The document summarizes key legislation related to homeopathic pharmacy in India. It discusses the origin of pharmaceutical legislation beginning in 1927 and the recommendations of committees that helped form acts like the Drugs and Cosmetics Act of 1940. The act established standards for importing, manufacturing, and selling drugs and set up licensing for pharmacists. It also covers laws specific to homeopathic medicines regarding licensing of sellers and manufacturers, conditions of licenses, labeling, and restrictions on packaging and alcohol content. The document traces the evolution of drug policy and regulation in India.
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.
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.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
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.
Homoeopathic dynamisation in detail with recent techniques of potentisation is explained. Trituration and succusion is also discussed. All the terms available according to different author are published.
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
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.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
This scale was introduced by Hahnemann in 5th edition of Organon of Medicine, aphorism 270 and is more commonly used.
Two methods of preparing medicines are recognized, one on the decimal, the other on the centesimal scale. The pure tinctures are denominated "mother tinctures,"
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.
A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
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.
IIMPORT AND REGISTRATION AS PER DRUG AND COSMETIC ACT Sagar Savale
The drug and cosmetic act was passed on 10th April, 1940.
Objective : To regulate the import, manufacture, distribution, and sale of Drug and Cosmetics.
All classes of the drugs and cosmetics imported into India, shall comply with the prescribed standards and labels.
Manufacture of all classes of drug require prior license.
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.
Homoeopathic dynamisation in detail with recent techniques of potentisation is explained. Trituration and succusion is also discussed. All the terms available according to different author are published.
Pharmaceutics is the discipline of pharmacy that deals with the process of turning a new chemical entity (NCE) or old drugs into a medication to be used safely and effectively by patients. It is also called the science of dosage form design.
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.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
This scale was introduced by Hahnemann in 5th edition of Organon of Medicine, aphorism 270 and is more commonly used.
Two methods of preparing medicines are recognized, one on the decimal, the other on the centesimal scale. The pure tinctures are denominated "mother tinctures,"
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.
A simple and essential guide to obtain a drug manufacturing license for ayurvedic medicine. It covers procedure, minimum requirements, documents & affidavits and all other necessities.
Indian regulatory requirements - industrial pharmacy 2Jafarali Masi
Indian Regulatory Requirements: Central Drug Standard Control Organization (CDSCO) and State Licensing Authority: Organization, Responsibilities, Certificate of Pharmaceutical Product (COPP), Regulatory requirements and approval procedures for New Drugs
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.
manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945Swarna kumari S
Manufacture of drugs - License. Drugs and cosmetic act 1940 and rules 1945. Licences are required for the manufacturing of following categories of drugs. PROHIBITED TO BE MANUFACTURED OR SOLD IN OUR COUNTRY. condition Precedent and condition subsequent
Regulatory provision related to manufacture of cosmeticManish Rajput
cosmetic, regulatory provision, schedule M, condition of licence, schedule U, prohibition of certain cosmetics, misbranded and spurious cosmetics, loan licence, offences and penalties,
the overall summary of regulation of herbal drugs in India and what document required for getting approval and summary of GMP, GCP guideline with labelling requirement.
Medical device and Patency
By MDD 93/42
Any devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
investigation, replacement or modification or support of the anatomy or of a physiological process;
supporting or sustaining life;
disinfection of medical devices; and
control of conception.
What is 510(k) ?
A 510(k) is a premarket submission made to FDA to demonstrate
that the device to be marketed is as safe and effective, that is,
substantially equivalent, to a legally marketed device
(section 513(i)(1)(a) FD&C act).
Medical Devices are notified as DRUGS under Drugs & Cosmetics Act. Section 3 (b) (iv) defines,
Medical Devices as “Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals”
India had no regulation for medical devices in place prior to 2005.
The import, manufacturing, distribution and Sale of medical devices in India are overseen by the Drugs and Cosmetics Act (1940) and Rules (1945)
Control and inspection are carried out by the CDSCO, state drug controllers and central/state laboratories.
CDSCO & Central Bureau of Narcotics are the two organizations which regulate Narcotic Drugs.
ACCREDITED CONSULTANTS PVT LTD
info@acplgroupindia.co.in
+919310040434
Similar to Legislation in respect of Homeopathic Pharmacy (20)
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
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Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
CHAPTER 1 SEMESTER V - ROLE OF PEADIATRIC NURSE.pdfSachin Sharma
Pediatric nurses play a vital role in the health and well-being of children. Their responsibilities are wide-ranging, and their objectives can be categorized into several key areas:
1. Direct Patient Care:
Objective: Provide comprehensive and compassionate care to infants, children, and adolescents in various healthcare settings (hospitals, clinics, etc.).
