|
 Mr. Amit
Dave
M. Pharm, MBA,
Former CEO - Brazil Operations/ Vice President Export
– Zydus Cadila/Claris Lifesciences |
Country Profile In the last
article, we saw the market opportunity in Guatemala,
the Central American country. During the same visit,
the author also visited Dominican Republic, a country
located in the Caribbean islands. This country shares
a border with Haiti. Both are on one island, where
Dominican Republic occupies the majority of the land.
This is the second-largest country in the Caribbean
region, after Cuba. The capital city is Santo Domingo
and the population is 11 mn (compared to 17.5 mn in
Guatemala). This country’s official language is
Spanish too, like that of Guatemala.
The country shares a close
relationship with the United States. A free trade
agreement called Dominican Republic-Central America
Free Trade Agreement allows the country to do easy and
smoother commercial transactions with the United
States, Costa Rica, El Salvador, Guatemala, Honduras,
and Nicaragua. Dominican Republic also has a growing
commercial relationship with the United States, and
the United States is one of the largest trading
partners. On the lines of Guatemala, again, the Indian
companies may be able to compete with the US prices. |
 Regulatory
Framework
The regulatory authority of the country is La Dirección
General de Medicamentos, Alimentos y Productos
Sanitarios (DIGEMAPS). It may be worth noting that
DGMAPS and CDSCO had signed a Memorandum of
Understanding in the field of pharmaceuticals
regulation, and a similar MoU is under process for the
devices also. This process was coordinated by the
Embassy of Dominican Republic in India, at the request
of DIGEMAPS. Their website is
https://gobdo.digital/digemaps/ and though the
website contents are in Spanish, it has a facility to
translate in English and this translated version is
fairly accurate.
The application process is fairly simple and here also,
like in Guatemala, the local parties prepare the
application by asking for necessary documents from the
Indian counterpart. The prescribed fee is 190 USD but
generally, this is paid by the local partner. This seems
to be a common practice in the whole region. There are
no special requirements like plant inspection or
clinical trial data or any other supportive documents.
The labeling requirements, being in the local language,
can easily be managed with the help of the local
partner. The normal registration time frame is about 6
to 8 months and once granted, the license is valid for
five years. Like Guatemala, a certificate of analysis
and quality guarantee certificates ( GMP / ISO) are
sufficient.
The process of product introduction, thus, is – Find a
partner – Paperwork with him – Regulatory documents
compilation – Fee payment – Follow up – Approval –
Product launch
Classification of Medical Devices
The medical devices classification is in line with the
conventional classification.
Class I : External use non-sterile products
Class IIa : Sterile products for external use
Class IIb : Nonsterile internal use products
Class III : Sterile internal use products
Dominican Republic Medical Devices Market
In the current year, total market value is projected to
reach US$ 525 mn. The readers will appreciate that this
is larger than that of Guatemala despite lesser
population. This is mainly because of better
realizations for the products. Also, this market is much
higher on per capita value basis when compared to India.
The growth rate projected is 8.4% per year for the
forthcoming years. Here also, the CVS segment makes up
almost 15 % of the market. The second largest segment is
diagnostic imaging devices. Large government tenders are
the practice here also. However, realizations are better
even in these tenders. Private hospitals are expanding
here and they are also good buyers.
The market description will not be complete without the
mention of the DR Free Tarde Zone. Almost 25% of exports
from the Free Trade Zone comprise medical devices.
Currently, some major medical device product
manufacturers are operating here, and the major product
groups are Ostomy Appliances, Surgical Drapes, and
Electro Medical Instruments. Medtronic, Braun, Baxter,
and Fresenius are some of the famous names operating in
this zone. Earlier, Puerto Rico was the base of
manufacturing but now, Dominican Republic competes with
Puerto Rico in this regard.
Opportunities and Challenges
Better Prices compared to many other markets, an easy
registration process and demand for high-quality
products make the market attractive. The major
challenges are language and distance, like Guatemala.
English knowledge is not an issue, however, mainly due
to American influence. Visa requirements are not an
issue because a US visa can qualify for entry here for a
visit.
A very large market for equipment is an opportunity. The
major supply, 75 %, is from the US and local
manufacturing is almost zero. This is a possible market
for grabbing. Orthopedic devices, electromagnetic
instruments and home care equipment are the largest
segments here. |
