Banned Drugs – Scenario in India

Before being put on the market, drugs must pass extensive testing. In clinical trials, their safety and efficacy are first evaluated in animals and subsequently in humans. Some side effects of medications only manifest themselves when they are used in the general public following approval, even with all safety precautions taken. Pharmacovigilance is a practice of routine monitoring used to identify these side effects after a medicine is introduced to the market. The production, marketing, and distribution of certain individual medications as well as fixed dose combinations are prohibited in India. Each specific FDC had its unique safety considerations, and the ban was a collective decision based on expert recommendations. Even if the prohibition seeks to enhance public health, patient, medical professional, and pharmaceutical industry cooperation is needed to carry it out. During this change, effective management and clear communication are crucial. Process of banning drug in India is done by DTAB (Drug technical advisory board) which is the final authority on imposing a ban. Drug controller general of India notifies all state drug authorities and manufacturer about ban on the drug.

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Introduction

Fixed dosage combination, or FDC is a pharmaceutical formulation with two or more active components combined in a predetermined ratio of doses. In pharmaceutical products or medicines, these mixtures are commonly used to treat a variety of diseases or ailments. By using these combinations Patients’ dosage schedules are made simpler and medication adherence may be enhanced. This type of combinations of medicines are used very frequently While treating chronic illnesses, where patients have to take many medications at once. Nonetheless, there has been discussion and examination surrounding the use of FDCs, especially with regard to their efficacy, safety, and potential for abuse. Regulators and medical experts frequently evaluate FDCs to make sure they provide therapeutic benefits without excessive hazards. The approval and use of FDCs may be subject to particular rules and regulations set forth by regulatory bodies in various nations. These combinations are often used to improve patient compliance, simplify dosing schedules, and enhance therapeutic efficacy. However, the use of FDCs has been a subject of debate due to concerns about their safety, efficacy, and potential for misuse. In recent years, the Indian government has implemented regulations to address these concerns and ensure the rational use of FDCs in clinical practice.

The Indian government occasionally outlaws specific medications in order to protect public health and guarantee the efficacy and safety of pharmaceuticals. This page offers a thorough overview of India’s list of medications that are prohibited as of 2023, with an emphasis on public accessibility and clarity. The following are some possible justifications for a drug ban:

Safety issues: Serious side effects, including liver damage, kidney failure, and even death, have been related to the medication. 

Ineffectiveness: It has not been demonstrated that the medication works to treat the intended ailment. 

Problems with quality: The medication is tainted or unclean. 

Manufacturing infractions: The medication was produced in a manner that did not adhere to safety regulations. 

In India, there are around 60,000 branded formulations available. These formulations include a single medication or multiple medications in a fixed dosage combination (FDC). Every composition is used to treat or prevent illnesses. Only a small number of them are necessary and life-saving medications; the majority are instead offered as interchangeable or complementary treatments.”

 

Types of Banned Drugs:

In India, there are two primary classifications of drugs that are prohibited:

Single Drugs: These are single prescription drugs that are not allowed to be used because of safety issues or insufficient evidence for their intended use.

FDC’S: If it is determined that they are dangerous, illogical, or lack sufficient scientific proof to justify their usage, they are outlawed.

Fixed dose combinations used in India

In India, These combinations (FDCs) are commonly used  to treat a wide range of conditions. Some of the commonly used FDCs in India include:

Anti-hypertensive FDCs: These combinations often include two or more drugs from different classes, such as calcium channel blockers, ACE inhibitors, diuretics, beta-blockers,  to effectively control blood pressure.

 

Anti-diabetic FDCs: FDCs combining different classes of antidiabetic medications, such as metformin with sulfonylureas etc are widely used to manage diabetes and associated conditions.

 

Anti-infective FDCs: These type of medicines are commonly used to treat bacterial infections, such as  combinations of antibiotics with different mechanisms of action or combinations of penicillins with beta-lactam antibiotics as inhibitors, or to broaden the spectrum of activity.

 

Anti-tuberculosis FDCs: India is facing a significant increase in number of patients of tuberculosis. Medicines combining multiple anti-tuberculosis drugs are commonly used for the treatment of tuberculosis to improve compliance and reduce the risk of drug resistance.

