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.
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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) ...
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 manufactur...
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 applicatio...
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 a...