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Correct answer is (a) True

The best explanation: It is essential that the prescription is legible i.e. clear enough to READ by the PATIENTS and by the shopkeepers. It is not allowed to SCRIBBLE something in the prescription. It should be written in a PERFECT manner with all the information about the illness and the MEDICINE.

Right answer is (b) SPURIOUS drug

Best explanation: A drug shall be deemed to the spurious drug if is imported under some different names RATHER than the registered one or mimicking any other different drug, an imitation of or is a substitute for another drug or resembles another drug such that it can deceive and bear upon its label the name of another drug. Such drugs are MANUFACTURED in small scale industries with very low-quality COMPONENTS and are sold by the name and the cost of BRANDED drugs.

The CORRECT choice is (c) Adulterated drugs

To elaborate: A drug shall be deemed to adulterated drugs if the CONTAINER is composed EITHER whole or a part of it, by any dangerous or deleterious substance which may render the contents injurious to health. If the drugs bear any other coloring RATHER than which is WRITTEN on the cover if it contains harmful toxic substance it will be deemed under adulterated drugs.

The correct choice is (c) Adulterated drugs

The BEST explanation: If a drug consists of any filthy, putrid, decomposed substances it will be deemed to be adulterated drugs. If the CONTAINER is composed either WHOLE or a part of it, by any dangerous or deleterious substance which may render the contents INJURIOUS to health. If the drugs bear any other coloring RATHER than which is written on the cover if it contains harmful toxic substance it will be deemed under adulterated drugs.

The correct answer is (a) Misbranded DRUGS

For EXPLANATION I would say: A drug SHALL be deemed to be misbranded drugs if he is colored, coated, powdered, packed in such a WAY that its damage is being concealed. If the drug is made to appear better or greater therapeutic value than it is original if it is not labeled in the prescribed manner if ANYTHING on the label is a false claim will be deemed to be a misbranded drug.

Right option is (a) Medicinal and Toilet Preparations Act

To elaborate: Medicinal and TOIL preparation act was passed in 1955. DRUG enquiring committee was established in 1931. The drugs and cosmetics rules were passed in 1945. The NARCOTIC drugs and PSYCHOTROPIC substances act were passed in 1985.

Correct option is (a) Drugs order

Easiest EXPLANATION: Drugs order ACT was passed in 1955 under the Essential commodities act. This order was passed to control any increase in the price of drugs since it is an IMPORTANT PRODUCT for human beings and India having a large number of BPL population this law was passed to PROTECT them from any hike in price.

Right OPTION is (b) Drug and Magic Remedies Act

For explanation I would say: Drug and Magic Remedies Act was passed in 1954. It prohibits the advertising for remedies which has magic PROPERTIES, qualities. For EXAMPLE, any drug which advertises intake of which will lead to having a male BABY rather than female will be deemed under this act. The drugs and cosmetics RULES were passed in 1945. The narcotic drugs and psychotropic substances act was passed in 1985.

The correct answer is (B) PHARMACY Act

The best explanation: The pharmacy Act was passed in 1948 by the Indian GOVERNMENT. Medicinal and Toil preparation act was passed in 1955. Drug enquiring committee was established in 1931. The drugs and cosmetics rules were passed in 1945. The narcotic drugs and psychotropic SUBSTANCES act was passed in 1985.

Correct answer is (a) The DANGEROUS Drugs ACT

The explanation: To control the production of cheaper and inferior drugs by some of the Indian Companies to compete with the IMPORTED drugs DUE to the increasing demand of cheap MEDICINE the Government of India passed the Dangerous Drugs Act in 1930.

The CORRECT choice is (c) List of equipment

To explain: MEDICINES in India are regulated by the Central DRUGS Standard Control Organization under the Ministry and Family welfare. According to this all kinds of equipment for the efficient running of the manufacturing wing, QUALIFIED personnel come under scheduled N. According to this all kinds of biological products including serums and vaccines come under Scheduled C and Cl drugs.

