Procedure For Drug License

DRUGS CONTROL DEPARTMENT The procedures for making applications for grant/renewal of licences Sale licence: Applications are to be made to the Office of the Drugs Inspector/Assistant Drugs Controller concerned. In the case of applications of Thiruvananthapuram District other than Thiruvananthapuram City Corporation, the application is to be made to the Drugs Controller.

Manufacturing licences: Application for manufacturing licences including blood banks are to be made to the Drugs Controller with copies to Zonal Assistant Drugs Controllers concerned. In the case of blood banks a copy of the application is to be furnished to the Drugs Controller General India and Dy.Drugs Controller (India) South Zone, Chennai. Copies of the statutory forms, details of the fees structure, documents to be furnished etc are appended.

In addition to the issue of Drugs Licences the department is also concerned with the inspection of sales and manufacturing premises, collect samples of drugs for analysis (quality check) initiate prosecution action, against law offenders etc.with a view to secure compliance of law. An intelligence wing headed by an Assistant Drugs Controller is functioning in the department to attend the public grievances regarding the manufacturing and sale of drugs in the State. Those who are desirous of lodging any complaint regarding quality, excess pricing, improper supply of medicines, unlawful possession, advertisement about medicines etc. can make complaint to the Drugs Controller or to the District or Zonal Offices. Zonal Offices (Office of the Asst.Drugs Controller) function at Kannur, Thrissur, Kozhikode, Ernakulam, Kollam and District Offices (Drugs Inspectors Offices) function in all Districts except Kannur and Thrissur.

Drugs Licences are prescribed for Blood Banks also. Licence to operate Blood Banks are issued jointly by Drugs Controller General of India, New Delhi and by the State Drugs Controller. Total No. of Blood banks in the State :128.

Details as: Total No. of Blood banks in the State 128

Central Government 2

State Government 30

Private Hospitals 94

Co-operative Blood Banks 2

A drugs testing laboratory with most modern facilities is also functioning under the control of the department. Smt. G. Sudha is the Chief Government Analyst and Head of the Drugs Testing Laboratory. Information regarding spurious or not of standard quality drugs are published through news media. Consumers who are desirous of getting the quality of drugs purchased can get them tested in the Drugs Testing Laboratory after remitting a nominal fee. The details of the fees can be ascertained from the Drugs Testing Laboratory.

Drugs Testing

Drugs Testing The Drugs Testing Laboratory is the testing wing of the Department . This Laboratory tests the samples of Allopathic, Homeopathic & Ayurvedic Drugs and cosmetics sent for analysis. Samples are drawn by the Drugs Inspectors and Regional Drugs Inspectors from the market and manufacturing premises at random, and sent to the Drugs Testing Laboratory. Besides these, samples from consumers are also analysed on payment of requisite fees. This is done by

(i) Allocating the samples received in the concerned section depending on the tests to be performed in the Labortaory

(ii) Reporting the tests and results, in the prescribed form and forwarding it to the concerned drugs inspector & Regional Drugs Inspector in Form 13 of D & C Rules 1945. (In case of Ayurvedic / Siddha / Unani Samples – Form 13A)

(iii) Sending the Sample Reports to the Private Parties in case of Private Samples in Form 14B.

Documents to be submitted for testing of Drug Samples from Private Parties :

1) Application in Form 14A

2) Original Copy of Treasury Chalan after remitting requisite fee

List of Samples Declared as Not of Standard Quality:

Manufacturing Licences

1 Form 25 – Licence of manufacture for sale or for distribution of drugs other than those specified in Schedules C,C1 and X.
Application for grant of form 25 licence is made in form 24 is prescribed.