This includes tasks like:
Monitoring vital signs and physical condition.
Administering medications and treatments.
Performing procedures as directed by doctors.
Assisting with daily living activities (bathing, feeding).
Providing emotional support and pain management.
2. Health Promotion and Education:
Objective: Promote healthy behaviors and educate children, families, and communities about preventive healthcare.
This includes tasks like:
Administering vaccinations.
Providing education on nutrition, hygiene, and development.
Offering breastfeeding and childbirth support.
Counseling families on safety and injury prevention.
3. Collaboration and Advocacy:
Objective: Collaborate effectively with doctors, social workers, therapists, and other healthcare professionals to ensure coordinated care for children.
Objective: Advocate for the rights and best interests of their patients, especially when children cannot speak for themselves.
This includes tasks like:
Communicating effectively with healthcare teams.
Identifying and addressing potential risks to child welfare.
Educating families about their child's condition and treatment options.
4. Professional Development and Research:
Objective: Stay up-to-date on the latest advancements in pediatric healthcare through continuing education and research.
Objective: Contribute to improving the quality of care for children by participating in research initiatives.
This includes tasks like:
Attending workshops and conferences on pediatric nursing.
Participating in clinical trials related to child health.
Implementing evidence-based practices into their daily routines.
By fulfilling these objectives, pediatric nurses play a crucial role in ensuring the optimal health and well-being of children throughout all stages of their development.
2. Origin of Pharmaceutical Legislation in India
1927: In a resolution Council of States to the Governor-
General urged all govts. to control indiscriminate use of
drugs & to legislate for standardization of prepn & sale of
drugs.
Govt of India appointed Drug Enquiry Committee with
Col R N Chopra as its Chairman to:
a) enquire import, manufacture or sale of defective drug
in india
b) recommend steps to control
c) recommend legislation to restrict the profession of
Pharmacy to qualified persons
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3. Recommendation of Chopra Committee:
• A central law to control drugs & pharmacy profession
• Set up testing labs in all states to check quality of drugs
• Appoint Advisory Board to Govt in making rules to carry
out the objectives of the Act
• Set up courses for training of pharmacist & prescribing
minimum qualifications for registration
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4. Recommendation of Chopra Committee:
• Registration of every patent & proprietary medicine
• Bring crude drugs & also combined medicines used in
indigenous system under control
• Develop drug industry in India
• Reduce manufacturing in Medical Stores/Depots
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5. Evolution of the Concept of Pharmacy as part
of Health Care System
Bhore Committee
In October 1943, Govt of India appointed Sir Joseph
Bhore to survey on existing position of health care
delivery organization in India
& to make recommendations for future developments
Bhatia Committee
In 1953 Major Gen S L Bhatia appointed to enquire into
the working of pharmaceutical industry to recommend
steps for further improvement
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6. Evolution of the Concept of Pharmacy as part
of Health Care System
Hereby following Acts introduced:
• Drugs & Magic Remedies (Objectionable Advertisements)
Act, 1954
• Medicinal & Toilet Preparations (Excise Duties) Act, 1955
• Narcotic Drugs & Psychotropic Substances Act & Rules,
1985
Mudaliar Committee
In June, 1959 Dr A Lakshmanswamy recommended
Indigenous drug preparations to bring under Drugs &
Cosmetics Act,1940
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7. Evolution of Drug Policy in India
Drug (Display of Prices) Order, 1962 – 1st policy paper
concerned with controlling prices of drugs
Drug (Display & Control) Order, 1966 – approval of
govt. before increasing price and fixing of prices of new
drugs
Hathi Committee: Report of Jaisukh Lal Hathi Committee
covered all aspects of licensing, price control, imports,
role of foreign sector, quality control etc. and encouraged
both indigenous industry & foreign multinationals
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8. Homoeopathic medicine
Homoeopathic medicines include any drug whichis
recorded in homoeopathic provings or the therapeutic
efficacy of which has been established through long
clinical experience as recorded in authoritative
homoeopathic literature of India or abroad and which is
prepared according to techniques of Homoeopathic
Pharmacy but does not include a medicine which is
administered by parenteral route.
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9. Manufacture, sale & distribution of homoeopathic
medicines are governed by:
• Drugs & Cosmetics Act,1940 (Act 23 of 1940) & its
amendments
• Drugs & Cosmetics Rules,1945 & its amendments
• Narcotic Drugs & Psychotropic Substances Act & Rules,
1985 (Act 81 of 1985)
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11. Drugs & Cosmetics Act, 1940
It was passed on 10th April, 1940
To regulate the import into, manufacture, distribution &
sale of drugs & cosmetics in the country
It contains:
6 Chapters – Chapter I, Chapter II, Chapter III,
Chapter IV, Chapter IVA, & Chapter V
2 Schedules – First Schedule & Second Schedule
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12. Drugs & Cosmetics Act, 1940
• Chapter I: Introductory – Short title, extent,
commencement, definitions, etc.
