The Central Drugs Standard Control Organisation (CDSCO) has recently announced a ban on the manufacture, sale, and distribution of 35 Fixed Dose Combinations (FDCs) across India. This move is part of a broader regulatory effort to enhance the scientific rigour behind drug approvals and align India’s pharmaceutical practices with global standards. Announced on April 11, 2025, the ban follows earlier actions such as the prohibition of 156 FDCs in August 2024, reflecting the government’s commitment to eliminating unsafe medicines.

FDCs are formulations that combine two or more active pharmaceutical ingredients in a fixed ratio and have long been prevalent in the Indian market, offering convenience in treating various ailments. However, concerns around irrational combinations, lack of clinical justification, and potential risks to patient safety have led to increasing scrutiny.

The CDSCO banned these 35 FDCs, including combinations like Nefopam Hydrochloride + Paracetamol (for pain relief) and Cefixime + Ofloxacin + Lactic Acid Bacillus (an antibiotic-probiotic mix), for several compelling reasons:

1. Lack of CDSCO Approval: These FDCs were approved by state authorities without CDSCO clearance, bypassing mandatory clinical trials required to prove their safety and efficacy.
   
2. Health Risks: These combinations can pose health hazards such as allergic reactions, gastrointestinal issues, or liver toxicity, especially when the ingredients do not work synergistically. Antibiotic FDCs, in particular, contribute to antimicrobial resistance (AMR), a growing public health crisis in India.
   
3. Lack of Therapeutic Advantage: Expert reviews found these FDCs offered no significant advantage over individual drugs or safer alternatives.

FDCs have played a vital role in India’s pharmaceutical landscape, simplifying treatment regimens, improving patient adherence, and being crucial in managing diseases such as tuberculosis, diabetes, and various infections. They account for roughly 40–50% of India’s ₹1.3 trillion ($15.6 billion) pharmaceutical market, driven by their affordability and ease of use, especially in regions with limited healthcare access. However, not all FDCs are scientifically validated, prompting necessary action by regulatory authorities.

A 2023 World Health Organisation (WHO) study noted that 41.5% of antibiotic FDC sales in India in 2020 involved combinations that were “not recommended.” Historically, many state authorities issued licenses without central oversight, resulting in the proliferation of thousands of unapproved FDCs. Additionally, some pharmaceutical companies used FDCs to evade price controls, marketing them at higher prices despite questionable benefits. India’s under-resourced pharmacovigilance system has struggled to monitor the adverse effects of such drugs, making regulatory crackdowns critical for public safety.

Beyond the ban, India’s over-the-counter medicine ecosystem faces broader challenges. Prescription-only drugs are frequently dispensed without proper authorisation, undermining patient safety. Banned or restricted medicines, including FDCs, often continue to be sold due to weak enforcement. Regulatory updates, such as bans, rarely reach pharmacists and retailers promptly. The CDSCO’s practice of uploading circulars online is insufficient for India’s fragmented and vast retail network. This communication gap leaves pharmacists unaware of their legal and ethical obligations, exposing consumers to risk, eroding trust in regulators, and burdening the healthcare system.

This recent ban will impact India’s pharmaceutical industry, a global leader in generics, in multiple ways. Financially, the impact is modest for large companies with diversified portfolios. For instance, the 2018 ban on 328 FDCs affected only ₹2,500 crore of the market. However, smaller firms that depend heavily on FDC sales may face significant revenue challenges. The ban encourages companies to invest in evidence-based, scientifically justified FDCs, thereby aligning with global standards, but this also increases resource demands, especially for smaller players. It helps declutter the market, creating a more level playing field for compliant firms. However, some may attempt to reformulate non-banned FDCs to circumvent regulations. While the ban reinforces India’s reputation as the “pharmacy of the world,” frequent regulatory actions and legal disputes may signal instability and create uncertainty in the industry.

Also Read :- U.S. Issues Most-Favoured-Nation Drug Pricing Order: Implications for Indian Pharma & Global Healthcare Markets

To address these issues, India must undertake systemic reforms. A centralised digital notification system using SMS, email, or mobile apps could ensure that pharmacists receive timely updates on regulatory changes. Mandatory training and certification programs could educate pharmacists on compliance and best practices. A collaborative framework involving regulators, industry stakeholders, and retailers could streamline communication, while regular audits linked to pharmacy licensing could enforce compliance. An API-based platform integrated with pharmacy software systems could provide real-time alerts, enabling immediate adherence to regulatory updates.

The ban on these 35 FDCs marks a crucial step toward ensuring safer medicines in India by addressing the risks associated with irrational and untested drug combinations. However, it also highlights deeper systemic flaws in the pharmaceutical retail ecosystem, from lax prescription practices to inadequate communication channels. By implementing comprehensive reforms, India can fortify its regulatory framework, better safeguard public health, and strengthen its leadership in the global pharmaceutical arena.

By Rishi Agrawal, CEO and Co-Founder, TeamLease RegTech

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