2 Form 25A – Loan licence to manufacture for sale ( or for distribution of) drugs other than those specified in Schedules C, C1 and X.
3 Form 25B – Licence to report for sale or distribution of drugs being drugs other than those specified in Schedule C and C1 (excluding those specified in Schedule X).
4 Form 25C – Licence to manufacture ( or for distribution) Homeopathic mediayurvedic drcines.
For the fresh or renewal application of the above licence form 24 C is prescribed.
5 Form 25D – Licence to manufacture for sale of Ayurvedic (including Siddha) or Unani Drugs.
For the fresh or renewal application of the above licence form 24 D is prescribed.
6 Form 25E – Loan licence to manufacture for sale Ayurvedic (Including Siddha) or Unani Drugs.
For the fresh or renewal application of the above licence form 24E is prescribed.
7 Form 25F – Licence to manufacture for sale (or distribution) of drugs specified in Schedule X and not specified in Schedules C and C1.
For the fresh or renewal application of the above licence form 24 prescribed.
a) Certificate of renewal of licence to manufacture for sale of drugs other than those specified in Schedule X is issued in form 26 and that of loan licence is form 26A.
b) Certificate of renewal of licence to manufacture for sale of homeopathic medicines is issued in form 26C and that of ayurvedic drugs are issued in form 26D.
c) Certificate of renewal of licence to manufacture for sale of drugs specified in Schedule X is issued in form 26F
8 Form 28 – Licence to manufacture for sale (or for distribution of) drugs specified in Schedules C and C1 (excluding thos specified in Schedule X)
Fresh/renewal application of the above licence form 27 is prescribed.
9 Form 28A – Loan licence to manufacture for sale ( or for distribution of) drugs specified in Schedul e C and C1 (excluding those specified in Schedule X).
For fresh/renewal application of the above licence form 27A is prescribed.
10 Form 28B – Licence to manufacture for sale (or for distribution of) drugs specified in Schedules C, C1 & X
For fresh/renewal application of the above licence form 27B is prescribed.
11 Form 28C – Licence to operate a Blood bank, processing whole human blood for components and/or manufacture of bloos peosuxra.
For fresh/renewal application of the above licence form 27C is prescribed.
12 Form 28D – Licence to manufacture for sale for distribution of Large Volume Parenterals/sera and vaccines specified on Schedules C and C1 excluding those specified in Schedule X
For fresh/renewal application of the above licence form 27D is prescribed.

Certificate of renewal of licence for the operation of blood bnk and/or processing of whole human blood fo component and/or manufacture of blood products is issued in form 26 D and that of Large Volume Parenterals/Sera and vaccines specified in Schedules C a and C1 excluding those specified in Schedule X is issued in form 26 H
1 Form 29 – Licence to manufacture drugs for purpose of examination, test or analysis.
For fresh/renewal application of the above licence form 30 is prescribed.
2 Form 3 2 – Licence to manufacture cosmetics for sale or for distribution.
For fresh/renewal application of the above licence form 31 is prescribed
3 Form 32A – Loan Licence to manufacture cosmetics for sale (or for distribution)
For fresh/renewal application of the above licence form 31 A is prescribed.
Certificate of renewal of licence to manufacture cosmetics for sale is issued in form 33 and
that of loan licence is issued in form 33 A.
The approval for carrying out tests on drugs , cosmetics and raw materials is issued in form
37 and application for this purpose is made in form 36.
Certificate of renewal of form 37 approval is issued in form 38.
The Report of test or analysis by the approved institution is issued in form 39.
Documents required for grant/renewal of manufacturing licences.
1 Concerned Form (Refer statutory forms)
2 Original chalan receipt required amount of fees.
3 Plan of the premises
4 Notarized affidavit in the prescribed form
5 Declaration of technical staffs on manufacturing and testing.
6 Documents to prove their qualification and experience
7 Details of products applied with their master formula records & SOPs (In the case of renewal details of products approved is also to be submitted)
8 Details of similar products in the market.
a ) In the case of renewal of licences the previous renewal certificate in original © of original Drugs Licences are to be attached.
b ) By remitting Rs. 7500/- as the licence fee along with application of allopathic drugs (form 25,27) a maximum of approval of 10 products could be obtained. For products beyond 10 numbers additional fee of Rs. 300/- is to be remitted.
The manufacture shall be conducted under the active direction and supervision of qualified person who is a whole-time employee and is-
(a) A graduate in Pharmacy or Pharmaceutical Chemistry of a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose) and has had at least (eighteen months’ practical experience) after the graduation in the manufacture of drugs . This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or