• Chapter II: Drugs Technical Advisory Board, Central
Drugs Laboratory, & Drugs Consultative Committee
• Chapter III: Import of Drugs & Cosmetics
• Chapter IV: Manufacture, Sale & Distribution of Drugs &
Cosmetics
• Chapter IVA: Provisions Relating To Ayurvedic, Siddha &
Unani Drugs
• Chapter V: Miscellaneous
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13. Drugs & Cosmetics Act, 1940
• First Schedule:
Part A – Ayurvedic & Siddha Systems
Part B – Unani Tibb Systems
• Second Schedule: Standards To Be Complied With By
Imported Drugs & By Drugs Manufactured For Sale,
Stocked/Exhibited For Sale/Distributed
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14. PART VI – A
Sale of Homoeopathic Medicines
67A: (1) Licensing authority appointed by State Govt.
(2) Application for the grant / renewal of a licence
in Form 19B, with a fee of Rs.250/- within 6
months of expiry
with a fee of Rs.250/- + Rs.50/-
after 6 months of expiry
(3) If damaged/Lost duplicate copy on Rs 50/-
67B: Power to sign licences & such other powers to any
person under the control of Licensing authority
with the approval of the State Govt.
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15. 67C: Forms of licences to sell drugs
Licence issued in Form 20C / 20D
67D: Sale at more than one place
Application for & issue of separate licence in
respect of each place
67E: Duration of licence
5 yrs. from the date it is granted / renewed
67EE: Certificate of renewal
Application for renewal of Form 20C & 20D
Licence issued in Form 20E
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16. 67F: Conditions to be satisfied before a licence granted
(1) Premises are clean & the sale premises are in
charge of a person who has been dealing in
Homoeopathic Medicines
(2) Any person , if aggrieved by the Licensing
authority may within 30 days from the grant of
the receipt of such order appeal to the State Govt.
67G: Conditions of licence
(1) Premises for sale of medicines clean
(2) Sale to be conducted under the supervision of
a person competent to deal in Hom.Medicines.
(3) To permit an Inspector to inspect & furnish
such information as he may require.
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17. 67G: Conditions of licence
(4) To maintain records of purchase & sale of
Hom.Medicines. containing alcohol with
names & addresses of parties.
(5) To maintain records of purchase & sale of
Hom.Medicines. containing alcohol over 30ml for
pot. medicines & 60ml for Qs.
(6) To maintain an Inspection Book in Form 35 to
enable an Inspector to record his impressions.
67GG: Additional information to be furnished
Documentary evidence in respect of the ownership/
occupation on rental / other basis of the premises.
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18. 67H: Cancellation & suspension of licences
(a) Licensing authority may, after issuing a
show- cause notice, cancel/suspend licence
for a certain period
(b) Appeal to State Govt. with in 3 months,
whose decision is final.
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19. PART VII – A
Manufacture for sale of Homoeopathic Medicines
85A: Manufacture on more than one premises
Application for & issue of separate licence in
respect of each place.
85B: Application for licence to manufacture
(1) Application for grant/renewal of licences
to made in Form 24C to the Licensing
authority appointed by the State Govt.
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20. 85B: Application for licence to manufacture Hom Medicines
(2) Application in Form 24C shall accompany
(a) a fee of Rs.200/- for the manufacture of
Hom. Qs & pot. medicines & an inspection fee
of Rs.100/- for 1st inspection & Rs,50/ in case
of inspection for renewal.
(b) a fee of Rs.200/- for the manufacture of Hom.
pot. medicines & an inspection fee of Rs.100/-
for 1st inspection & Rs,50/ in case of
inspection for renewal.
(c) a fee of Rs.200/- for the manufacture of
pot. medicines from back potencies of
pharmacies already licensed & an inspection
fee of Rs.100/- for 1st inspection & Rs,50/ in
case of inspection for renewal.
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21. 85B: Application for licence to manufacture Hom Medicines
(3) Application for renewal after expiry but within 6
months with a fee of
(a) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture of Hom. Qs &
pot. medicines.
(b) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture pot. medicines
(c) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture of pot.
edicines from back potencies of pharmacies
already licensed.
(4) A fee of Rs.50/- to be paid for the duplicate copy.
5) To manufacture additional items a fee of Rs.50/-
to be paid for each additional item.
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22. 85C: Application to manufacture New Hom. Medicine
(1) No New Hom. Medicine shall be manufactured
unless it is approved by the Licensing authority
mentioned in Rule 21.
