fb


Loan License for Drug Manufacturing

Loan License for Drug Manufacturing

Introduction

For a person who wants to establish his manufacturing or production unit, the term loan license plays a great role. People with no requirements and equipment can also start their business with all the facilities that are needed in the manufacturing procedure of a drug.

What is Loan License?

A loan license is a permit that a licensing body may grant to a candidate who does not already have manufacturing arrangements in place but plans to use the manufacturing facilities used by another licensee. A business that holds the marketing authorization for a medicine that is legally permitted to be manufactured and marketed enters into a loan license manufacturing agreement. This arrangement is made possible by Rule 75A and Form 28 of the 1945 Drugs and Cosmetics Rules. A loan license agreement transfers the trademark and product specification knowledge to a manufacturing firm so that it may use the facilities and personnel of the manufacturing company. The medication is produced under the direction of a business that holds a Loan License by Form 28. 

The owner of the Loan license is accountable for the product's quality, effectiveness, and safety. The name of the loan licensee and the location where the product is produced by the licensee manufacturing firm are both clearly stated on the product label. For this arrangement, the producer requests state drug licensing authority permission. In the event that a pharmacy operates in more than two states, a drug license must be obtained in each state in which the operation is conducted. In the event that medicines are sold in more than one location, a separate license must be granted.

Documents required for a Loan License

List of Documents for Loan License Applications in Forms 25-A, 28-A, and 32 -A duplicate of each document must be included with the application:

  • Cover Letter

  • For the necessary amount, submit a challan under the Head of Account.

  • Form Fees for Statutory Forms

  • Affidavit-I with attested copies of the partnership deed or memorandum of articles containing the proprietor's, partners', directors', and other parties' declarations.

  • Affidavit-II (Format included) (Format enclosed) The name, address, and other information about the person in charge of the company's daily operations and business conduct, as well as his fully attested photograph, are attested by a notary.

  • Copy of ration card, passport, voter registration card, etc. as evidence of the person's residential address.

  • Consent letter by the parent company outlining the service provided as well as the specifics of any licenses held, including the type of pharmaceuticals covered and the number of loan licenses previously held.

  • Technical Staff Declaration for Production and Analysis

  • Whether the company currently has a manufacturing license for its own unit or loan license, and if so, details of those licenses, as well as a statement that the formulations being used now were not previously allowed under the same brand name or any other brand names.

Request for Bulk Drugs: Necessary Documentation

The brief manufacturing process and flow diagrams, consumption coefficient, affluent generation, and treatment for the pharmaceuticals requested, along with test/analysis methodologies and procedures.

Important schedules for Loan Licensing

  • C- List of biologicals and special products whose import, sale, distribution, and manufacture are governed by special provisions.

  • K-Drugs are exempted from certain provisions relating to the manufacture of drugs

  • M- Good Manufacturing Practices (GMP) requirements of factory premises, plants, and equipment.

  • X - List of drugs whose import, manufacture, and sale are governed by special provisions.

Other Requirements

A loan license is one that a licensing authority may provide to a candidate who lacks his own manufacturing arrangements but plans to use the production facilities controlled by another licensee.

  • It is issued for the production, sale, or distribution of medications not included in Schedules C, C1, or X.

  • Form 24 A is used for license applications, and Form 25 A is used for license issuance.

  • Before granting a license, the LA or CLAA must arrange for one or more inspectors to visit the property.

  • Inspector is required to examine every aspect of the plant and to find out the professional qualifications of the technical people involved.

  • An application must be submitted to LA in order to manufacture more goods.

  • Each batch of raw materials and completed goods must be tested by the licensee, and the records must be kept for five years after the date of production (2yrs in case of drugs having an expiry date, from the date of expiry)

  • If the license of the lending licensee, from whom the licensee has rented manufacturing facilities, is revoked or suspended, the license is presumed to have been canceled or suspended.

Rules and Government fees under Section  75A of The Drugs and Cosmetics Rules, 1945

  • Applications for the issuance as well as renewal of loan licenses for the manufacture, sale, or distribution of drugs listed in Schedules C and C(1), with the exception of those listed in Part XB and Schedule X, must be submitted to the licensing authority in Form 27A. 

  • They must also include up to ten items for each category of drugs listed in Schedule M and Schedule MIII, as well as a license fee of Rs. 6,000 and an inspection fee of Rs. 1,000. 

  • The renewal fee for a license will be rupees 6,000 and an inspection fee of rupees 1,500 plus an additional fee at the rate of rupees 1,000 per month or a portion thereof if the individual applies for the renewal of a license after its expiration but within six months of such expiration.

  • Before granting a loan license, the licensing authority must be certain that the production plant has the necessary tools, personnel, manufacturing capacity, and testing facilities to carry out the manufacturing on behalf of the loan license applicant.

  • An additional charge of Rs. 300 per additional item of medication must be submitted with the application for manufacturing more than ten of each type of drug under a loan license.

  • Upon payment of a cost of Rs. 1,000, the licensing authority may issue a duplicate copy of a loan license if it is determined that the original has been disfigured, destroyed, or lost.

Conclusion

Loan licensing is similar to hiring or renting another manufacturer's facility for producing one's own items. Two parties are needed for loan licensing: a marketing firm and a manufacturing company. In loan licensing marketing, a firm can put its name at the address of the place where a product was created, but the address will be the location of the manufacturer's business. You will produce the product under a loan license, promote it, and supply it. Technical personnel and laborers will be employed by the manufacturing company, but you or a representative you have authorized will manage the production process.

eStartIndia is a team of experienced experts who help you to get a drug license quickly without any hassle.

Get a call back with an experienced drug consultant to sign up with us!

Author:

Archita Sharma
Kanpur
Archita Sharma, IV year BA.LLB (Hons.) student from PSIT College of Law


Leave a Comment



Previous Comments


Related Blogs