Brief History, Objectives, Various Definitions, Authorities and officers, The Narcotic Drugs and Psychotropic Substances Consultative Committee, National Fund for Control of Drug Abuse, Prohibition, Control And Regulation, Power to control and regulate controlled substances and Offences and Penalties, small quantity and a commercial quantity for some popular drugs and Amendments.
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which regulates the import, manufacture and distribution of drugs in India. The primary objective of the act is to ensure that the drugs and cosmetics sold in India are safe, effective and conform to state quality standards.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
Drug and magic remedies (objectionable advertisement) act 1954 and rules 1955Dr. Ambekar Abdul Wahid
Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
Contents :
Introduction
Definitions
Authorities and Officers
The Consultative Committee Prohibition, control and Regulation
Power of Central Govt. to Permit, Control and Regulate
Power of State Govt. to Permit, Control and Regulate
Offences and Penalties
National Fund.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
Drug and magic remedies (objectionable advertisement) act 1954 and rules 1955Dr. Ambekar Abdul Wahid
Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
The poison Act, 1919 was passed on 3rd September , 1919, with a view to control the import, possession and sale of Poisons.
It extends to whole of India but is not applicable to the state J&K.
The Act of 1919 replaced the poison Act of 1904.
The term “Poison” has not been defined under the Act.
Under the Act, the central Govt. has been authorised to regulate the import of poison across, while the various State Govt. has been authorised to make rules regarding the possession and sale of poison within their respective territories.
Contents :
Introduction
Definitions
Authorities and Officers
The Consultative Committee Prohibition, control and Regulation
Power of Central Govt. to Permit, Control and Regulate
Power of State Govt. to Permit, Control and Regulate
Offences and Penalties
National Fund.
Narcotic and Psychotropic Substance act 1985Prakash Mali
The statutory control over narcotic drugs was being exercised under The Opium Act, 1857, The Opium Act, 1878 and The Dangerous Drugs Act, 1930.
India had no legislation regarding narcotics until 1985. Cannabis smoking in India has been known since at least 2000 BC and is first mentioned in the Atharvaveda, which dates back a few hundred years BC.
Narcotic Drugs and Psychotropic Substances Act, 1985Ganesh Shevalkar
The Narcotic Drugs and Psychotropic Substances Act, 1985, commonly referred to as the NDPS Act, is an Act of the Parliament of India that prohibits a person to produce/manufacture/cultivate, possess, sell, purchase, transport, store, and/or consume any narcotic drug or psychotropic substance.
Act related to narcotic and psychotropic substance and illegal drug trafficing in India. In this slide we will disscussed on a very importnent topic Act related to narcotic and pschotropic substances and Illegal drug trafficing. Now a days prevalence of substance or drug abused disorder is increasiing due to illegal drug traffing not only in Inida but all over the world so every counries has made some some act related to these problems.
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
The Asian and Pacific Centre for Transfer of Technology (APCTT) is a regional institution of the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP) servicing the Asia-Pacific region.
The National Research Development Corporation (NRDC) was a non departmental government body established by the British Government to transfer technology from the public sector to the private sector.
TIFAC is an autonomous organization set up in 1988 under the Department of Science & Technology to look ahead in technology domain, assess the technology trajectories, and support innovation by networked actions in select areas of national importance.
Biotech Consortium India Limited (BCIL) is a public limited company, promoted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and set up by All India Financial Institutions including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Role of IT in Pharma Industry, Role of Pharm Industry in Indian GDP, Role of Engineers in Pharmaceutical Industry, PHARMACY INFORMATICS, Importance in Pharma Industry, Pharmacy management software, Computerized Physician Order Entry (CPOE), Bar-coded medication administration, Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Customer Relationship Management (CRM), Sales Force Automation (SFA) Software, Electronic Batch Records (EBR) Software
Some of the software use in pharmaceuticals Research & Development, Virtual Labs.
History, Objectives, Various Definitions, The Pharmacy Council of India (PCI), Functions and duties of PCI, State Pharmacy Council, Functions of The State PharmacyCouncils, Joint State Pharmacy Council, Offences and penalties and List of amending Acts and adaptation orders.
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.
The presentation is about the basics of Sprayer dryer, its design, types of systems, process stages, Schematic representation of spray drying mechanism, and its application.
