1. 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 Cnaullae
- Bone Cement
- Heart Valves
- Scalp Vein Set
- XIII Orthopedic Stents
- Internal Prosthetic Replacements
2. Why Drug should be taken?
Consumption of drug greatly depends on seriousness of the illness a person is facing and urgency of the condition. It is taken in severe conditions like combating the life threatening diseases as well as in trivial cases of subsiding pain. They should be taken to improve or maintain health & general well being.
3. 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.
4. 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
5. 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 nearest Drug Control department official.
6. 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.
7. 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.
8. 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.
9. 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.
10. What type of licences/ approvals /permissions are granted by your department?
This department grants/ renews licenses to manufacture Of Drugs and Cosmetics / sell Drugs . It grants approval for the laboratories to carry out test and analysis on behalf of the manufacturers. It also grants licence to operate a blood bank. This department issues Good Manufacturing Certificates as per WHO Guidelines, Free sale certificates, Export registration documents, etc, for the purpose of export registration if required and Performance certificate, Market standing certificate, No conviction certificate, etc, for the purpose of participation in Government tenders if required.
11. 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.
12. Where are the applications for the grant or renewal of licences/approval of approved Laboratories/blood banks available?
The applications are available in Drugs Control Department, Palace Road, Bangalore-560 001 or the same can be down loaded from this website.
13. Whether prescribed fees can be paid for the grant of fresh licence /renewal by way of D.D/ Cash/Cheque?
(i) No, fees cannot be paid by D.D/ Cash/Cheque. It has to be paid by way of challan with Head of Account as follows
- 0210 Medical and Public Health
- 04 Public Health
- 104 Fees Fines etc.
- 201 Drugs & Cosmetics Act and Rules
- Drugs Control Department
14. Whether a check lists of documents to be submitted along with the applications available?
Checklist is provided along with the application at Drugs Control Department, Palace Road, Bangalore and it can also be down loaded from this website.
15. 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.
16. Whether your department is having library facilities and is it available for general Public.
This department is having library facilities and general public can avail the Facilities for reference. However books cannot be borrowed.
17. Whether applications can be submitted on line?
At present this facility is not available.
18. 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
(ii) Medical shop (Chemists and Druggists): 10sq mt.
(iii) Wholesale outlet: 10sq mt
(iv) Retail & Wholesale combined:15sq mt
19. registered pharmacist must to run a medical shop (Chemists and Druggists)?
YES
20. refrigerator must to start the medical shop?
YES
21. 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
22. Is there any special license required to run 24 hrs Medical shop (Chemists and Druggists)?
No.Special licence is required
23. Whether the presence of the registered pharmacist required through out the working hours?
Yes,
24.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 concerned area Drugs Control Officer.
25.Is there any special license requirement for dealing in Veterinary drugs?
NO
26.Is it a requirement to display the original license?
Yes, the original license should be displayed in a prominent place. All the medical shops have been advised to display the photograph of the registered pharmacist along with the licence.
27.Whether a license is required for the sale of cosmetics?
NO
28.Whether a separate license is required for the sale of drugs through motor vehicle?
YES
29.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.L.C with 4years experience in dealing in drugs.
30.Can general items Eg: cosmetics, chocolates, mineral water etc be stored along with drugs in the licenced premises
YES
31.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.
32.Whether any consumer can send the drug for analysis to the Government analyst? If so what is the procedure?
Yes, any consumer, whether he is the member of the consumer organization or not , can send the sample of drug for analysis to the Government analyst as per Section 26 of Drugs & Cosmetics Act,1940 .The details may be obtained from the Government Analyst, Karnataka, Drugs Testing Laboratory, Palace Road, Bangalore.
33.Where do we get the information pertaining to Drugs Prices Control Order, 1995?
The information is available with National Pharmaceutical Pricing Authority , New Delhi . The details are available on www.nppaindia.nic.in.