FAQ – TEST LICENCE SECTION
Q1- What is form 11 Licence
Ans- 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.
Q2- What is the fees required for form 11 licence
Ans- T.R 6 Challan of Rs 100/- for 1st drug and Rs 50/- for each additional Product is required.
Q3- What Documents is required for filing the form 11 application
Ans- 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
Q4-Drugs imported under form11 licence can be used for commercial purpose
Ans- No, drugs imported under form11 licence will used for testing and analysis purpose only it will not used for any commercial activity
Q5-what documents should be attached in case of import of large bulk API
Ans-Whenever appreciably large quantities of drugs are required to be imported then Justification for import and utilization breakup of the proposed quantities of drugs with reference to the detailed test parameter batch manufacturing plan in accordance with official regulatory documents/guidelines circulated by the National Drug regulatory authority of the country is where the study data would require to be submitted alongwith commercial batch size and list of equipment with capacity and other relevant documents
Q6-IS form11 licence is applicable for banned drugs, excipients, startingmaterial, herbal and ayurvedic products
Ans- Excipients, starting material, herbal products and ayurvedic product can’t be granted under form11 licence however banned drugs can be imported under form11 licence
Q7-form11 licence can be renewed or not
Ans- 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
Q8 how many drugs can be imported under single form 11 licence
Ans- only 10 drugs can be imported under single form11 licence
Q9-Drugs imported under form11 licence can be utilized for BA/BE studies
Ans- 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
Q10- Is it possible to import narcotic drugs under form 11 licence for test examination and analysis
Ans- The firm has to apply for form11licence then after getting the licence the firm has to approach CBN Gwalior to get No Objection certificate(NOC) for import of narcotic drugs.
Q11- is it possible to import bulk API of morphine, codeine, thebaine and their salt under form 11 licence for test, examination and analysis
Ans- 1 kg of morphine,codeine ,thebaine and its salts can be imported in one financial year under form 11 licence but the firm has to submit NOC from opium alkaloid factory alongwith with form 12 application
Q12-Is it possible to take form 11 licence with different testing location as per form25/28/29 or DSIR
Ans-No,the firm has to submit manufacturing licence or DSIR Approval for same testing location as propose in Form 12.
Q13-The drugs imported under form 11 Licence can be used for animal studies
Ans-for animal studies firm has to submit IAEC Approval or CPCSEA permission copy of subject drug
Q14-Is it possible to do test examination and analysis at others firm premises.
Ans-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
FAQ – BLOOD BANK SECTION
1. What is blood bank? Blood bank means a place or organization or unit or institute or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation,storage and distribution of blood components.
2. What is apheresis? Apheresis is the process by which blood drawn from a donor, after separating plasma or platelets, or leucocytes, is re-transfused simultaneously into the said donor.
3. Is the licence required to run a blood bank? Yes, licence is required to run a blood bank.Without licence to run a blood bank is an offence under Drugs & Cosmetics Act 1940 & Rules made thereunder.
4. What are the documents required for grant of licence to operate a blood bank & where to apply? a) Application in Form 27-C with required fees. b) Plan of Premises c) Copies of certificates relating to the educational and experience of the all the technical staff d) SBTC Approval e) Documents relating to the ownership andtenancy of the premisesand constitution of the applicant. f) List of Equipments& Machinery g) SOPs The applicant has to apply to State Licensing Authority for Grant/Renewal of the licence and one set
5. What is the fee required to open a blood bank? Total Rs. 7500/- is required to open a blood bank where Licence fee of rupees Six thousand and an inspection fee of rupees one thousand and five hundred.
6. Who allare the competent technical staffs required for a blood bank? Every blood bank shall have following categories of whole time competent technical staff:- Medical Officer:- Postgraduate degree in Medicine M.D (Pathology/Transfusion Medicines); or M.B.B.S with diploma in pathology or Transfusion Medicines having adequate knowledge in blood group serology,blood group methodology and medical principles involved in the procurement of blood and /or preparation of its components; or M.B.B.S having experience in blood bank for one year during service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and /or preparation of its components.
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 year’s 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 year’s experience in the preparation of blood components;
7. What is Form-27C? Application for grant/renewal of licence for the operation of a blood bank for processing of whole blood and/or preparation of blood components.
8. What is Form-28 C? It is a Licence to operate a blood bank for collection,storage and processing of whole human blood and/or its components for sale or distribution.
9. What is Form- 26 G? Certificate of renewal of licence to operate a Blood Bank for processing of Whole Human Blood and/or* for preparation for sale or distribution of its component.
10. What do you mean by SBTC? State Blood Transfusion Council. It is required only for blood banks run by charitable trust/voluntary organization.
11. What is the validity of blood bank licence? A licence is Valid for a period of five years from the date on which it is granted or renewed.
12. What is Umblical cord blood bank? Umlical cord blood bank is a place or organization or unit for carrying out and responsible for operations of collection, processing, testing, banking, selection and release of cord blood units.
13. What is Form 27-F.? It is the application for grant/renewal of licence for collection,processing,testing,storage,banking and release of umbilical cord blood stem cells.
14. What is Form 26-J.? It is certificate of renewal of licence for collection, processing, testing, storage, banking and release of umbilical cord stem cells.
15. What is Form 28-F.? It is the licence to collect, process, test, store, banking and release of umbilical cord blood stem cells.