This document outlines the regulatory requirements and approval procedures for drugs, cosmetics, medical devices, biological products, herbal medicines, and foods/nutraceuticals in India. It discusses the key regulatory bodies like the Central Drugs Standard Control Organization (CDSCO) and the application processes. For drugs, the new drug approval procedure is described involving applying to the DCGI and undergoing clinical trials and reviews. For other products, the document explains the application forms and documents required for approval from bodies like FSSAI.

1. REGULATORYREQUIRNMENTSAND
APPROVAL PROCEDURE FOR DRUGSAND
COSMETICS, MEDICALDEVICES,
BIOLOGICAL& HERBALSAND FOODAND
NUTRACEUTICALS IN INDIA
PRESENTED BY : SANDEEP BANSAL
M.PHARMACY 1st yr
( DRA)

2. CONTENTS
1. REGULATORY REQUIRNMENT FOR NEW DRUG
APPROVAL PROCEDURE IN INDIA.
2. The Central Drugs Standard Control Organization
(CDSCO).
3. State licensing authority.
4. Functions of State licensing authority.
5. Regulatory Provisions for the approval of Cosmetics in
India.
6. Medical Device Registration in India .
7. Registration process for food & Neutraceutical in India.
8. Regulatory Requirements for Herbal Medicines in India.
9. References.

3. REGULATORY REQUIRNMENT FOR NEW
DRUG APPROVAL PROCEDURE IN INDIA:
In 1988, the Indian government added
ScheduleY to the Drug and Cosmetics Rules
1945. ScheduleY provides the guidelines
and requirements for clinical trials.
When a company in India wants to manufacture/
import a new drug it has to apply to seek
permission from the licensing authority (DCGI)
of CDSCO by filing in Form 44 also submitting
the data as given in ScheduleY of Drugs and
Cosmetics Act 1940 and Rules 1945

4. APPLICANT
APLICATION TO
ETHICAL
COMITTEE
IND application
filing to CDSCO
head quarters
Detailed review by
IND committee
Recommendation
to DCGI
IND application
approved
Clinical trials
started
Application for new
drug registration to
CDSCO
Review by DCGI
Examination by
new drug division
REPORT OF
ETHICAL
COMITTEE
LICENCE IS
GRANTED
IF POSITIVE
WITH
IN 12
WEEKS
REFUSED
TO GRANT
LICENCE
If not complete
Flow chart

5. The Central Drugs Standard Control
Organization (CDSCO)
•The Central Drugs Standard
Control Organization (CDSCO)
under Directorate General of
Health Services, Ministry of Health
& Family Welfare and Government
of India is the National Regulatory
Authority (NRA) of India.
•Under the Drugs and Cosmetics Act, CDSCO is responsible for approval
of l Drugs, Conduct of Clinical Trials in India.
•Its headquarter is located at FDA Bhawan, Kotla Road, New Delhi
110002 and also has six zonal offices, four sub zonal offices, thirteen Port
offices and seven laboratories spread across the country.

6. State licensing authority:
"STATE LICENSING
AUTHORITY" MEANSTHE
AUTHORITY CREATED FORTHE
PURPOSE OF REGULATING AND
CONTROLLINGTHE LICENSING
OFTHE CULTIVATION,
MANUFACTURE,
DISTRIBUTION, AND SALE OF
MEDICAL MARIJUANA INTHIS
STATE.

7. Functions of state licensing authority
 Licensing of Manufacturing Site for Drugs
including API and Finished Formulation .
 Licensing of Establishment for sale or distribution
of Drugs.
 Approval of Drug Testing Laboratories.
 Monitoring of Quality of Drugs and Cosmetics
marketed in the country.
 Recall of sub-standard drugs.

8. Regulatory Provisions for the approval of
Cosmetics in India
Application is required to made in form no 31. The
application should accompanied by a fee of Rs.2500 and
inspection fee of Rs. 1000 additional fee will be deposited.
This license is issued by the state regulatory
authorities (State Food and drugs administration).
A license is required for the manufacture of
cosmetic for sale/distribution.

9. The application is accompanied with
following documents
A list of equipment and machinery to be installed. A
document showing the possession of applicant on the
proposed premises for factory e.g. rent receipt.
A document showing the constitution of the firm.
Layout plan of the factory premises.

10. Medical Device Registration in India
The Central Drug Standards Control Organization (CDSCO) is
India’s main regulatory body for pharmaceuticals and medical
devices. The Drug Controller General of India (DCGI) is the
key official within the CDSCO. The DCGI is responsible for
the approval of the manufacturing of medical devices.
• CDSCO
Application for the grant of license for manufacture of
Medical Devices in India shall be made in Form 27.
• CDSCO

11. APPLICANT
ONLINE SUBMISSIONOF
APPLICATIONWITH REQUISITE
DOCUMENTS AND FEES
APPLICATION RECEIVED BY
NODEL OFFICER
APPLICATION
FORWARDEDTO
REVIEWING
OFFICER
AFTER REVIIEW
FORWARDEDTO NODAL
OFFICER
AFTER REVIEW
FORWARDEDTO
DDA ( department of
drug administration
FORWARDED
TO LA
APPROVAL
QUERY
If any deficiency in
documents
FLOW CHART
OF MEDICAL
DEVICES
APPROVAL

12. The following documents are required to be submitted in
the following manner and order for grant of license in
form-28 for Manufacture of Medical Devices in India:-
1. Covering letter.
2. An Authorization letter.
3. A duly filled form of 27.
4. The requisite fees i.e. 7500 Rs.
5. Approved manufacturing premises plan.
6. Site master file.
7. Device master file.
8. List of devices for manufacturing.
9. ISO 13485:2003 Certificate (if any) .

