PCD Pharma Model (Standard Pharma Products)

PCD in pharma stands for Propaganda Cum Distribution, which refers to a business model where a pharmaceutical company grants a franchisee the right to promote and distribute its products in a specific region. In this franchise system, the franchisee handles the marketing (promotion) and sales of the company's medicines without needing to establish a separate manufacturing unit, making it a low-investment option for entrepreneurs. 

• Propaganda: In this context, "propaganda" means the promotion and marketing of products, not misleading information. It involves activities like building brand awareness among healthcare professionals and consumers.
• Distribution: This refers to the actual distribution and sale of the pharmaceutical products within a defined geographical area.
• Franchise model: PCD is a type of franchise, where the parent company provides its brand, products, and sometimes marketing support to the franchisee, who operates with the established brand name and image.
• Benefits: This model is often attractive to individuals and smaller companies because it requires a lower initial investment compared to starting a full-fledged pharmaceutical company. The franchisee can also benefit from the parent company's brand reputation and an exclusive range of products. 

• - 
• PCD Pharma: This model, sometimes considered a "standard" business approach, involves marketing and distribution without significant R&D investment. A company gets the right to sell a parent company's products in a specific territory.

difference between Ethical , Standard and Generic pharma products

Ethical pharma focuses on innovation, research, and development of new, patented drugs, while generic pharma manufactures affordable, off-patent versions of these drugs. "Standard" is not a standard industry term for a type of pharmaceutical product; instead, it's more accurately understood in contrast to ethical and generic drugs as a potential way of referring to a non-promotional, or "PCD" (Propaganda-cum-Distribution) model, or simply a category of approved, quality-assured medicines. 

Feature	Ethical Pharma	Generic Pharma
Focus	Research and development of new, patented drugs.	Production of affordable, off-patent alternatives.
Cost	Higher, due to R&D and marketing costs.	Lower, due to the absence of R&D and patent costs.
Examples	New cancer treatments or vaccines.	A generic version of a branded medication, like Metformin being sold as Glucophage.
Marketing	Heavily marketed to healthcare professionals.	Focuses on cost-effectiveness and wide distribution.
Regulation	Subject to strict regulations for drug development and clinical trials.	Must meet drug equivalency standards to prove they are bioequivalent to the original drug.

Understanding "standard":

• PCD Pharma: This model, sometimes considered a "standard" business approach, involves marketing and distribution without significant R&D investment. A company gets the right to sell a parent company's products in a specific territory.
• Quality Assurance: In a general sense, all ethical and generic drugs approved by regulatory bodies are "standard" in that they have met the required safety, efficacy, and quality standards. 

Key takeaway: The primary distinction is between innovating new drugs (ethical) and producing affordable, bioequivalent copies (generic). 

What is the Difference Between Generic And Ethical Medicine?

• Posted By Sumesh Sharma

In This Article

1. What Are Ethical Medicines?
   1. What Are Generic Medicines?
   2. Differences Between Generic and Ethical Medicines
   3. Generic Vs Ethical Medicine In Pharma
      1. Final Thought 

What is the Difference Between Generic And Ethical Medicine? The pharmaceutical industry serves as a backbone for healthcare worldwide, delivering medicines to treat, manage, and prevent diseases. Among the vast categories of medications, generic and ethical medicines are the most prominent. While both aim to provide effective healthcare, their production, marketing, and distribution differ significantly. Understanding the difference between generic and ethical medicine can guide consumers, healthcare providers, and pharma professionals in making informed decisions.

This blog explores the differences between generic and ethical medicines, focusing on their definitions, cost structures, accessibility, regulations, and more.

What Are Ethical Medicines?

Ethical medicines, often referred to as branded or innovator drugs, are produced by pharmaceutical companies that have developed the product through extensive research and trials. 

These medicines are protected by patents, giving the company exclusive manufacturing and distribution rights for a set period.

Key Features of Ethical Medicines

1. Innovative: Result from years of research aimed at addressing specific medical needs.
2. Higher Costs: Pricing reflects R&D, marketing, and patenting investments.
3. Exclusive Branding: Marketed under unique names to build trust and recognition.
4. Limited Accessibility: Available only through prescriptions, ensuring controlled usage.

What Are Generic Medicines?

Generic medicines are alternatives to branded drugs that become available after the patent of the original product expires. These medicines must meet strict bioequivalence standards, ensuring that they are as effective and safe as the branded versions.

Key Features of Generic Medicines

1. Same Active Ingredients: They have identical active components to their branded counterparts.
2. Cost-Effective: Without marketing or R&D expenses, these medicines are significantly cheaper.
3. Widespread Availability: Easily accessible in pharmacies, making them an affordable option for many.
4. Regulated Quality: National health authorities, such as the FDA in the USA and CDSCO in India, oversee production to ensure high-quality standards.

