To prepare an application for manufacturing license for allopathic drugs in India.
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The document outlines the process for obtaining a manufacturing license for allopathic drugs in India, including submitting layout plans for approval, applying using the appropriate forms along with documents such as technical staff details and product information, and an inspection of the premises. It also discusses the application process for obtaining licenses to sell drugs wholesale and the forms and documents required.
![Drug Regulation & Regulatory Authorities
Dept. Of Quality Assurance & Regulatory Affairs
L. J. Institute of Pharmacy, Ahmedabad.
FORM 24-A
(SEE RULE 69-A)
Application for grant or renewal of a loan licence to manufacture for sale
22(or for distribution of) drugs other than those specified in 23[Schedule C,
C(1) and X]
1. I/We……………………………………of*……………………………..hereby apply
for the grant/renewal of a loan licence to manufacture on the premises situated at
………………………………………………….C/o**……………………………..the
under mentioned drugs, other than those specified on 23[Schedule C, C(1) and X] to
the Drugs and Cosmetics Rules. Name of drugs (each substance to be separately
specified).
2. The names, qualifications and experience of the expert staff actually connected
with the manufacture and testing of the specified products in the manufacturing
premises.
3. I/We enclose
(a) A true copy of letter from me/us to the manufacturing concern whose
manufacturing capacity is intended to be utilized by me/us.
(b) A true copy of letter from the manufacturing concern that they agree to lend the
services their expert staff, equipment and premise for the manufacture of each item
required by me/us and that they will analyse every batch of finished product and
maintain the registers of raw material, finished product and reports of analysis
separately in this behalf.
(c) Specimens of the labels, cartons of the products proposed to be manufactured.
4. A fee of rupees………………………………………………..has been credited to the
Government under the head of account…………………………………
Date………………. Signature………………….
* Enter here the name of the proprietor, partners or Managing Director as the case
may be ** Enter here the name of the applicant firm and the address of the principal
place of business
________________________________________________________________________
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To prepare an application for manufacturing license for allopathic drugs in India.
- 1. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. EXPERIMENT NO.: DATE: AIM: To prepare an application for manufacturing license for allopathic drugs in India. REFERENCES: 1) http://www.wbhealth.gov.in/download/form24a.pdf 2) http://www.delhi.gov.in/wps/wcm/connect/.../19c.pdf 3) http://www.fda-mha.com/guidelinesown.aspx THEORY: PRECONDITIONS FOR GRANT OF MANUFACTURING LICENCE (MODERN / ALLOPATHIC MEDICINE/HOMEOPATHIC) A prospective manufacturer will have to first to submit a plain paper application/Project report along with a site plan of his proposed Mfg. Unit either at the District Office or at the Directorate Headquarters along with a check list to be supplied from this Directorate or may be downloaded from this website. In case of loan license, the manufacturer will have to first to submit a NO OBJECTION CERTIFICATE from the parent concern along with their shareable capacity for the proposed category. On receipt of the site plan an inspection of the proposed premises will be carried out by a team of officers of the Mfg., Cell of this Directorate headquarter along with the area officer of the respective District. On inspection, if the premises is found suitable in respect of measurement of the area as well as surrounding suitability for the respective category of product as per Revised GMP norms, the firm then be advised to submit their layout plan ( in triplicate ) for final approval. On receipt of the compliance report of the approved layout plan the firm will be finally allowed to apply in appropriate form (i.e. Form-24, 24A, 27, 27A as the case may be) with prescribed fees as well as list of their technical personnel, list proposed products, product labels and so on as prescribed in the Drugs and Cosmetics Act and Rules there under for
- 2. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. consideration of their application towards grant of licence. With the introduction of Revised Schedule M (2001) all manufacturers of allopathic medicines will have to comply the statutory norms in respect of their manufacturing premises. Unless & until the same is complied with no existing licenses will be liable for renewal & no new licenses will be liable for grant. Fees for submission of application (for modern medicine) in each form is Rs. 7500/- for products not exceeding ten of each category, for each products exceeding ten @ Rs. 300/-. Fees for submission of application (for homeopathy medicine) in each form are Rs. 300/- Fees are subject to change from time to time by notification Govt. of India. Grant of Drug and Cosmetic Manufacturing License in Own Premises Food and Drug Administration, Puducherry. Grants Own Manufacturing Licenses for Drugs (Allopathy, Homeopathy, Ayurvedic, Siddha, Unani ) and Cosmetics in Forms 25, 28, 25B, 25C,25D and 32 • The Administration also grants Licenses for Blood & Blood products Vaccines & Sera in form 28C & 28D. However the said licenses have also to be approved by Central Licensing Approving Authority i.e. Drug Controller General of India. Procedure to obtain Drug Manufacturing license Stage 1 Approval of Layout Plan : 1. For Approval of Lay out Plan the Applicant has to submit 3 Blueprint copies of plan to the concerned licensing Authority.(in case of Licenses for Blood Products and Vaccines Sera 4 Blue print copies of plan to be submitted) 2. The plan should be as per the requirements prescribed for manufacturing premises in the Drugs and Cosmetics Act 1940. 3. The prescribed requirements as per the Act for Layout plan are given in the checklist. 4. The plan is scrutinized by panel of officers as per the requirements of the Drugs and Cosmetics Act 1940. • If necessary the premises is inspected by the concerned Inspector before plan Approval. 5. Finally after scrutiny and compliance as per requirements of the Act the layout plan is approved and a copy is given to the Applicant.
