Generics

All You Need to Know About Generic Medicines in India

Generic drugs are copies of any approved brand name medicines. These medicines are similar to their originator drug in dosage form, strength, route of administration, and  effect on the body. They are cheaper, increasing the accessibility of basic medicine. Adoption of generic medicines is important for India, as these medicines decrease the out-of-pocket health expenditure. To understand why generic medicines are cheap, and how they benefit society, let’s understand where they come from.

How is a medicine discovered?

Pharmaceutical companies have dedicated research departments engaged in developing medicines from scratch, which is a huge task. It involves various steps starting from clinical trials, to regulatory filing in multiple countries. All of this requires sophisticated tools, lots of people, and obviously a lot of money/time.

For example, Pfizer developed a cholesterol lowering drug named Lipitor, the molecule/salt (read: generic name) of which is Atorvastatin. This research for this drug started in the 1970’s, and this particular molecule got approval from the USFDA in 1996. It took the pharma company more than 20 years before they could sell atorvastatin.

What are Medicine Patents?

Manufacturers want to be rewarded for their effort and patience, so they are granted a patent. The patent guarantees the manufacturer exclusive rights to sell the drug for 20 years. 

The patent incentivizes the companies to research and formulate more drugs. Imagine spending lakh crore rupees on research, just for the market to take your product and sell it at 80% cheaper prices. You would feel cheated and never want to invest in research again.

What Happens When Medicine Patents Expire?

After 20 years of exclusively selling the medicine, the patent expires. After the patent expiry, the formulation of the drug is open for anyone in the market to make and sell. This rule benefits the general public (and also the small manufacturers who cannot spend on R&D) as the medicine is now available at lower rates.

All the other medicines except for the innovator brand are called generic medicine by definition. Other manufacturers can also brand the generic version with their own branding to make a market foothold and promote their brand. When everybody is making the same product with no differences, marketing/branding becomes the difference.

Pfizer held Lipitor (atorvastatin) patent until 2011. When the patent expired, the gates opened for other manufacturers to make this molecule under various other names at a much lower cost. This helped increase access and compliance among the patients.

Who Manufactures Generic Medicine?

In India, all the medicine manufacturers with valid licences and certifications can make generic medicines. Unlike in the US, they don’t even have to file for Bioequivalence(BE) studies, making the market entry much easier, cheaper, and also lower quality. Bioequivalence (BE) is whether a generic drug has the same rate of absorption in the bloodstream as the innovator/branded drug. 

Atorvastatin is currently manufactured by numerous pharma companies under various brand names, and at various price points. 

Strovas – sun

Aztor – sun

Tonact – Lupin

Atorva –  Zydus cadilla

Atrolip – cipla

What Types of Generic Medicine are There?

  • Branded Generic – Many companies market these meds and sell them through the doctors (which some call ethical marketing). As the salesmen, and doctors take heavy commissions the cost of these medicines are generically 10-20x the manufacturing cost. Many people associate the higher cost with higher quality, but that is inaccurate. The higher cost reflects the marketing channel – the quality is uncertain.
  • Trade generics – These generic medicines are directly sold to customers through pharmacies. These medicines are generally low priced as they don’t have a long marketing channel associated with it. These are generally 2-10x the manufacturing cost. Many associate the low cost with low quality, but that is inaccurate. The low costs reflect the small marketing channel – the quality is uncertain. 
  • Double tested generics – This is a recent development in the generics space. These are generic medicines that are tested at third party laboratories for quality assurance before being made available. They are a type of quality assured trade-generic medicine. These are exclusively available at SayaCare and are generally 2-3x the manufacturing cost.

Why are Generic Medicines Cheap?

Generic Medicines are cheap as their manufacturers do not have to spend on research and approvals. The main ingredient of the drug, the APIs (Active Pharmaceutical Ingredient) prices are commoditized, leaving not much difference in the raw material costs. 

In a commoditized market, the only difference then is how the product is marketed. Hence the big pharma companies who have huge marketing spend are able to make a space in consumer’s homes by pushing their branded-generics through doctors.

Some manufacturers are playing smart by placing the exact same medicine in two very different price categories. For example, Mankind’s Atorvastatin’s brands, Lipikind and Atorvakind, sell at two diff price points of Rs 65 and Rs 125 respectively. These are marketing tactics to capture different markets. But be assured, these medicines are getting manufactured in the same manufacturing plant, it’s just that they are wearing different clothes to appeal to different people. See cost comparison between Generic and Branded medicines

Why Don’t People Trust Generic Medicine?

Doctors & Patients cast a wary eye towards trade-generics. This lack of trust comes from:

  1. The Low Price makes them think it will be of Low Quality.
  2. There is no incentive for doctors to prescribe these.

People spend whatever they have to in order to feel better. They put their trust in doctors who put their trust in brands. They reason that big brands that can spend on marketing to them must put the same effort in quality assurance, but as the random testing from the Central Drug Authority shows, this is a faulty assumption. If a good quality check is put on drugs, then trust for generic medicines can be built which can reduce out-of-pocket expenditure in India.

Which Generic Medicines Should I Buy?

You should buy generic drugs from a  trusted source. Trust should come from Transparency. Ask yourself, is any Pharmaceutical Company going to show me the quality of the medicine I need? Generic medicine can save you up to 80% on health costs, but you may end up paying more than just money if the quality of the drug is poor. Buy double-tested generics to get the best value in terms of quality and affordability.

Conclusion

Low quality, spurious medicines, and fake medicines are also available in the market; there is no denying that. However, wouldn’t it be just great if we lived in a society where we would pay Rs. 400 per month on our medical bills instead of 4000?  Wouldn’t it be great if we were able to actually trust these too good to be true medicines henceforth saving money for some good use – education of our children, improving our lifestyle, etc. 

Until the government makes the regulations stronger, we at SayaCare take matters in our hands and test every batch of the medicine before it goes out to the customer. Our platforms show you the test reports of medicines too. So, TRUST what you SEE, and not what you have heard. 

We want these too good to be true medicines to be a part of the general healthcare, we want people to actually benefit from these drugs. This only happens with awareness. And as the awareness about generic drugs rises, their usage will be a boon for the chronic patients living with diabetes, high BP, thyroid, etc.

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