Indian generic drugs are "good and cheap", where should domestic companies find breakthroughs?

Looking at the world, India is indeed a "magic" country
.

When it comes to the field of medicines, Indian generic drugs are famous all over the world for being "good and cheap" .
Why is this?

“Nice and cheap”

There are three main reasons:

There are three main reasons:

01strong imitation policy

01 strong imitation policy

Generic drugs in India started from the well-known strong imitation policy .
For example, Gleevec in "I'm Not the God of Medicine" was copied and marketed by an Indian company during the patent period
.

More importantly, Indian law also stipulates that Indian generic drugs can be exported to other countries

Strong imitation policy

▲ I am not the God of Medicine

In other words, Indian pharmaceutical companies can not only legally infringe in India, but also sell the infringed products to other countries
.

This is impossible in any other country in the world

Infringement is legal in India, and the infringed products are sold to other countries

At this stage, Indian medicines are moving faster in the U.
S.
market.
With their extraordinary experience in generic drugs and familiarity with U.
S.
regulations, they continue to challenge new drug patents in the U.
S.
and compete for the first imitation.
They bring the super bonus of making generics
.

02Lowercost

02Lower cost

After solving the problem at the policy level - whether imitation is allowed or not, the second step is to control the cost of research and development, production, and preparation
.

R&D, production, preparation and other costs

The first is the labor cost
.

The labor cost in India is super cheap, only 1/2 to 1/3 of the labor cost in China

cheap labor

▲ Indian pharmaceutical factory

At the same time, bioequivalence has also achieved "low price and high quality"
.

Bioequivalence (BE) testing is always involved in the development of generic drugs, which in layman's terms ensures that every pill given to a patient produces the same effect

Bioequivalence also achieves "low price and high quality"

Furthermore, some Indian pharmaceutical companies have established a department dedicated to tracking drug listings.
Its function is to track and analyze reported clinical data when a new drug is still in the clinical approval stage, and work with the commercial department to analyze the potential of the drug.
market, and based on this conclusion to decide whether to carry out the research and development and project approval of the drug, it can promptly kill projects with uncertain market prospects, and scientifically reduce the time, manpower and material resources invested in R&D project approval
.

Analyze the potential market of the drug together with the commercial department, and decide whether to conduct research and development and project approval of the drug based on this conclusion.

03  Fewer circulation links

03 Fewer circulation links

After the production is completed, the circulation and sales link becomes the last step
.

Circulation and sales link

We know why drugs are expensive and there are too many main links
.

From pharmaceutical factories to distributors, to wholesalers, to pharmacies, to hospitals.

However, due to the developed generic drug industry in India, it has formed a tradition of direct supply from pharmaceutical factories, and the medicines are ex-factory prices
.

Also taking Gleevec for the treatment of leukemia as an example, Novartis' original research drug sells for more than 7,000 yuan per box in China, while the printing plate generic drug is about one-tenth, which is equivalent to the direct ex-factory price, which is higher than the normal price.

The tradition of direct supply from pharmaceutical factories,

04Inspiration  for local pharmaceutical companies

04Inspiration for local pharmaceutical companies

Since Indian generic drugs are "good quality and cheap", where should domestic pharmaceutical companies find breakthroughs? Especially for companies whose preparations go overseas
.

I think we should start from two points of improving R&D efficiency and developing differentiated products :

From improving R&D efficiency and developing differentiated products

(1) Take the bioequivalence test (BE) as an example.
It not only costs a lot, but also causes a lot of time cost.
If the experiment fails, it will waste more than 6 or 7 months of time, and there is also early research and development.
and time to scale up production
.

Since the cost of research and development is so high, why not try to bypass the BE test?

Bioequivalence Test (BE)

To a certain extent: yes
.

To a certain extent: yes
.

In 1984, the United States took the lead in proposing a full set of regulations and concepts for generic drugs, and successively announced policies for many types of generic drug exemptions.
By 2016, the United States had passed 32 years, and now the FDA has also begun a new attempt: using in vitro experiments and computer simulations Simulation, a large-scale exemption in the field of generic drugs, strives to remove the BE test from the development process
.
This can not only greatly reduce the cost of generic drug research and development, but also speed up the listing of generic drugs, killing two birds with one stone
.

Generic Drug Exemption Policy,

Looking at China, the BE test cost of generic drugs accounts for more than half of the entire R&D cost, and some even reach 2/3
.
If we can follow the practice of the United States, on the premise of ensuring the quality of drugs, most of the BE tests are exempted, and the cost is reduced, and we will naturally have the capital to fight the "world pharmacy" (India)
.

(2) In addition to the cost of fighting, the development of complex and differentiated products with better efficacy is also another breakthrough
.

Develop complex, differentiated products with better efficacy

After all, from the research and development to the preparation of traditional regular-release preparations, the technical threshold is not high, and the competition track is crowded, making it difficult to find a suitable market position
.
Domestically, more and more pharmaceutical companies with strong R&D capabilities are emerging, and looking for high-quality imitation products can effectively avoid the competitive risks of similar products
.

As a pioneer of preparations going overseas, Renfu Pharmaceutical has a number of high-end preparations approved for listing in the United States, including: Memantine Hydrochloride Sustained-Release Capsules, Bupropion Hydrochloride Sustained-Release Tablets (II), and Potassium Chloride Sustained-Release Tablets Etc.
; Chenxin Pharmaceutical's esomeprazole magnesium enteric-coated capsules, Puli Pharmaceutical's azithromycin for injection and other products are also the same, relying on the method of "preparation to go overseas and Chinese and foreign reports" to gradually develop and expand, and open domestic and foreign sales.
market
.

Renfu Pharmaceutical 's "Preparation Goes Overseas, Chinese and Foreign Reports"

Compared with Indian pharmaceutical companies, domestic pharmaceutical companies have inherent deficiencies in the application experience and preparation cost of generic drugs, but we are absolutely not bad in terms of R&D level, import and export advantages, and API production .
, is undoubtedly a demonstration of the comprehensive strength of domestic pharmaceutical companies, and it is also an excellent way to catch up
.

Focus on high-end preparations,