Govt Banned 156 FDC Medicines Commonly Used - Here's the list of banned medicines

In a significant move aimed at safeguarding public health, the Indian Govt banned 156 FDC medicines. This decision follows extensive recommendations from an Expert Committee appointed by the Central Government, which concluded that these combinations were “irrational” and posed potential health risks. The list includes commonly used antibiotics, painkillers, and multivitamins, all of which have now been outlawed from production, marketing, and distribution in India.

What Are Fixed Dose Combination (FDC) Medicines?

Fixed Dose Combination (FDC) medicines are pharmaceutical products that contain two or more active ingredients in a fixed ratio. These combinations are designed to improve patient compliance by reducing the number of pills they need to take. However, not all FDCs are beneficial; some can be irrational, meaning that the combination of drugs either does not provide additional therapeutic benefit or, worse, can lead to increased risks and side effects.

Why Govt Banned 156 FDC medicines ?

The recent ban on 156 FDC medicines was not made lightly. The decision was based on the recommendations of the Drug Technical Advisory Board (DTAB) and an Expert Committee, both of which found these combinations to be irrational. The central government, convinced by these findings, concluded that the use of these FDCs could potentially harm patients, particularly when safer alternatives are available, that’s why Govt banned 156 FDC medicines.

The Health Ministry issued a gazette notification on August 21, stating that the Govt banned 156 FDC medicines includes antibiotics, anti-allergic drugs, analgesics, multivitamins, and combinations used to treat conditions like fever and hypertension. The notification emphasized that the decision was made in the interest of public health, with the primary goal of eliminating unnecessary health risks.

What Makes an Govt Banned 156 FDC medicines Irrational?

An FDC is deemed irrational when the combination of drugs does not have a justified therapeutic benefit or when the risks outweigh the benefits. For instance, some of the banned FDCs included combinations that had no proven additional advantage over individual drugs taken separately. In some cases, the interactions between the drugs in the combination could lead to harmful side effects or reduced efficacy.

The Expert Committee and the DTAB found that many of these banned FDCs offered no therapeutic justification. Moreover, the presence of multiple active ingredients in these combinations could increase the risk of adverse drug reactions, making their use dangerous, especially when safer alternatives exist, that’s why Govt banned 156 FDC medicines.

A Closer Look at the Banned Medicines

The list of Govt banned 156 FDC medicines include a wide range of commonly used medications. For example, the combination of Omeprazole Magnesium and Dicyclomine HCl, often used to treat stomach pain, has been prohibited. Another banned combination is Mefenamic Acid and Paracetamol, commonly used for pain and swelling. These combinations were found to be irrational, with the potential for significant health risks.

Additionally, combinations like Povidone Iodine, Metronidazole, and Aloe, used for preventing and treating skin infections, and Ursodeoxycholic Acid and Metformin HCl, used for treating fatty liver in diabetics, were also included in the banned list. The DTAB concluded that the harm to patients from these combinations far outweighed any potential benefits.

Fixed Dose Combinations: Benefits and Risks

While FDCs can offer certain benefits, such as improved patient compliance and reduced pill burden, they also come with significant risks. The primary concern with FDCs is that the fixed ratio of drugs may not be suitable for all patients. For instance, one component of the combination may be required in a higher dose than the other, but the fixed ratio does not allow for this flexibility.

Furthermore, the presence of multiple active ingredients increases the likelihood of drug interactions, which can lead to adverse effects. In some cases, one drug in the combination may reduce the effectiveness of the other, making the FDC less effective than individual drugs taken separately.

The Role of Regulatory Bodies in Ensuring Drug Safety

The Govt banned 156 FDC medicines highlights the critical role of regulatory bodies in ensuring the safety and efficacy of medicines. The Drugs Technical Advisory Board (DTAB) and the Expert Committee were instrumental in evaluating these FDCs and recommending their prohibition. Their rigorous analysis and review process ensured that only those combinations that posed significant health risks were banned.

The Drugs and Cosmetics Act, 1940, under which these bans were enforced, empowers the government to prohibit the manufacture, sale, or distribution of drugs that are found to be unsafe or lacking in therapeutic justification. This act serves as a safeguard for public health, ensuring that only safe and effective medicines are available to consumers.

