How to obtain a license for a Drug manufacturing firm (pharmaceuticals) in India (Manufacturing License/Test License/Product License)

How to obtain a license for a Drug manufacturing firm (pharmaceuticals) in India (Manufacturing License/Test License/Product License)

 In India a drug substance (API) or a drug product (formulation) can manufactured and marketed only after obtaining a valid manufacturing license and a product license. Manufacturing license is issued for a facility and is subjected for periodic renewal, where as product license is product specific, which are required to manufacture any product under a valid manufacturing license. 

The Central Drugs Standard Control Organization (CDSCO) under Ministry of Health & Family Welfare is the National Regulatory Authority (NRA) for pharmaceuticals (API, Formulations & Biologics) and medical devices in India. CDSCO is headed by the drug controller general of India (DCGI). 

Manufacturing, sale and distribution of drug in India is regulated under Drugs and Cosmetics Act 1940 and Drugs and Cosmetic Rules 1945. Currently, bulk drug (Active Pharmaceutical Ingredients) and finished dosage formulations (FDF) are regulated under the said Act.  

Drug and cosmetic act is a federal act, enforced by both central and state governments of India. Under the Drugs and Cosmetics Act, CDSCO is responsible for approval of Drugs, Conduct of Clinical Trials, laying down the standards for Drugs, control over the quality of imported Drugs in the country and coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act (Central Drugs Standard Control Organization (CDSCO) is the national level regulator, where as State Drug Regulatory Authorities (SDRAs) are the state level regulators. Powers are shared between the center and states). Sate drug controller (SDC) heads the SDRA.   

Who grants drug manufacturing License in India

Respective State Drug Regulatory Authority (Local FDA) is responsible for inspecting new manufacturing facility and granting manufacturing license as per the provisions of Drugs and Cosmetic Act -1940.  

When/How to apply manufacturing License for a new facility?

To obtain a manufacturing license, applicant should have a manufacturing facility in India which is registered under company act or work as a firm.

A company can register as

    One Person Company

   Private limited company

   Limited liability company

   Public Company

Documents required for company registration includes DSC (Digital signature certificate),DIN (Director Identification Number),Pan card (Permanent account number),TAN (Tax deduction and collection number),identity proof, Photo, address proof etc. Applicant shall also apply for GSTIN (Goods and service tax identification number)

Before applying for manufacturing license, new firm’s production and quality control area should be qualified with required equipment's/instruments and must have competent technical staff to perform production/quality control activities (Production area should meet schedule M requirements and Quality control lab should meet schedule L1 requirements of Drug and cosmetic act,1940 & rules 1945).

Application for manufacturing license for the new firm shall be submitted to the relevant State Drug Regulatory Authority/local FDA. After submission of the application and required documents, the application will be scrutinized and will be forwarded to senior drugs control officer of the concerned zone for facility inspection. Premises will be inspected by the senior drugs control officer of the concerned zone and report will be submitted to state drugs control with recommendation for approval or rejection of firm (Drug authority reserves the right to approve or reject the application based on the evaluation of the statutory requirements and GMP compliance of the firm).

 

Documents required for fresh Manufacturing License application of a Pharmaceutical firm in India

Introductory Cover letter specifying name and address of the plant and administrative office

Application at prescribed form and format Ø Application on Form 24 for Non-biological drugs manufacturing license. Ø Application on Form 27 for manufacturing of Biological drugs

Prescribed fee receipt.

Details of constitution of the firm, partnership or company.

Documents related to ownership of the premises, rent or lease agreement.

Identity proof of all authorized persons, proprietor, partners and or directors.

Blue print of Plant and Lay out of premises specifying installation of equipment and instruments.

Design and layout of HVAC system.

SMF (Site Master File).

Fire NOC.

NOC from Pollution Board.

Proof of electricity load sanction.

Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.

Non-conviction affidavit of approved technical staff as per required which should also finds mention the defaults of his/her academic qualification & approval.

List of Equipments used for manufacturing (Production Equipments).

List of Instruments used for testing (QC instruments).

A fresh manufacturing license and product license can be applied simultaneously or product license can be applied after obtaining a valid manufacturing license. Each product manufactured and commercialized by the firm must have a product license.

R&D development and trail manufacturing of any new product shall be carried out under a test license which is issued by the drug licensing authority.

Test License

Test license is issued for the purpose of examination, test or analysis of a drug in small quantities which is otherwise prohibited under section 10 of the Drugs and Cosmetics Act and Rules, 1945. This license is issued in form 11 and form 29.

Test licence or form 11 licence is issued for the import of small quantities of drugs, for the purpose of examination, test or analysis.Import of new drugs including biological products and medical devices for the purpose of clinical trials,the test license is granted by CDSCO HQ. 

The Form 29 is a license to manufacture drugs for the purpose of examination testing and analysis.

A test license is valid for a period of 3 years and can be renewable if required. Test license cannot be used for manufacturing commercial batches, for which, a valid commercial license to be obtained from drugs control department.