Purpose Of Application New Renewal Revision: Fill & Download for Free

LOAN LICENCING is a pure business arrangement and all normal business regulations will apply.You will have to enter into a loan/ licence manufacturing agreement with the facility/ factory owner________________LOAN LICENCING in Pharmaceutical Manufacturing is the term used for getting manufactured own product at other’s premises at LOAN LICENCE contract.LOAN LICENCING is just like hiring/ renting others manufacturing premises for manufacturing owns products.LOAN LICENCING require two parties: One is marketing company and second one is manufacturing company.In LOAN LICENCING marketing company can use its company name at place of manufactured by address but address will of manufacturer’s company premises.It is similar to third party manufacturing but has few differences.In LOAN LICENCING you can use marketed by address and manufactured by name of your company.LOAN LICENCE: Under Drugs and Cosmetics Rules, A Loan license is defined as “For the purpose of this rule a LOAN LICENCE means a license which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in FORM 25 or in FORM 28 as the case may be.”____________________________LABELLING REQUIREMENTS ARE AS FOR PROBIOTICSSchedule – X (See regulation 10) List of Strains as Probiotics (Live Micro- organisms) 1 Lactobacillus acidophilus 2 Lactobacillus planatrum 3 Lactobacillus reuteri 4 Lactobacillus rhamnosus 5 Lactobacillus salivarius 6 Lactobacillus casei 7 Lactobasillus brevis 8 Lactobacillus infantis 9 Lactobacillus johnsonii 10 Lactobacillus bulgaricans 11 Lactobacillus asporogenes 12 Lactobacillus fermentis 13 Lactobacillus caucasicus 14 Lactobacillus helvetucs 15 Lactobacillus lactis 16 Lactobacillus amylovorus 17 Lactobacillus gallanarum 18 Lactobacillus debrueckii 19 Bifidobacterium bifidum 20 Bifidobacterium lactis 21 Bifidobacterium breve 22 Bifidobacterium longum 23 Bifidbacterium animalis 24 Bifidbacterium infontis 25 Streptococcus thermophilus 26 Streptococcus bouraldi 27 Saccharomyces species (as in codex) PS: These organisms may be used either singly or in combination but must be declared on the label with full information and has to be non-GMO.Schedule – XI (See regulation 11) List of Prebiotic Compounds 1 Polydextrose 2 Soybean Oligosaccharides 3 Isomalto-oligosaccharides 4 Fructo-oligosaccharides 5 Gluco-oligosaccharides 6 Xylo-oligosaccharides 7 Inulin 8 Isomaltulose 9 Gentio-ologsaccharides 10 Lactulose 11 Lactoferrin 12 Sugar alcohols such as lactitol, sorbitol, maltitol, etc.____________________________For revised FEES/ FORMS update kindly refer to Website of Drug Controller etc.loan licence1[70A. Form of loan licence to manufacture for sale 2[or for distribution] of drugs other than those 3[specified in Schedules C, C (1) and X].—A loan licence to manufacture for sale 2[or for distribution] of drugs other than those specified in 2[Schedules C, C(1) and X] shall be issued in Form 25A.]73A. A certificate of renewal of loan licence—The certificate of renewal of a loan licence in Form 25A shall be issued in Form 26A.]73AA. Duration of loan licence—An original loan licence in Form 25A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:2[Provided that if the application for the renewal of a licence is made before its expiry or if the application is made within six months of its expiry, after payment of the additional fees, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]1[75A. Loan licences.—(1) Applications for the grant or renewal of loan licences for the manufacture for sale 2[or for distribution] of drugs specified in Schedules C and C(1) 3[excluding those specified in Part XB and Schedule X] shall be made in Form 27A to the licensing authority and 4[shall be made upto ten items for each category of drugs categorised in Schedule M and Schedule MIII and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences]:5[Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be rupees 4[rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand] per month or a part thereof.]Explanation.—For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by another licensee in Form 28.(2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.6[(3) Subject to the provisions of sub rule (2), the application for manufacture of more than ten items of each category of drugs on a loan licence, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs.(4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence.]76A. Form of loan licence to manufacture for sale 2[or for distribution of] drugs specified in Schedules C and C(1) 3[excluding the drugs specified in Schedule X] and conditions for the grant or renewal of such licence.—A loan licence to manufacture for sale 4[or for distribution of] drugs specified in Schedules C and C (1) 5[excluding the drugs specified in Schedule X] shall be issued in Form 28A, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines—(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;(iii) are stable under the conditions of storage recommended; and(iv) contain such ingredients and in such quantities for which there is therapeutic justification.]1[83A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan licence in Form 28A shall be issued in Form 26A.]295 [ 83AA Duration of loan licence. —An original loan license in Form 28A or renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 296 [valid for a period of five years on and from the date on which] it is granted or renewed:297 [Provided that if the application for the renewal of licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]138A. Application for loan licence to manufacture cosmetics.