Accredited Consultants Pvt Ltd provides regulatory consulting services for new drug approval in India. The Drug Controller General of India regulates drugs and medical devices through the Central Drugs Standard Control Organization. New drug approval involves submitting a Common Technical Document with information on quality, non-clinical studies, and clinical studies. Approval takes approximately one year and involves fees of Rs. 50,000. After approval, an import license must be obtained through additional documents and fees in order to import the drug. The import license process takes about one month.

1. WELCOME
Accredited
Consultants Pvt Ltd
D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091
Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91-
9266665201 Email: info@acplgroupindia.com,
info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web:
www.acplgroupindia.co.in

2. New Drug Approval
[NDA]
Accredited Consultants Pvt Ltd

3. Accredited Consultants Pvt Ltd
DRUG REGULATION SYSTEM IN INDIA
The Objective of a Drug Regulatory Authority is to ensure
that of medicinal products are of acceptable Quality, Safety
and Efficacy which are Approved, Manufactured and
Imported.
Drug Controller General of India is the head of Central Drug
Standard Control Organization , which regulates Devices &
Drugs in India.

4. Accredited Consultants Pvt Ltd
Drug Controller General of India
Deputy Drug Deputy Drug Deputy Drug Deputy Drug
Controller Controller Controller Controller
[New Drug/GCT [Medical Device] [Biologicals &Vaccines] [Drugs]
/FDC/P’ovigilance]
Asst Drug Controller Asst Drug Controller Asst Drug Controller Asst Drug Controller
T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15) T.O/D.I (5-15)
TDA (0-10) TDA (0-10) TDA (0-10) TDA (0-10)

5. Functions of CDSCO
 Approval of new drugs and clinical trials
 Import Registration and Licensing
 Licensing of Blood Banks, LVPs,Vaccines, r-DNA
 products & some Medical Devices
 Amendment to D &C Act and Rules
 Banning of drugs and cosmetics
 Grant ofTest License, Personal License, NOCs for
Export
 Testing of Drugs
Accredited Consultants Pvt Ltd

6. Approval of Clinical Trials, Import, &
Manufacture of New Drugs
Accredited Consultants Pvt Ltd
Requirements and Guidelines - ScheduleY
 Rule 122 A -: Permission to import and market new drug
 Rule 122 B -: Permission to manufacture new drug
 Rule 122 DA -: Permission of Clinical trials/IND
 Rule 122 E -: Definition of New Drugs*
• New substance having therapeutic
indication
• Modified or new claims, new route of
administration for already approved drug
• Fixed Dose Combination

7. Accredited Consultants Pvt Ltd
FLOW CHART FOR New Drug Approval
(NDA)
Biologicals Vaccines New drugs/Devices
Common Technical documents [CTD]
(Modules 1-5)
• Veterinary Product - CTD Modules 1-4
- Noc from Animal Husbandry

8. Accredited Consultants Pvt Ltd
Common Technical Documents
MODULE-1: Administrative Information
MODULE- 2: Quality Overall Summary
MODULE-3: Quality
MODULE-4: Non- Clinical Studies
MODULE-5: Clinical Studies

9. Accredited Consultants Pvt Ltd
New Drug Approval
Form 45 Form 45 A Form 46
(Finished Formulation) (Bulk Substance) (Manufacturing)
Registration
Form 41
Import License
Form 10

10. TIME LINE & FEES FOR NDA
Accredited Consultants Pvt Ltd
It generally takes about one year to scrutinize these
documents byTechnical DataAssociates/Drug inspectors
of CDSCO and during this period clarification if any, are
required by them are answered and thereafter the
importer gets theApproval.
TR Challan of Rs 50,000 is required for the fresh
application.
TR Challan of Rs 15,000 is required for subsequent
application.