 

Anti-malarial FDCs: Combination therapies are recommended for the treatment of malaria to prevent the development of resistance. FDCs combining different antimalarial agents are commonly used for this purpose.

 

Analgesic and anti-inflammatory FDCs: Combinations of analgesics and anti-inflammatory drugs, such as paracetamol with nonsteroidal anti-inflammatory drugs (NSAIDs) or muscle relaxants, are used for pain management in conditions like arthritis and musculoskeletal disorders.

 

These are only a few examples, and many more FDCs  are used in India across various therapeutic areas. 

Safety concerns associated with drugs that were banned

The specific safety concerns associated with the 14 fixed-dose combination (FDC) drugs that were banned in India in June 2023 varied depending on each combination. Here are some general reasons for the ban:

 

Lack of Therapeutic Justification: Many of these FDCs lacked clear evidence of improved efficacy or safety compared to individual drugs taken separately. The absence of robust clinical data supporting their combined use raised concerns.

 

Risk of Adverse Effects: Some FDCs had the potential to cause adverse effects due to interactions between their components. For example, combining certain antihistamines with cough suppressants or sedatives could lead to excessive drowsiness or respiratory depression.

 

Unapproved Combinations: Some FDCs were formulated without proper regulatory approval or scientific validation.The Indian government emphasized the need for evidence-based combinations.

 

Overuse and Misuse: Inappropriate prescribing and overuse of FDCs can lead to drug resistance, adverse reactions, and treatment failure. The ban aimed to curb unnecessary consumption.

 

Public Health Impact: Ensuring patient safety and promoting rational drug use were key drivers behind the ban.The government sought to protect public health by restricting access to questionable FDCs.

FDC Banned in india

According to an expert panel’s recommendations, the Indian government has banned 14 types of fixed-dose combination (FDC) medicines recently in 2023. In 2016 also a Supreme Court-appointed expert panel found that 344 drug combinations were being sold to patients without adequate scientific support. The manufacturers then challenged the order in court, and the government announced that these 344 drug combinations would no longer be manufactured, sold, or distributed.

 

These 344 medication combinations include the 14 FDCs that are currently prohibited.

These medicines are banned due to a lack of therapeutic justification and potential risks to humans. The FDCs that have been banned include Nimesulide+ Paracetamol dispersible tablets and Pholcodine+ Promethazine, amongst others. Regarding this, a notification was also released by the Union Health Ministry. The following are some specific medications that are prohibited in India : 

For example some of the drugs used for Obesity and Weight Loss are sibutramine, rimonabant, fenfluramine, dexfenfluramine, and phenylpropanolamine. Many overweight and obese persons in India had optimism when weight loss medications were introduced to the market. These medications promised to lessen the negative effects of obesity on health in addition to helping patients feel better about their bodies. Regretfully, these medications have to be discontinued due to their significant adverse effects. The cardiovascular system was impacted, which were linked to heart valve disorders, fibrous tissue development in the heart, and pulmonary hypertension (high blood pressure in the lung circulation). Among the recently prohibited medications mostly were those for fever, cough, and common illnesses.

 

List of prohibited Single Drugs:

1. Metronidazole (topical application for acne)

2. Phenylpropanolamine

3. Phenacetin

4. Amidopyrine

5. Nialamide

6. Furazolidone

7. Oxyphenbutazone

8. Chloramphenicol (Except for ophthalmic and topical preparations)

List of prohibited FDCs:

In December 2023, a total of 14 FDCs have been banned in India. These include:

 

1) Amoxicillin + Bromhexine

2) Nimesulide + Paracetamol Dispersible Tablet

3) Pholcodine + Promethazine

4) Chlopheniramine Maleate + Dextromethorphan +Guaiphenesin + Ammonium chloride + Menthol

5) Chlopheniramine Maleate + Codeine syrup

6) Ambroxol Hydrochloride + Gen + Levosalbutamol + Menthol

7) Dextromethorphan Hydrobromide + Ambroxol Hydrochloride + Guaiphenesin

8) Diphenhydramine Hydrochloride + Phenylephrine Hydrochloride + Ammonium Chloride

