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Showing posts from December, 2023
The prevention of cruelty to Animal Act 1960  Prevention of Cruelty : The primary objective is to prevent the infliction of unnecessary pain or suffering on animals. Punishment for Cruelty : The Act provides for punishment for people who subject animals to undue pain and torture. Protection of Animals : It aims to protect animals against unnecessary cruelty and abuse. Regulation of Animal Welfare : The Act enshrines the provisions relating to the establishment of an animal welfare board, its constitution, powers, and functions. Guidelines for Experimentation : It provides guidelines for the experimentation on animals for scientific purposes.
EDUCATION REGULATION Education regulation refers to the policies and rules formulated by the government or relevant authorities to manage and oversee the education system. It covers various aspects of education, from elementary to higher education, in both rural and urban areas. Flexibility : It provides flexibility for learners to choose their learning trajectories and programs. Multidisciplinarity : The policy promotes a holistic education across the sciences, social sciences, arts, humanities, and sports. Emphasis on Conceptual Understanding : It encourages conceptual understanding rather than rote learning and learning-for-exams. Creativity and Critical Thinking : The policy promotes creativity and critical thinking to encourage logical decision-making and innovation. Ethics and Human & Constitutional Values : It emphasizes ethics and human & constitutional values like empathy, respect for others, cleanliness, courtesy, democratic spirit, spirit of service, respect for publ
National List of Essential Medicines: Section Class Example Section – 1 A naesthesia General – NO Local – Lidocaine Section – 2 A nalgesic, Antipyretic, NSAIDs Aspirin, Paracetamol, Diclofenac, Morphine Section – 3 Anti- a llergic Ceterizine, Levoseterizine Section – 4 Anti d otes Activated charcoal, N-acetylcysteine Section – 5 Anti- e pileptics Carbamazepine, Diazepam Section – 6 Anti- i nfective Azithromycin, Amoxicillin Section – 7 Anti- M igraine Paracetamol, Aspirin Section – 8 Anti- n eoplastic / immunodepression Methotrexate, Ondansetron. Section – 9 Anti- p arkinsonium Levodopa + Carbidopa Section – 10 Medicine affecting the B lo
Discuss the classes of Advertisements prohibited under Drug and magic remedies act [6] Following are the classes of advertisements prohibited under this Act:  1) Advertisement of drugs:   For miscarriage or for preventing conception in women,  For removing menstrual disorders in women,  For improving the capacity of sexual pleasure in humans, and For diagnosing, preventing, or curing appendicitis, arteriosclerosis, blindness, blood poisoning, cancer, cataract, deafness, diabetes, brain disorders, uterus disorders, disorders of menstrual flow, disorders of nervous system and prostatic gland, dropsy, epilepsy, female diseases (in general), fevers (in general), fits, form and structure of female bust, gall stones, kidney and bladder stones, gangrene, glaucoma, goitre, heart diseases, high or low blood pressure, hydrocele, hysteria, infantile paralysis, insanity, leprosy, and leucoderma.  2) Advertisements providing false impression about any drug or making false claims for it, or if
Discuss the penalty for manufacturing and sale of drug in contravention of drug & cosmetics act 1940 The Drugs and Cosmetics Act, 1940 (DCA) in India prescribes various penalties for manufacturing and selling drugs in contravention of its provisions. Offence Penalty Adulterated or Spurious Drugs with Toxic Substances Minimum 5 years imprisonment which may be extend up to life. Fine of Minimum R.s 10000 for the 1 st Contravention. For subsequent contravention, 10 years imprisonment and fine of minimum 20000.   Adulterated Formulation but Not containing Toxic Substances Imprisonment 1 – 3 Years, Fine minimum 5000, on 1 st contravention. Imprisonment for 2 – 4 Years, fine minimum 10000 on subsequent contravention. Drug Manufactured without License. Imprisonment 1 – 3 Years, Fine minimum 5000, on 1 st contravention. Imprisonment for 2 – 4 Years, fine minimum 10000 on su
Conditions of a license for the manufacture of Drugs for the purpose of Test, Examination and Analysis: The license must specify the place of manufacture and Test of the drugs.  The Application must be signed by the Head of the Institution where the Test, Examination is supposed to be happened.  License is valid for 1 year period if not cancelled before.  For the purpose of Examination of a drug, the drug must be placed in container with proper labelling.  Shall allow Drug inspectors for inspect and check the records. Shall maintain a Inspection Book with all records done by the inspector.  Condition for Loan License: It is issued by a licensing Authority to a person who do not have any manufacturing license.  A separate license may be issued for the sale of drug more than 1 place.  Before the grant of license the license authority must satisfy the conditions for the grant of license like the manufacturing unit must have enough staff and components for manufacture.  For the manufacture
Explain the classes of drugs to import under licensee or permit The following class of drugs can be imported under License: Drugs specified in schedule C and C1 , excluding drugs under schedule X Drugs specified in schedule X Drugs for Research, test, analysis Drugs for personal use on the prescription of RMP Any new drug An application for the import license can be made by the manufacturer or by the agent of the manufacturer in India with the license fees of Rs. 1000 for a single drug or Rs. 1000 for every additional drugs.  The Import license is valid for upto 31st December of the following year if not cancelled earlier.  The importer must have adequate storage facilities  A fee of Rs. 250 is paid for a duplicate copy of license, if the original is lost or damaged. 