13. Registration process for food & Neutraceutical
in India
In India the Food Safety and Standards Authority of India(FSSAI) is the apex
food regulator.
It is empowered by and functions under the Ministry of Health and Family
Welfare, Government of India.
The FSSAI implements and enforces food regulations as prescribed in
the Food Safety and Standards Act, 2006 (FSS Act).
The FSS Act is an Act of Parliament, popularly known as the Food Act.
Previous to the FSS Act there were a number of food legislations. All these
have been consolidated into a homogenous whole in the FSS Act.

14. Documents required for application in fssai
Documents Requirement for FSSAI Food LicenseThe FSSAI
required documents for Food License depends on the kind of
registration – simple Registration Form A or Food License Form
B which depends on annual turnover.
AnnualTurnover Registration / License Below 12 Lakhs or 12 – 20
Lakhs for form A
State License FORM B Above 20 Lakhs Central License FORM B
Basic Registration is required.

15. Documents required with FormA6 :
Passport size photograph of Food Business Operator.
Document for Identity proof like ration card, voter ID card, Pan card,
Driving License, Passport,Aadhar card, Senior citizen card, Department
issued ID .
Supporting documents (if any): NOC by Municipality/Panchayat, Health
NOC State License is required for FBO having an annual turnover of 12 –
20 Lakhs Documents required with Form B (State License)6
Form B must be appropriately completed and signed (in duplicate) by
the proprietor or partner of the authorized signatory.

16. Apply to state licensing
authority for site
registration in Form A
Inspection in 30
days
Rejection of
application
Approval of site
Apply mfg license in
FORM B
A unique application
number has been issued
Queries/ response
based inspection on
premises
Grant of license and mfg
shall start the business Rejection of license
7 days
30 days
60 days
60 days
Flow chart

17. Regulatory Requirements for Herbal
Medicines in India
1.
• Herbal medicines are being used in India since Vedic age and
it has been documented in Rig-Veda. It has been mentioned
in Charak Samhita.
2.
• Herbal drugs are regulated under drug and cosmetic act 1940
& 1945 in India.
• schedule T act lays down the GMP in India.
3.
• Herbal medicines are also used since long back in other
different countries like China.
• In India herbal medicines are being used in Ayurveda,
Siddha, Unani and Homoeopathic system of medicines.

18. Continued…..
Research Councils (ICMR and CSIR), Department of
AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and
Homoeopathy) & Drugs and Cosmetics Act 1940
(Amendment) regulates herbal medicines in India
.
Section 33EEB in the Drugs and Cosmetics Act, 1940.
Regulation of manufacture for sale of Ayurvedic, Siddha and
Unani drugs.—No person shall manufacture for sale or for
distribution any Ayurvedic, Siddha or Unani drugs in India
except in accordance with such standards

19. References
 Patel j, Parikh k, shah d. NEW DRUG APPROVAL PROCEDURE IN
INDIA | PharmaTutor [Internet]. Pharmatutor.org. 2018 [cited 08
december 2018]. Available from:
https://www.pharmatutor.org/articles/new-drug-approval-
procedure-india.
 Welankiwar A. REVIEW: REGULATORY PROVISIONS
REGARDING COSMETICS IN INDIA | PharmaTutor [Internet].
Pharmatutor.org. 2018 [cited 08 december 2018]. Available from:
https://www.pharmatutor.org/articles/review-regulatory-
provisions-regarding-cosmetics-in-india.
 India Medical Device Registration - CDSCO Approval [Internet].
Pacific Bridge Medical. 2018 [cited 9 december 2018]. Available
from: https://www.pacificbridgemedical.com/regulatory-
services/medical-device/product-registration/india/
 Home | Ministry of AYUSH | GOI [Internet]. Ayush.gov.in. 2018
[cited 9 December 2018]. Available from: http://ayush.gov.in/

20. Reference continued…
 [Internet]. Cdsco.gov.in. 2018 [cited 09 december 2018]. Available from:
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-
documents/medical-device/Guidance1.pdf.
 . Us A, Mission F, Us C, Subscription M, Archive M, Policy P et al. Food
Regulations—What is the Current Scenario in India? - Food Quality &
Safety [Internet]. Food Quality & Safety. 2018 [cited 09 december 2018].
Available from: https://www.foodqualityandsafety.com/article/food-
regulations-what-is-the-current-scenario-in-india-2/.
 home [Internet]. Cdsco.gov.in. 2018 [cited 09 december 2018]. Available
from: https://cdsco.gov.in/opencms/opencms/en/Home/.
 [Internet]. Cdsco.nic.in. 2018 [cited 09 december 2018]. Available from:
http://www.cdsco.nic.in/writereaddata/statefunction.pdf.
 DefinedTerm: State Licensing Authority [Internet]. DefinedTerm. 2018
[cited 09 december 2018]. Available from:
https://definedterm.com/state_licensing_authority.