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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We specializes in exporting high quality Research chemical, medical intermediate, Pharmaceutical chemicals and so on. Products are exported to USA, Canada, France, Korea, Japan,Russia, Southeast Asia and other countries.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Explore natural remedies for syphilis treatment in Singapore. Discover alternative therapies, herbal remedies, and lifestyle changes that may complement conventional treatments. Learn about holistic approaches to managing syphilis symptoms and supporting overall health.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Anti ulcer drugs and their Advance pharmacology ||
Anti-ulcer drugs are medications used to prevent and treat ulcers in the stomach and upper part of the small intestine (duodenal ulcers). These ulcers are often caused by an imbalance between stomach acid and the mucosal lining, which protects the stomach lining.
||Scope: Overview of various classes of anti-ulcer drugs, their mechanisms of action, indications, side effects, and clinical considerations.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Narcotic drugs and psychotropic substances act 1985
1. Narcotic Drugs and
Psychotropic Substances
Act 1985
Dr. Ambekar Abdul Wahid
M. Pharm, Ph.D
Department of Pharmaceutics
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vadgaon Gupta (Vilad Ghat) PO MIDC
Ahmednagar (MS), India
E-mail: wahidambekar@gmail.com
1
2. History
Drug abuse has become a universal and growing issue of concern to
humanity.
The illicit drugs have multiple consequences to health, society and economy.
These consequences include health: mortality, morbidity, psychiatric and
physical disorders; social: accidents, absenteeism, family disintegration,
prostitution, organized crime etc; and economic: finances spent on developing
services, drain on national resources, loss of productivity, etc.
3. The statutory control over narcotic drugs was being exercised under The
Opium Act 1857, The Opium Act, 1878 and The Dangerous Drugs Act,
1930.
India had no legislation regarding narcotics until 1985. Cannabis smoking
in India has been known since at least 2000 BC and is first mentioned in
the Atharvaveda, which dates back a few hundred years BC.
History
4. Objectives
To consolidate and amend the existing law relating to Narcotic Drug.
To make stringent provision for control and regulation of operations
relating to Narcotic Drugs and psychotropic substances.
To considerably enhance penalties particularly for trafficking offences.
To make provisions for implementations of International Convention
relating to Narcotic Drugs and Psychotropic substances to which India is
party.
5. Chapter I: Definitions
Cannabis (hemp)" means:
A. Charas, that is, the separated resin, in whatever form, whether crude or
purified, obtained from the cannabis plant and also includes
concentrated preparation and resin know as hashish oil or liquid
hashish.
B. Ganja, that is, the flowering or fruiting tops of the cannabis plant
(excluding the seeds and leaves when not accompanied by the tops), by
whatever name they may be know or designated; and
C. Any mixture, with or without any neutral material, of any of the above
forms of cannabis or cannabis or an drink prepared there from;
6. “Coca derivative" means:
A. Crude cocaine, that is, any extract of coca leaf which can be used,
directly or indirectly, for the manufacture of cocaine;
B. Ecgonine and all the derivatives of ecgonine from which it can be
recovered;
C. Cocaine, that is, methyl ester of benzoyl-ecgonine and its salts; and
D. All preparations containing more than 0.1 percentage of cocaine
Definitions (Continued…)
7. Addict means: “addict” means a person who has dependence on any narcotic
drug or psychotropic substance
Small quantity: in relation to narcotic drugs and psychotropic substances,
means any quantity lesser than the quantity specified by the Central
Government by notification in the Official Gazette.
Controlled substance: means any substance which the Central Government
may, having regard to the available information as to its possible use in the
production or manufacture of narcotic drugs or psychotropic substances or
to the provisions of any International Convention, by notification in the
Official Gazette, declare to be a controlled substance.
Definitions (Continued…)
8. Controlled delivery: means the technique of allowing illicit or suspect
consignments of narcotic drugs, psychotropic substances, controlled
substances or substances substituted for them to pass out of, or through or
into the territory of India with the knowledge and under the supervision of an
officer empowered in this behalf or duly authorized under section 50A with a
view to identifying the persons involved in the commission of an offence under
this Act
Psychotropic substance: means any substance, natural or synthetic, or any
natural material or any salt or preparation of such substance or material
included in the list of psychotropic substances specified in the Schedule.
Definitions (Continued…)
9. Medicinal cannabis: that is, medicinal hemp, means any extract or tincture of
cannabis (hemp)
Narcotics Commissioner means: the Narcotics Commissioner appointed
under section 5;
Narcotic drug means: coca leaf, cannabis (hemp), opium, poppy straw and
includes all manufactured drugs.
Definitions (Continued…)
10. Opium means:
A. The coagulated juice of the opium poppy; and
B. Any mixture, with or without any neutral material, of the coagulated juice
of the opium poppy, but does not include any preparation containing not
more than 0.2 per cent. of morphine
Definitions (Continued…)
11. Opium derivative means:
I. Medicinal opium
II. Prepared opium
III. Phenanthrene alkaloids such as morphine, codeine, thebaine and their
salts.
