Drug License – Documents and Application Process

A drug license is a precondition in India for any activity, be it manufacturing, importing, distributing, or selling drugs. The drug licensing procedures are enshrined in The Drugs and Cosmetics Act of 1940, which aims at protecting the public from the health risks posed by substandard and unproven drugs, both medicine and medical apparatus. This certificate is a sanction that may be issued by either the state or central drug controlling authority, and without it, it is almost impossible for the business of drug or cosmetic products for human or veterinary use to operate.

The definition of a “drug” as under Section 3(b) of the Drugs and Cosmetics Act, 1940 includes –

(i) all medicines for internal or external use of human beings or animals and all substances intended to be used for in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations, applied on the human body for the purpose of repelling insects like mosquitoes,

(ii) such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermin or insects, which cause disease in human beings or animals as may be specified from time to time by the Central Government by notification in the Official Gazette,

(iii) all substances intended for use as components of a drug, including empty gelatin capsules, and

(iv) such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board.

The regulatory authorities under the Directorate General of Health Services, Ministry of Health and Family Welfare, for drug control and regulation and the issue and grant of drug licenses are as follows:

1. Central Drugs Standard Control Organisation (CDSCO) – Central Drug Authority that regulates the clinical trials,  blood banks, medical devices, r-DNA drugs, large volume parenterals and vaccines in India and approves the license applications for the newly made drugs and imports and exports of drugs in India.
2. State Drug Control Administration (SDCA) – This varies from state to state in the country and is responsible for discharging license applications for sale, distribution or manufacturing of drugs in their respective states.

Documents Required for Obtaining a Drug License

In India, it is a process called application for the drug license containing specific documents to be submitted to ensure that applicants meet the necessary safety, quality and compliance levels as mandated by the Drugs and Cosmetics Act of 1940. Below is a list of documents that are generally needed irrespective of the type of drug license applied for –

1. Cover letter specifying the name and designation of the applicant along with the application form for the issue of license.
2. Constitution of the entity if the applicant is a sole proprietorship, Memorandum of Association (MoA), Articles of Association (AoA), Board Resolution if it is a company, Partnership Deed if it is a partnership firm and Limited Liability Partnership Agreement if it is a Limited Liability Partnership (LLP).
3. Identity proofs and recent photos of the partner or director or proprietor.
4. Documents related to the premises of applicant such as proof of ownership or rental or lease agreement in case of a rented or leased property and a No Objection Certificate (NOC) from the main owner along with the site plan and key plan of the premises.
5. Qualification certificate of the applicant, in case of an individual or proprietor.
6. Notarised Affidavits for the satisfaction of competency and non-conviction of the proprietor or partner or director and firm or company under the Drugs and Cosmetics Act, 1940 and any other act of law related to drugs or otherwise.
7. Proof of availability and adequate arrangements for storage and preservation of the products is the subject of the drug license application.
8. In the case of a retail pharmacist – proof of qualification, an appointment letter and a pharmacist registration certificate are mandatory.
9. In case of a wholesale pharmacist – proof of qualification, experience certificate, appointment letter and Goods and Service Tax (GST) registration certificate are mandatory.
10. Specific additional documents for a manufacturing drug license –

1. List of products intended to be manufactured.
2. Proof of ownership or lease of the plant and machinery and the manufacturing site.
3. Detailed description of the manufacturing plant and machinery, complete layout of the manufacturing site and quality control measures.
4. Certificate of compliance with the Good Manufacturing Practices (GMP) standards.
5. Information related to the staff, labour and employed personnel.
6. Water Analysis Report.

11. Such other additional documents as may be required or prescribed or directed by the said regulating authority.

Application Process for Obtaining a Drug License

According to the Drugs and Cosmetics Act of 1940, a drug license is available only in India. The process is rather extremely exhaustive so that the business adheres to safety, quality, and efficacy standards. First and foremost, one needs to determine the kind of drug license required based on the activities that the applicant intends to engage in. For instance, processes like drug retail, wholesale, imports, exports or drug manufacturing, among other activities, require different types of drug licenses. Secondly, it is equally important to ensure that one meets the qualification requirement for the drug license category chosen since qualifications vary from one type to another. Finally, the mandatory documents should be stocked and ready for application for license submission.

1. State Drug Control Department Website or CDSCO Portal Registration: Most of these licenses, whether it’s retail or wholesale or manufacturing, as the case may be, need to be submitted online through the website of the State Drug Control Department of that particular state. For import/export licenses, the CDSCO portal should be used. The official portal of CDSCO is www.cdscoonline.gov.in, while for the State Drug Control Departments, the websites vary from state to state.
2. Information to be Attached and Uploaded: All the information attached should be factual of the information presented in the application of the nature of the license one is applying for. This is due to the fact that different forms are needed for each license, hence ensuring that no information provided or documents uploaded to support the application are incorrect.
3. Payment of Fees & Application Submission: Upon the completion of the application form, collection of supporting documents & additional requirement(s) if any, submit the application. Under the umbrella of application, internet based tendering and payment of appropriate fee, which varies from type to type of applications, will be sought.
4. Inspection of the Premises: You will have to get most of your licenses, be it business or research, evaluated by a drug inspector or any person in charge from the Department of Drug Control. The inspector will check your premises for compliance with the basic needs and will inspect such things as appropriate fittings, adequate space and holding conditions, and trained staff.
5. Assessment, Verification and Feedback: After the inspection, along with the application, inspection reports will be processed by the Drug Control Department called CDSCO, and case processing will start also. Here, they may ask for further information or clarification.
6. Issuance of Approval and Grant of License: After satisfying all the requirements of the Application and clearing the respective Inspection, more often than not, an authority concerned, the Department of Drug Control or CDSCO, issues the drug control license. Normally, the license is issued in the form of a certificate to be framed and put up in the office.

Conclusion

In India, the procedural arrangement to obtain a drug license is an important safeguard measure to enhance safety, legality, and quality in the distribution, manufacture, and selling of drugs. The regime is governed by the Drugs and Cosmetics Act of 1940, under which, inter alia, applicants have to meet particular standards relating to premises, trained staff, and documentation. Migration through this linear entryism and meeting of set standards gives the companies the legal space to operate, which in turn adds strength to the health care system in India.

As previously stated, drug licenses are different depending on the nature of the business. The common ones include the Manufacturing License for the manufacture of drugs, Wholesale License for distribution services, Retail License for the sale of drugs to consumers, Import License for importing drugs from outside countries, and the Multi-Drug License issued to firms operating in several states at the same time. Each of these licenses has its own conditions that may provide warehouse spaces, qualified personnel in the field (pharmacists, etc.) and practices under good manufacturing or distribution practices.

Gives power to a pharmaceutical business by allowing the acquisition of a drug license. Some of the permissive capabilities that are included in getting a drug license are the improvement in reputation, assurance of the quality of the goods, and the assurance for a bigger market. Some additional supportive features of gaining a drug license are the reduction of apprehensions and anxieties about the legality of carrying out commercial activities and of contributing to the pharmaceutical sector in India because of ethical business practices.

A valid existing drug license supports law-abiding operations of businesses and further reassures the public and health professionals that the drugs concerned are of quality and will do the intended purpose.