—(1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics 2[shall be made up to ten items of each category of cosmetics categorised in Schedule MII in Form 31A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof].Explanation.—For the purpose of this rule a ‘loan licence’ means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.(2) If a person applies for the renewal of a loan licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be 2[rupees two thosuand and five hundred plus an additional fee at the rate of rupees four hundred for each month or part thereof].(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities to undertake the manufacture on behalf of the applicant for a loan licence.(4) The loan licence shall be granted by the licensing authority to only such applicants who propose to avail of the facilities of manufacture of cosmetics in the premises of a manufacturer located in the same State where the applicant is located. In case the manufacture of cosmetics involves any special process of manufacture or use of equipments which are not available in the State where the applicant is located, the licensing authority, after consulting the licensing authority where the manufacturing unit is located, may grant the loan licence.(5) Subject to the provisions of sub-rule (2), application for manufacture of additional items on a loan licence shall be accompanied by a fee of 2[rupees one hundred for each item subject to a maximum of rupees three thousand per application].(6) A 2[fee of rupees two hundred and fifty] shall be paid for a duplicate copy of a licence issued under sub-rule (1) if the original is defaced, damaged or lost.]1[139B. Form of loan licence to manufacture cosmetics for sale 1[or for distribution].—A loan licence to manufacture cosmetics for sale 2[or for distribution] against application in form 31A shall be granted in Form 30A.]1[141A. Certificate of renewal of loan licence.—the certificate of renewal of a licence in Form 32A shall be issued in Form 33A.]1[141AA. Duration of a loan licence.—An original loan licence in Form 32A or a renewed loan licence in Form 33A, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] in which it is granted or renewed:Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]1[153A. Loan Licence.—(i) An application for the grant or renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25E to the licensing authority along with 2[a fee of rupees six hundred].Explanation.—For the purpose of this rule, a loan licence means a licence which a licensing authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licensee in Form 25D:Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case 3[the fee payable for renewal of such licence be rupees six hundred plus an additional fee of rupees three hundred].(ii) 4[A fee of rupees one hundred and fifty] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.]1[154A. Form of loan licence to manufacture for sale Ayurvedic (including Siddha) or Unani drugs.—(1) A loan licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25E.(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.(3) The licensing authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.]1[155A. Certificate of renewal of a loan licence.—The certificate of renewal of a loan licence in Form 25E shall be issued in Form 26E.]1[156A. Duration of loan licence.—An original loan licence in Form 25E or renewed loan licence in Form 26E, unless sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue]:Provided that if the application for the renewal of a loan licence is made in accordance with rule 153A, the loan licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if application for its renewal is not made within three month of its expiry.]1[158A. Conditions of loan licence.—A licence in Form 25E shall be subject to the following further conditions, namely:—(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IVA of the Act,provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.(c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, the raw materials and finished products.(d) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules have been observed.]2[(e) The licensee shall maintain as Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]___________1[SCHEDULE M (See rules 71, 74, 76, and 78)GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS29.9 Loan licence manufacture and licensee (a) description of the way in which compliance of Good Manufacturing Practices by the loan licensee shall be assessed.______________________________________Guidelines For Grant Of Additional Products Permissions Under The Licence In Form-25 & FORM-28.STEP-IThe following Documents/Details To Be Submitted:1. Covering letter Addressed to the Drugs Controller and Licencing Authority for the State of Karnataka (or other state) duly signed by the applicant viz Proprietor/Partners/Managing Director/Authorized Signatory[The covering letter is an important part of the application and should clearly specify the intent of the application. The list of documents that are being submitted (Index with page number) as well as any other important and relevant information may be provided in the covering letter The covering letter should be duly signed and stamped the authorized signatory, indicating the name & designation of the authorized signatory in original issued by the Director/Company]2. Duly filled additional product proforma duly signed by the licensee viz Proprietor/Partner/Managing Director/Authorised Signatory.3 FeesFees of Rs. 300/- (for each additional product) has to be paid through challan at Government Treasury, State Bank of Mysore (or relevant other Bank for other state) under the Head of Account ‘0210 Medical and Public Health-04 Public Health-104 Fees, Fines etc.