IV. Diacetyl morphine (heroin) and its salts V. All preparation containing more
than 0.2% of morphine or any amount of diacetyl morphine.
Definitions (Continued…)
14. Chapter II: Authorities and officers
Central Government to take measures for preventing and combating abuse of
and illicit traffic in narcotic drugs, etc
Co-ordination of actions by various officers, State Govt. and other authorities
under this act, or under any other law for time being in force relating to the
enforcement of provision of this act.
Obligations under the International convention.
Assistance to concerned authorities in foreign countries and concerned
international organization regarding prevention and suppression of illicit traffic
in narcotic drugs & psychotropic substances.
15. Identification, treatment, education, after care, rehabilitation & social re-
interaction of addicts
Such other matters for effective implementation of this act and preventing &
combating the abuse of narcotic drugs and psychotropic substances and illicit
traffic therein.
Chapter II: Authorities and officers
16. Officers of Central Government
Without prejudice to the provisions of sub-section (3) of section 4, the Central
Government shall appoint a Narcotics Commissioner and may also appoint such
other officers with such designations as it thinks fit for the purposes of this Act.
Under the provision of this act, the Central Government may appoint Narcotic
Commissioner & such other officers as it thinks fit.
Performs the function relating to:
1. Supervision of cultivation of opium poppy
2. Production of opium
3. Other functions as may be entrusted to him Central Government.
17. The Narcotic Drugs and Psychotropic
Substances Consultative Committee.
The Central Government may constitute, by notification in the Official
Gazette, an advisory committee to be called "The Narcotic Drugs and
Psychotropic Substances Consultative Committee" (hereafter in this
section referred to as the Committee) to advise the Central Government on
such matters relating to the administration of this Act as are referred to it by
that Government from time to time.
The Committee shall consist of a Chairman and such other members, not
exceeding twenty, as may be appointed by the Central Government.
18. • The Committee shall meet when required to do so by the Central Government
and shall have power to regulate its own procedure.
• The Committee may, if it deems it necessary so to do for the efficient discharge of
any of its functions, constitute one or more sub-committees and may appoint to
any such sub-committee, whether generally or for the consideration of any
particular matter, any person (including a non-official) who is not a member of
the Committee.
The Narcotic Drugs and Psychotropic
Substances Consultative Committee.
19. Officers of State Government
• The State Government may appoint such officers with such designations as it
thinks fit for the purposes of this Act.
• The officers appointed under sub-section (1) shall be subject to the general
control and direction of the State Government, or, if so directed by that
Government, also of any other authority or officer.
20. Chapter II A: National Fund for Control of
Drug Abuse
The Central Government may, by notification in the Official Gazette,
constitute a Fund to be called the National Fund for Control of Drug Abuse
and there shall be credited thereto:
a. An amount which the Central Government may, after due appropriation made
by Parliament by law in this behalf, provide;
b. The sale proceeds of any property forfeited under Chapter VA;
c. Any grants that may be made by any person or institution;
d. Any income from investment of the amounts credited to the Fund under the
aforesaid provisions.
21. The Fund shall be applied by the Central Government to meet the
expenditure incurred in connection with the measures taken for:
a. Combating illicit traffic in narcotic drugs, psychotropic substances or
controlled substances;
b. Controlling the abuse of narcotic drugs and psychotropic substances;
c. Identifying, treating, rehabilitating addicts;
d. Preventing drug abuse;
e. Educating public against drug abuse;
f. Supplying drugs to addicts where such supply is a medical necessity.
Chapter II A: National Fund for Control of
Drug Abuse
22. Chapter III: Prohibition, Control And
Regulation
Prohibition of certain operations.—No person shall—
a. Cultivate any coca plant or gather any portion of coca plant; or
b. Cultivate the opium poppy or any cannabis plant; or
c. Produce, manufacture, possess, sell, purchase, transport, warehouse, use,
consume, import inter-State, export inter-State, import into India, export from
India or tranship any narcotic drug or psychotropic substance,
23. • Power of Central Government to permit, control and regulate
• Subject to the provisions of section 8, the Central Government may, by
rules:
A. Permit and regulate:
i. The cultivation, or gathering of any portion (such cultivation or gathering
being only on account of the Central Government) of coca plant, or the
production, possession, sale, purchase, transport, import inter-State, export
inter-State, use or consumption of coca leaves;
Chapter III: Prohibition, Control And
Regulation
24. ii. The cultivation (such cultivation being only on account of Central Government) of
the opium poppy;
iii. The production and manufacture of opium and production of poppy straw;
iv. The sale of opium and opium derivatives from the Central Government factories for
export from India or sale to State Government or to manufacturing chemists;
v. The manufacture of manufactured drugs (other than prepared opium) but not
including manufacture of medicinal opium or any preparation containing any
manufactured drug from materials which the maker is lawfully entitled to possess;
Chapter III: Prohibition, Control And
Regulation
25. vi. The manufacture, possession, transport, import inter-State, export inter-State,
sale, purchase, consumption or use of psychotropic substances;
vii. The import into India and export from India and transshipment of narcotic
drugs and psychotropic substances;
B. Prescribe any other matter requisite to render effective the control of the
Central Government over any of the matters specified in clause (a).
