Temptation to reduce the cost of DMF

5523 registered in 11 years, 2066 in India, 1329 in China

India·China registrations rose from 17.9% in 2009 to 67.7% in 2019

About 7 out of 10 DMF that pharmaceutical companies have registered for use are from India and China.

 

Compared to 10 years ago, the share of DMF in India and China is also increasing significantly.

 

It is an analysis that pharmaceutical companies have increased demand for inexpensive Indian·Chinese drug products to cut costs.

 

According to the MFDS on the 4th, the number of DMF last year was 601.

 

Excluding 71 cases in Korea, 530 cases were registered overseas.

 

By country, India had the largest number of DMFs.

 

The total number was 254, accounting for 42.3% of the total.

 

China was followed by 153 cases (25.5%).

 

The share of the rest of the countries was less than 5%.

 

India and China combined account for 67.7% of the total.

 

7 out of 10 DMF were made in India or China.

 

Top 10 countries for DMF in 2019.

 

Of the total 601 cases, 407 cases were from India and China (67.7%) (Source: the MFDS)

Cumulative number of DMF in 2009-2019.

 

Of the 5,523 cases, India·China accounted for 61.5% (the MFDS)

From 2009 to 2019, a total of 5,523 DMF were registered for 11 years (including re-registration).

 

Of these, Korea had 875 cases (15.8%) In the cumulative DMF, India was the largest with 2,066 cases (37.4%).

 

China was followed by 1,329 cases (24.1%).

 

Excluding Korea, 227 cases in Italy (4.1%), 183 cases in Spain (3.3%), and 84 cases in Germany (1.5%) were followed.

 

Looking at the changes for the past 10 years since 2009, the proportion of registration of DMF from India·China is increasing.

 

In 2009, only 17.9% of Indian·Chinese ingredients were registered.

 

Then, it increased to 39.4% in 2010, and has remained in the mid to late 60% since 2011.

 

Compared to 2012, when DMF notification system was changed to a registration system, the share of DMF in India and China increased by 9.8% p from 57.9% to 67.7%.

 

On the contrary, the proportion of Korean DMF is generally small.

 

It decreased from 47.4% in 2009 to 11.8% last year, down to a quarter level in 10 years.

 

The share of DMFs in India·China over the past 10 years (Source; the MFDS)

It is analyzed that the biggest reason for the increase in the share of DMF registration in India and China is the low price.

 

It is known that Indian and Chinese ingredients are about 20 to 30% cheaper than domestic ones.

 

As pharmaceutical companies are looking for inexpensive DMF to cut costs, registration of drug products from India and China seems to have increased.

 

There are also some institutional reasons.

 

In 2011, the MFDS changed the regulations to register as a DMF if salts or hydrates are different even if the same active ingredient is used.

 

As a result, the number of DMF registrations exploded.

 

In the process, registration of DMF from India and China has also increased significantly.

 

At that time, 377 cases were made in India and 194 cases in China in one year.