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Drugs
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Food
If the chemist refuses to give me a cash memo, what should I do?
In such a situation, lodge a complaint with the FDA office.
When I purchase a medicine from a chemist, what should I do?
When you purchase any medicine, insist on a cash memo, verify the expiry date and price mentioned on the label.
Is there any fees for obtaining different kinds of certificates? If yes, where are the details available & how should the fees be paid?
Yes, different fees structure is prescribed for various certificates. The information regarding the amount to be deposited for a particular certificate is available in FDA office and it is also available on this website
If any application is rejected, does the department inform the same in writing along with rejection letter/order?
Yes
Challan – Where should the amount be deposited?
payment of fees and fines are to be done using the e-challan payment gateway of Directorate of Accounts (see under links)
Application Whether printed format issued by department only to be used. Can we make a photocopy of the same?
Either you can use the same application form or you can photocopy the application and submit the same.
Where do we get the information pertaining to Drugs Prices Control Order, 2013?
The information is available with National Pharmaceutical Pricing Authority, New Delhi. The details are available on www.nppaindia.nic.in.
What is the minimum area prescribed to open a medical shop or wholesale distribution outlet?
The minimum area prescribed in the statute to start a
(i) Medical shop (Chemists and Druggists): 15sq m2.
(ii) Wholesale outlet: 15sq m2 .
Whether applications can be submitted on line?
Yes, applications for Drug sale can be applied through XLN INDIA PORTAL and applications for Manufacturing of Medical Devices/Invitro Diagnostic Kits can be submitted online through MEDICAL DEVICE PORTAL.(see links)
What is the time frame for the grant of licence/renewal of manufacturing licences? What is the time frame for the grant of permission for additional products?
The time frame for the grant of fresh licenses/ renewal of manufacturing licenses additional products is given in Citizens charter available from this website.
What are the different types of licences for manufacture/sale of drugs and Cosmetics, and what is the fee structure for the same?
The different types of licences and the fees structure is given in Licensing Requirements and fees structure available on this web site.
Can Ayurvedic drugs be stocked in the medical store & whether any license is required for dealing with Ayurvedic drugs?
Ayurvedic drugs can be stocked in the medical shop & no license is required to deal with the same.
Do we require to inform if there is any change in the registered pharmacist?
Yes, and relevant documents of the newly appointed registered pharmacist are to be submitted to the concerned licensing authority & necessary endorsement on the license is to be obtained immediately.
Can the refrigerator be switched off after the working hours of the medical store?
No, at any point of time the refrigerator should be on & should be in working conditions.
Is it an offence to stock physician sample in sales premises?
Yes
Whether fresh licence is required to be obtained due to change in premises or change in constitution?
Yes, fresh licence is to be obtained if there is any change in premises or change in constitution of the firm.
Is a registered pharmacist must for the sale of drugs in the wholesale?
NO, the sale of drug by wholesale shall be made either in the presence of registered pharmacist or in the presence of a person who shall be a graduate with 1 yr experience in dealing in drugs or a person who has passed S.S.C.E with 4years experience in dealing in drugs and who is approved by the Licensing Authority.
Whether a separate license is required for the sale of drugs through motor vehicle?
No
Whether a license is required for the sale of cosmetics?
No
Is there any special license requirement for dealing in Veterinary drugs?NO; One can deal in veterinary drugs under the drugs licenses issued for human use drugs also.
What measures to be taken if the stock of banned drug / not of standard quality drugs are available in the medical shop?
Immediately inform the FDA office along with the sales cash memos, if possible.
Whether the presence of the registered pharmacist required through out the working hours?
Yes
Is there any special license required to run 24 hrs Medical shop (Chemists and Druggists)?
No Special licence is required.
Is it a requirement to store all drugs in the refrigerator?
According to the labeling specifications certain drugs like Vaccines, Sera, Insulin Injections etc., are required to be stored in the refrigerator.
Is refrigerator must to start the medical shop?
Yes
Is registered pharmacist must to run a medical shop (Chemists and Druggists)?
Yes
What instructions should be followed for storing the drug?
Drugs should be stored as mentioned on the label strictly. Remember the “Expiry Date” will not stand valid until proper storage instructions are followed as mentioned on the label. Keep all drugs out of reach of children. Maintain hygienic conditions in the place where you store the drug.
What should I do if I observe change in color of the medicine or flavor from regularly seen medicine?