11. Accredited Consultants Pvt Ltd
FLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form 40 POA, DI & DII PMF DMF Labels/Inserts

12. LEGAL DOCUMENTS
DocumentsTo be submitted by Indian agent
 Form 40- It should be signed and stamped by Indian agent.
DocumentsTo be submitted by Manufacturer
 POA- Power of attorney should beAppostilised or Consularized
from Indian embassy of the country of origin, and should be co-
jointly signed by both the parties i.e Manufacturer and Indian
Agent.
 Schedule DI & DII- They should be signed and stamped by
Manufacturer (Need not to be notarized)
Accredited Consultants Pvt Ltd

13. REGULATORY DOCUMENTS
 Notarized Plant Registration Certificate
 Notarized Manufacturing & Marketing License
 Notarized Free Sale Certificate
 GMP/COPPCertificate Notarized
Accredited Consultants Pvt Ltd

14. Accredited Consultants Pvt Ltd
Technical Documents
A) Plant master file: Should include the
following points.
 Sketch of the Plant
 Profile of the company
 Organogram of the Company
 Plant & Machinery
 Hygienic & Sanitary measure details
 IQPQDQOQ
 HAVAC System
 MEN MATERIAL MOVEMENT

15. Accredited Consultants Pvt Ltd
B). Drug master file: Should include the
following points.
 Manufacturing process/Flow Chart
 Quality Assurance procedures/process controls
 The provision to control contamination & cross contamination in
the final product
 Process control, control of critical steps and intermediates.
 Container Closure System
 RiskAssessment as per ISO 14971.
 Process validation/verification
 Stability data
 Biocompatibility andToxicological data
 Clinical Studies & reports

16. Accredited Consultants Pvt Ltd
Post marketing Surveillance- It is the part
of Device Master File, should include following points:
 Procedures for distribution of records
 Complaint handling.
 Adverse incident reporting
 Procedure for product recall
 Corrective ActionTaken

17. Accredited Consultants Pvt Ltd
C). LABELS AND INSERTS
 Product labels should show the address of
Manufacturer.
 Product inserts should describe the brief description
of the product and its intended use.

18. Accredited Consultants Pvt Ltd
PROCESSING PROCEDURE
After ensuring all documents correctly as per the
requirements of FDA, they are submitted. It generally
takes about 2-3 months to scrutinize these documents by
Technical DataAssociates/Drug inspectors of CDSCO
and during this period clarification if any, required by
them are answered and thereafter we get the
Registration Certificate (RC) in Form 41.

19. Accredited Consultants Pvt Ltd
IMPORT PROCESSING
After getting the registration certificate from CDSCO, the
Indian agent is now import the products from the
manufacturer. Following documents are further required to
get Form 10 (Import license).
 Form 8
 TR Challan- (Rs 1000 for Ist product then Rs 100 for each
additional product)
 Form 9
 Copy ofWholesale License (Indian agent)-Notarized
 Copy of Registration Certificate-Notarized

20. Accredited Consultants Pvt Ltd
TIME LINE FOR IMPORT LICENSE
The Importer (Indian agent) is not authorized to import the
products from foreign manufacturer unless he obtains Import
license (Form 10) form CDSCO.
It generally takes about one month to scrutinize these documents
byTechnical DataAssociates/Drug inspectors of CDSCO and
during this period clarification if any, are required by them are
answered and thereafter the importer gets the Import license.
For Import license applicationTR Challan of Rs 1000 for Ist
product then Rs 100 for each additional product is required.

21. THANK YOU
Accredited Consultants Pvt Ltd
OUR HEARTFUL THANKS
WE BELIEVE OUR CLIENTS ARE OUR
KINGS!!!
D-29, First Floor, Acharya Niketan, Mayur Vihar Phase-I, Delhi-110091
Ph: 011-22758204, Fax: 011-22758994 (M) +91-9310040434:+91-
9266665201 Email: info@acplgroupindia.com,
info@acplgroupindia.co.in; prasad_bhat@hotmail.com; Web:
www.acplgroupindia.co.in