Write the classes of drugs prohibited to import in India Following drugs and cosmetics can not be imported in India: Any drug or cosmetics which is not at the standard Quality .  Any Drug which is Misbranded , Spurious , or Adulterated .  Any drug without the Import License .  Any patient or Proprietary medicine which is not displaying the true formula and List of APIs in the Label. Any drugs that claims to cure or prevent any disease specified in schedule J  Any drug and Cosmetics containing API which is unsafe or Harmful .  Any drug or cosmetics which Manufacture, Sale is prohibited in India except Research purposes.  Drug not labelled in the prescribed Manner.  Drugs which are expired . 
Conditions of license for the manufacture of Schedule C, C1 and X drugs  Following are the general conditions for the manufacture of schedule C, C1 and X drugs; License Must - 01 Provide and maintain staff, premises and equipments as per schedule M and M3 02 Test raw materials and final products of each batch by licensing authority. 03 Maintain records of Manufacturing and Testing of each batch. 04 Allow drug inspector to enter to inspect the premises and conduct the essential tests. 05 Allow drug inspector to check the registers and records. 06 Time to time report to the licensing authority about the (i)               Changes in staff (ii)             Alterations in material (iii)           Samples of Drugs 07 Not sell any batch until the licensing authority gives permission 08
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Manufacture of New Drugs:  As per the Rule: A new drug can be a new substance of chemical or biological origin; in bulk or prepared dosage from; used for prevention, or treatment of disease in human or animal which is not used in the country except the clinical Trial  If the ratio of ingredients is in an already marketed combination must be changed with certain factors like- Indications  Dosage from  Route of Administration  All vaccines are new drugs unless certified by the licensing authority.  A drug is said to be a new drug for about 4 years from the date of tits approval.  Loan License:  It is issued by a licensing Authority to a person who do not have any manufacturing license.  A separate license may be issued for the sale of drug more than 1 place.  Before the grant of license the license authority must satisfy the conditions for the grant of license like the manufacturing unit must have enough staff and components for manufacture.  For the manufacture of drugs more than 10 ite
Constitution of International Animal Ethical Committee (IAEC)  There are 8 members in the AIEC including: The chairperson. 2 scientists from 2 different biological sectors. A scientist from the outside of the institute. A non-scientist socially aware member. A CPCSEA nominee. A scientist in-charge of the animal facility of the institute.  A Veterinarian. Microbiologist/Pathologist.  Explain the CPCSEA guidelines for Breeding and Stocking of Animals Breeding of Animals; Breeding of animals for the purpose of experiment can be carried out only by a registered institute. If the registration is Denied or Cancelled, breeding must be stopped immediately.  The Application should be in the specified format to the Member-Secretary or any other authorized member of the committee (IAEC).  If the Member-secretary or the authorized officer is satisfied to the premises, position and quality of animal house where the breeding will be conducted as described in the application, then the applicant ma
Manufacture of Ayurveda Preparations under M and TP act  Ayurveda Preparations containing alcohol may be of 2 types: Those containing self-generated alcohol. E.g., Asavas  Those in which alcohol is added in any stage of manufacture.  Duty shall not be applied on preparation containing self-generated alcohol in which the alcohol content is less than 2 % In case of preparation in which the alcohol is more than 2% and if it can be taken as alcoholic beverages, the duty shall be paid.  Registered Ayurvedic Practitioner are allowed to manufacture and dispense preparations free of duty-  They must take a license  Use that products for only patients not for general people.  They should allow Excise officer to draw sample in order to check the sample contains only self generated alcohol.  They should maintain a record of the preparations along with the name and address of the patients.  Can be manufactured with bond or without bond. 
 Offence and penalties of NDPS act  OFFENCE PENALTY Contraventions of provisons in the Act or Rules in relation to poppy straw, opium poppy, coca leaves, prepared opium, manufactured drugs and psychotropic substances. Rigorous imprisonment upto 10 to 20 years and fine of not less than ₹1 lakh rupees on first conviction and with Rigorous imprisonment upto 15 to 30 years and a fine of ₹2 lakh on second and subsequent conviction. Illegal import or export or external dealings in narcotic drugs or psychotropic substances. Rigorous imprisonment upto 10 to 20 years and fine of not less than ₹1 lakh rupees on first conviction and with Rigorous imprisonment upto 15 to 30 years and a fine of ₹2 lakh on second and subsequent conviction. Embezzlement/Stealing of opium by the cultivator Rigorous imprisonment upto 10 to 20 years and fine of not less than ₹1 lakh rupees on first conviction and with R