This PPT covers the B. Pharm, Pharmaceutical Jurisprudence Unit-I topics with Objectives, Definitions, Legal definitions of schedules to the Act and Rules Import of drugs – Classes of drugs and cosmetics prohibited from import, Import under license or permit. Offences and penalties. Manufacture of drugs – Prohibition of manufacture and sale of certain drugs, Conditions for grant of license and conditions of license for manufacture of drugs, Manufacture of drugs for test, examination and analysis, manufacture of new drug, loan license and repacking license.

1. Drugs and Cosmetics
Act, 1940, and its
Rules, 1945
UNIT-1

2. Overview
The Drugs and Cosmetics Act, 1940 is an important
legislation in India that governs the manufacture,
distribution, and sale of drugs and cosmetics.
The Act was enacted on 10th April 1940, during the
British colonial rule in India.
It is a comprehensive law to ensure the safety, efficacy,
and quality of drugs and cosmetics available to the
public.

3. Historical Background
The history of the Drugs and Cosmetics
Act dates back to the early 20th
century.
Before the Act's enactment, no specific
law governing drugs and cosmetics in
India led to unregulated practices.
The need for dedicated legislation arose
to protect public health and ensure the
availability of safe and effective
medications and cosmetics.

4. Purpose of the Drugs
and Cosmetics Act
The primary purpose of the Drugs and
Cosmetics Act is to safeguard public health
by regulating drugs and cosmetics.
It aims to ensure that drugs and cosmetics
available in the market are high-quality,
safe for use, and fulfill their intended
purpose.

5. Key Objectives
Regulating the import,
manufacture, distribution,
and sale of drugs and
cosmetics.
Controlling the quality and
standard of drugs and
cosmetics to prevent
consumer harm.
Prohibiting the manufacture
and sale of substandard or
adulterated drugs and
cosmetics.
Ensuring accurate and
informative labeling of drugs
and cosmetics.

6. Jurisdiction
The Drugs and Cosmetics
Act, 1940, applies to the
entire territory of India.
It covers all drugs and
cosmetics intended for
human use, including those
imported or manufactured
within the country.

7. Definitions
The Act provides specific definitions for "drugs" and
"cosmetics" to define the scope of its regulation.
• “Drugs" include medicines, substances used to
diagnose or treat diseases, and those intended to alter
physiological functions.
• "Cosmetics" include products used for beautifying or
enhancing appearance, such as creams, lotions, and
perfumes.

8. Regulatory Authorities
The Central Drugs Standard Control Organization
(CDSCO) is India's apex regulatory body responsible
for drug and cosmetic regulation.
Additionally, State Drug Control Authorities at the
state level play a crucial role in enforcing the Act's
provisions within their respective jurisdictions.

9. Role of CDSCO
Granting licenses to
manufacture, import, and
distribute drugs and
cosmetics.
Monitoring clinical trials for
new drugs and cosmetics.
Overseeing the import and
export of drugs and
cosmetics.
Ensuring compliance with
quality and safety standards.

10. Drug and
Cosmetic
Rules,
1945
These rules provide detailed guidelines
and procedures for implementing
various provisions of the Act.
They cover aspects such as licensing
requirements, labeling, packaging, and
clinical trials.

11. Salient
Features of
the Rules
Licensing requirements for drug and
cosmetic manufacturing, sale, and
distribution.
Guidelines for the labeling and packaging of
drugs and cosmetics.
Regulations for clinical trials and
import/export of drugs and cosmetics.
Inclusion of schedules listing drugs and
cosmetics with specific requirements.

12. Amendments to
the Act and Rules
Over the years, the Drugs and
Cosmetics Act and its Rules
have undergone several
amendments to adapt to
changing healthcare needs
and advancements.
Amendments have
strengthened regulations,
enhanced patient safety, and
improved drug quality.

13. Legal Definitions
Misbranded Drugs: Falsely labeled or misleadingly packaged
drugs.
Adulterated Drugs: Drugs with compromised purity or quality.
Spurious Drugs: Deceptive imitations of other drugs.
Drugs of Unproven Efficacy: Drugs without proven effectiveness
for claimed conditions.
Contravention of Licensing in Drug Manufacturing: Drugs
produced without/violating licensing conditions.
Unprescribed Dyes in Cosmetics: Cosmetics using unapproved
colors, dyes, or pigments.

