India’s Government Takes Bold Step: Ban on Fixed Dosage of 156 Drug Combinations

In a significant move aimed at improving public health, the Indian government has recently announced a ban on 156 fixed-dose drug combinations (FDCs). This decision, which has sparked considerable debate, reflects a growing emphasis on regulating the pharmaceutical industry to ensure drug safety and efficacy. Let’s delve into the implications of this ban and what it means for patients, healthcare providers, and the broader healthcare landscape in India.

Understanding the Ban

Fixed-dose combinations (FDCs) are pharmaceuticals that combine two or more active ingredients into a single dosage form. While FDCs can offer convenience and potentially enhanced efficacy for certain conditions, they have also come under scrutiny for their safety and effectiveness. The government’s decision to ban these specific FDCs stems from concerns about their therapeutic benefit, safety profiles, and the potential risks they pose to patients.

The 156 FDCs banned include a range of medications used for various health conditions such as cough and cold, pain relief, and gastrointestinal issues. The ban affects both over-the-counter and prescription medications, reflecting a broad effort to ensure that all medications meet stringent safety and efficacy standards.

The announcement states that an expert group appointed by the central government as well as the Drug Technical Advisory Board (DTAB) made recommendations that were considered in making this decision.

“The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs,” the notification stated.

The ministry added that two committees — including one under the Central Drugs Standard Control Organisation’s (CDSCO) Drugs Technical Advisory Board (DTAB) — examined the FDCs and found that “there is no therapeutic justification for the ingredients contained” in the combination drug while they may involve “risk to humans”.

The list of major FDC medicines includes a combination dose of Omeprazole Magnesium and Dicyclomine HCl which is used for treating stomach pain, as well as a combination of Mefenamic Acid and Paracetamol Injection for reducing pain and swelling in various diseases.

Additional FDCs include a combination of povidone iodine, metronidazole, and aloe used to prevent and cure skin infections, as well as ursodeoxycholic acid and metformin HCl used to treat fatty liver in diabetics.

In the notification, the government has said that it feels that these FDCs are “likely to involve risk to human beings whereas safer alternatives to the said drug are available”.

“The DTAB did not find the claims of these combination medicines correct and took the decision considering that the harm to the patient is more than the benefit,” the gazette notification stated. “Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act 1940,” the ministry added.

Impact on the Pharmaceutical Industry

The pharmaceutical industry is likely to experience several effects from this ban:

-Market Adjustments: Pharmaceutical companies producing the banned FDCs will need to adapt their strategies, either by reformulating their products or focusing on other areas of the market.

Regulatory Scrutiny: The ban underscores the need for rigorous regulatory practices and may prompt other companies to reassess their FDCs to ensure compliance with safety and efficacy standards.

Looking Ahead

The ban on 156 FDCs is a bold step in the Indian government’s ongoing efforts to enhance drug safety and efficacy. While it may pose challenges in the short term, the long-term benefits of improved patient safety and more effective treatments are significant. As the healthcare system adapts to these changes, it will be important for all stakeholders—patients, healthcare providers, and pharmaceutical companies—to collaborate and navigate this transition effectively.