MANUFACTURING DRUG LICENSE

 

 

1. DEFINITION
2. OVERVIEW OF MANUFACTURING DRUG LICENSE
3. REQUIRED DOCUMENTS FOR MANUFACTURING DRUG LICENSE
4. MANUFACTURING DRUG LICENSE FOR SALE AND DISTRIBUTION:
5. MANUFACTURING AND IMORT DRUG LICENSE:
6. APPLICATION PROCEDURE OF MANUFACTURING DRUG LICENSE:

 

WHAT IS MANUFACTURING DRUG LICENSE:

 

Manufacturers of Allopathic, Homeopathic Medicines, cosmetics, and other drugs need a Manufacturing drug License.

The manufacturers prevent allopathic/homeopathic medicines, cosmetics, and medicines; one has to obtain a Manufacturing Drug License.

 

OVERVIEW OF MANUFACTURING DRUG LICENSE:

 

The government of India has developed it to get a manufacturing license which is mandatory for all those who want to deal with the manufacturing pharmaceutical business. The license includes all kinds of medicines like Ayurvedic, Allopathic, Unani, and Cosmetics products. The State Licensing Authority is responsible for issuing the license and at the same time monitor different licenses such as Drug Sales License, Drugs Manufacturing License for Ayurvedic, Allopathic, and Cosmetics, etc. This state government authority also conducts regular inspections of sales units, manufacturing units and at the same time protects the pharmaceutical manufacturing units from misconduct.

Multiple licenses related to blood drugs and cosmetics by the state licensing authority such as blood bank licenses, blood components, and blood products have the potential to be associated with a large number of parenteral, sera and vaccines but state authority can only issue it once they have the approval of Central License Approving Authority, The Drugs Controller General India New Delhi. Before issuing such licenses, both state and central drug regulatory authorities conduct joint inspections of the premises.

Form-28 is needed under Drugs and Cosmetics Rules to apply for Manufacturing License. The information related to the issue of manufacturing license in Rule 76 of Drugs and Cosmetics provides.

Produces disposable hypodermic syringes, disposable hypodermic needles, disposable perfusion sets, and in-vitro diagnostic devices to determine state drug licensing authority.

 

Required Documents for Manufacturing Drug License:

 

• 1 copy of the Covering letter along with payment of application fee.
• 1 copy Self Assessed checklist of documents.
• 1 copy Form 24 & 27 (Maximum 10 Products should apply under each form)
• 1 copy Form 24D(for Ayurvedic manufacturing license)
• 2 copy Product List.
• 1 copy List of Excipients
• 1 copy Similar Product
• 1 copy Draft Label
• 1 copy Method of Analysis
• 1 copy Additional Information Form
• 1copy Certificate of Incorporation,
• 1copy Association Memorandum and Association Article (for the company, partnership deed (for the partnership firm), LLP agreement (for the Limited Liability Partnership Firm).
• 1 copy List of Directors with the address.
• 1copy Copy of Power of attorney to sign the documents.
• 1 Copy of Plan approval.
• 1 copy Non- Objection Certificate/Consent from SSI, Pollution.

 

MANUFACTURING DRUG LICENSE FOR SALE AND DISTRIBUTION:

 

The manufacturing drug license for sale and distributions of drugs is granted by the Central License Approving Authority (CIAA). It requires an application for other licenses like grant or renewal manufacturing for sale or distribution drug license to make to the License Authority, that approved by the State Government.

The manufacturing license for drugs or distribution is valid for 5years unless sooner the License Authority is canceled or suspended the license.

 

Manufacturing and import drug license:

 

It is an order of laws and regulations made under it that No new drugs will be imported or manufactured for sale without the approval of the Licensing Authority. The word ‘new drug’ is defined under the 122E rules. It is provided in Rule 122E that a new drug must be considered a new drug for four years from the date of its first approved approval.

The manufacturing and import of new drugs are approved by the licensing authority of the central drugs standard control organization (CDSCO).

 

APPLICATION PROCEDURE FOR MANUFACTURING DRUG LICENSE:

Stage 1:

1. 1. The Applicant must apply online to the state drug Controller-cum-State license authority.
2. 2. Upload the documents and it will be handed over to the Inspector Officer / Drug Control Officer during the inspection.
3. 3. The applicant has to apply in the required form. Details of the forms and required fees are given below:-

 

1. Non-biological drugs manufacturing license with a fee of Rs. 7500 per category for ten items and Rs. 300 per item for more than 10 products per category mentioned in Application Form 24 and in application Form 27 for manufacturing of a Biological drug with a fee of Rs.7500 per category for ten items and items more than 10 items per category Rs. 300 per item.
2. Application Form 24B for repacking of license with a fee of Rs. 700 up to 10 items per category and if the items are over 10 items Rs. 100 per item.
3. Application Form 24C for Homeopathic manufacturing drug license with a fee of Rs. 300 for mother tincture, Rs. 300 for potentized preparations and Rs. 300 for potentized and if the items are over ten Rs.50 for additional items.
4. User has the option to pay the fee online through Net Banking/Debit Card/Credit Card and download the challan.

Stage 2.

      Applicants must submit an application to the State Drugs Controller by online mode. Licensing authority with all necessary documents. Scrutinized the application form. The application is then sent to the Senior Drugs Control Officer of the concerned zone of the premises of the firm for inspection. The locations are inspected by the Senior Drugs Control Officer of the respective zone; Premises are inspected by Senior Drugs Control Officer of the concerned zone, the report is forwarded by Senior Drugs Control Officer along with his recommendation to State Drugs Controller.

 

Stage 3.

If all the conditions prescribed by law are complied with, the license is approved by the state drug regulator and The applicant receives the information via SMS / email.