14. Legal Definitions
Contravention of Licensing in Cosmetic Manufacturing: Cosmetics made
without/violating licensing conditions.
Misbranded Cosmetics: Falsely labeled or misleadingly packaged cosmetics.
Spurious Cosmetics: Deceptive imitations of other cosmetics.
Adulterated Cosmetics: Cosmetics with modified purity or quality.
Patent/Proprietary Medicine: Non-homeopathic remedy or prescription for
humans/animals, described or not in a monograph authorized by the
Central Government.

15. Legal Definitions
Registered Medical Practitioner: Person reported as a medical
practitioner under prevailing law.
Government Analyst: Appointed person to analyze/test drug/cosmetic
samples for compliance with the Act's standards.
Inspector: Individual appointed to inspect premises for drug/cosmetic
manufacturing, distribution, or sales to ensure Act compliance.
Imported Drugs: Drugs brought into India from abroad.
Label: Any written, printed, or graphic matter on a drug's immediate
container or packaging.
Batch Number: Designation on a label for product traceability to
manufacturer's production records.

16. Import of Drugs and Cosmetics
The import of drugs and
cosmetics into any
country, including India,
is governed by specific
regulations to ensure
that these substances are
safe, efficacious, and
high-quality.
In India, these rules are
laid out in the Drugs and
Cosmetics Act of 1940
and its amendments,
which are enforced by
the Central Drugs
Standard Control
Organization (CDSCO).

17. Classes of
Drugs and
Cosmetics
Prohibited
from
Import
Misbranded Drugs: Drugs that are falsely
labeled or packaged misleadingly.
Adulterated Drugs: Products with purity or
quality compromise, such as dilution or adding
foreign substances.
Spurious Drugs: Drugs that are made to
imitate another drug, often in a deceptive
manner.
Drugs of Unproven Efficacy: Drugs that have
not been shown to effectively treat the
conditions they claim to address.
Drugs Manufactured in Contravention of
Licensing Provisions: Drugs produced
without the necessary licensing or violating the
licensing conditions.

18. Classes of
Drugs and
Cosmetics
Prohibited
from
Import
Cosmetics containing Dyes, Colors, or
Pigments not Prescribed: Any makeup that
uses colors, dyes, or pigments that regulations
have not approved.
Cosmetics Manufactured in Contravention
of Licensing Provisions: Cosmetics produced
without the necessary licensing or violating the
licensing conditions.
Misbranded Cosmetics: Cosmetics that are
falsely labeled or packaged misleadingly.
Spurious Cosmetics: Cosmetics are designed
to imitate another product, often deceptively.
Adulterated Cosmetics: Cosmetics that have
been modified in a way that impacts their purity
or quality, such as by adding foreign
substances.

19. Import Under
License or Permit
For Drugs: A Central Drugs Standard Control
Organization (CDSCO) license is needed.
Compliance with quality standards and
labeling requirements is mandatory.
For Cosmetics: A registration certificate from
the CDSCO is required. This involves
submitting product details; the certificate is
valid for three years.
These permits ensure the safety, efficacy, and
quality standards of health products
imported into India.

20. Offences and Penalties
Unlicensed Import: Importing drugs
without a valid license can lead to
imprisonment (typically 1-3 years) and/or
fines.
Import of Prohibited or Substandard
Drugs: Importing banned, misbranded,
adulterated, or spurious drugs can lead to
imprisonment (possibly for life) and/or
fines.
Violation of Standards: Importing drugs
that fail to meet prescribed standards can
lead to imprisonment and/or fines.
Repeat Offences: Repeat offenders may
face harsher penalties.

21. Prohibition of
manufacture and sale
of certain drugs
The manufacture of drugs is a highly regulated process, and there
are laws and regulations in place to ensure the safety, efficacy, and
quality of pharmaceutical products. Prohibiting the manufacture and
sale of certain drugs is an essential aspect of drug regulation to
protect public health.

22. Regulatory Bodies
• Health authorities, such as
the Food and Drug
Administration (FDA) in the
United States or the
European Medicines
Agency (EMA) in the
European Union, oversee
drug regulation and
enforcement of prohibitions.

23. Schedule of
Prohibited Drugs
• Governments classify drugs into
different schedules based on their
potential for abuse, medical use, and
safety risks.
• Schedule I: Drugs with a high potential
for abuse and no accepted medical use
(e.g., heroin, LSD).
• Schedule II: Drugs with a high potential
for abuse but with accepted medical
use (e.g., opioids like oxycodone,
fentanyl).

