Central Drugs Standard Control Organization
Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India
FAQ
Frequently Asked Questions about Test Licence
As per Rule 33 of Drugs and Cosmetics Acts and Rules Form 11 is granted for the import of small quantities of drugs for the purposes of examination testing or analysis.
T.R 6 Challan of Rs 100/- for 1st drug and Rs 50/- for each additional Product is required.
Form12, T.R 6 Challan, utilization break up, signing authority letter, form 25/28/29 or DSIR in case of formulation and form 29 is must in case of bulk API.
No, drugs imported under Form11 licence will used for testing and analysis purpose only it will not used for any commercial activity.
Excipients, starting material, herbal products and ayurvedic product cannot be granted under Form11 licence however banned drugs can be imported under form11 licence.
There is no provision for the renewal of Form 11 licence once it is expired the firm has to apply for fresh form11 licence with challan all other relevant documents.
Only 10 drugs can be imported under single Form11 licence.
Drugs imported under Form 11 licence cannot be utilized for conducting BA/BE studies the firm has to apply in BA/BE division for permission to conduct BA/BE studies.
The firm has to apply for Form11 licence then after getting the licence the firm has to approach CBN Gwalior to get No Objection certificate(NOC) for import of narcotic drugs.
No,the firm has to submit manufacturing licence or DSIR Approval for same testing location as propose in Form 12.
For animal studies firm has to submit IAEC Approval or CPCSEA permission copy of subject drug.
Yes,for test examination and analysis at other firm premises a notarized agreement between them and manufacturing Licences or DSIR approval of other firm premises has to submit .
Frequently Asked Questions about Blood Bank Section
Plan of Premises
Copies of certificates relating to the educational and experience of the all the technical staff
SBTC Approval
Documents relating to the ownership andtenancy of the premisesand constitution of the applicant.
List of Equipments& Machinery
SOPs The applicant has to apply to State Licensing Authority for Grant/Renewal of the licence and one set
Blood Bank Technician(s) possessing:-
Degree in Medical Laboratory Technology (M.L.T) with six months experience in the testing of blood and/or its components; or Diploma in Medical Laboratory Technology (M.L.T) with one years experience in the testing of blood and/or its components Registered nurse(s);
Technical Supervisor:-
(where blood components are manufactured), possessing:- Degree in Medical Laboratory Technology (M.L.T) with six months experience in the preparation of blood components; or Diploma in Medical Laboratory Technology (M.L.T) with one years experience in the preparation of blood components;