In case you observe any such changes, immediately go to your chemist & ask whether the manufacturer has done any changes .If you find it damaged or spoiled return immediately. If you are not clear of the information, clarify from manufacturer or report to FDA office immediately along with the original sales cash memo.
What should I do if I observe abnormal response after taking drug?
These abnormal responses are termed as “Adverse Drug Reactions”. Do not get panic. Report immediately to your doctor. Do not terminate abruptly or take self medication to counter the response without physician’s advice.
What do I do if I miss a dose?
If you miss any dose never take additional doses. It is very dangerous to take double doses to supplement missed once, as it produces “EXTRA” effect that may be hazardous to the health. Adhere strictly to your normal dosing schedule and take appropriate measures to memorize or consult your physician.
How do I lodge a complaint with FDA?
You can lodge a complaint with the FDA at office phone 0832-2459226,2459230, or send email or post a letter
Can I take alternate medicine suggested by chemist?
Until unless you have firm directions given by your physician to go for alternate brands, in case the prescribed medicine is not available, do not substitute the medicine. In case you observe any damage with the strip or vial or bottle you buy or spots observed on the tablets return to the chemist or druggist.
What precautions should be taken while consuming a drug?
While consuming a drug, strict precautions are to be observed through out its course. The drug should be stored as per the labeled conditions during is use. The drug should be used in accordance with the directions stated by the physician, e.g., whether it should be taken before or after meals, the frequency of administration, whether the correct dose is being administered especially in case of liquid formulations. Drugs should not be consumed without consulting a physician or a pharmacist during conditions like pregnancy, old age or infancy.
Can I take only half the prescription or use half the dose if I feel better?
Do not change the course of medication, even if you feel better; continue the full course of medication until specifically advised by your physician. Never take half doses while it is prescribed for a full dose.
What are prescription drugs?
Drugs which are covered under Schedule H and which carry on the product label the warning: To be sold on the prescription of a Registered medical Practitioner are identified as ‘prescription drugs’; One requires to produce the RMP prescription at the Chemist counter for dispensing any prescription drugs.
What is a Drug?
DRUG” include – All medicines for internal or external use of human begins or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes, such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of [vermin] or insects which cause disease in human beings or animals, as may be specified from time to time by the central government by notification in the official gazette.
All substances intended for use as components of a drug including empty gelatin capsules and Such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the central government by notification in the official gazette, after consultation with the board. i.e. The following devices are notified as Drug:-
- Sterile disposable perfusion sets for single use only
- Sterile disposable hypodermic syringes for single use only
- Sterile disposable hypodermic needles for single use only
- In – vitro diagnostic devices for HIV, Hbs Ag & HCV
- Cardiac Stents
- Drug Eluting Stents
- Catheters
- Intra Ocular Lenses
- I V Canullae
- Bone Cement
- Heart Valves
- Scalp Vein Set
- XIII Orthopedic Stents
- Internal Prosthetic Replacements
How do I lodge a complaint with FDA?
You can lodge a complaint with the FDA at office phone 0832-2459226,2459230, or send email or post a letter
Where is the FDA office?
Office of FDA,Goa, is located Opposite Shrine of Holy cross, Bambolim-Goa
Whether applications can be submitted on line?
Yes, applications for food registration certificate and Licences can be applied through FOSCOS PORTAL.(see links)
FAQ’s on Food Safety
Food Safty FAQ’s
Is it possible to find out adulteration in food items without going to any laboratory?
Yes one can detect adulteration in food items using simple house-hold methods as given below:
| Sr. no | Name of the Food article | Adulterant | Test to identify Adulterant |
|---|---|---|---|
| 1. | Milk | Water Starch Powder | Measure the specific gravity with lactometer. The normal milk values will fall between 1.030 and 1.034; Add 2 to 3 drops of iodine solution to tumeric powder. The turmeric powder will turn blue; |
| 2. | Turmeric | Metanil Yellow colour | Put turmeric powder in concentrated hydrochloric acid the colour of turmeric turns slightly blackish (magnetic colour). After addition of water, the magnetic colour shall persists, which will demonstrate presence of metanil colour. |
| 3. | Chillies | Colours | Sprinkle on the surface of water chillie powder. Added colour will stain water. |
| 4. | Pure Coffee | Chicory | Shake a small quantity in cold water .Coffee will float while chicory will sink, staining the water brownish red. |
| 5. | Asafoetida | Resin or gum, scented and coloured | 1. Pure asafetida dissolves in water to form milk-white solution. 2. Pure asafoetida bums with a bright flame on being ignited. |
How do we identify vegetarian and non-vegetarian food articles?
