The document discusses the pharmaceutical industry development process in India. It outlines the legal requirements and licenses needed to manufacture or import APIs and drugs. Companies must seek approval from the DCGI and adhere to CDSCO guidelines. The application process requires submitting chemical, pharmaceutical, pre-clinical and clinical data. Various forms are used for obtaining manufacturing, import, and sales licenses from the CDSCO. The CDSCO-SUGAM project aims to streamline approval processes.

1. Presented by- Rohit Koli
Guided by- Dr. Sapna Ahirrao
Class- M Pharmacy First Year Sem-II
Subject- Pharmaceutical Manufacturing Technology
Pharmaceutical Industry
Development

2. M. Pharm Sem- II Presentations
Title- Pharmaceutical Industry Development
SUBMITTED TO
SAVITRIBAI PHULE, PUNE UNIVERSITY , PUNE
FOR
PARTIAL FULFILMENT OF REQUIREMENTS FOR THE AWARD OF
MASTER OF PHARMACY
IN THE SUBJECT
Pharmaceutical Manufacturing Technology
IN THE FACULTY OF SCIENCE AND TECHNOLOGY
Bhujbal Knowledge City,
MET’s Institute of Pharmacy,
Adgaon, Nashik, 422003.
Maharashtra, India
Academic Year-2021-22 2
Presented By-
Rohit Koli
Guided By:-
Dr.Sapna Ahirrao

3. Content
• Overview
• Legal requirements and Licences for API and
Formulation industry
• Manufacturing or importing of drugs
• Application and data required
• Licenses for APIs/ Drugs
• CDSCO- Sugam
• Conclusion
• References
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4. Pharmaceutical Industry Developments
Overview-
• The pharmaceutical industry discovers, develops, produces,
and markets drugs or pharmaceutical drugs for use as
medications to be administered (or self-administered) to
patients, with the aim to cure them, vaccinate them, or
alleviate the symptoms.
• Pharmaceutical companies may deal in generic or brand
medications and medical devices.
• They are subject to a variety of laws and regulations that
govern the patenting, testing, safety, efficacy and marketing of
drugs.
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5. Legal Requirements and Licenses for API and
Formulation Industry
All new drugs (drugs not previously used in India or in use for less than four
years) proposed to be introduced must be approved for import or manufacture
in India by the DCGI.
The full set of data to be submitted consists of:
• Introduction: description of drug and therapeutic class
• Clinical and pharmaceutical information
• Animal pharmacology
• Animal toxicology
• Human/ clinical pharmacology (Phase I)
• Exploratory clinical trials (Phase II)
• Confirmatory clinical trials (Phase III)
• Special studies Regulatory status in other countries
• Marketing information
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6. • To manufacture or import Active Pharmaceutical Ingredient
(API)/drugs to India, the company or the organisation should
seek prior approval from Drugs Controller General Of India
(DCGI) for licencing to produce and distribute.
• To produce the drugs, the company should also follow the
norms as stipulated by the Central Drugs Standard Control
Organisation (CDSCO).
• The DCGI and CDSCO will be monitored by the Ministry of
Health and Family Welfare.
• To support DCGI and CDSCO for widening scope and
research, Government of India (GoI) has formed the Drug
Technical Advisory Board (DTAB) and Drug Consultative
Committee (DCC).
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Manufacturing or importing of Drugs

7. 7
Any new drug that is yet to be introduced into the country should
conduct trails, collect sample data, approval process and adhere
to Appendix 1, IA and VI of Schedule Y and the following rules
as mandated by the Drugs and Cosmetics Act 1940 and Rules
1945:
1. Rule 122 A- Permission to Import new Drugs
2. Rule 122 B- Permission to Manufacture new Drugs
3. Rule 122 DA- Definition of Required clinical trials
4. Rule 122 E- Definition of Drugs

