Import of Drugs

Dr Pravina K,
ICRI, Bangalore
Pharmaceutical Regulations
Pharmaceuticals regulated under the Drugs
and Cosmetics Act,1940 (DCA)
Applies to imported and domestic products
made in India
Enforced by Central Government, New
Delhi
Office of the Drug Controller of India
(DCI) has prime responsibility
Enforcement also done by individual State
governments through their Food and
Pharmaceutical Regulations
DCA regulates:
Product approval and standards
Clinical trials
Introduction of new drugs
Import licenses

State governments regulate:

Approvals for setting up manufacturing facilities
Obtaining licenses to sell and stock drugs
Import or manufacture of
new drug for clinical trials

Licencing Authority
Procedure
Forms
Fees
D&C Rules
 

122-A. Application for permission to import

New Drug

122-B. Application for approval to manufacture

New Drug other than the drugs
classifiable under Schedules C and C(1)
 
122D. Permission to import or
manufacture fixed dose combination
122DA. Application for permission to conduct
clinical trials for New
Drug/Investigational New Drug.
122DB. Suspension or cancellation of
Permission / Approval.
122DC. Appeal.
Form 44

Application for grant of

permission to import or
manufacture a New Drug or to
undertake clinical trial.
Application fees for
conducting clinical trials
Phase I Rs 50,000/-
Phase II Rs 25,000/-
Phase III Rs 25,000/-

Special studies
BE studies Rs 15,000/-

(No separate fees to be paid along with the

application for import/mfg based on successful
completion)
 Application fees for
import/mfg of new drug
Import / manufacturing (ff/rm) Rs 50,000/-

Reapplication after one year of Rs 15,000/-

grant of approval

Subsequent application by the Rs 15,000/-

same applicant for modified
dosage form or with new claims
Form 12

Application for licence to

import drugs for purpose of
examination, test or analysis
Form 12 : Application fees

A fee of Rs 100/- for a single drug

Additional fee of Rs 50/- for each

additional drug
Form 11

Licence to Import drugs for the

purpose of examination, test or
analysis

Permission for Import of drug samples

for Clinical trials
Customs

Application at customs
Supporting documents
• Copy of clinical trial approval from DCGI,
• Form 11
• Copy of Performa in voice
• Copy of list of participating centres

Taking direct delivery from customs

Duty exemption
Import of trial product

Careful review the Proforma in voice &

labels before import
Check the quantity on import licence Vs
Performa in voice
To be received in cargo mode
Protocol no
“For Clinical Trial purpose Only”
Expiry dates
Cold Chain
 Import of drugs

Form 45 - Permission to import

Finished
Formulation of a New Drug

Form 45A - Permission to import raw

material (new bulk
drug substance)
 Manufacturing of drugs

Form 46 - Permission/Approval
for manufacture of a
new drug formulation

Form 46A - Permission / Approval for

manufacture of raw
material (new bulk drug
substance)
India: Manufacturing Capacity

 $6 billion pharmaceutical industry

 About 20,000 foreign and domestic
drug makers
 Over 60% of India’s bulk drug
production is exported
 India is home to the largest number of
USFDA approved pharmaceutical
plants outside U.S.
Manufacturing
opportunities
• Increased generic drug use by US and Europe
due to rising costs of healthcare
• During the next 4 years, $45 billion worth of
drugs to go off-patent
• Indian generic drug firms will benefit
• India has the capabilities to manufacture
• Many foreign drug firms now looking for
partnerships, mergers or acquisitions in India