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PCD Pharma Franchise: Navigating Banned Drugs & CDSCO Compliance in India

Understanding Banned Medicines & Blacklisted Pharma Companies for Your Franchise

Essential CDSCO Regulations & Licensing for PCD Pharma Success

How to Identify & Avoid Non-Compliant Pharma Manufacturers

Key Reasons for Drug Bans: FDCs, Safety & Quality Standards
Immediate Steps for Your PCD Pharma Franchise When a Drug is Banned

Blacklisted and Banned Medicines in India: Regulatory Framework, Key Cases, and Public Health Implications

PCD pharma Franchise Banned products images.
In this Blog we will talk about drugs that are "banned" means not allowed to be sold and companies that are "blacklisted" not allowed to sell medicines to the government. The main goal is to keep people healthy and make sure medicines work as they should.

What are "Ban" and "Blacklisted". They are same or Different.
In India, there are two main ways the government deals with unsafe medicines or companies:
  • Banned Medicines: These are drugs that the government has completely stopped from being made, sold, or given to people. This happens when a drug is found to be unsafe, doesn't work, or is a bad composition of ingredients. For example, some cough syrups or pain relievers might be banned if they cause harm.  
  • Blacklisted Companies: This means a medicine company is put on a "blacklist." This usually happens if they make medicines that are not good quality or fake. When a company is blacklisted, they might not be allowed to sell their medicines to government hospitals or participate in government deals.  
Who is the main authority for medicines in India for medicines?
The Central Drugs Standard Control Organization (CDSCO) is like the main authority for medicines in India. Their job is to make sure all medicines made, brought into, and sold in India are safe, work well, and are of good quality.  
The CDSCO does many things:
  • They approve new medicines and check how new medicines are tested. To Know more about how CDSCO works please click Here
  • They set rules for how good medicines should be.  
  • They check medicines that come from other countries.  
  • They can ban medicines that are dangerous.  
  • They also work with smaller government offices in different states to make sure rules are followed everywhere.  
Sometimes, it's tricky because both the main CDSCO and state offices have roles, which can make things a bit confusing or slow down action.  

List of Rules for Medicines in India Authorized by CDSCO.
The main rulebook for medicines in India is called the Drugs and Cosmetics Act, 1940, and its Rules, 1945.This law makes sure that all drugs and beauty products sold in India are safe and good quality.  

Who has the Power to Ban Drugs?
The government has a special power under Section26A of this law. This allows them to stop the making or selling of any drug if it's not good for people or doesn't work as it should. This is often used to ban "Fixed Dose Combinations" (FDCs), which we'll talk about next. 

WHO-GMP Certificates are stamp of Quality.
The CDSCO also makes sure companies follow Good Manufacturing Practices (GMP). These are like strict recipes and cleanliness rules for making medicines. Inspectors visit factories to check if these rules are followed. If a company doesn't follow them, they can be told to stop making drugs or even lose their license.  
Sometimes, drugs that have been sold for along time are later found to be unsafe and get banned. This shows that the system is always learning and improving, but it also means some unsafe drugs were sold for years. Also, there aren't always enough inspectors, and there's no clear rule to quickly remove bad medicines from the market once they're found.  

Types of Banned Medicines
Most banned medicines in India fall into two groups:
  1. Fixed Dose Combinations (FDCs)
    FDCs are medicines that mix two or more active ingredients into one pill. While they can be convenient, many have been banned because:  
    • They don't make sense together: The mixed ingredients don't help each other, or one might cancel out the other's good effects.  
    • More side effects: Mixing drugs can sometimes cause more or worse side effects than taking them separately.  
    • Over-medication: People might take more medicine than they need because multiple drugs are combined in one pill.  
    Many FDCs have been banned in recent years:
    • In 2016, 344 FDCs were banned.  
    • In 2018, another 328 FDCs were banned because experts found they had no real use and could be risky.  
    • More recently, in June 2023, 14 FDCs were banned, and in August 2024, 156 more were prohibited.
  2. Individual Drugs Banned for Safety
    Along with Fixed Dose Combinations Some single drugs have also been banned because they were found to be unsafe:
    • Rofecoxib: This painkiller was banned because it increased the risk of heart attacks and strokes.  
    • Nimesulide (for children under 12): This pain and fever medicine was banned for young children only because it could seriously harm their liver. It's still allowed for adults.  
    • Sibutramine: This weight-loss drug was banned because it increased the risk of heart problems and strokes.  
    • Dextropropoxyphene: This pain reliever was banned because it was linked to many deaths from overdose and could affect the heart.