- 3. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. Stage 2 The applicant has to make application in the requisite form ( 24, 24B, 24C, 27, 27C, 27D) and pay Necessary fees. The fee can be paid through challan at State Bank of India (Main Branch), Puducherry, Karaikal, Mahe and Yanam under Head Account----- Documents to be attached along with the application form: 1. Receipt for the fees paid or challan, as the case may be or their attested copies. 2. Copy of Approved layout plan of the manufacturing area. 3. Documents viz. Rent receipt, purchase documents or its attested copies showing lawful possession of the premises 4. List of machinery and equipments. 5. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc. 6. Full particulars of the competent technical staff employed for manufacturing and testing of drugs and cosmetics along with copies of their educational qualifications and experience certificates approval letter as competent staff. The competent technical staff is required to furnish consent letter for full time employment with the applicant firm. 7. List of Drugs Cosmetics in triplicate along-with undertaking to be submitted. 8. In case, the application is for the products covered under Schedule C and C (I) category, then the details of stability data is required. 9. If the products are covered under ‘Patent and Proprietary’ definition, then the two copies of methods of Analysis of the products be supplied. 10. Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorized signatory, if any, shall be provided in the application . Stage3 Inspection The application is scrutinized and premises inspected. Stage 4 Grant of License If all conditions as prescribed by the act are compiled license is granted.
- 4. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. TO APPLY FOR GRANT OF SELLING DRUGS LICENCE (WHOLESALE) FOLLOWING PAPERS ARE REQUIRED FOR ALLOPATHIC DRUGS IN FORM 20B & 21 B (AFTER QUALIFYING THE PRELIMINARY INTERVIEW ) 1. Application in Form No: 19. 2. Additional information form (With Competent Person’s present photograph) 3. T.R. Challan No: 7 showing License fees of Rs. 3000/- (For Biological & Non – Biological Licenses) deposited at R.B.I. / S.B.I. Main branch. 4. XEROX COPY OF HOUSE RENT BILL (In case of rented shop premises), with full signature of House owner. 5. Xerox copy of House Tax Receipt (Issued by local Municipality / Government Tax 6. Receipt issued by B.L.R.O.) in case of Panchayat area 7. Xerox copy of Purchase record of Refrigerator in the name of the proposed firm, with full address. 8. Appointment letter of competent person (as per format affixed on Notice Board) 9. Xerox copy of experience certificate issued by Drug Licensed firm with attestation of the signature of experienced salesman by the proprietor of the said licensed firm. 10. If the candidate is Graduate with minimum 1 (One) year experience after passing the last examination as salesman is required and in case of under graduate but Madhyamik passed persons 4 years’ experience (joining date & release dates are to be mentioned) after passing the Madhyamik examination is required. 11. Academic qualification Certificate (Xerox Copy). 12. Date of birth certificate / Affidavit of experienced person (competent person) 13. Affidavit of competent person (format affixed in Notice Board) 14. Partnership deed (copy) in case of partnership firm (if registered no other papers are required) 15. Copy of receipt of Registration of firms (In case of Partnership firm) 16. List of Directors ( In case of Limited, or Private Limited, Company) 17. Memorandum of Article of Association (In case of Limited or Private Limited, Firm).
- 5. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. 18. Copy of extract of resolution taken in the meeting of Board of Directors of the company regarding start of business in drugs & to appoint authorized Signatory (In case of Limited or Private Limited, Company.) 19. Affidavit of Proprietor / Partner / Director (as per format affixed on Notice Board) 20. Sketch plan with actual dimensions, surroundings and signature of Proprietor / Partner/ Director of the proposed firm. Any other relevant paper which will be required during inspection. An affidavit as stating that applicant will be liable for any false, misleading or counter fit paper if detected during processing or after granting license. N. B.: - 1. Required area of the proposed business premises – 108 Sq. Ft. (Carpet Area) 2. Required ceiling height – 8`2” minimum. 3. The premises shall be brick built, plastered floor cemented with R.C.C. Roofing. 4. The proposed premises should be completely separated with completely 5. separate and identical entrance (No residential common passage will be allowed) 6. House owner of the proposed premises should sign himself in full, in the Rent bill. 7. Address of the firm must be same as in House Tax Receipt in all related Papers. 8. Items No: 9,10 & 11 are to be verified by the P.R.O. / Head Assistant of this Office before submitting the application.