Vegetarian food are required to have a symbol of a green spot in a rectangular square, whilst non-vegetarian shall carry a red spot in a rectangular square on the label of such food articles.
How do I lodge a complaint with FDA?
You can lodge a complaint with the FDA at office phone 0832-2459226,2459230, or send email or post a letter.
With what sort of food items is the FDA concerned?
FDA is concerned with all food items including soft drinks and other non-alcoholic beverages
Safety tips at Sweet Marts
- Purchase sweets only from credible sweet marts; Insist on fresh stocks;
- Buy coloured sweets cautiously, as very dark coloured sweets should be avoided;
- Ask for disclosure of colours added in sweets, as some yellow (metanil yellow) and dark pink colour (rhodamine) are prohibited;
- Consume within recommended best before use date; Store the sweets at recommended temperature;
- Always insist on a bill or cash memo so as to help you in the event of any quality complaint;
- Do not buy sweets kept in open as its quality cannot be vouched;
- Do not buy un-labeled food products or sweets
What is a food additive?
In its broadest sense, a food additive is any substance added to food.
Where is the FDA office?
Office of FDA,Goa, is located Opposite Shrine of Holy cross, Bambolim-Goa.
How does food become hazardous?
Food becomes hazardous by contamination. Contamination is the unintended presence of harmful substances or microorganisms in food. Food can become contaminated from chemical, physical, or biological sources
Are sponges safe for use?
Sponges are safe only when cleaned properly. Bacteria live and grow in damp conditions. Wash dishcloths, sponges and towels often in the hot cycle of your washing machine. Disinfect sponges in chlorine bleach solution. Replace worn sponges frequently.
How often should I wash my hands when preparing meals?
Hands should be washed in warm, soapy water before preparing foods and especially after handling raw meat, poultry and seafood. Never forget to wash your hands after switching tasks, such as handling raw meat and then cutting vegetables. Also, it is important to wash hands after taking out garbage, sneezing or petting your dog or cat.
What is the biggest most common mistake when it comes to food safety?
We have identified four major food handling mistakes. That’s why we offer four simple tips to promote home food safety:
- Wash hands often
- Keep raw meats and ready-to-eat foods separate
- Cook to proper temperatures
- Refrigerate promptly below 8oC
SAFETY TIPS FOR HANDLING FRESH FRUIT AND VEGETABLES
a. Purchase fruits and vegetables that look and smell fresh and handle them gently to avoid bruising.
b. Throw away any fruit or vegetable that is moldy or slimy; Wash fruits & vegetables whole produce  thoroughly under clean running tap water before use.
c. This is vital to remove any dirt or extraneous matter that may on the outer skin. Besides, this would also reduce the bacterial contamination to the inner flesh.
d. Do Not wash fruits or vegetables with detergent as they can absorb the detergent;
e. Store all cut fruit and vegetables in covered containers in the refrigerator. Once produce is cut bacteria can grow on surface.
f. Wash your hands well with soap and use clean utensil, and clean cutting board;
Can Gutka or tobacco related food products be sold or stocked in the premises?
Under section 87A of the Goa Public Health (Amendment) Act, 2005 all injurious food articles containing tobacco are prohibited or banned from their manufacture for sale, distribution or sale or stocking or storing in the entire State of Goa and hence no person can stock or sell such products, like Gutka, Khaini, or any other food articles containing tobacco.
How do I identify any packaged drinking water product?
All packaged drinking water products are mandatorily required to possess a BIS certification mark, whose number should be conspicuously displayed and printed on the label of such products.
Should all food carry the best before use date?
All packaged food products or any packed food products should carry the date of packing as well as the best before use date for consumption of the food articles on its label or wrapper.
Can fruits be artificial ripened?
Under the provisions of the Prevention of Food Adulteration Rules 1955, use of carbide gas is prohibited in the artificial ripening of fruits.
What are the various types of food licences granted by FDA?
Food licences are granted for undertaking food activities by way of retail, wholesale, manufacturing, fast food stalls, mobile hand carts, hotels, restaurants, road-side food stalls, temporary stalls at exhibitions and festivals, mobile motor vehicle, caterers, canteens, etc.
Which food articles can contain food colours?
Food articles namely ice-cream biscuits, pastries, confectionery, sweets, flavoured milk, yogart, jams, jellies, fruits syrups, fruit squash, custard powder, ice candy.