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Some other examples of banned drugs and FDCs:
  • Amidopyrine (old painkiller)  
  • Phenacetin (old painkiller)  
  • Methaqualone (sedative)  
  • Human Placenta Extract (for certain uses)  
  • Combinations of vitamins with tranquilizers or painkillers  
  • Certain combinations of antibiotics  
  • Colistin (for food-producing animals, to fight antibiotic resistance)  
  • Oxytocin (restricted due to misuse concerns)  
Click here to get updated list of banned drugs in India.

When Do Medicines Get Banned?
Medicines usually get banned or blacklisted for a few main reasons:
  1. No Real Benefit: Sometimes, medicines (especially "fixed-dose combinations," which are like "mixed" medicines with several ingredients) are found to have no genuine medical purpose. They might just be a blend of drugs that don't work well together or offer no extra advantage.
  2. Dangers Outweigh Benefits: If a medicine causes too many severe side effects or risks, even if it has some positive effects, it might be removed from the market.
  3. Safety Concerns: If new information emerges showing a medicine is unsafe, it will be investigated and potentially prohibited.
  4. Misleading Claims: Medicines that make false promises or use deceptive advertisements can also be targeted.
Some Examples of Banned Medicines/Combinations:
India has banned many medicines over the years, often those with "fixed-dose combinations" that were deemed illogical or risky. Common examples include certain combinations of:
  • Painkillers mixed with other drugs that don't make sense together.
  • Antibiotics combined with other medicines that could lead to antibiotic resistance.
  • Certain cough syrups with problematic components.
  • Specific individual drugs like Nimesulide (an anti-inflammatory, particularly for children under 12) have also faced limitations or bans due to safety concerns.
How Drugs Get Banned and Companies Get Blacklisted
First, groups of experts, like the Drugs Technical Advisory Board (DTAB), carful study drugs. They look at whether a drug or combination is truly useful, safe, and doesn't pose risks to people. 

If the experts recommend a ban, the government officially announces it through special public notices called Gazette Notifications. These notices tell everyone which drugs are banned and why. The CDSCO also puts these alerts on its website.  

If a company makes drugs that are "Not of Standard Quality" (NSQ), meaning they don't meet quality rules, they can face serious trouble.  
  • Fake or harmful drugs: If drugs are fake or have bad stuff in them, it's a very serious crime, and the company can face big fines and even jail time.  
  • Bad quality due to carelessness: If a company makes drugs with serious flaws because they weren't careful like not enough active ingredient, they might be prosecuted or have their license suspended.  
  • Small mistakes: For small issues like broken tablets or wrong labels, companies might get a warning or a temporary license suspension.  
What Happens When Banned Medicines Are Still Around?
However, drug companies often go to court to fight these bans, which can make the process very long. Sometimes, courts allow companies to sell their old stock of banned drugs, which means these drugs stay in the market longer. Also, because different states handle drug control, it can be hard to have one clear rule across the whole country. There are also not enough drug inspectors to check all the factories properly.  

