Essentially, CDSCO Approval for Drug manufacturing in India serves as a mandatory legal permit. The drug manufacturing license is accorded by the Central License Approving Authority (CLAA). Those lacking a production facility can secure a loan license to outsource the drug manufacturing drugs to a third party. The validity of the drug sale or manufacturing license is maxed out at 5 years. Let’s dig into the process and paperwork for securing CDSCO Approval for Drug manufacturing in India.
An Overview of Different Manufacturing Licenses and Forms
|License Name||Description||Relevant Rule||Licensing Authority||Timeline|
|Test License For Manufacturing||Form-29 serves as a license to produce testing drugs only. The application used for this purpose is called Form 30, which remains valid for one year.||Rule- 89||DGCI||3-6 months|
|Approval to Manufacture medical devices Post Successful Clinical Trial||A license is accorded in Form 46 against the application filed in form 44||Rule- 122 B||DGCI||6 months|
|Approval to Manufacture Notified Medical Devices||Form 28 acts as a license for the production of notified medical devices for sale in the country. The application for this license is made in form 27.||Rule 76||DGCI and State Drug Licensing Authority.||3-6 months|
|Loan License||Manufacturing of notified medical devices in the outsourced production facility requires this license in Form-25 A and Form-28 A.||Rule- 69A and Rule- 76A||DGCI and State Drug Licensing Authority.||3-6 months|
Documents for CDSCO Approval for Drug manufacturing
The followings are the mandatory documents to be furnished by the applicant for securing CDSCO Approval for Drug manufacturing.
- Application form ( to be filled on the respective state portal)
- Premises’ site plan or blueprint enclosing signature of the owner/partner/director
- Lease paper or Rent receipt (real and signed copies)
- A copy of the Partnership Deed (duly attested)
- Memorandum (MOA) and Article of Association (AOA) if the firm falls under the Companies Act, 2013
- List of active directors managing the company, along with their names and address.
- If the directorship position has recently been vacated or is awarded to a new candidate, declaration in Form 32.
- Complete information about the in-house staff along with copies of academic certificates.
- Non-conviction affidavit relating to the technical staff
- Attested copies of education certificates and the authorization of technical workforce as per norms mentioned in the Drugs and Cosmetics Act, 1940, and Rules, 1945.
- List relating to machinery and lab equipment
- Purchase invoice concerning the machinery and equipment
- Fire NOC and pollution NOC from competent state authority.
- Proof of loan sanction
- Attested photocopy of occupation certificate form
- Declaration in the affidavit pertaining to the Director/patners accountable for managing daily operations along with the affidavit confirming that no case has been registered against the owner under the Cosmetics Act, 1940 and Rules, 1945.
- Resolution of BODs concerning the authorized signatory’s appointment.
- Non-conviction affidavit to be rendered by the authorized signatory.
Procedure for securing CDSCO Approval for Drug Manufacturing in India (fresh)
Following is the step-by-step procedure for Securing CDSCO Approval for Drug Manufacturing in India:
Stage 1: Online Filing:
The applicant needs to visit the portal of the State Drugs Controller. The documentation must be attached during online filing and the same should be shared with the vetting officer during the inspection. The standard application form is required to be filed for this purpose. The detail of the same is shown below, along with the mandatory fee structure:
- Application on Form 24 for Non-biological medicine production attracting a license fee of Rs 7500 for 10 items/category and Rs 300/item for more than 10 items/category.
- Form 27 for biological drugs production attracts a license fee of Rs 7500 for 10 items/category and Rs 300/item for more than 10 items/category.
- Application on Form 24 A for loan license for the production of non-biological drugs. Similarly, Form 27A is used for applying for the production of biological drugs at a third-party facility.
- Form 24 C – Application for the production of Homeopathic drugs attracts a license fee of Rs 300 for mother tincture. The same fee is applied to potentized.
- Applicants can submit these fees online via debit card or net banking and can also download the challan.
Stage 2: Document and on-site inspection
The applicant must furnish a form via web-based mode after providing the licensing authority with the mandatory documents. The application will be vetted for compliance and then shared with the Senior Drugs Control Officer for on-site vetting of the firm.
Premises are checked by the said official and the report of the same is shared with the State Drugs Controller. This phase sets the stage for the CDSCO Approval for Drug manufacturing.
Stage 3: Grant of Manufacturing Drug License
If all underlying norms have complied, the State Drugs Controller will accord the license to the applicant.
Due diligence must be taken into account by every firm seeking to make a mark in the pharma sector. Keeping a tab on prevailing drug norms and operating legalities is of utmost importance for new businesses. The process of securing CDSCO Approval for Drug manufacturing in India is not that seamless, owing to the presence of stringent rules. That is why it is prudent to proceed professionally.
Read our Article:CDSCO Certificate for Drugs Import to India: An Overview