Differences Between Generic and Ethical Medicines

Aspect	Generic Medicines	Ethical Medicines
Cost	Affordable due to low overhead expenses.	Higher cost due to R&D and branding investments.
Regulatory Approval	Requires bioequivalence tests.	Requires extensive clinical trials and studies.
Patent Protection	No patent protection; introduced after the original patent expires.	Protected by patents, offering exclusivity.
Marketing	Minimal promotion; relies on affordability and utility.	Heavily marketed to healthcare providers and consumers.
Accessibility	Readily available over the counter or with prescriptions.	Strictly available through prescriptions.

Generic Vs Ethical Medicine In Pharma

The Generic Pharma Business focuses on producing affordable, off-patent medications that match branded drugs in quality and effectiveness. It emphasises cost efficiency, large-scale production, and wide distribution, often catering to lower-income demographics and healthcare systems.

The Ethical Pharma Business, however, develops innovative medicines backed by extensive research and clinical trials. These drugs are patented, heavily marketed to healthcare professionals, and sold at higher prices to recover R&D costs.

Both business models play vital roles in healthcare, with generics ensuring accessibility and ethical pharma driving innovation.

Pharmacare Awareness Rallies are different from Healthcare Awareness Rallies

Pharmacare Awareness Rallies are different from Healthcare Awareness Rallies

"Prescription is decided by the doctor, but the brand of medicine should be chosen by the patient with the help of a pharmacist, based on the patient’s income."

"Prescription is decided by the doctor, but the brand of medicine should be chosen by the patient with the help of a pharmacist, based on the patient’s income."

🔍 1. Role of the Doctor:

Doctors are responsible for diagnosing the illness and prescribing the generic name of the medicine (e.g., Paracetamol, Amoxicillin).

This ensures that the treatment is medically appropriate and based on clinical judgment.

💊 2. Role of the Pharmacist:

A qualified pharmacist is trained in pharmacology, drug interactions, and therapeutic alternatives.

In #communitypharmacy practice, pharmacists help patients choose from available brands of the prescribed generic medicine.

They consider:

1. Patient’s income level

2.Availability of brands

3. Quality and reputation of manufacturers

Patient preferences (e.g., tablet size, packaging, ease of use)

👥 3. Role of the Patient:

The patient has the right to be informed and involved in the decision-making process.

With guidance from the pharmacist, the patient can select a brand that is affordable and effective, rather than being forced to buy a specific brand that may be expensive or unavailable.

⚖️ 4. Legal and Ethical Basis:

According to Pharmacy Practice Regulations and Pharmaceutical Jurisprudence in India:

Doctors are encouraged to prescribe generic names.

Pharmacists are legally allowed to dispense any brand of the prescribed generic, unless the prescription explicitly prohibits substitution.

This model promotes rational drug use, cost-effectiveness, and patient empowerment.

This model promotes rational drug use, cost-effectiveness, and patient empowerment.

It reduces healthcare costs and ensures access to essential medicines for all income groups.

This approach aligns with the principles of community pharmacy, where:

Doctors diagnose and prescribe generics.

Pharmacists guide brand selection.

Patients make informed choices based on affordability and need.

It promotes transparency, accessibility, and collaborative care—the foundation of a strong healthcare system.

Thanks

Rohit Gupta, Pharma Expert

The Power Shift : from Physicians to Pharmacists

Is it GAME OVER for Physicians ?

In India, big pharmaceutical companies are struggling to do business compared to small, room-based local companies. Everyone knows the reason money matters more than quality. That's why patients should choose their medicine brands with the help of registered pharmacists (RPh).

In which book: brand names of medicines given, and how do Drs decide their quality, Is there any specific subject available, If No, then please prescribe Gen-medicines

ऐसा कौन सा ब्रांड प्रिस्क्राइब किया जाता है जो सिर्फ़ अस्पताल या क्लिनिक में ही मिलता है? समझ नहीं आया। क्या इनोवेटर्स का कोई नया ब्रांड आ गया है? अगर हाँ, तो कृपया जानकारी दें।😃

Brands matter because of quality, agreed. But why so many doctors prescribing branded products from local companies instead of Indian MNCs or global MNCs, I really don’t understand the logic. Poor-quality medicines are harming innocent patients.

POV: Rohit Gupta

Indian FDA(The "Indian FDA" is not a single entity but refers to the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs, medical devices, and cosmetics in India) Vs USFDA

#IndianFDAVsUSFDA.

source:ChatGPT

Quote'

1. In 2005, there were 3 infants aged under 6 months in the US where cough & cold medications were determined by medical examiners or coroners to be the underlying cause of death. 