a) Empower the Central Government to fix from time to time the limits within
which licenses may be given for the cultivation of the opium poppy;
Chapter III: Prohibition, Control And
Regulation
26. b. Require that all opium, the produce of land cultivated with the opium poppy,
shall be delivered by the cultivators to the officers. authorized in. this behalf by
the Central Government;
c. Prescribe the forms and conditions of licenses for cultivation of the opium
poppy and for production and manufacture of opium; the fees that may be
charged therefor;
d. Prescribe that opium shall be weighed, examined and classified according to its
quality and consistence by the officers authorized in this behalf by the Central
Government in the presence of the cultivator at the time of delivery by the
cultivator;
Chapter III: Prohibition, Control And
Regulation
27. e. Empower the Central Government to fix from time to time the price to be paid
to the cultivators for the opium delivered;
f. Provide for the weighment, examination and classification, according to the
quality and consistence, of the opium received at the factory and the
deductions from or additions (if any) to the standard price to be made in
accordance with the result of such examination;
g. Require that opium delivered by a cultivator, if found as a result of
examination in the Central Government factory to be adulterated, may be
confiscated by the officers authorized in this behalf;
Chapter III: Prohibition, Control And
Regulation
28. h. Prescribe the forms and conditions of licenses for the manufacture of
manufactured drugs, the authorities by which such licenses may be granted
and the fees that may be charged therefor;
i. Prescribe the forms and conditions of licenses or permits for the manufacture,
possession, transport, import inter-State, export inter-State, sale, purchase,
consumption or use of psychotropic substances, the authorities by which such
licenses or permits may be granted and the fees that may be charged therefor;
j. Prescribe the ports and other places at which any kind of narcotic drugs or
psychotropic substances may be imported into India or exported from India or
transshipped;
Chapter III: Prohibition, Control And
Regulation
29. Chapter III: Power to control and regulate
controlled substances
• If the Central Government is of the opinion that, having regard to the use of any
controlled substance in the production or manufacture of any narcotic drug or
psychotropic substance, it is necessary or expedient so to do in the public
interest, it may, by order, provide for regulating or prohibiting the production,
manufacture, supply and distribution thereof and trade and commerce therein.
• Without prejudice to the generality of the power conferred by subsection (1), an
order made thereunder may provide for regulating by licenses, permits or
otherwise, the production, manufacture, possession, transport, import inter-
State, export inter-State, sale, purchase, consumption, use, storage,
distribution, disposal or acquisition of any controlled substance.
30. Power of State Government to permit, control and regulate:
I. Subject to the provisions of section 8, the State Government may, by rules
A. Permit and regulate:
i. The possession, transport, import inter-State, export inter-State, warehousing,
sale, purchase, consumption and use of poppy straw.
ii. The possession, transport, import inter-State, export inter-State, sale, purchase,
consumption and use of opium;
iii. The cultivation of any cannabis plant, production, manufacture, possession,
transport, import inter-State, export inter-State, sale, purchase, consumption or
use of cannabis (excluding charas);
Chapter III: Power to control and regulate
controlled substances
31. Power of State Government to permit, control and regulate (Continue…)
iv. The manufacture of medicinal opium or any preparation containing any
manufactured drug from materials which the maker is lawfully entitled to possess;
v. The possession, transport, purchase, sale, import inter-State, export inter- State,
use or consumption of manufactured drugs other than prepared opium and of
coca leaf and any preparation containing any manufactured drug;
vi. The manufacture and possession of prepared opium from opium lawfully
possessed by an addict registered with the State Government on medical advice for
his personal consumption:
B. Prescribe any other matter requisite to render effective the control of the
State Government over any of the matters specified in clause (a).
