SCHEDULE N (1).pdf
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This document outlines the minimum requirements, or Schedule N, for operating a pharmacy in India. It discusses requirements for the pharmacy premises including being well-lit and ventilated with a minimum size based on the number of pharmacists. Specific requirements are outlined for furniture, apparatus, books, and general provisions. The pharmacy must be under the supervision of a registered pharmacist and maintain clean premises, records, and properly store and label medications according to legal requirements.
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2) It aims to provide uniform excise duty rules and rates throughout India, control the misuse of alcohol, and prevent irregularities seen under the previous Act.
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This document discusses pharmaceutical ethics and the code of ethics for pharmacists. It covers several key points:
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2) The code addresses how pharmacists should conduct themselves professionally, including by providing comprehensive services to patients, ensuring drug safety, and maintaining high ethical standards in their work and interactions.
3) Pharmacists must not engage in practices like self-medication, advertising exaggerated health claims, or entering secret arrangements with doctors. Their primary duty is to serve patients and uphold integrity in the profession.
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1 pharmaceutical legislation in india
1) The objective of Pharmaceutical Legislation in India is to ensure patients receive safe, effective, and quality-tested drugs.
2) Pharmaceutical legislation originated in India in response to a lack of domestic drug production and import of inferior drugs. The Chopra Committee was formed in 1931 to recommend comprehensive drug legislation.
3) The Chopra Committee's key recommendations were the formation of central and state pharmacy councils, a drug control machinery, and establishment of drug testing laboratories. This led to the passage of the Drugs and Cosmetics Act of 1940.
Pharmaceutical Legislations Notes (Pharmaceutical Jurisprudence Ist)
This document discusses the history of pharmaceutical legislation in India. It describes several committees that were formed to address issues with drug quality, regulation of the pharmaceutical industry and pharmacy profession, and development of the healthcare system. The key committees mentioned were the Drugs Enquiry Committee chaired by R.N. Chopra in 1930, the Health Survey and Development Committee chaired by Joseph Bhore in 1943, the Hathi Committee chaired by Jaysukhlal Hathi, and the Mudaliar Committee chaired by A. Lakshman Swami Mudaliar in 1959. These committees made recommendations that led to important laws regulating drugs and the pharmaceutical industry in India.
Pharmaceutical legislations
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The document discusses various pharmaceutical legislations in India. It provides a brief history of pharmaceutical companies in India from the early 19th century. It then summarizes key committees that shaped drug regulations, including the Drugs Enquiry Committee headed by Col. R.N. Chopra in 1931. The Chopra Committee made recommendations that led to the Drugs Act of 1940, establishing drug control authorities and the regulation of drug manufacturing. Subsequent acts and amendments expanded regulations to areas like pharmacy education and advertising. The overall objective of pharmaceutical legislation in India is to ensure safe, effective and quality-tested drugs for public health.Medicinal and toilet preparations act and rules,1955
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.
SCHEDULE N.pptx
Schedule N outlines the minimum equipment requirements for operating a pharmacy. It specifies that the pharmacy premises must be separated from private rooms, well-built, dry, well-lit, ventilated, and large enough to properly store and display medicines. The dispensing area must be at least 6 square meters for one pharmacist plus 2 square meters for each additional pharmacist. Furniture and equipment must be suitable for their intended uses and include items like dispensing benches, locked poison cabinets, containers, apparatus, and reference books. Pharmacies must always be under the supervision of a registered pharmacist and maintain clean, orderly premises and proper record-keeping in accordance with laws.
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Manufacture of drugs (other than homeopathy)
This document outlines the requirements and conditions for obtaining different types of licenses to manufacture, repack, or loan drugs in India. The key types of licenses covered are:
1. Manufacturing license - Issued to those who can independently manufacture and test drugs. Separate licenses are needed for different drug classes.
2. Loan license - Issued to those who want to use another licensed manufacturer's facilities. They must demonstrate adequate testing capabilities.
3. Repacking license - Allows breaking bulk drugs into smaller packages and relabeling for sale. Testing of materials and products is required.
Stringent good manufacturing practices, record keeping, and testing standards apply to all license types to ensure drug quality and safety
Code of Pharmaceutical Ethics
This document discusses pharmaceutical ethics and the code of ethics for pharmacists. It covers several key points:
1) Pharmaceutical ethics refers to the moral principles and standards that govern the pharmacy profession. The code of pharmaceutical ethics guides pharmacists in their job, trade, and relations with other professions.
2) The code addresses how pharmacists should conduct themselves professionally, including by providing comprehensive services to patients, ensuring drug safety, and maintaining high ethical standards in their work and interactions.
3) Pharmacists must not engage in practices like self-medication, advertising exaggerated health claims, or entering secret arrangements with doctors. Their primary duty is to serve patients and uphold integrity in the profession.
Medicinal and toilet preparation act 1955
The document summarizes the key aspects of the Medicinal and Toilet Preparations Act and Rules, 1955 in India. The objectives of the act are to provide for excise duties on medicinal and toilet preparations containing alcohol, narcotics or drugs and to control their manufacture and misuse. The act defines relevant terms and outlines the licensing process and requirements for the manufacture of such preparations both within bonded premises and outside. It also describes the duties and powers of excise officers, search and seizure procedures, offenses and penalties. The schedule lists the categories of dutiable goods and applicable rates of duty.
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The document discusses the administration of the Drugs and Cosmetics Act and Rules in India. It outlines the roles and qualifications of government analysts, drugs inspectors, and their powers and duties. Government analysts are appointed by state and central governments to analyze drug and cosmetic samples. They must have qualifications in medicine, science, pharmacy or pharmaceutical chemistry. Drugs inspectors inspect premises where drugs are manufactured and sold. They collect samples which are sent to government analysts. Based on the analysis, drugs may be destroyed if substandard or auctioned if of standard quality.