(2) To produce documents & evidence when
applying to the Licensing authority for assessing
the therapeutic efficacy of the medicine
including the minimum proving carried out with
it.
(3) To produce evidence when applying to the
Licensing authority that the New Hom. Medicine
has already been approved.
85D: Form of licence to manufacture Hom. Medicine
Licence issued in Form 25C.
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23. 85E: Conditions for grant / renewal of licence
(1) Manufacture shall be conducted under the direction
& supervision of at least one full time competent
technical staff.
(2) Factory premises shall comply with the reqts. &
conditions specified in Schedule M-I.
(i) Have arrangements for identifying raw materials
& for testing Qs.
(ii) Make arrangements with some institution
approved by LA.
(4) Premises shall be distinct & separate from the
residential area.
(5) Shall not manufacture Hom. Medicine
simultaneously with drugs of other system.
(6) Make arrangements for proper storage.
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24. 85EA: Inspection before grant / renewal of licence
To inspect premises, plant, appliances, process of
manufacturing, standardizing, testing & professional
qualification.
85EB: Report by Inspector
Inspector shall forward a detailed report to LA.
85EC: Grant / refusal of licence
(1) Granted if LA is satisfied
(2) If not satisfied LA shall reject the application &
inform the applicant of the reasons.
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25. 85ED: Further application after rejection
Within 6 months from the rejection one can apply
after fulfilling the conditions with deposit of Rs.250/-
as inspection fee.
85EF: Appeal to the State Govt.
Aggrieved person may within 90 days apply
85F: Duration of licence
5 yrs. from the date it is granted / renewed
85G: Certificate of renewal
Application for renewal in Form 25C
Licence issued in Form 26C
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26. 85H: Conditions of licence
(a) To provide & maintain staff & premises as
specified in Rule 85E
(b) To allow an Inspector to inspect the premises &
take samples
(c) To allow an Inspector to inspect registers &
records & supply such information as he may
require
(d) To maintain an Inspection Book in Form 35 to
enable an Inspector to record his impressions
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27. 85H: Conditions of licence
(e) To comply following conditions in respect of Qs:
(i) to identify crude drugs & keep record of
identification for 5 yrs
(ii) to determine total solids of Qs & keep record
for 5 yrs
(iii) to determine alcohol content of Qs & keep
record for 5 yrs
(iv) to use clean, neutral glass containers
(v) to maintain hygienic condition during the
process of manufacture, storage & handling
(ea) To add no colour to any Hom. Medicine
(f) To maintain records of Hom. Medicines.
containing alcohol & the qtys. with names &
addresses of parties for 5 yrs
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28. 85HH: Additional information to be furnished
Documentary evidence in respect of the ownership/
occupation on rental / other basis of the premises
85-I: Cancellation & suspension of licences
(1) Licensing authority may, after issuing a show-
cause notice, cancel/suspend licence for a certain
period
(2) A licensee may apply within 3 months of the date
of order against that order to the State Govt
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29. PART IX – A
Labelling & Packing of Homoeopathic Medicines
106A: Manner of labelling of Homoeopathic Medicines
(A) To appear following particulars either printed or
in indelible ink in a conspicuous manner on the
label of the innermost container & any other
covering of the packing
(i) the words ‘Homeopathic Medicine’
(ii) name of the medicine
(a) for drugs included in pharmacopoeias the
name specified in particular
pharmacopoeia
(b) for other drugs, the name descriptive of
the real nature of the drug
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30. 106A: Manner of labelling of Homoeopathic Medicines
(A) (iii) potency of the Homoeopathic medicine
either in decimal, centesimal or millesimal
system
(iii-A) in case of Hom. medicine containing
two/more ingredients, the name of each
ingredient with its potency & proportion in
metric system
(iv) name & address of manufacturer / seller
(v) alcohol in % by volume, if the container is
30ml / more
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31. 106A: Manner of labeling of Homoeopathic Medicines
(B) In addition to the above label shall display the
following
(i) a distinctive batch number by the words
“Batch No.” or “batch” or “Lot Number” or
“Lot No.” or “Lot” or any distinguishing prefix
(ii) manufacturing licence number by the words
“Manufacturing Licence Number” or “Mfg.
Lic. No.” or “M.L.”
(C) No Hom. medicine containing a single ingredient
shall bear a proprietary name
106B: Prohibition of quantity & percentage
No Hom. medicine containing more than 12%
alcohol v/v shall be packed & sold in packing more
than 30ml except to hospitals / dispensaries in
packing not more than 100ml
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32. Dr.A.B.Ram Jyothis MD (Hom)
Reader
Department of Homoeopathic Pharmacy
Athurasramam NSS Homoeopathic Medical College
Phone No: 9497053705
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