Right answer is (a) True

The explanation: GOOD Clinical Practice includes protection of human RIGHTS as a subject in a clinical trial. It ALSO provides assurance of the safety and efficacy of the newly developed compounds. GCP also includes STANDARDS on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry, monitors are OFTEN called Clinical Research Associates.

Correct option is (d) Vaccines

The best explanation: Medicines in India are regulated by the Central Drugs Standard Control Organization under the Ministry and FAMILY welfare. According to this all KINDS of INJECTABLE, ANTIBIOTICS, and ANTIBACTERIAL comes under Scheduled H and L drugs. According to this, all kinds of biological products including serums and vaccines come under Scheduled C and Cl drugs.

The correct OPTION is (b) Injectable

The best I can explain: Medicines in INDIA are regulated by the Central Drugs Standard Control ORGANIZATION under the Ministry and Family welfare. According to this all kinds of Injectable, antibiotics, and antibacterial comes under Scheduled H and L drugs. Biological products COME under Scheduled C and Cl drugs.

The CORRECT option is (a) Narcotics

For explanation: MEDICINES in INDIA are regulated by the Central Drugs STANDARD Control Organization under the Ministry and Family welfare. According to this, all kinds of narcotics drugs come under Schedule X drugs. Such as opium, morphine, codeine, etc. comes under the schedules X drugs.

Correct option is (a) CLINICAL trials are not supervised well

For explanation I would SAY: Clinical trials are always closely supervised by regulatory AUTHORITIES. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ETHICS committee and after that permission is granted to RUN the trial further. To be ethical, researchers must obtain the full and informed consent of participating human subjects and the subjects must know what can be the consequences.

Correct ANSWER is (b) Good CLINICAL practice

The best I can explain: Good clinical practice is an INTERNATIONAL quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. This includes the protection of human rights and PROVIDES ASSURANCE of the safety and efficacy of the trials.

The correct choice is (d) Phase IV

Easiest explanation: Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve safety surveillance (pharmacovigilance) and ongoing technical SUPPORT of a drug after it RECEIVES permission to be sold. Phase 1 consists of research WORK on a group of 20-50 people. Phase 2 and 3 has a group of 20-300 and 300 to 3000 respectively.

Right option is (a) Multiple Ascending Dose

Easiest explanation: Multiple Ascending Dose studies are conducted to better UNDERSTAND the PHARMACOKINETICS & pharmacodynamics of multiple DOSES of the drug and SAD is Single Ascending Dose studies are those in which small groups of subjects are given a single dose of the drug while they are OBSERVED and tested for a period of time.

The correct answer is (b) SINGLE Ascending Dose

To explain: Single Ascending Dose studies are those in which small groups of SUBJECTS are GIVEN a single dose of the DRUG while they are observed and tested for a period of time and MAD is Multiple Ascending Dose studies are conducted to better understand the PHARMACOKINETICS & pharmacodynamics of multiple doses of the drug.

The correct answer is (a) Phase I

The explanation: Phase I TRIALS are the first STAGE of TESTING in human subjects. A small (20-50) group of healthy volunteers will be selected. This phase includes trials designed to ASSESS the SAFETY, tolerability, pharmacokinetics, and pharmacodynamics of a drug.

Correct option is (a) The whole market will be under surveillance

To explain: Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be SOLD. Phase 1 trial will be done on 20-50 people. Phase 2 trial will be done on 20-300 people. Phase 3 trial will be done on 300-3000 people.

Right option is (b) 300-3000 people

To ELABORATE: Phase III studies are controlled tests on large PATIENT groups 300–3,000 or more depending upon the disease and are aimed at being ASSESSMENT of how EFFECTIVE the drug is, in comparison with current treatment method. Phase 1 trial will be done on 20-50 people. Phase 2 trial will be done on 20-300 people. Phase 4 trial is post-marketing surveillance.