(b) A graduate in Science or a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose) who for the purpose of his degree has studied Chemistry as a principal subject and has had at least three years practical experience in the manufacture of drugs after his graduation; or

(c) A graduate in Chemical Engineering or Chemical Technology or Medicine of ( a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose) with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or

(d) Holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause

(a), clause
(b) or clause
(c) and is permitted to work as competent technical staff under this rule by the Central Government

Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25 (or Form 26-F) as it existed before that date shall be deemed to be qualified for the purpose of this rule:

For drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years’ practical experience in the manufacture of drugs.

In the matter of manufacture of disinfectant fluids ,insecticides, liquid paraffin, medicinal gases, non chemical contraceptives , plaster of Paris and surgical dressings the licencing authority may permit a competent technical staff who although not having any of the qualification mentioned above.

Before a repacking licence in Form 25-B is granted or renewed the following condition shall be complied with by the applicant-

The operation should be carried out under the direct supervision of a competent person.

A person who satisfies the following minimum qualifications shall be deemed to be a “competent person”
A person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is registered under the said Act, or
a. A person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the licensing authority as equivalent to it, or
b. A person who has passed the Matriculation examination or an examination recognized by the licensing authority as equivalent to it and has had not less than four years practical experience in the manufacture, dispensing or repacking of drugs)
Before a licence in Form 25-C is granted or renewed the following conditions shall be complied with by the applicant-
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee (and who is-
(a) A graduate in Science with Chemistry as one of the Subjects with three years experience in manufacture of Homoeopathic Medicines; or
(b) A graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or © Holds qualification as defined under sub-clause (g) of clause (g) of clause (1) of Section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines:
Provided that the persons who are already in employment with five years experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25-C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.)
Blood Banks Licences
• The licence for operating a blood bank shall be issued in form 28 C.
• A blood blank shall have an area of 100 square metres for its operations and an additional area of 50 square metres for preparation of blood components.
Documents required for grant/renewal of blood bank licences
1 Covering letter with court fee stamp with 5 rupees affixed.
2 Form 27.C( Refer Statutory forms)
3 Questionnaire.
4 Chalan for Rs. 7500/- remitted under the head of account 0210-04-104-99.
5 Plan of the building.
6 Declaration of the medical officers, technicians and technical supervisor (blood component units) and registered nurses.
7 Attested copies of qualification of the medical officers, technicians and technical supervisors
8 Experience certificates of medical officers,technicians and technical supervisors
9 List of equipments provided.
10 List of blood products required.
11 Details of labels.
12 Standard operating procedures.
The validity of Drug Licence is 5 years from the date of grant of drug licence.
The operation of Blood bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of whole-time competent technical staff consisting of :
(i) Medical Officer, possessing-
a. Postgraduate degree in Medicine-M.D. (Pathology/Transfusion Medicines) or
b. Degree in Medicine (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
c. Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also have 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.The degree or diploma being from a University recognized by the Central Government.
(ii) Blood Bank Technician (s), possessing-
a. Degree in Medical Laboratory Technology(M. L. T) with six months experience in the testing of blood and/or its components; or
b. Diploma in Medical Laboratory Technology (M. L. T) with one year experience in the testing of blood and/or its components
The degree or diploma being from a University /Institution recognized by the Central Governmentor State Government.
(iii) Registered Nurse(s)
(iv) Technical Supervisor (where blood components are manufactured),possessing –
a. Degree in Medical Laboratory Technology (M. L. T) wit six month`s experience in the preparation of blood components ; or
b. Diploma in Medical Laboratory Technology (M. L. T) with one year experience in the
preparation of blood components,
The degree or diploma being from a University /Institution recognized by the Central Government
or State Government.
Permit for Blood Storage Centres

The validity of permit is 2 years from the date of grant of permit
Documents required for the approval of blood storage centres
1 Covering letter with court fee stamp with Rs. 5 affixed.
2 Prescribed application form (see below)
3 List of equipments provided.
4 Declaration of the medical officer and laboratory technician.
5 Attested copy of qualification and experience certificate of medical officer and technician.
6 Consent of the mother blood bank supplying the blood units.
7 Plan of the proposed building.