8. 8
The following are the rules and regulations Guidelines
that should be followed By the company to introduce
the new drug in India:-
1. Drugs and Cosmetics Act 1940 and its rules 1945
2. Narcotic Drugs and Psychotropic Substances of 1985
3. Drugs Price Control Order of 1995
4. Protection Act of 1986
5. ICH GCP Guidelines
6. Schedule Y Guidelines
7. ICMR Guidelines

9. Application and Data Required
9
To seek permission to manufacture or import new drugs for
production, marketing or for clinal trials, the company should
attach the following data in Form 44 as stipulated by Schedule Y
(Rules 122A, 122B, 122D, 122DAAAND 122E):
• Chemical and Pharmaceutical details, as mentioned in item 2
of Appendix I
• Data of Animal Pharmacology, as mentioned in item 3 of
Appendix I and Appendix IV
• Actions taken for general pharmacology as prescribed in item
3.3 of Appendix I and item 1.2 of Appendix IV

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• Pharmacokinetic data with respect to the absorption,
distribution, metabolism and excretion of the test substance as
prescribed in item 3.5 of Appendix I
• Data of Animal Toxicology, as mentioned in item 4 of
Appendix I and Appendix III
• Regulatory Status, as mentioned in item 9.2 of Appendix I
• Details related to marketing new drugs as mentioned in item
10 of Appendix I
• Protocols and methods involved for testing quality, as
mentioned in item 11 of Appendix I
• If the drug involved in the study has to be imported, details
should be furnished in Form

11. Drug approval process in India
11
Applicant
Application to ethical committee
Report of ethical committee
IND Application to CDSCO
Examination by New drug division
Detail review by IND Committee
Recommendation to DCGI
IND Application Approved
Clinical trials started
NDAApplication to CDSCO
Review by DCGI
Refused to grant license License granted
If positive
Within 12 weeks
If not complete If complete

12. Licenses for API/ Drugs
12
Form 27-B: Application for grant or for renewal of
license to manufacture for sale or distribution of drugs
specified in schedule C, C(1) and X.
Form 28-B: License to manufacture for sale or
distribution of drugs specified in schedule C, C(1) and
X.
Form 24-D: Application for grant or for renewal of
license to manufacture for sale or distribution of
Ayurvedic, Siddhaor Unani medicine.

13. • Form 25-D: License to manufacture for sale or
distribution of Ayurvedic, Siddha or Unani
medicine.
• Form 40: submission of application in Form 40
to CDSCO for Registration Certificate and issuing
License for importof drugs into India.A duly filled
Form 40 as per the proforma prescribed in the
Drugs & Cosmetics Rules, signed & stamped by
the (Local Authorized Agent/manufacturer) along
with name & designation and date.

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Form 19: Application for grant or renewal of a license
to sell, stock, exhibit or offer for sale or distribute Drugs
other than those specified in schedule X.
Form 19 A : Application for grant or renewal of
restricted license stock or exhibit or offer for sale, or
distribute Drug by retail by dealers who do not engage
the service of qualified person.
Form 19 AA: Application for grant or renewal of a
license to sell,stock or exhibit sale by wholesale or
distribute drug from motor vehicle.

15. Joint responsibilities of CDSCO and SLA's
Licensing of Specilised
Products
Vaccines
And
Sera
Blood
And Its
Components
LVPs R-DNA
Products
Medical
Devices

16. CDSCO- SUGAM
• This project has brought simplicity, transparency, reliability,
accountability, timeliness and also simplified ease of business.
• It is the project of national importance that directly reflects the
Governments DIGITAL INDIA initiatives.
Prime Objectives:-
1. To establish single window for multiple stack holders
involved in the process of CDSCO.
2. To consolidate the Indian Drug Regulatory Framework by
streaming the CDSCO processes.
3. To enable paperless grant of various clearances by CDSCO.