The correct answer is (c) 20-300 PEOPLE

Explanation: Once the initial safety of the study DRUG has been confirmed in Phase I trials, Phase II trials are performed on larger groups 20-300 and are designed to assess how well the drug works, as well as to CONTINUE Phase I safety assessments in a larger group of volunteers and patients. Phase 1 trial will be done on 20-50 people. Phase 3 trial will be done on 300-3000 people. Phase 4 trial is post-marketing surveillance.

Correct option is (B) Patient recruitment

Easiest EXPLANATION: After FDA has approved the IND the manufacturer company has to choose groups of patients and HEALTHY people with their informed consent to start the PROCEDURE of the phase I trial. This the patient recruitment phase. Once the healthy INDIVIDUAL for phase I trial are selected and the phase I trial is successful they have to again recruit for phase II trial.

Right choice is (d) Data filed and registration

Easiest explanation: The last step of the clinical trial is when the data are filed and registration from the FDA is obtained and the product is ready to be MARKETED. FDA approves the New DRUG Application. Now the drug appears in the MARKET and post-marketing STUDIES, inspection starts.

Correct option is (d) Signed DOCUMENT of the recruited patient for the clinical trial procedures

The BEST I can explain: An essential component of initiating a clinical trial is to recruit study subjects following procedures USING a signed document called “informed consent.” FAKE treatment or placebo allows the researchers to isolate the effect of the study treatment. Patient injected with active dose and placebo is also known as a DOUBLE dummy.

The correct choice is (c) Fake treatment

The explanation is: The use of a PLACEBO (fake treatment) ALLOWS the RESEARCHERS to isolate the effect of the study treatment. It allows the researchers to see the effect on the patients or the healthy INDIVIDUAL when they don’t get the drug rather they get a fake treatment. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.

The CORRECT answer is (a) The subjects do not KNOW which study TREATMENT they receive

To elaborate: The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the RESEARCHERS also do not know which treatment is being given to any given subject. In this kind of study the subjects or the patients will not be KNOWING which study treatment they receive.

The correct choice is (c) RANDOMLY assigning SUBJECTS either for placebo or active dose

To elaborate: Randomized design is when each study subject is randomly assigned to receive either the study TREATMENT or a placebo. The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the RESEARCHERS also do not know which treatment is being given to any given subject.

Correct choice is (a) 6

To explain: The U.S institutes of HEALTH organize trials into 6 different TYPES and these are prevention trial, screening trial, DIAGNOSTIC trial, treatment trial and QUALITY of life trials. One way of classifying clinical trials is, by the way, the researchers behave that is an OBSERVATIONAL study and other is interventional study.

Right choice is (d) Study based only on animals

Easy explanation: Clinical trials are BIOMEDICAL or behavioral research studies on human subjects that are designed to answer specific questions about biomedical or behavioral interventions such as novel vaccines, drugs, TREATMENTS, devices or new ways of using known interventions, generating SAFETY and efficacy DATA. These trials are to test the safety and efficacy of a NEWLY invented drug.

Correct option is (a) Stethoscope

For explanation: Radiological products such as lasers, x-rays and ultrasound MACHINES ALSO may be medical DEVICES are subjected to FDA regulations. Television RECEIVERS, microwave ovens, and laser range finding devices, as “radiation-emitting electronic products,” also are subject to FDA regulation. These devices are subject to varying levels of reporting and record-keeping requirements. The radiation-emitting levels are checked by the FDA and are kept under a controllable range.

Correct OPTION is (c) Pacemakers

Explanation: FDA has different classes of devices. These have different kind of manufacturing guidelines and practices which should be followed.Such as CLASS I includes bandages, gloves, STETHOSCOPES. Class II devices include thermometers and endoscopes. Class III devices include those which come in contact with the body fluids and are kept at that place for a long time such as that of pacemakers and heart VALVES.