-02 Drugs and Cosmetics Act and Rules/Drugs Control Department’4 Attested true copy of the valid manufacturing licence(s).5 Declaration regarding the manufacturing facility and approved CTS for the proposed dosage form.6 Photocopy of DCG (I) permission/NOC in case of new drug.7 Photocopy of export order, rate contract order if the proposed products are required to be supplied against specific order.8 List of product/s to be manufactured In triplicate, with declaration duly signed.DownLoad Format of Declaration9 Copy of the specimen label duly signed by licencee.10 Standards & analytical procedure of each product for the patent and proprietary drugs proposed (quote the relevant authoritative books followed).11 Detail formula, shelf life, details of parallel products and packing specifications for each product.12 Details of the following:(a) Stability studies conducted and the justification for the shelf life period assigned under the conditions of storage recommended.(b) Therapeutic justification for each constituent in the product in relation to the claims made or the product is recommended for use, in case of Patent and Proprietary Medicines. (c) safety declaration as required under Rule 71(6), 71-B, 76(7), 76-A as applicable of Drugs & Cosmetics Rules depending upon the product for P & P medicines as applicable.DownLoad Safety Declaration13 Flow sheet in the case of Bulk Drugs along with the details like in process controls employed during the manufacture,14 Chemical reactions involved in the synthesis of Bulk Drug and Brief Method of Manufacture.15 Brand name declaration in the format specified duly signed by the licencee.DownLoad Brand name declaration16 Copy of the test licence in form 29 and product development data of the trial batches.17 Standards, and method of analysis of active/excipients which are not official in any pharmacopoeia.18 In case of proposed products intended to be manufactured in Principle-to-Principle basis, the photocopy of the agreement supported with trademark registration document and the copy of the whole sale Drug licence of the Third party.19 Photocopy of official monographs for the proposed product/s and its active ingredient and excipients.Download Additional Information FormNote* The above documents shall be serially numbered and to be submitted as per the sequence mentioned above.** The above requirements are not exhaustive one. In case of products of special nature/category, additional documents/ clarifications is required to be submitted whenever called for.STEP-IIThe application is verified by the manufacturing section for the correctness of the list of documents submitted and is then processed and forwarded to concerned Drugs inspector/Assistant Drugs Controller (HQ) for scrutiny and if the submitted documents are in order the application is forwarded to Drugs controller and licensing Authority through Deputy Drugs Controller (HQ) and Additional Drugs Controller for orders for the Grant of permission.STEP-IIIIf the submitted application & information is not in order or requires any clarifications a compliance letter will be served to the applicant at the level of Deputy Drugs Controller only.STEP-IVIf all documents / conditions / requirements as prescribed under the Drugs and Cosmetics Act and Rules there under and any specific office orders are complied, it is recommended by the concerned officer for grant of permission to manufacture additional product/s under the valid licence through proper channel as per the administrative order of Drugs Controller, additional product/s permission will be granted by Licensing Authority.

Animal sacrifices followed the influence of sin on creations varied species. As such, God’s initiation of sacrificial offerings was intended to be instructive, not punitive. The animal was not being subjected to personal penal consequences. However, the infraction against the imagio dei needed attention, this the brutality of the sacrifice.The penal portion of the sacrifice was to let the person know that sin violated the standards of relationship. The rectification of the broken relationship happens through the acknowledgement of sins presence and the need to reestablish trust. The sacrificial system was designed for the purpose of showing a willingness on the part of the offender to take seriously their desire to have right relationship with God.Another factor that must be added into the equation is the temporality of the sacrifice, which necessitates a renewal mandate. In the Judeo-Christian Scripture, these sacrifices were conducted annually until the revision of the mandatory sacrifices. Under the new contractual relationship, God provided the sacrifice as once only application for the penitent.We know the identity of the sacrificial lamb as Jesus the Christ, God’s only Son. The long tutorial of temporary sacrifice was displaced by the final instrument of instruction, the sacrifice of the perfect Lamb of God. I hope this helps.