The Impact of the Ban on the Pharmaceutical Industry

The ban on these FDCs is likely to have a significant impact on the pharmaceutical industry. Manufacturers of these combinations will need to halt production and distribution, potentially leading to financial losses. However, this move also presents an opportunity for the industry to innovate and develop safer, more effective drug formulations.

For pharmaceutical companies, the ban serves as a reminder of the importance of rigorous research and development. Ensuring that drug combinations are both safe and effective is crucial, not only for regulatory approval but also for maintaining public trust.

Public Reaction and Industry Response

The response to the ban has been mixed. While some in the pharmaceutical industry have expressed concerns about the financial impact, others have welcomed the move as a necessary step to protect public health. Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance, stated that the decision is in the best interest of patients and is a result of ongoing discussions and recommendations from various expert committees.

The public, on the other hand, has largely supported the ban, with many people expressing relief that potentially harmful medicines are being removed from the market. The ban has also sparked discussions about the importance of informed decision-making when it comes to medication use.

The Legal Background: Section 26A of the Drugs and Cosmetics Act

The Govt banned 156 FDC medicines was enforced under Section 26A of the Drugs and Cosmetics Act, 1940. This section gives the central government the authority to prohibit the manufacture, sale, or distribution of any drug that is found to be unsafe or lacking in therapeutic justification. The use of this legal provision underscores the seriousness of the government’s commitment to ensuring drug safety.

The decision to ban these FDCs was not taken lightly. The Expert Committee and the DTAB conducted thorough evaluations of each combination, considering factors such as therapeutic efficacy, safety, and the availability of safer alternatives. Only after these rigorous assessments were the bans recommended and subsequently enforced.

Govt banned 156 FDC medicines .
Medicines on a table ( Representative pic )

The Future of FDCs in India

The Govt banned 156 FDC medicines raises important questions about the future of combination medicines in India. While FDCs can offer benefits, particularly in improving patient compliance, it is essential that these combinations are both safe and effective. The ban highlights the need for ongoing vigilance and regulation to ensure that only rational and beneficial combinations are approved for use.

For patients, the ban serves as a reminder of the importance of being informed about the medications they take. Patients should consult their healthcare providers before starting any new medication, especially combination therapies, to ensure that the benefits outweigh the risks.

The government’s decision to ban 156 fixed dose combination medicines is a significant step toward ensuring public health and safety. While FDCs can offer benefits in terms of convenience and compliance, it is crucial that these combinations are both safe and effective. The ban, enforced under Section 26A of the Drugs and Cosmetics Act, 1940, reflects the government’s commitment to eliminating irrational and potentially harmful drug combinations from the market.

As the pharmaceutical industry adapts to this new regulatory landscape, the focus must remain on developing safe, effective, and rational drug formulations that meet the highest standards of quality and safety. For patients, this ban serves as a reminder of the importance of informed decision-making when it comes to medication use.

Here is the complete list of Govt Banned 156 FDC medicines

FDC of Amylase + Protease + Glucoamylase + Pectinase + Alpha Galactosidase + Lactase + Beta-Gluconase + Cellulase + Lipase + Bromelain + Xylanase + Hemicellulase + Malt diastase + Invertase + Papain
FDC of Antimony Potassium Tartrate + Dried Ferrous Sulphate
FDC of Benfotiamine + Silymarin + L-Ornithine L-aspartate + Sodium Selenite + Folic acid + Pyridoxine hydrochloride
FDC of Bismuth Ammonium Citrate + Papain
FDC of Cyproheptadine HCl + Thiamine HCl + Riboflavine + Pyridoxine HCl + Niacinamide
FDC of Cyproheptadine Hydrochloride + Tricholine Citrate + Thiamine Hydrochloride + Riboflavine + Pyridoxine Hydrochloride
FDC of Rabeprazole Sodium (As enteric coated tablet) + Clidinium Bromide + Dicyclomine HCl + Chlordiazepoxide
FDC of Fungal Diastase + Papain + Nux vomica Tincture + Cardamom Tincture + Casein Hydrolysed + Alcohol