Right option is (a) Bandages

For explanation I would say: FDA has different classes of devices such as Class I includes bandages, gloves, STETHOSCOPES. Class II devices include THERMOMETERS and endoscopes. Class III devices include those which COME in contact with the body fluids such as that of pacemakers and heart valves.

Right choice is (a) Over the counter

To ELABORATE: OTC drugs are available to consumers without a prescription. Drugs are CLASSIFIED as OTC based on their safety PROFILE, the DEGREE to which their benefits outweigh risks. Such as PANTOPRAZOLE, paracetamol, etc. These drugs are OTC drugs and are available without a prescription.

Right answer is (b) Patented PRODUCTS can be manufactured by other companies once the patent is lost

To explain I would say: When new drugs are INTRODUCED, they are patented by brand-name drug companies. When these patents get expire, other companies can make drugs using the same active ingredient. These drugs are known as generic drugs. Generic drug companies must submit an abbreviated new drug application demonstrating that their products are bioequivalent to a drug product already on the market. Generic drugs are SOLD at much LOWER PRICES than the original one.

The CORRECT answer is (a) Followed by manufacturing companies

To explain: According to the rules of FDA good manufacturing practice regulations to which the companies MUST conform in their manufacturing. All the drugs, MEDICAL equipment, injections, cosmetics, etc, have different manufacturing guidelines according to FDA which should be followed by manufacturing units. Products which will not be manufactured in accordance with good manufacturing practice regulations may be adulterated or misbranded and subject to seizure and in the worst cases, these companies can be TOLD to shut down.

Right option is (d) Good MANUFACTURING practice

The explanation: ACCORDING to the rules of FDA good manufacturing practice regulations to which the companies must conform in their manufacturing. Products which will not be manufactured in accordance with good manufacturing practice regulations may be adulterated or misbranded and subject to seizure and in the worst CASES, these companies can be told to shut down. All the medicines, cosmetics, etc. have DIFFERENT manufacturing guidance which each and every industry is intended to LISTEN to.

Right answer is (c) Rapid APPROVAL of priority medications

The best I can explain: Under the Food and Drug Modernization Act of 1997 which is also known as the FAST track provisions, the FDA tries to rapidly approve “priority” medications intended for serious illnesses and for which no alternative CURRENTLY is available. Such as medicines for Alzheimer, cancers, AIDS, Viral infection may GET a speedy approval from the FDA and thus can be available in the market as soon as they are approved.

The correct CHOICE is (a) True

To elaborate: FDA monitors POTENTIAL risks of the product, regulate aspects of prescription drugs such as testing, MANUFACTURING, labeling, advertising, MARKETING, efficacy, and SAFETY. FDA also evaluates marketing applications in a timely fashion. Facilities inspections by FDA are common.

Correct CHOICE is (d) Vehicles

Easiest explanation: FDA is responsible for the safety regulation of foods, DIETARY supplements, drugs, VACCINES, biological medical products, blood products, medical devices, radiation-emitting products, veterinary products, and COSMETICS. FDA is not at all responsible for the MANUFACTURING of vehicles.

The correct option is (b) Food and Drug Administration

Explanation: Food and Drug Administration or FDA is under the agency of the United States DEPARTMENT of Health and Human Services. FDA gives permission for the marketing of all the medical equipment, drugs, FOODS, food COLORANTS, preservatives, spices, neutraceuticals, PHARMACY compounds, and everything has proper guidelines which should be followed by the manufacturer, retailer, storage, etc.

Right option is (a) Wiley Act

Easy explanation: In June 1906, President Theodore ROOSEVELT signed the Food and Drug Act which is also KNOWN as the “Wiley Act”. Under these acts, all the medical equipment, drugs, foods, food colorants, preservatives, spices, nutraceuticals, pharmacy compounds everything has proper GUIDELINES which should be followed by the manufacturer, RETAILER, storage, etc.