Difference Between Law and Ethics Feature Law Ethics Definition Law is a set of rules that are created and enforced by a government or other authority. Ethics are a set of moral principles that govern how we should behave towards others. Origin Created and enforced by a government or other authority. Not created by any government or authority. Flexibility Law is Flexible, it can be changed depending upon the demand. It can not be changed. Not flexible. Purpose To Punish People who breaks the law. To guide people’s behaviour. Sources Statutes, regulations, case law. Social norms, customs, personal conscience. Nature Legal system (courts, police, prisons) Social norms, customs, personal conscience. Scope Focuses on behaviour
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Geographical Indication Geographical indications (GIs) are signs used on products that have a specific geographical origin and possess qualities or a reputation that are due to that origin. GIs are a form of intellectual property (IP) that can be registered and protected. Example: Darjeeling tea - Darjeeling tea is a type of black tea that is grown in the Darjeeling district of India. It is known for its distinctive flavor and aroma. Importance: Consumer protection: GIs provide consumers with information about the origin and quality of products. Producer protection : GIs help to protect producers from unfair competition by preventing others from using their GI without authorization. Economic development of the AREA : GIs can contribute to economic development by promoting local products and traditions. Rural development : This can help to create jobs, generate income, and preserve cultural heritage. Environmental sustainability : GIs can promote sustainable production methods by
TRADEMARK A Trademark is a graphical mark which is capable of distinguishing the goods and services of one person from other goods and services of another person as defined by the Trade Mark Act (TMA) 1999. Significance of Trademark: Useful in distinguishing similar products in the market, if the products are very closely similar. Eliminates confusion and reduces product searching costs. Identifies the product on the basis of TMs Indicates the origin of product and also establish the relation between goods and people. It advertises the product. Symbol of Guarantee and assures the original quality of the product. A strong trademark can help to increase the value of a business. Different Trademarks: A name Alphabet, Numbers, or Letters or any combination Image, Symbol, Letters etc
First Register The first register is prepared by the State Government under the Pharmacy Act, 1948. The first register includes - The full name and residential address of the registered person, The date of his first admission to the register, Tis qualifications for registration, His professional address etc. - There are Various qualification criteria for a person to enter his name in the first register. Subsequent Register The Subsequent Register is prepared after the First Register and before the Education Regulations have taken effect in a state . A person desirous of having his name registered in the Subsequent Register has to qualify for the following particulars: Should be at least 18 years of age. Should have paid the prescribed fee Removal of Name From Register: The names of the registered persons may be removed from the register on the following reasons: If his name has been entered into the Register by error, misrepresentation A person who gives false information a
Discuss in detail about State Pharmacy Council Each state of India can constitute state pharmacy council under the provision of Pharmacy Act by their respective State Governments. CONSTITUTION: Elected Members: 6 members elected by the Registered Pharmacists of the state. 1 member elected by the Medical Council of the state. Nominated Members: 5 members nominated by the State Govt. of whom at least 3 should have a degree or diploma in pharmacy or half should have degree or diploma in pharmacy, Pharmaceutical Chemistry or be registered Pharmacist. Ex-officio Members: Chief Administrative medical officer of the state. Officer-in-charge of Drug Control Administration of the state. Government analyst of the state. The president and vice-president of the state pharmacy council are nominated by the central Council and hold their post for 5 years. All members are eligible for re-election. FUNCTION: Inspection : Inspecting any premises where drugs are compounded and dispensed. I
Functions of DTAB To advice the Central and State Governments in all technical issues related to the administration of the Drug and cosmetics act. To make sub-committees and appoint member experts who are not members of the board. To send recommendations to the Ministry of health and family welfare, regarding the D & C act and Rules.
