cervical cancer?

The approval of the Cecolin 9 HPV vaccine, the first domestically developed 9-valent HPV vaccine, marks a transformative moment for public health, enhancing access and affordability across the nation. This development not only meets global health goals but also reshapes the landscape of cervical cancer prevention in China.

Curious to learn how this advancement is set to impact vaccination efforts and healthcare economics? Dive into the full article for deeper insights!

#SyenzaNews #globalhealth #HealthEconomics

When you partner with Syenza, it’s like a Nuclear Fusion.

Our expertise are combined with yours, and we contribute clinical expertise and advanced degrees in health policy, health economics, systems analysis, public finance, business, and project management. You’ll also feel our high-impact global and local perspectives with cultural intelligence.

SPEAK WITH US

CORRESPONDENCE ADDRESS

1950 W. Corporate Way, Suite 95478
Anaheim, CA 92801, USA

JOIN NEWSLETTER

© 2025 Syenza™. All rights reserved.