9) Dextromethorphan Hydrobromide + Doxylamine Succinate + Phenylephrine Hydrochloride

10) Dextromethorphan Hydrobromide + Phenylephrine Hydrochloride + Chlorpheniramine Maleate

11) Ambroxol Hydrochloride + Guaiphenesin + Levosalbutamol + Menthol

12) Pholcodine + Dextromethorphan Hydrobromide + Chlorpheniramine Maleate

13) Ambroxol Hydrochloride + Dextromethorphan Hydrobromide + Guaiphenesin

14) Dextromethorphan Hydrobromide + Doxylamine Succinate + Guaifenesin

 

Impact on patients and healthcare providers

The ban on 14 types of fixed-dose combination (FDC) medicines in India could have several implications for patients and healthcare providers:

Patient Impact:

Availability of Medications: The accessibility of substitute drugs may present difficulties for patients who were taking these prohibited FDCs. Healthcare professionals will have to direct patients toward appropriate substitutes. 

Treatment interruption: Patients who were dependent on the prohibited FDCs may have treatment interruption. Healthcare professionals will need to handle this change with caution. 

Health Outcomes: Patient health outcomes may be impacted by stopping some FDCs, depending on how serious the underlying illness is. Throughout this shift, providers should keep a careful eye on their patients.

Affordability: The price of substitute drugs may differ. The new solutions may be more costly for some patients, which would increase their financial burden.

Healthcare Provider Impact:

Prescription Practices: In order to avoid prescribing the prohibited FDCs, healthcare providers will need to change their protocols. They ought to inform patients about appropriate substitutes and be knowledgeable about them. 

Patient Counseling: Healthcare professionals ought to advise patients on the rationale for the prohibition, possible hazards, and the necessity of switching to substitute drugs.

Monitoring and Reporting: Healthcare professionals are essential in keeping track of how patients react to novel treatments and in reporting any unfavorable side effects. 

Legal Compliance: In order to avoid prescribing the forbidden FDCs, healthcare organizations and providers must abide by the restriction. 

Pharmaceutical Industry Impact:

Manufacturers: Businesses that make the prohibited FDCs will experience a decline in sales. They might have to change their attention to other items. 

Supply Chain: The elimination of these FDCs will need adjustments to the supply chain. Pharmacies and distributors need to refresh their stock.

Research and Development: Studies into safer and more efficient substitutes may be aided by the prohibition. 

Exceptions or special cases where these drugs could still be used:

Although all 14 types of fixed-dose combination (FDC) medications are prohibited, there may be unique circumstances or exceptions that allow the use of these medications. Here are several examples: 

Research and Clinical Trials: A specific FDC can be permitted under strict guidelines if it is a component of a continuing clinical trial or research project. When doing research, institutions and researchers should adhere to ethical standards and secure the required authorizations. 

Specific Patient Information: A patient’s particular medical situation may occasionally call for the use of an FDC that is prohibited. If there are no appropriate alternatives available for a specific patient, healthcare providers may request special approval to prescribe certain medications. These requests are assessed individually for each circumstance. 

Emergencies: 

Transition Period: For patients already using the banned FDCs, a transition period might be allowed to switch to alternative medications. This grace period allows patients to adjust without abrupt treatment changes.

Veterinary Use: The ban primarily applies to human medications. Veterinary use of these FDCs might still be permitted.

Legal Challenges and Appeals: Manufacturers or healthcare providers can challenge the ban legally. If a court grants a stay or modifies the ban, exceptions may arise.

Conclusion

There are still a lot of fake medications being sold in India that have been outlawed, taken off the market, or subject to other limitations in other nations. The lives of thousands of people who are unaware of the dangerous effects of the pharmaceuticals that pharmaceutical firms and defaulters offer are being played with. According to a report of  World Health Organization not even  a single case of an adverse drug reaction has been documented in the nation about any substance. But the business of production of these type of discarded drugs is booming in India.

Ms. Ranjna Rani

Ms. Ranjna Rani

Assistant Professor,
Geeta Institute of Pharmacy,
Geeta University, Panipat

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