Importance of BMR Manufacturing records are required to provide a List of raw materials and their quantities obtained from the stores. Quality and Safety : They ensure the quality and safety of pharmaceutical production. Detailed Documentation : They provide detailed documentation of production processes. Proof of Compliance : They offer proof that a particular product batch was manufactured according to the procedures detailed in the master formula record. Quality Standards : They establish a product’s quality standards. Legal Evidence : They provide legal evidence that the company followed Good Manufacturing Practices (GMP). Importance of MFR Reference Standard : The MFR is used as a reference standard for preparing the Batch Manufacturing Record (BMR) by manufacturing units. It provides proof that a particular product batch was manufactured according to the procedures detailed in the master formula record Uniformity Across Batches : The MFR ensures that there is uniformity across b
Schedule H This schedule contains the prescription drugs, which should be sold by retail only when a prescription is formed by a Registered Medical Practitioner. Time and date mention on the prescription should be noted. The drug level should have the text "Rx" And schedule "H" drug written on it. The level should also bear warning that "To be sold by retail on the prescription of a registered Medical Practitioner (RMP) only. If any narcotic and psychotropic drug comes under schedule H, Should be labeled by the symbol NRX and Schedule H warning, Schedule H contains total 536 number of drugs. Examples of Schedule H drugs: Abciximab, Diclofenac. Schedule H1: This schedule is introduced to control the sale of antibiotics. It has a separate regulation to check unauthorized sale of antibiotic and abuse of these antibiotics. The drugs under schedule H are labeled with symbol Rx in red and displayed on left corner of the label and words in box with red border. Th
Discuss in detail about various parts of schedule M as per Drugs & cosmetics act. It is defined as "the part of quality assurance which is aimed to ensure that the product are consistently manufactured to the quality appropriate to their intended use." Schedule M has Different parts discussed bellow: M GMP requirements of factory premises , plant and equipment for manufacturing drugs and pharmaceutical products . PART- I GMP for Premises and Materials PART - I-A : Specific Requirements for the manufacture of Sterile products. Parenteral products and Sterile ophthalmic preparations. PART - I-B : Specific Requirements for the manufacture of Oral solid dosage form (Tablet & Capsule). PART - I-C : Specific Requirements for the manufacture of Liquid Orals (Syrup, Elixirs, Suspensions, emulsions) PART - I-D : Specific Requirements for the manufacture of Topical Products (Creams) PART - I-E : Specific Requirements for the manufacture of Metered Dose Inhalers (
Explain the duties of Drug Inspector The Central and state government appoints suitable number of drug inspector who are referred as public servants For specific area. Duties of drug inspector: Manufacturer drug or cosmetics: To inspect all the premises licensed for the manufacture of drugs and cosmetics at least two times in a year. To inspect the process of manufacture , standardization of drugs & cosmetics, method and place of storage of Drugs under schedule C and C1 To take samples of manufactured drugs for qualitative analysis. To check all the record and registers that are required for the maintenance of the act. Sale of Drug & Cosmetics: To inspect all the premises licensed for sale of drug at least two times in a year. To take the sample of drugs in the suspecting of being sold and stocked in contravention of the Act and rules. Investigate any written compliance made to him and carry out any enquiries or inspections that are required to detect the sale of such drugs
Significance of CDL Central Drugs Laboratory is an analytical laboratory established by the Central Government under the control of a Director with its headquarters located at Kolkata . Significance of CDL: Testing and analyzing the samples of drugs and cosmetics that have been sent by the Court. Advises the Central and State Governments including Union Territories on all the matters related to the analysis of drugs and cosmetics and also carries out analysis of specific samples sent by the Central and State Governments . Developing new methods of analysis of drugs and cosmetics through research. Receiving samples for analysis from consumer organizations , private parties etc. on payment of required fee. CDL actively collaborates with international organizations like the World Health Organization (WHO) to harmonize drug testing standards and promote global public health. CDL conducts training programs for drug inspectors, analysts, and other stakeholders to enhance their skill
General Labelling Requirements The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed: 1. Drug name: the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any. 2. Net content: weight, volume, in metric system or units. 3. Content of Active ingredients: Oral liquids: Contents per single dose, i.e. 5 ml or multiple thereof. If dose is below 5 ml, then per ml. Liquid parenterals: Contents per ml or in percentage or per dose. Solid parenterals: Contents per mg or per gm or in terms of units. Tablets, capsules and pills: Contents per tablet, capsule, pill. For other preparations: Contents in terms of percentage by w/w or w/v or units per gm or ml. 4. Name and address of manufacturer. 5. Manufacturing license number: Mfg. Lic. No. or ML No. 6. Batch number: Batc
Describe in detail about constitution and function of pharmacy Council of India. (6+4) CONSTITUTUIN of PCI A. Elected members: Six members , at least one teacher each of Pharmacy, Pharmaceutical Chemistry and Pharmacognosy elected by UGC from the teaching staff of an Indian University or an affiliated college granting a degree or diploma in Pharmacy. One member , elected by the Medical Council of India from amongst its members. One member elected by each State Pharmacy Council who shall be a Registered Pharmacist. B. Nominated members: Six members, nominated by the Central Government , including at least four persons possessing degree or diploma in Pharmacy and engaged in the practice of Pharmacy or Pharmaceutical Chemistry. One representative each of University Grants Commission and the All India Council for Technical Education. One Registered Pharmacist to represent each State nominated by the State Government/Union Territory Administration. C. Ex-officio Members: The Directo