24. Illicit Drug
Manufacturing
• Prohibition targets
clandestine manufacturing of
illegal drugs, such as
methamphetamine, ecstasy,
and synthetic opioids.
• Illicit manufacturing poses
significant health and safety
risks due to poor quality
control and oversight.

25. Counterfeit
Drugs
Prohibition addresses the
manufacture and sale of
counterfeit drugs.
Counterfeit drugs may contain
incorrect ingredients, inadequate
doses, or no active ingredients,
posing severe health risks to
consumers.

26. Unapproved Drugs
Prohibition extends to
manufacturing and selling
unapproved drugs without
proper regulatory authorization.
Unapproved drugs have yet to
undergo rigorous testing for
safety and efficacy.

27. Public Health
Impact
Prohibiting certain drugs
safeguards public health by
reducing the availability of unsafe
and potentially harmful
substances.
It helps combat drug abuse, drug-
related crime, and adverse health
consequences.

28. Enforcement
and
Penalties
Regulatory bodies and
law enforcement
agencies actively
enforce drug
prohibitions.
Violators may face
significant legal
penalties, including
fines and
imprisonment.

29. Pharmaceutical
Quality
Assurance
Drug manufacturers must adhere to Good
Manufacturing Practices (GMP) to ensure
product quality, safety, and consistency.

30. • Prohibition of the manufacture and sale of certain drugs is
essential for protecting public health and promoting safe
medication use.
• Stringent regulations and enforcement efforts help ensure the
availability of safe and effective pharmaceutical products.

31. Conditions for grant
of license and
conditions of license
for manufacture of
drugs

32. Conditions for
Grant of License
• Compliance with GMP: Applicants must
demonstrate adherence to Good
Manufacturing Practices (GMP) to maintain
high-quality manufacturing standards.
• Technical Competence: Demonstrate
technical expertise and capability to
manufacture drugs in accordance with
approved processes.
• Premises and Facilities: The manufacturing
facility must meet the required cleanliness,
layout, and equipment standards.
• Quality Control: Implement a robust quality
control system to ensure consistent product
quality.
• Qualified Personnel: Employ qualified
personnel, including pharmacists and
chemists, to oversee manufacturing

33. Categories of
License
Formulation License: For
manufacturing finished dosage
forms (tablets, capsules, etc.).
Bulk Drug License: To
manufacture active
pharmaceutical ingredients.
Loan License: License granted
to use another manufacturer's
facilities for drug production.

34. Conditions of
License
Product-Specific Approval: The license for
specific drugs and dosage forms mentioned
in the application is granted.
Compliance Reporting: License holders
must regularly submit compliance reports to
regulatory authorities.
Adverse Event Reporting: Per guidelines,
report adverse drug reactions and incidents
to the regulatory authority.
Record Keeping: Maintain comprehensive
records of manufacturing and quality control
procedures.
Inspection and Renewal: Subject to periodic
inspections and renewal based on
compliance and adherence to regulations.

35. Post-
Approval
Changes
• Manufacturers must
seek prior approval for
significant changes to
manufacturing
processes, equipment,
or locations.
• Minor changes may
require notification to
the regulatory
authority.

36. Good
Manufacturing
Practices (GMP)
• Strict adherence to GMP is mandatory
for license holders.
• GMP guidelines encompass all aspects
of drug manufacturing, including
facilities, personnel, equipment, and
documentation.

37. Quality
Assurance
and Quality
Control
Establish a robust quality
assurance system to ensure
product consistency and
compliance with standards.
Implement quality control
measures to test raw materials,
in-process samples, and
finished products.

38. Compliance
and
Inspections
Regulatory authorities
conduct periodic
inspections to assess
license conditions and
regulations compliance.
Non-compliance may result
in penalties, license
suspension, or revocation.

39. Granting licenses and imposing
conditions ensures the
manufacturing of drugs in a
controlled and standardized
manner.
Adherence to regulations
promotes patient safety and
access to high-quality
medications.

40. Manufacture of Drugs for Test,
Examination, and Analysis under
Drugs and Cosmetics Act
The Drugs and Cosmetics Act, 1940,
and its Rules, 1945, govern the
manufacturing, sale, distribution, and
testing of drugs in India.

41. Section 26A -
Test and
Analysis
Section 26A of the Act deals with
the "Power to Prohibit Manufacture,
etc., of Drugs and Cosmetics in
Public Interest."
It allows the Central Government to
prohibit manufacturing, selling,
distributing, or importing drugs and
cosmetics for specific periods or
permanently for public safety
reasons.