Even with strict rules, sometimes banned or counterfeit medicines can still be found. This poses a significant problem because:
  • Life-Threatening Risks: Taking a banned or fake medicine can be extremely dangerous. It might not treat your illness, could worsen your condition, or even lead to death.
  • Antibiotic Resistance: If people take fake or poor-quality antibiotics, it contributes to bacteria becoming resistant to these drugs, making future infections harder to treat.
  • Loss of Trust: When people lose faith in medicines and the healthcare system due to substandard drugs, they might avoid doctors or proper treatment.
  • Financial Strain: People might spend money on medicines that don't work, leading to wasted funds and delaying effective treatment.
  • Undiagnosed Conditions: If someone takes a fake medicine for symptoms that are actually a sign of a serious underlying condition, that condition might remain undiagnosed and untreated.
Blacklisted products in PCD Pharma Franchise Products List
All above rules and regulations from the Central Drugs Standard Control Organization (CDSCO) are applicable to PCD Pharma Franchise companies, medical wholesalers, and distributors in India.

Drugs and Cosmetics Act, 1940,is the main law in India to sell or exhibit the medicines as retail or wholesale and its rules, covers the entire journey of a medicine: from when it's made, to when it's sold, and how it's given out.
  • PCD Pharma Franchise Companies: These companies are given rights to market and distribute medicines for a parent company in a specific area. They are directly responsible for the sales, distribution, and marketing of those products.5 To even start, they need a proper
  • Registered Drug License and must follow all legal and quality rules.
  • Medical Wholesalers and Distributors: These are the links between the manufacturers and the pharmacies or hospitals. They need specific wholesale drug licenses to operate. Their job involves overseeing the sale and distribution of medicines.
Essentially, anyone involved in bringing a medicine to a patient in India must follow CDSCO's rules to ensure the medicine is safe and effective.

What a PCD Pharma Franchise Company Should Do When Products Are Banned
Here's what they must do immediately:
  1. Stop Sale Immediately: The most important step is to immediately stop the sale, distribution, and marketing of banned products. Continuing to sell them is against the law and can lead to serious penalties.
  2. Check Official CDSCO Website: Don't just rely on news. The company should go to the official CDSCO website and look for the "Gazette Notifications" or "Public Notices" sections. This is where official bans are announced with full details.
  3. Identify and Separate Stock: Quickly find all the stock of the banned products in their warehouses and distribution channels. These products must be clearly marked and separated so they are not accidentally sold.
  4. Inform Their Network: The PCD company must inform all their distributors, wholesalers, and any pharmacies they supply to, about the ban. They need to tell them to stop selling these products and return any existing stock.
  5. Coordinate with the Manufacturer: Since a PCD company distributes for a manufacturer, they must immediately contact their manufacturing partner. The manufacturer is ultimately responsible for the drug's quality and compliance, and they will need to handle the recall process.
  6. Follow Recall Procedures: If CDSCO issues a formal "recall" for these banned products, especially if they are very dangerous, known as Class I recalls, the company must follow strict timelines:
    • Stop selling the product within 24 hours of the recall decision.
    • Complete the physical collection of the product from the market within 72 hours.
    • Keep detailed records of all recalled stock and make them available for inspection by drug inspectors.
  7. Seek Legal Advice: Because drug bans can lead to legal challenges and complications, sometimes courts allow existing stock to be sold for a short period, it's wise for the PCD company to get legal advice to understand their exact rights and responsibilities regarding the existing stock.
Staying updated by regularly checking the CDSCO website and having clear internal procedures for handling banned or recalled products is crucial for any company in the pharmaceutical supply chain.
Permanently Banned Medicines for PCD Pharma Franchise.
Conclusion: India has a system to control medicines and keep people safe. The CDSCO works hard to ban drugs that are unsafe or don't work, especially those with bad combinations of ingredients. They also try to stop companies from making bad quality drugs.

But there are still challenges. Some unsafe drugs were sold for a long time before being banned. Also, the system can be slow because of court cases and because different government offices handle things differently. There aren't enough people to check all the medicine factories regularly, and there's no clear rule to quickly remove bad medicines from the market.

To make things even better, India needs a stronger, clearer system with enough people to check medicines and a quick way to remove bad drugs from the market. This will help keep everyone healthier and make sure India continues to be known for good quality medicines.

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