18. Registering with CDSCO -
Companies importing drugs should register with
CDSCO in Form 41. The Form shall contain details of
the manufacturing site and drugs used and required.
After furnishing in Form-41, the company can approach
CDSCO for Import Registration Certificate and Import
Licence.
Though registration is not required for clinical tests,
New Drug and Clinical Trial Rules, 2019 states that the
company imports drugs should furnish details in Form
16 for NOC and Test Licence.
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19. Fees for registration with CDSCO-
• For manufacturers in India, the registration fee is Rs.3,00,000
• For companies importing drugs, the registration fee is USD 1500
• For registering a new drug, the fee is USD 1000 per drug
Validity of the Registration Certificate-
The registration certificate issued by CDSCO is valid for three years
from the date issued.
Renewal of Registration Certificate-
To renew the registration certificate, the company should apply nine
months before the expiry date with all required documents.
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20. 20
Regulatory
Functions
•Applications
online in the
Clinical Trials
Registry - India
(CTRI)
•Approval of
applications
•Good Clinical
Practices
•Inspections
•Registration of
Ethics
Committee
•Serious
Adverse
Events(SAE)
•12 Subject
Expert
Committees
(SECS) for
deliberation on
new drug
applications for
grant of
marketing
licence
•Import of new
drugs
(Registration of
foreign
manufacturer s
and grant of
licence to
import)
Application for
Licence to
manufacture
•Inspection of
Good
Manufacturing
Practices (WHO
GMP/Schedule
M)
• Grant of
Licence to
Manufacture
• Collection of
Samples, testing
and prosecution
for Non
Compliance
•Application for
Licence to
distribute and
sell
•Inspection of
Good
Distribution
Practices(GDP)
and sale
premises
•Grant of
Licence to
distribute and
sell
•Prosecution for
Non
Compliance
•Periodic Safety
Update Reports
(PSURS)
required to be
submitted for
new drugs
granted
marketing
licence
•Banning of
Drugs
considered
harmful or sub
therapeutic
•Pharmacovigila
nce Programme
of India (PvPI)
STAGES CLINICAL
TRIALS
NEW DRUG
APPROVALS
MANUFACTU
RING
DISTRIBUTION
AND SALES
POST
MARKETING
SURVEILLANCE
Pre Manufacturing Manufacturing
Distribution
And sale Post marketing

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Authority
Responsible
CDSCO
(appointed by
the MOHFW,
Central
Government.)
has the sole
responsibility -
relies on expert
committees.
CDSCO has the
sole
responsibility.
SDRA
(appointed by
the Department
of Health, State
Government)
has primary
responsibility.
Exceptions
(CDSCO
competence)-
•CDSCO acts as
SDRA in Union
Territories (e.g.
Delhi)
•WHO-GMP
Inspections
•High Risk
Products
(CDSCO may
include new
products in this
list via
notification)
SDRA has the
Sole
Responsibility.
CDSCO has
sole
responsibility
for PSURs and
Indian
Pharmacopoeia
Commission
(IPC) is in
charge of co-
ordinating
Adverse Drug
Reports (ADRs)

22. Conclusion
• The pharmaceutical company which has proposed to introduce
a new drug in the market must comply with all the legal
requirements and must acquire all the licenses needed to
introduce the drug in the market by following all the rules and
regulation’s guidelines.
• The purpose of drug registration is to guard the general public
health and not to facilitate profit of pharmaceutical
manufacturers.
• Registration should be seen as a critical step in ensuring access
to safe and effective medicinal products.

23. Reference
1. https://www.indiafilings.com/learn/manufacturing-or-
importing-api-drugs/
2. https://www.researchgate.net/publication/303279229_OVER
VIEW_OF_DRUG_REGISTRATION_REQUIREMENTS_F
OR_PHARMACEUTICALS_IN_EMERGING_MARKET
3. https://cdsco.gov.in/resources/guidance_on_approval_of_clini
cal_trials_and_new_drugs
4. http://www.ncbi.nlm.nin.gov/pmc/articles/PMC3148610/
5. https://sciencedirect.com/topics/pharmaceuticals_regulations
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