32. II. In particular and without prejudice to the generality of the foregoing power, such
rules may:
a. Provide that the limits within which licenses may be given for the cultivation of any
cannabis plant shall be fixed from time to time by or under the orders of the State
Government;
b. Provide that only the cultivators licensed by the prescribed authority of the State
Government shall be authorized to engage in cultivation of any cannabis plant;
c. Require that all cannabis, the produce of land cultivated with cannabis plant,: shall be
delivered by the cultivators to the officers of the State Government authorized in this
behalf;
Power of State Government to permit, control and regulate (Continue…)
33. d. Empower the State Government to fix from time to time, the price to be paid to
the cultivators for the cannabis delivered;
e. Prescribe the forms and conditions of licenses or permits for the purposes
specified in sub-clauses (i) to (vi) of clause (a) of subsection (1) and the
authorities by which such licenses or permits may be granted and the fees that
may be charged therefor
Power of State Government to permit, control and regulate (Continue…)
34. Chapter IV: Offences and Penalties
(Continue…)
Offences Penalty
Cultivation of opium, cannabis or
coca plants without license
Rigorous imprisonment up to 10
years + fine up
to Rs.1 lakh
Embezzlement of opium by licensed
farmer
Rigorous imprisonment - 10 to 20
years + fine Rs. 1 to 2 lakhs
(regardless of the quantity)
Production, manufacture, possession,
sale, purchase, transport, import
inter- state, export inter-state or use
of narcotic drugs and psychotropic
substances
Small quantity:
Rigorous imprisonment up to 6
months or fine up to Rs. 10,000 or
both. Rigorous imprisonment. up to
10 years + fine up to Rs. 1 Lakhs.
Commercial quantity:
Rigorous imprisonment 10 to 20
years + fine Rs. 1 to 2 Lakhs
35. Chapter IV: Offences and Penalties
Offences Penalty
Import, export or transshipment of
NDPS
Same as above
External dealings in NDPS i.e.
engaging in or controlling trade
whereby drugs are obtained from
outside India and supplied to a
person outside India
Rigorous imprisonment 10 to 20
years + fine of Rs. 1 to 2 lakhs
(Regardless of the quantity)
Knowingly allowing one's premises
to be used for committing an offence
Same as for the offence
Violations pertaining to controlled
substances (precursors)
Rigorous imprisonment up to 10
years + fine Rs. 1 to 2 lakhs
Financing traffic and harboring
offenders
Rigorous imprisonment 10 to 20
years + fine Rs. 1 to 2 lakhs
Attempts, abetment and criminal
conspiracy
Same as for the offence
36. The table below lists the current definition of a small quantity
and a commercial quantity for some popular drugs
Drug Small quantity Commercial quantity
Amphetamine 2 grams (0.071 oz) 50 grams (1.8 oz)
Charas 100 grams (3.5 oz) 1 kilogram (2.2 lb)
Cocaine 2 grams (0.071 oz) 100 grams (3.5 oz)
Ganja 1 kilogram (2.2 lb) 20 kilograms (44 lb)
Heroin 5 grams (0.18 oz) 250 grams (8.8 oz)
LSD 2 milligrams (0.031 gr) 100 milligrams (1.5 gr)
Methadone 2 grams (0.071 oz) 50 grams (1.8 oz)
Morphine 5 grams (0.18 oz) 250 grams (8.8 oz)
Opium 25 grams (0.88 oz) 2.5 kilograms (5.5 lb)
37. Amendments
1988 Amendment: The Narcotic Drugs and Psychotropic Substances
(Amendment) Act, 1988 (Act No. 2 of 1989) received assent from then President
Ramaswamy Venkataraman on 8 January 1989.
2001 Amendment: The Narcotic Drugs and Psychotropic Substances
(Amendment) Act, 2001 (Act No. 9 of 2001) received assent from then President
K. R. Narayanan on 9 May 2001.
2014 Amendment: The Narcotic Drugs and Psychotropic Substances
(Amendment) Act, 2014 (Act No. 16 of 2014) received the assent of then
President Pranab Mukherjee on 7 March 2014, and was published in The
Gazette of India on 10 March.
38. Reference
1. Forensic Pharmacy by B. S. Kuchekar, A. M. Khadatare, S. C. Itkar : Narcotic
Drugs and Psychotrophic substance act, 1985 with rules, 1985 10th edition
Nirali Prakashan 2014 p. no. 6.1-6.12.
2. Pharmaceutical Jurisprudence & Ethics (Forensic Pharmacy) by S.P. Agrawal,
Rajesh Khanna 3rd edition Birla Publication Pvt. Ltd. 2004 p. No. 169-191.
3. A text book of forensic pharmacy by N.K Jain. Vallabh Prakashan.
4. Pharmaceutical regulatory affairs by Subrahmanyam C.V.S and Thimma Setty
J. Vallabh Prakashan.