2. More broadly, in that period (2004-2005), about 1,519 children under age 2 were treated in US emergency departments for adverse events including overdoses from cough and cold medications. 

3. In the 1930s, there were more than 100 deaths (mostly children) in the US from #DiethyleneGlycol (DEG) poisoning, including from Elixir Sulfanilamide, which was given for coughs/sore throats. That tragedy helped lead to major drug safety laws. 

4. There is no recent public record I found that gives a reliable count of how many deaths from FDA-approved or FDA-regulated cough syrups have occurred in, say, the last 10–20 years in the US specifically attributed to either contamination or misuse.

5. Many of the recent deaths globally from toxic cough syrups have been linked to products from outside the US. 

6. The most noteworthy fact is that

 the contaminated products which caused recent deaths abroad have not and cannot  entere the US drug supply chain.

Unquote'

Now the million dollar questions :

  i. Are we deficient in technology?

  ii. Are our Regulators deficient in 

       quality or in Character?

  iii  Are our FDA officers are as 

        accountable as their 

        counterparts in US - FDA

   iv. Are our Drug Laws are so weak 

         to let loose all lapse?

     v. Don't we have strong political 

          will to adopt Zero-Tolerance?

There are two institutions meant to safeguard the pharmacy profession and the integrity of medicines:

A. Department of Food and Drug Control

B. State Pharmacy Council

Both these institutions have their own inspectors.

Yet, despite that, medical shops continue to operate freely and openly even in the prolonged absence of pharmacists.

Due to the fear of pharmacy inspectors, the attendance of pharmacists in medical shops had slightly improved for some time.

However, after the government took over control of the State Pharmacy Council, inspectors have been left without an effective system to perform their duties, and once again, license conditions are being openly flouted, with unauthorized or fake persons running medical stores, posing a serious public health risk.

The Drugs Inspectors are unable to stop this menace.

It is also unfortunate that pharmacy-based NGOs in the state — such as the Indian Pharmaceutical Association and the Registered Pharmacists Association — have failed to rise issues affecting public health and patients safety..

POV: Bhagwan PS

The "Indian FDA" is not a single entity but refers to the Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs, medical devices, and cosmetics in India. It serves a similar function to the U.S. FDA, ensuring the safety, efficacy, and quality of medical products. In addition, individual states, like Maharashtra, have their own state-level "FDA" to handle state-specific food, drug, and cosmetic regulations.  

National regulatory authority Central Drugs Standard Control Organisation (CDSCO): 

The national regulatory authority responsible for ensuring the safety, efficacy, and quality of drugs, cosmetics, and medical devices throughout India.
Role: 
CDSCO regulates the quality of medical products through the implementation of the Drugs and Cosmetics Act, 1940.
Headquarters: 
Located in New Delhi.
Drug Controller General of India (DCGI): 
The executive head of the CDSCO, who is responsible for regulating pharmaceutical and medical devices. State-level authorities

State FDA: 
Many states have their own Food and Drug Administration (FDA) to enforce regulations at the state level.
Example: 
The Food and Drug Administration, Maharashtra is an example of a state-level body responsible for food and drug safety within Maharashtra. Other international relevance

U.S. FDA India Office: The U.S. FDA also has an office in New Delhi to ensure that food and medical products exported from India to the U.S. meet U.S. safety standards. 

Pharma Scandals and Loopholes

Pharmacy - Ajeeb daastaan hy ye...

- kahaa shuru kahaa khatam

👉🏼 Pharmacists lending degree  PhD certificates to colleges, while working elsewhere and appearing in person only on Inspection day.

👉🏼Postfacto signing of all registers and records of the college a day before inspection day.

👉🏼 PCI inspectors ignoring lapses and deficiencies and sending Ok report to PCI for approval or renewal of the College

👉🏼Pharmacists lending Regn certificate to retailers while working elsewhere.

👉🏼 Drugs inspectors suppressing the Pharmacist's absence and allowing dispensing without Pharmacists.

👉🏼PCI and State Regulatory Officers working on paper bundles (false reports) to justify salary of establishment 😄

👉🏼Acts, Rules, Regulations have become Arterial circulation to energise officers to make money

👉🏼Money Money  Money - Venous circulation - to clean and clear hurdles and catches to rejuvenate😄

👉 Honest stakeholders know everything but dont open the mouth being obligated.

😜🤪😝🤑

POV: Bhagwan PS

The way Mohalla clinic started in Delhi, Government of India should open pharma clinics across the country on the same line and employ pharmacists to end the unemployment of pharmacists.

The way Mohalla clinic started in Delhi,

Government of India should open pharma clinics across the country on the same line and employ pharmacists to end the unemployment of pharmacists.

If you agree then share 🙏 

POV: Unknown