- 6. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. FORM 19-C (See Rule 59 (2)) Application for grant or renewal of a (licence to sell, stock exhibit or offer for sale, or distribute) drugs specified in Schedule X : 1. I/We………………………………..of………………………..hereby apply for a licence to sell by *wholesale/retail drugs specified in Schedule X to the Drugs and Cosmetics Rules, 1945. We operate a pharmacy on the premises, situated at………….. 2. **The sale and dispensing of drugs will be made under the personal supervision of the qualified person mentioned below:- (Name)……………………………….(Qualification)……………………… (Name)……………………………….(Qualification)……………………… 3. Name of Drugs to be sold. 4. ***Particulars of storage accommodation. 5. A fee of rupees………………….has been credited to Government account under the head of account………………. Date………………………. Signature………………. ________________________________________________________________________ ________ *Delete whichever is not applicable **To be delted if drugs will be sold only by wholesale ***Required only if products requiring special storage are to be sold.
- 7. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. FORM 24 (See Rule 69) Application for grant of renewal of a licence to manufacture for sale and or for distribution of drugs other than those specified in schedule C & C(1)& X 1. I/We…………………………………………………………………………… of………………………………………………………………………………….. hereby apply for the grant/renewal of a licence to manufacturer on the premises situated at ………………………………………………………….the following drugs being drugs other than those specified in schedule C and C(1) and X of the Drugs and Cosmetics Rules, 1945. 2. Name of Drugs categorized according to Schedules M. 3. Names, qualifications and experience of technical staff, employed for manufacture and testing. 4. A fee of rupees………………………………………………………………..of rupees has been credited to Government under the Head of Account vide Treasury receipt attached. Date…………………. Signature……………… Note:- The application should be accompanied by a plan of the premises. _______________________________________________________________________
- 8. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. FORM 24-A (SEE RULE 69-A) Application for grant or renewal of a loan licence to manufacture for sale 22(or for distribution of) drugs other than those specified in 23[Schedule C, C(1) and X] 1. I/We……………………………………of*……………………………..hereby apply for the grant/renewal of a loan licence to manufacture on the premises situated at ………………………………………………….C/o**……………………………..the under mentioned drugs, other than those specified on 23[Schedule C, C(1) and X] to the Drugs and Cosmetics Rules. Name of drugs (each substance to be separately specified). 2. The names, qualifications and experience of the expert staff actually connected with the manufacture and testing of the specified products in the manufacturing premises. 3. I/We enclose (a) A true copy of letter from me/us to the manufacturing concern whose manufacturing capacity is intended to be utilized by me/us. (b) A true copy of letter from the manufacturing concern that they agree to lend the services their expert staff, equipment and premise for the manufacture of each item required by me/us and that they will analyse every batch of finished product and maintain the registers of raw material, finished product and reports of analysis separately in this behalf. (c) Specimens of the labels, cartons of the products proposed to be manufactured. 4. A fee of rupees………………………………………………..has been credited to the Government under the head of account………………………………… Date………………. Signature…………………. * Enter here the name of the proprietor, partners or Managing Director as the case may be ** Enter here the name of the applicant firm and the address of the principal place of business ________________________________________________________________________ _______________--
- 9. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. FORM-24-B (See Rule 69) Application for grant or renewal of licence for repack for sale or distribution drugs, being drugs other than those specified in schedule C and C(1)(Excluding those specified in Schedule X) 1. I/We………………………………………………………………………………………. ………………………………………………………………………………………………. hereby apply for grant/renewal of a licence to repack the following drugs at the premises situated of………………………………………………………………………... 2. Name of the drugs to be repacked……………………………………………………... ………………………………………………………………………………………………. 3 Name, qualification and experience of competent staff……………………………… ………………………………………………………………………………………………. 4. A fee of Rs………… has been credited to Government under the head of account 0210 Medical A. Allopathy Fee under the Drugs and Cosmetics Rules, 1945 , vide treasury receipt attached. Dated: Signature of applicant: Note : The application shall be accompanied by a plan of the premises. ________________________________________________________________________
- 10. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. Form 24-C (See Rule 85-B) Application for the grant or renewal of a licence to manufacture for sale of Homoeopathic medicines or a licence to manufacture potencies preparations from back potencies by licensees holding licence in Form 20-C. 1. I/We………………………………………………………………………………………… of holder of licence No…………………………………in Form 20-C hereby apply for the grant/renewal of licence to manufacture the under mentioned Homeopathic mother tinctures/potentised and other preparations on the premises situated at…… ……………………………………………………………………………………………… Names of the Homoeopathic reparations………………………………………………… ……………………………………………………………………………………………… ……………………………………………………………………………………………… 2. Names, qualifications and experience of technical staff employed for manufacture and testing of Homoeopathic medicines. 3. A fee of rupees……………………………………………has been credited to Government under head of account................................................................................. Dated…………………….. Signature…………………............