For any Drug to be imported to India Drug Manufacturing Site and Drug to be Registered and Import Licence is Required

1. Accredited Consultants Pvt. Ltd.
WELCOME

2. India Greetings
•Greetings From India! Greetings
from Accredited Consultants Pvt.
Ltd.
•We hope you are all safe and healthy
during this unforeseen pandemic.
Accredited Consultants Pvt. Ltd.

3. DRUG REGULATION SYSTEM IN
INDIA
Drug Controller General of India is the head
of Central Drug Standard Control
Organization, which regulates Drugs in India.
TR Challan: Fees of 10,000 USD is required
for Manufacturing Site registration and 5000
USD for registration of each product.
Accredited Consultants Pvt. Ltd.

4. Who is the Regulatory Body ?
The Drugs Controller General (India) of Central
Drugs Standard Control Organisation (CDSCO) is
the Regulatory Authority That governs the
• Import,
• Manufacture,
• Sale and Distribution of Medical Devices under
the Medical Devices Rules, 2017.
Accredited Consultants Pvt. Ltd.

5. Hierarchy of Drug Regulatory
entities in India
Accredited Consultants Pvt. Ltd.
Ministry of Health and Family Welfare
Drug Controller General of India - DCG(I)
Separate Division for Drugs, Medical Devices and
Cosmetics wherein Joint Drug controller, Deputy
Drug controller, Assistant Drug controller, Drug
Inspectors etc are reviewing in the process of
approvals

6. Drug Regulation –Recent Changes
in India
• Only Soft copies of documents required and
submitted online
• Fee to be paid online only
• Govt. Fee is increased
Accredited Consultants Pvt. Ltd.

7. What is Drug?
• (i) all medicines for internal or external use of human beings or animals and
all substances
• intended to be used for or in the diagnosis, treatment, mitigation or
prevention of any disease or disorder in human beings or animals, including
preparations applied on human body for the purpose of repelling insects like
mosquitoes;]
• (ii) such substances (other than food) intended to affect the structure or any
function of the human
• body or intended to be used for the destruction of vermin or insects which
cause disease in human beings or animals, as may be specified from time to
time by the Central Government by notification in the Official Gazette;
• (iii) all substances intended for use as components of a drug including empty
gelatin capsules
Accredited Consultants Pvt. Ltd.

8. Drug Regulated In India
All Drugs are Regulated Under Drugs and Cosmetics Act
& Rules
If the Drug Falls under the definition of New Drug then
New Drug and CT Rules are applicable.
The permission under this Rules are to be submitted in
Import Registration Application
Accredited Consultants Pvt. Ltd.

9. What is a New Drug
• A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not
been used in the country to any significant extent, and has not been approved as safe and
efficacious by the Central Licencing Authority with respect to its claims; or
• A drug approved for certain claims and proposed to be marketed with modified or new claims
including indication, route of administration, dosage and dosage form; or
• A fixed dose combination of two or more drugs, approved separately for certain claims and
proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in
an approved combination is proposed to be changed with certain claims including indication,
route of administration, dosage and dosage form; or
• A modified or sustained release form of a drug or novel drug delivery system of any drug
approved or
• A vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified
organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or
xenografts, intended to be used as drug;
• Explanation.— The drugs, shall continue to be new drugs for a period of four years from the date of
their permission granted by the Central Licencing Authority and the drugs referred to in sub-clauses
(iv) and (v) shall always be deemed to be new drugs;
Accredited Consultants Pvt. Ltd.

10. Documents Required
LEGAL DOCUMENTS
Documents To be submitted by Indian agent
• Form 40- It should be signed and stamped by Indian agent.
Documents To be submitted by Manufacturer
• POA- Power of attorney should be Appostilised 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.

11. Technical Documents
A) Plant master file: Should include the
following points.
List of Major equipments in Production and QC
List of key personals with qualification, experience and their
responsibilities
Organizational Chart
QA functional Chart
Plant Layout
HVAC system drawing
Water system drawing
Pressure differential drawing
Personal movement drawing
Material movement drawing
Distribution, Complaints & products recall SOP
List of Contract Manufacturing/analysis

12. B). Drug master file: Should include the following points.
• Process Flow chart
• Manufacturing Process development Report
• Control of critical Steps
• Process validation report of three batches
• List of Impurities and related substances
• List of Residual solvents and its limits
• Testing procedure of impurities, related substances and residual solvents
• Source and maintenance of reference standards
• Container and closure system and its testing procedure
• Batch determination: batch numbering system & batch size
• Specification of the products & material used in its manufacturing
• Justification of the Specification
• Certification of analysis of five batches
• Stability data
• MSDS
Accredited Consultants Pvt. Ltd.

13. Post marketing Surveillance
It is the part of Device Master File
and should include following
points:
•Procedures for distribution of
records
•Complaint handling.
•Adverse incident reporting
•Procedure for product recall
•CAPA
Accredited Consultants Pvt. Ltd.

14. C). LABELS AND INSERTS
•Product labels should show the
address of Drug Name &
Ingredients, Manufacturer, Importers
Address, provision for Import
Licence No.
Manufacturing Date, Expiry Date,
Lot No.
•Product inserts
Accredited Consultants Pvt. Ltd.

15. Accredited Consultants Pvt. Ltd.
FLOW CHART FOR REGISTRATION
Legal Documents Regulatory documents Technical Documents
Form-40 POA Plant Master File, Device Master File,
Undertakings ,
Labels/Inserts
GMP, Manufacturing Lice/Product
Registration Certificate, COPP/FSC

16. OTHER RELATED REGULATION
National Price Control Authority Controls the price under Drug
Price Control Order under Ministry of Pharmaceuticals &
Fertilizers
Customs Act for Import Customs Clearances
Accredited Consultants Pvt. Ltd.

17. 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 Data
Associates/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
Accredited Consultants Pvt. Ltd.

18. 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- (INR 10,000 for first product and INR
1000 per additional Product)
• Form 9
• Copy of Wholesale License (Indian agent) Self-
attested
• Copy of Registration Certificate-Self-attested
• Label -Self-attested
Accredited Consultants Pvt. Ltd.

19. 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 by Technical Data Associates/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 application TR Challan of INR
10,000 for first product and INR 1000 per additional
Product is required.
Accredited Consultants Pvt. Ltd.

20. Contact Details
Address:
Accredited Consultants
Private Limited,
B-3, Sec.-6,Ground Floor,
Noida UP 201301,
INDIA
Telephones:
Landline: 011-22758204,
Mobile: +91-9310040434,
+91-9266665201
Fax: 011-22758994
Email:
bhatbio@gmail.com
info@acplgroupindia.com
info@acplgroupindia.co.in
Prasad_bhat@hotmail.com
Websites:
www.acplgroupindia.co.in
www.acplgroupindia.com

21. THANK YOU