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This document outlines the Medical Termination of Pregnancy Act of 1971 in India. It establishes that registered medical practitioners can terminate pregnancies up to 12 weeks, or up to 20 weeks if two practitioners agree it is necessary to protect the woman's life or physical/mental health or to prevent serious abnormality or handicap of the child. Guardians must consent in writing for terminations of minors or lunatics. Terminations can occur in government hospitals or approved places.
Medicinal and toilet preparations act and rules,1955 (excise duties)
The document summarizes the Medicinal and Toilet Preparations Act and Rules of 1955 in India. The key points are:
1) The Act provides for uniform excise duties on medicinal and toilet preparations containing alcohol, opium, cannabis, or other narcotics throughout India.
2) Manufacturing such preparations requires a license from excise authorities and following strict rules regarding facilities, storage, record keeping and excise oversight.
3) Excise duties are collected when preparations containing alcohol or narcotics are removed from licensed manufacturing premises, with some exemptions for charitable facilities. Penalties are prescribed for violations.
Narcotic Drugs and Psychotropic Substances Act, 1985
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.
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This document outlines the Medicinal & Toilet Preparation Act of 1955, which was passed to standardize excise duties across states in India. The key objectives of the act were to levy and collect duties on alcohol used in medicinal and toilet preparations and curb irregularities. The act established procedures for licensing the manufacture of preparations containing alcohol or narcotics. It also differentiated between manufacturing processes that took place within bonded laboratories versus outside of them, and outlined exemptions, duties, and responsibilities of excise officers in enforcing the act.
State pharmacy council and joint state pharmacy council
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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 & TOILET PREPARATION ACT
The document discusses the Medicinal and Toilet Preparations Act of 1955 and related rules from 1976. The Act provides for the collection of excise duties on medicinal and toilet preparations containing alcohol, cannabis, or narcotic drugs. It aims to provide uniform rules and rates of excise duties across India. The document outlines definitions, licensing procedures, and regulations for the manufacture of such preparations in bonded and non-bonded facilities. Strict rules are in place for procuring and storing alcohol and finished products in bonded laboratories.
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Pharmaceutical Legislations Notes (Pharmaceutical Jurisprudence Ist)
Pharmaceutical Legislations Notes (Pharmaceutical Jurisprudence Ist)
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Medicinal and toilet preparations act and rules,1955 (excise duties)
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PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
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2. Specific sections cover water treatment systems, warehousing, production area layout, quality control laboratory independence, personnel training, and inventory/raw material management. Equipment must be properly located, maintained and defective units removed.
3. Quality assurance systems must ensure pharmaceutical products meet GMP standards and are developed to requirements for design, development, manufacturing and quality management.
Community Pharmacy Ravinandan A P 7th Sem.pptx
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Hospital pharmacy
The document discusses hospital pharmacy services in India. It outlines the Pharmacy Act of 1948 and amendments that regulate pharmacy practice and qualifications. It describes the types of pharmacies and their functions, including compounding, storage, distribution, and providing safe medication to patients. It also discusses pharmacy planning, staffing, record keeping, drug procurement and quality control to efficiently provide pharmacy services in hospitals.
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GMP of ASU Drugs
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PHARMACEUTICAL PRODUCTION MANAGEMENT & INVENTORY CONTROL
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SCHEDULE N (1).pdf
- 2. SCHEDULE N: • Schedule N includes the list of minimum equipment for the efficient running of a pharmacy.
- 3. 1. ENTRANCE • The front of a pharmacy shall bear an inscription “Pharmacy” in front.
- 4. 2. PREMISES • The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. • The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. • The height of the premises shall be at least 2.5 meters.
- 5. • The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices. • A pharmacy shall be provided with ample supply of good quality water. • The dispensing department shall be separated by a barrier to prevent the admission of the public.
- 6. 3. FURNITURE AND APPARATUS • The furniture and apparatus of a pharmacy shall be adapted to the uses for whichthey are intended and correspond to the size and requirements of the establishment. • Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. • Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust. • Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.
- 7. • A pharmacy shall be provided with a dispensing bench, the top of whichshall be covered with washable and impervious material like stainless steel, laminated or plastic, etc. • A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the word “POISON” in red letters on a whitebackground. • Containers of all concentratedsolution shall bear special label or marked with the words “To be diluted”
- 8. • A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions: APPARATUS : • Beakers • Bottles • Corks assorted sizes and tapers • Filter paper • Funnels, glass • Litmus paper blue and red • Measure glasses • Mortars and pestles • Ointment slab • Pipettes • Rubber stamps and pad • Scissors • Thermometer • Tripod stand • Watch glasses
- 9. BOOKS : • The Indian Pharmacopoeia (Current Edition) • National Formulary of Indian (Current Edition) • The Drugs and Cosmetics Act, 1940 • The Drugs and Cosmetics Rules, 1945 • The Pharmacy Act, 1948 • The Dangerous Drugs Act, 1930
- 10. 4. GENERAL PROVISIONS • A pharmacy shall be conducted under the continuous personal supervision of a RegisteredPharmacist whose name shall be displayed conspicuously in the premises. • The Pharmacist shall always put on clean white overalls. • The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean. • All records and registers shall be maintained in accordance with the laws in force. • Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keysof the poison cupboard shall be kept in the personal custody of the responsible person. • Medicaments when supplied shall have labels conforming to the provisions of laws in force.
- 11. THANK YOU….