Sales Licences
1. Different Forms of Licences are specified in the drugs and cosmetics Rules for sales of drugs:
(i) Form 20 – Licence to sell, stock ot exhibit ot offer for sale or distribute drugs y retail other than those specified in Schedule C, C1 and X
(ii) Form 21 - Licence to sell, stock or exhibit or offer for sale or distribute drugs by retail drugs specified in Schedule C and C1 (excluding those specified in Schedule X)
(iii) Form 20B - Licence to sell, stock or exhibit or offer for sale or distribute by wholesale drugs other than those specified in Schedule C, C1 and X.
(iv) Form 21B - Licence to sell, stock or exhibit or offer for sale or distribute by wholesale drugs specified in Schedule C and C1 (excluding those specified in Schedule X).
For the fresh/renewal applications of the above licences form 19 is prescribed.
(v) Form 20A – Restricted licence to sell, stock or exhibit (or offer) for sale or distribute drugs by retail other than those specified in Schedule C, C1 and X for dealers who do not engage services of qualified person.
For the fresh/renewal application of the above licence form 19A is prescribed.
(vi) Form 20BB – Licence to sell, stock or exhibit or offer for sale by whole sale or distribute drugs other than those specified in Schedule C and C1 from a motor vehicle.
(vii) Form 21BB – Licence to sell by wholesale or to distribute drugs specified in Schedule C & C1 from a motor vehicle.
For the fresh/renewal application of the above licences form 19 AA is prescribed.
(viii) Form 20 C – Licence to sell, stock or exhibit or offer for sale or distribute Homeopathic Medicines by retail.
(ix) Form 20D – Licence to sell, stock exhibit or offer for sale or distribute Homoeopathic medicines by wholesale.
For fresh/renewal application of the above licence form 19B is prescribed.
(x) Form 20F – Licence to sell, stock or exhibit (or offer) for sale, distribute by whole sale drugs specified in Schedule X.
(xi) Form 20 G – Licence to sell, stock or exhibit (or offer) for sale or distribute by whole sale drugs specified in Schedule X.
For the fresh or renewal application of the above licence in form 19 C is prescribed.
(xii) Certificate of renewal of licence to sell, stock or exhibit or offer for sale or distribute drugs in the case of all the above licences except form 20BB and form 21BB are issued in form 21C and that of 20BB and 21BB are issued in form 21 CC.
2. Documents required for grant/renewal of sales licences.
1 Form 19/19B/19C
2 Questionnaire.
3 Original Chalan receipt for required amount of fees.
4 Attested copy of pharmacy registration certificate
5 Hand written declaration of pharmacist/competent person
6 Option form.
7 Affidavit in prescribed form.
8 Self addressed envelopes with postal stamps worth Rs. 27/-
9 Attested copies of documents of constitution of the proposed firm.
10 Covering letter with court fee stamp worth Rs.5/-
11 Proof for identity of the applicant (Attested Copy)
1 Duplicate copy of the above documents are also to be submitted to the drugs inspector offices concerned.
2 In the case of renewal application in addition to the above documents the previous renewal certificates in original/copy of original Drugs Licences are also to be attached.
3 In the case of application made in form 19AA the attested copy of RC book of the vehicle is to be provided along with application.
4 In the case of application in form 19A the questionnaire, Chelan, affidavit and attested copies of documents of constitution of the proposed firm , proof of identity etc are to be provided.

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