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Publisher: sidharthkapil@yahoo.com
SIIB
INTRODUCTION
• Growth of Indian medicine and medical equipment
market
• Import of same
• India: Geographic location
: Population
: natural disasters
• affordability by patients, increased awareness on
health care, improved hospital infrastructure are
primary drivers boosting growth of this industry.
IMPORTS OF MEDICINES AND
MEDICAL EQUIPMENTS IN INDIA
Value in Rs.
30,000.00
25,000.00
20,000.00
10,000.00
5,000.00
0.00
2004-05 2005-06 2006-07 2007-08 2008-09
TRENDS OF IMPORT OF MEDICAL
EQUIPMENTS IN INDIA
Value
3,000.00
2,500.00
2,000.00
Value
1,500.00
1,000.00
500.00
0.00
2004-05 2005-06 2006-07 2007-08 2008-09
CLASSIFICATION OF MEDICAL
EQUIPMENTS
• Schedule M-III, divides medical devices
divided into four classes - A, B, C, and D;
according to their risk level.
Class A- includes low risk devices such as
thermometers.
Class B- include slow to moderate risk devices like
hypodermic needles will fall under.
Class C- covers moderate to high risk devices like lung
ventilators
Class D-high risk devices like heart valves and
pacemakers.
MEDICAL EQUIPMENTS & DEVICES
Need for importing medical
equipments
Medical tourism on the rise
1200 1072
1000
No. of Medical 800
tourists 549
600
treated Series 1
(in 1000s) 400
180
200
10
0
Year
Import Incentives on medical
equipments
• Incentives given by Government
Lower Import Duties
Higher depreciation on life-saving medical
equipment (i.e. 40% from 25%)
DECISION MAKING FOR PURCHASING
• Govt. authorize both Govt. owned and Private
hospitals to issue global tenders.
• Govt. Tender has two parts:
Govt.
tender
Technical Commercial
Bid Bid
(Source: http://www.trade.gov)
Regulation
• Authority regulating medical devices – Central Drug
Standard Control Organization (CDSCO), Ministry of
Health.
• Lays down rules, standards and approves import and
manufacturing of drugs, diagnostics, devices, and
cosmetics.
• Normally FDA and CE approved products are preferred
because of better quality and performance.
• But, price sensitivity comes into picture.
• Acc. to Govt. Notification, both manufacturer and
importer have to register with CDSCO.
Regulation (contd…)
• To register a new or non FDA/CE approved
medical devices in India, an application has to
be submitted to the regulatory authority along
with documents:
Details of the regulatory status in other countries.
Restrictions of use in approved countries.
Free sale certificate from the country of origin.
IMPORT PROCEDEURE
• Step1. Exporter provides the proforma invoice
stating the offer price (Insurance and Freight).
• Step2. After agreeing on mode of payment,
either L/C or wire transfer of funds, importer
places order.
• Step3. Exporter either ships the consignment
or uses airfreight.
• Step4. Importer or CCA responsible for
clearing the goods after payment of duties.
IMPORT PROCEDEURE (Contd…)
• Step5. Bill of entry is submitted in four copies.
On the bill of entry, the purpose for which the
device will be used is mentioned.
– Other documents required along with Bill of Entry
are:
Signed Invoice
Packing list
Bill of lading or Delivery order/Airway Bill
GATT declaration form duly filled in
Importers/Clearing House(agents) declaration
IMPORT PROCEDEURE (Contd…)
License (wherever necessary)
Letter of Credit/Bank Draft(wherever necessary)
Insurance document
Import license
Industrial License (if required)
Test report in case of chemicals
Catalogue, Technical write up, Literature in case of
machineries, spares or chemicals as may be
applicable
IMPORT PROCEDEURE (Contd…)
Separately split up value of spares, components
machineries
Certificate of Origin* (if preferential rate of duty is
claimed)
* Certificate of origin is not an essential document for all
imports (earlier it was mandatory) but it is still a preferred
document in order to expedite clearances.
• Step 6. Consignment is sent to the appraising
section of the Customs House for assessment
and payment of duty.
IMPORT PROCEDEURE (Contd…)
• Step7. After the assessment of the duty
liability, the importer has to deposit the duty
calculated with the treasury or the nominated
banks.
• Step8. Obtain delivery of the goods from the
custodians.
DRUGS/VACCINES
IMPORT INCENTIVES ON DRUGS
• Life saving drugs and medicine (except restricted) -
imported free of custom duty.
from………………………………………………………………………………………
…
Source: http://cdsco.nic.in/html/importdrugs.htm
Central Drug Standard Control
Organization
• Registration of Drugs
• Data Uniformity
• Indian Standard
• Mode of Transportation
• Other
Low R & D
Lack of quality focus
Problem/ Challenges in Import of Life
saving Drugs: