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1. Pharmacy Laws
and Regulations for
Narcotic Drugs
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Ensuring Safe and
Responsible Medication
Management
By:Sailesh Shukla
B.pharm 4 year
SHEAT College of Pharmacy

2. TABLE OF CONTENTS
Introduction
Importance of regulation in
pharmacy
Regulatory
Bodies
Central Bureau of Narcotics
(CBN)
Narcotic Drugs and
Psychotropic Substances
Act, 1985
Legal framework for
regulating narcotics
Licensing and
Registration
Pharmacy licensing and
registration requirements
01
03
02
04

3. TABLE OF CONTENTS
Prescription
Requirements
Schedule X prescription
rules
Dispensing Narcotic
Drugs
The role of pharmacists in
dispensing
Civil and criminal penalties
05
07
06
Penalties and
Consequences

4. Introduction to
Narcotic Drugs
in India
01
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5. Definition of Narcotic
Drugs in India
Narcotic drugs in India refer to substances that have the
potential to cause physical and psychological dependence
or addiction. These substances are known for their mind-
altering effects and are commonly used for medical and
recreational purposes
.
They include opioids (such as morphine and codeine), synthetic
opioids (like fentanyl), cannabinoids (cannabis), and some
central nervous system depressants (e.g.,
benzodiazepines) that are classified as narcotic drugs
under Indian law.

6. Importance of
Regulation in Pharmacy
The regulation of narcotic drugs in pharmacy is crucial due to
the risks associated with their misuse and abuse. These
substances, when not handled properly, can lead to
addiction, adverse health effects, and even criminal
activities.
In India, where pharmaceuticals play a significant role in
healthcare, it's imperative to have stringent regulations in
place to ensure that narcotic drugs are used safely and
responsibly.

7. Potential for Abuse:
Narcotic drugs are substances with a high
potential for abuse. This means that when
individuals use them, they can experience feelings
of euphoria or pleasure, making them susceptible
to misuse and addiction. Key points to consider
regarding the potential for abuse include:
Addictive Nature
Risk of Overdose
Seeking Euphoria:

8. Medical Use:
Pain Relief: Narcotic drugs are highly effective at
relieving severe pain, making them valuable in
medical settings. They are commonly used after
surgeries, for cancer patients, and in palliative
care.
Improved Quality of Life: For patients suffering from
chronic or acute pain, narcotic drugs can
significantly improve their quality of life by
providing relief from pain and discomfort.
Prescription and Supervision: Medical use of
narcotic drugs is closely regulated. Healthcare
providers carefully evaluate patients' conditions
and prescribe these drugs when necessary,
monitoring their use to minimize risks.

9. The Narcotic Drugs and
Psychotropic Substances
Act, 1985
02

10. Overview of the NDPS Act:
The Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, is
the primary law in India governing the production, manufacture,
possession, sale, purchase, transport, warehousing, use, consumption,
inter-State movement, import inter-State, export inter-State, import
into India, export from India, import into India from a foreign country,
counterfeiting, or manufacture, use, possession, sale, purchase,
transport, warehousing, use, consumption, import inter-State, export
inter-State, import into India, export from India, or transshipment of
narcotic drugs and psychotropic substances.

11. Classification of Narcotic
Drugs
Under the NDPS Act, narcotic drugs are categorized into various schedules, with
Schedule I containing the most dangerous substances and Schedule V the least.
These schedules are used to determine the severity of offenses and penalties.
: Schedule I — drugs with a high abuse risk. These drugs have NO safe, accepted
medical use
: Schedule II — drugs with a high abuse risk, but also have safe and accepted
medical uses
: Schedule III, IV, or V — drugs with an abuse risk less than Schedule II.

12. Regulatory
Bodies in India
03

13. Role:
CBN is the apex regulatory authority responsible for
implementing the provisions of the Narcotic Drugs and
Psychotropic Substances (NDPS) Act, 1985.
Functions
CBN issues licenses and permits for the cultivation,
manufacture, possession, sale, purchase, transport,
warehousing, use, consumption, inter-State movement,
import inter-State, export inter-State, import into India,
export from India, or transshipment of narcotic drugs and
psychotropic substances.
Enforcement:
CBN also monitors and enforces compliance with
the NDPS Act at the national level.
Central Bureau of Narcotics
(CBN):
1
2
3

14. Role:
Each state in India has its own State Drug Control
Authority, responsible for regulating pharmacy practices
within the state's jurisdiction.
Functions
State Drug Control Authorities issue licenses and permits for
pharmacies and healthcare institutions. They also oversee
the distribution and dispensing of narcotic drugs within their
respective states.
Enforcement:
State authorities work alongside CBN to ensure that
pharmacy laws and regulations are upheld at the state
level.
State Drug Control Authorities
1
2
3

15. Role:
PCI is a statutory body responsible for regulating the
education and practice of pharmacy professionals in India.
Functions
PCI sets standards for pharmacy education and practice,
including guidelines for the handling of narcotic drugs by
pharmacists.
Enforcement:
PCI plays a crucial role in educating pharmacy students
and practitioners about their responsibilities and legal
obligations regarding narcotic drugs.
Pharmacy Council of India
(PCI):
1
2
3

16. Role:
Customs authorities, including the Directorate of Revenue
Intelligence (DRI), monitor the import and export of
narcotic drugs at international borders.
Functions
. They prevent illegal trafficking of narcotic drugs across
international boundaries, collaborating with other law
enforcement agencies.
Customs Authorities:
1
2

17. Licensing and
Registration
04

18. Pharmacy License:
Requirements:
: Proof of ownership or occupancy of the
premises (e.g., rental agreement or
ownership documents).
: Adequate storage facilities and security
measures for narcotic drugs.
: Qualified and registered pharmacist(s) in
charge of the pharmacy.
: Compliance with state and central
pharmacy laws and regulations.
Application Process:
Typically, you would need to apply to the State Drug Control
Authority or State Pharmacy Council in your state.
Forms:
These authorities usually provide application forms specific to
pharmacy licensing. These forms will require information about the
pharmacy's ownership, location, infrastructure, and compliance with
storage and dispensing requirements for narcotic drugs.
Regulatory Authority:
State Drug Control Authorities oversee the issuance of
pharmacy licenses. These authorities ensure that pharmacies
adhere to state-specific pharmacy laws and regulations,
including those related to narcotic drugs

19. Wholesale Drug License:
Requirements:
: A designated and registered wholesale
drug premises.
: Adequate storage and warehousing
facilities with security measures
.
:Qualified personnel, including a registered
pharmacist.
: Compliance with Good Distribution
Practices (GDP) and relevant drug laws.
Application Process:
Application is typically made to the State Drug Control
Authority.
Forms:
The authority usually provides specific application forms for
wholesale drug licensing. Applicants need to provide details about
their business, storage facilities, and compliance with drug
distribution regulations
Regulatory Authority:
State Drug Control Authorities grant wholesale drug licenses.
They assess the qualifications and infrastructure of wholesale
entities to ensure compliance with all relevant laws and
standards.

20. Manufacturing License:
Requirements:
:Compliance with Central Bureau of
Narcotics (CBN) guidelines and the
Narcotic Drugs and Psychotropic
Substances (NDPS) Act
.
:Secure and compliant manufacturing
facilities with controlled access.
Qualified personnel, including pharmacists
and technical staff
.
:Comprehensive documentation of
manufacturing processes and quality
control.:
Approval from CBN for the specific narcotic
drugs to be manufactured.
Application Process:
Application for manufacturing licenses is made to the Central
Bureau of Narcotics (CBN).
Forms:
CBN provides application forms specific to manufacturing licenses
for narcotic drugs. The application process is rigorous, involving
assessments of production facilities, security measures, and
compliance with the Narcotic Drugs and Psychotropic Substances
(NDPS) Act.
Regulatory Authority:
Manufacturing licenses are issued by the Central Bureau of
Narcotics (CBN), the apex authority responsible for regulating
the production of narcotic drugs in India. CBN ensures strict
adherence to the provisions of the NDPS Act.

21. Prescription
Requirements
05
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22. 1. Elements of a Valid Prescription:
a. Patient Information: A valid prescription must include the patient's full name, age,
and address. Accurate patient identification is crucial for ensuring that the right
medication reaches the right person.
b. Prescriber Information: The prescriber's full name, qualifications, registration
number, and contact details must be clearly stated on the prescription.
c. Drug Details: The prescription should specify the name, strength, dosage form, and
quantity of the narcotic drug prescribed.
d. Directions for Use: Clear and precise instructions on how to take the medication,
including dosing frequency and duration, should be provided.
e. Date of Prescription: The prescription must include the date it was issued by the
healthcare professional.
f. Signature: The prescriber's signature, either handwritten or in a digital format, is
essential for validation.
Overview of Prescription Requirements

23. 1. Schedule X Prescription Rules:
a. Schedule X Drugs: Schedule X includes narcotic and psychotropic substances with a
higher potential for abuse. Prescriptions for Schedule X drugs must adhere to
additional regulations.
b. Prescription Validity: Schedule X prescriptions are typically valid for 30 days from
the date of issue. Renewals are generally not allowed.
c. Duplicate Copies: Schedule X prescriptions are required to be written in triplicate,
with one copy given to the patient, one retained by the pharmacist, and one
submitted to the regulatory authorities for monitoring purposes.
d. Prescriber's Responsibility: Prescribers must exercise extra caution when
prescribing Schedule X drugs, as non-compliance with these rules can result in legal
consequences.
Overview of Prescription Requirements

24. Dispensing
Narcotic Drugs
06

25. Dispensing Narcotic Drugs{1}
● Role of Pharmacists:
○ Gatekeepers: Pharmacists act as gatekeepers for the dispensing of narcotic drugs, ensuring that
they are provided only to patients with valid prescriptions.
○ Patient Counseling: Pharmacists play a vital role in counseling patients on the proper use of
narcotic drugs, potential side effects, and the importance of adhering to prescribed dosages and
schedules.
● Verification of Prescriptions:
○ Accuracy: Pharmacists must meticulously verify the authenticity and accuracy of prescriptions,
including the prescriber's details, patient information, and drug specifications.
○ Schedule Classification: Ensure that the prescribed narcotic drug falls under the appropriate
schedule as per the Narcotic Drugs and Psychotropic Substances (NDPS) Act.
● Patient Identification:
○ Verification: Confirm the identity of the patient receiving the narcotic drug. Ensure that the patient
matches the details on the prescription.
○ Privacy: Dispensing should be conducted in a private and confidential manner to protect patient
privacy.

26. Dispensing Narcotic Drugs{2}
● Safe Storage and Security:
○ Storage Conditions: Ensure that narcotic drugs are stored under appropriate conditions, such as
controlled room temperature or refrigeration, as required by the specific drug.
○ Security Measures: Implement security measures to prevent theft, diversion, or unauthorized access to
narcotic drugs, including the use of safes and surveillance systems.
● Dispensing Practices:
○ Proper Packaging: Narcotic drugs should be dispensed in appropriate and tamper-evident packaging to
maintain their integrity.
○ Labeling: Dispensed containers should be clearly labeled with essential information, including the patient's
name, drug name, dosage, and instructions for use.
● Monitoring for Red Flags:
○ Suspicious Activities: Pharmacists must be vigilant for any red flags, such as unusual prescription patterns
or patient behavior, which could indicate potential misuse or diversion.
○ Reporting: Report any suspicious activities to regulatory authorities as required by law.

27. Dispensing Narcotic Drugs{3}
● Patient Education:
○ Counseling: Pharmacists should provide patients with information about the prescribed narcotic drug, its
intended use, potential side effects, and the importance of following the prescribed regimen.
○ Recognizing Signs of Addiction: Educate patients about the signs of addiction and the need to seek
medical help if they experience such symptoms.
● Legal and Ethical Considerations:
○ Compliance: Pharmacists must comply with all relevant laws and ethical guidelines related to the
dispensing of narcotic drugs.
○ Professional Integrity: Uphold the highest standards of professionalism and ethics in all dispensing
activities.
● Regulatory Oversight:
○ Inspections: Be prepared for inspections by regulatory authorities, which may assess compliance with
dispensing regulations and record-keeping.

28. Offences and
Penalties under NDPS
Act, 1985
07

29. OFFENCES AND PENALITIES
UNDER THE ACT
Drug Quantity & Punishment
Small
Quan
tity
Commerci
al
Quantity
Heroin 5mg
Maximum of 6 months rigorous
imprisonment or a fine up to Rs.
10,000 or both.
250gms
Rigorous imprisonment from 10 years (min.) to 20 years (max.) & a fine
from Rs. 1 Lakh to 2 Lakhs.
Opium 25mg 2.5kgs
Morphine 5mg 250gms
Ganja 1000mg 20kgs
Charas 100mg 1kg
Cocaine 2mg 100gms
Methadone 2mg 50gms
Amphetami
ne
2mg 50gms
LSD 0.002gm 0.1gm

30. Section 15
Punishment for
contravention in
relation to poppy straw
Section 16
Punishment for
contravention in relation
to coca plant and coca
leaves.
CHAPTER IV
Section 18
Punishment for
embezzlement of opium
by cultivator.
Section 20
Punishment for
contravention in relation
to cannabis plant and
cannabis.
Section 17
Punishment for
contravention in
relation to prepared
opium.
Punishment for
contravention in relation
to opium poppy and opium.
Section 19
CHAPTER IV, that is from Section 15 to 40, provides for various offences and punishments under the
Act. It has identified certain activities that are against the acceptable social norms which have
been included in the category of offences in the Act.

31. The drug problem in India is much worse than it appears. In ancient India, ganja, charas, and other
psychoactive substances were used for healing, pain relief, and even psychotherapy. India had no law
criminalizing possession or use of drugs prior to 1985. Now, it is important to note that the NDPS Act
contains several provisions that specify serious punishments.
In conclusion, our exploration of pharmacy laws and regulations for narcotic drugs in India
underscores the critical importance of safe and responsible practices in the healthcare sector. As
healthcare professionals and entities, we have a vital role in safeguarding public health, preventing
abuse, and maintaining the integrity of the healthcare system
Pharmacists and healthcare practitioners bear a significant responsibility in counseling patients,
recognizing red flags, and reporting suspicious activities related to narcotic drugs.
Conclusion:

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