1. Whether licence is required for the manufacture of Drugs and/or Cosmetics?
Yes, to manufacture Drugs & Cosmetics for the purpose of sale or distribution, licence under the provisions of Drugs &Cosmetics Act, 1940 & Rules thereunder is required.
2. Whether your department grants licences to manufacture Ayurvedic /Homeopathic /Unani drugs?
This department does not grant licence to manufacture Ayurvedic /Homeopathic /Unani drugs.This department grants licences to manufacture only Allopathic drugs and Cosmetics.
3. What type of licences/ approvals /permissions are granted by your department?
This department grants/ renews licenses to manufacture/ sell Drugs and Cosmetics. 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.
4. What are the different types of licences for manufacture/sale of drugs and Cosmetics, and what is the fees 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.
5. 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.
6. Whether prescribed fees can be paid for the grant of fresh licence /renewal by way of D.D/ Cash/Cheque?
No, fees cannot be paid by D.D/ Cash/Cheque. It has to be paid by way of challan with Head of Account as
- 0210 Medical and Public Health
- 04 Public Health
- 104 Fees Fines etc.
- 201 Drugs & Cosmetics Act and Rules
- Drugs Control Department
7. Whether a check list 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.
8. 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 charters available from this website.
9. 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.
10. Challan – Whether printed format issued by department only to be used. Can we make a Xerox?
Either you can use the same challan or you can photocopy the same and get it attested before remittance.
11. Challan - Where should the amount be deposited?
Either you can deposit the amount in STATE BANK OF MYSORE , Near Bowring Hospital, Bangalore or in any bank where the amount is accepted.
12. After submission of all the required documents, if there is no response within the time frame, whom to be approached?
In case of application pertaining to manufacturing, you can approach the Drugs Controller for the state of Karnataka, Palace Road, Bangalore and in case of application meant for sale licensing ,you can approach the jurisdictional Assistant drugs controller.
13. If any application is rejected, does the department inform the same in writing along with rejection letter/order?
Yes.
14. 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 Drugs Control Department and it is also available on this website .
15. What is the procedure for obtaining permission for manufacture of " New Drugs" What is the role of State Drugs Controller in this respect?
New Drug clearance is given by Drugs Controller General (India) New Delhi. Therefore, you have to submit the application to Drugs Controller General (India), New Delhi for the permission/ clearance to manufacture ‘NEW DRUG", as explained under Rule 122 E of the Drugs and Cosmetics Rules, 1945. After obtaining the permission from Drugs Controller General (India) New Delhi, you are required to submit the application to State Licensing Authority for the permission to manufacture.
16. Does the State Licensing Authority issue Test License for all the products irrespective of whether the drug is marketed in India or not?
The state licensing authority issues licence in form 29 for the purpose of manufacture of drug for carrying out test or analysis if such product is available in India. However, in case of a drug, the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use , no licence in form 29 is granted unless the applicant firm obtains No objection certificate from Drugs Controller General (India) New Delhi .
17. What is the responsibility of manufacturer if his product is declared as Not of Standard Quality. Whether recall is to be done even if the report is not of a Government Analyst ?
To manufacture the quality drugs is the responsibility of the manufacturer. Hence it is imperative on the part of the manufacturer to recall the stocks if the drug is declared as Not Of Standard Quality by the approved laboratory or by the Government Analyst.
18. Whether any left over bulk imported for own use can be disposed off by selling to dealers or other manufacturers?
No.
19. For how long should Batch manufacturing records, stock books control sample, analysis records should be preserved.
The records shall be retained for a period of five years from the date of manufacture. The reference samples should be maintained for a period of three months beyond the date of expiry.