42. Section 33 - Powers of
Inspectors for Sampling
Section 33 empowers Drug
Inspectors to take samples of
drugs, including those intended for
test and examination.
Samples are collected to assess
drug quality, efficacy, and
compliance with standards.

43. Rule 86 - Prohibition of
Manufacture and Sale
of Certain Drugs
Rule 86 of the Drugs and Cosmetics Rules,
1945, lists the drugs and substances
whose manufacture, sale, and distribution
are prohibited.
This includes psychotropic substances and
narcotics.

44. Rule 96 -
Standards for
Drugs Used for
Examinations
Rule 96 lists specific standards
for drugs manufactured for
testing, examination, and
analysis.
The drugs must meet the
prescribed quality parameters to
ensure accurate and reliable
testing results.

45. Rule 97 - Drugs for
Testing
Rule 97 outlines the requirements for the
import and sale of drugs for testing,
examination, and analysis.
These drugs must be duly authorized and
comply with the prescribed labeling and
packaging standards.

46. Schedule D -
Requirements for
Biological Products
Schedule D of the Rules provides
requirements for biological products,
including vaccines, sera, and
diagnostics.
These products are subject to
stringent testing and examination
before use.

47. Quality Assurance
and Good
Manufacturing
Practices (GMP)
Manufacturers of drugs for test,
examination, and analysis must
adhere to GMP to ensure
consistent product quality.
Quality assurance measures are
essential to maintain integrity and
reliability during testing.

48. Role of Central and State Regulatory
Authorities
Central and State Drug Control
Authorities play a vital role in
regulating drug manufacture,
import, and sale for test and
analysis.
They enforce compliance with the
Act and Rules to safeguard public
health.

49. The Drugs and Cosmetics Act and
its Rules provide a robust
regulatory framework for drug
manufacture, testing, and analysis.
Ensuring compliance with these
regulations guarantees the quality
and safety of pharmaceutical
products.

50. Manufacture
of New Drug
The Drugs and Cosmetics Act, of 1940, governs
the manufacture, import, sale, and distribution of
drugs in India.
Manufacturing a new drug requires compliance
with specific regulatory procedures to ensure
patient safety and efficacy.

51. Definition of
New Drug
The Act defines a "new drug" as:
A drug not previously used in India.
A drug that includes a new
combination of known drugs.
A drug that is a fixed-dose
combination of two or more drugs
individually approved.

52. Clinical Trials and
Approval Process
Manufacturers must conduct
clinical trials to assess the new
drug's safety and efficacy in
humans.
Data from pre-clinical and
clinical studies are submitted to
the Central Drugs Standard
Control Organization (CDSCO)
for approval.

53. Investigational New Drug
(IND) Application
Before conducting clinical trials,
manufacturers must submit an IND
application to the CDSCO for review
and approval.
The IND application includes data
from pre-clinical studies,
manufacturing details, and proposed
clinical trial protocols.

54. Phase I to
Phase IV
Clinical Trials
Clinical trials are conducted in multiple phases to
evaluate different aspects of the drug's safety
and efficacy.
Phase I: Initial safety assessment in a small
group of healthy volunteers.
Phase II: Safety and dosing assessment in a
small group of patients.
Phase III: Efficacy and safety evaluation in a
larger patient population.
Phase IV: Post-marketing surveillance for long-
term safety monitoring.

55. New Drug
Application
(NDA)
After successful clinical trials,
manufacturers submit a New Drug
Application (NDA) to the CDSCO for
marketing approval.
The NDA includes comprehensive data
on pre-clinical and clinical studies,
manufacturing details, and labeling.

56. Expert Committee Review
The CDSCO refers the NDA to an
expert committee for a thorough
evaluation.
The committee assesses the data
and makes recommendations for
approval or rejection.

57. Manufacturing
and Quality
Control
Manufacturers must comply with
Good Manufacturing Practices
(GMP) to ensure consistent
product quality during
commercial production.
Quality control measures are
essential for batch release and
ongoing product monitoring.

58. Post-
Approval
Surveillance
Even after approval, manufacturers
must continue to monitor the new
drug's safety and report adverse
events to regulatory authorities.

59. The Drugs and Cosmetics Act provides
a rigorous regulatory framework for
manufacturing new drugs in India.
The process ensures that new drugs
meet the highest safety and efficacy
standards before reaching patients.