Decoding Pharmaceuticals: Exposing the truth behind Branded Drugs and Generic Drugs

 

 Generic Drugs and a marketed brand drug are same in dose, form, safety, strength, mode of administration, quality, performance characteristics, and intended use.

These parallels support the concept of bioequivalence, which states that generic medication functions and offers the same therapeutic benefit as a brand-name medication in exactly the same way. Put simply, a generic medication can be taken in place of a branded one on an equivalent basis.
In the early years of the Indian Patent Act of 1970. With their groundbreaking discoveries and inventions in the pharmaceutical industry, several multinational companies were dominating the market. India, meanwhile, never lagged behind in discoveries and inventions either, but it was prohibited from releasing pharmaceutical items that were the generic equivalent of those made by multinational companies  (MNCs) or foreign organizations that owned the intellectual property rights (IPR) or patents for those products.

Tea (Brand medicine)	Tea (Generic medicine)
Tea powder A	Tea Powder A
Milk A	Milk B
Water A	Water A
Heating 10 minutes	Heating 15 Minutes
Tea Cup and Saucer	Steel Cup
(End Output) Taste – flavorful and refreshing	(End Output) Taste – flavorful and refreshing

 

Brand Medicine	Common	Generic Medicine
Active Pharmaceutical Ingredient – A Paracetamol	API Paracetamol	Active Pharmaceutical Ingredient – A Paracetamol
Excipients – B Lactulose		Excipients – D Glucose
Standard Process of Patented Product		Patented Process (Approved under IPA)
Safety – 99%	Safety	Safety – 99%
Efficacy – 99%	Efficacy	Efficacy – 99%
BABE studies – Approval by CDSCO	CDSCO Approval	BABE studies – Approval by CDSCO
Appearance – Round and White		Appearance – Oval and Blue
Dosage Form : Tablet	Dosage Form	Dosage Form : Tablet
Dose / Strength : 650 mg	Dose	Dose / Strength : 650 mg
A+B = C (Brand Medicine)		A+D = C (Generic Medicine)
End Result : Dolo 650	Medicine	End Result : Para 650

Because of this, the Indian government created the Indian Patent Act (IPA), which grants process patent rights. As per the statute, process patents were acknowledged to be more valuable than just product patents. Indian Government intended for this act to be released to give the nation's poor population easier access to inexpensive medications.

Put another way, India would grant patents to the manufacturing process rather than specific medications. This gave Indian pharmaceutical businesses the ability to produce the same medication (a generic drug) through alternative manufacturing techniques—a process known as reverse engineering. New pharmaceuticals could now be made accessible to the nation at reasonable prices because Indian companies were not spending much on research and development.

Let's dig a little deeper into the pharmaceutical sector. To guarantee safety and effectiveness, every medication that reaches the market must pass many approval processes and rigorous quality assessments. Drug regulatory agencies like the FDA (Food and Drug Administration) in the United States and CDSCO (Central Drug Standard Control Organization) in India are primarily in charge of this.

To be straightforward, it takes between 15 and 20 years to discover, research, develop, improve, and ultimately provide you with an effective molecule as an Active Pharmaceutical Ingredient (API) in your medication. A chemical needs to pass through several clinical research phases, including processes in Phases 0, I, II, III, and IV.

Each phase assesses how well the medicine can outperform the chemical to meet the expectations of researchers and scholars who want the drugs to reach the benchmarks for bioavailability and bioequivalence. These clinical trials' primary goal is to confirm a molecule's safety and effectiveness in helping to diagnose, prevent, treat, and cure a disease or discomfort.

Allow me to start by providing a few well-known instances of branded medications.
Branded medications include Eliquis (Pfizer), Brilinta (Astra Zeneca), Kryxana (Novartis India Ltd.), Amaryl (Sanofi India Ltd.), Galvus Met (Cipla), and many more. Each of these massive pharmaceutical companies invests a significant sum of money in the research and development of a single pharmaceutical product (drug or medicine).
Not only that, but they also heavily invest in infrastructure, labor, raw materials, sophisticated instruments and technology, research academics, scientific research procedures, and other interdependent resources.

Counting backward to several regulatory filings and regulatory body approvals to only reach Phase III, once authorized, a pharmaceutical product painstakingly crafted to support the need (drug use indication) in a well-furbished manner enters the massive market with a population size of innumerable people with complex comorbidities. It is referred to as Phase IV, or "The Post Marketing Phase," however research on the safety profile of the medications is still ongoing.

The giants in the pharmaceuticals apply for patents on newly discovered drugs. A crucial step for any pharmaceutical company is the patenting process. Drug manufacturers have functional exclusivity over their medications, thanks to patent rights, which prevents rivals from producing, using, or marketing the patented medication without the patent owner's consent.
Patents encourage industrial innovation and establish a monopoly in the market.
And that's the main reason these brand medications are being sold for such a high price.

On the other hand, other government-approved pharmaceutical manufacturers identify a market need for a molecule and use the patent company's consent to build the same medication.

With the required FDA and CDSCO approvals for the bioequivalence studies (a quality, safety, and efficacy - marker) for the alternative pharmaceutical entity manufactured with different excipients, shape, and appearance but not changing the active pharmaceutical ingredient in it, these Indian manufacturers now only need to invest in the manufacturing and marketing of the pharmaceutical drug. And that remains a perfect replica of the proprietary medication. 

Consequently, it is more reasonably priced when compared to the giant pharmaceutical companies' current products when it hits the market.

 

Vision: QnQ Healthcare – Quality healthcare, accessible and affordable for every human life.