Drug refers to any substance or combination of substances that are used internally or externally for medical purposes that include diagnosis, treatment, prevention, or mitigation of any disease or disorder in humans or animals. Furthermore, you can find drugs in the form of tablets, capsules, syrups, injections, creams, etc. The purpose and usage of drugs compel us to gather complete information before seeking a drug manufacturing license or drug import license.
Drugs License in India: Role of CDSCO
Drug License in India follows a regulatory approval process conducted by the Central Drugs Standard Control Organization (CDSCO), which is a National Regulatory Authority (NRA) that works under the Directorate General of Health Services, Ministry of Health & Family Welfare, and Government of India. CDSCO handles the Import and product permissions of New drugs, investigational new drugs, Subsequent New Drugs, unapproved Fixed Dose Combination (FDC) in the country. Through the streamlined process of licensing, the Indian government ensures the available drugs in the market are safe, efficacious, and of good quality.
The Drugs & Cosmetics Act, 1940 and Rules 1945 describe the responsibilities of central and state regulators to regulate drugs and cosmetics in India. CDSCO is responsible to maintain transparency, accountability, and uniformity in its services to ensure the safety, efficacy, and quality of the medicinal product manufactured, imported, and distributed in the country.
Under the Drugs and Cosmetics Act, CDSCO manages approval, clinical trials, standardization, quality control of drugs, and activities of State Drug Control Organizations. Moreover, the licenses of certain special categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera are also regulated by CDSCO along with State regulators.
Indian Pharmaceutical Industry: Dynamics of Drug Market
India secured 3rd Rank worldwide in producing pharma products by volume and 14th by value.
According to the Economic Survey 2022-23, the domestic pharmaceutical market of India is expected to reach USD 130 billion by 2030.
India is one of the biggest suppliers of low-cost vaccines in the world. One of the greatest stories of medicine showcases the accessibility of affordable HIV treatment.
CDSCO Registration
Have you tried to get an online drug license? Whether you want to obtain a Drug Registration Certificate or drug import license, you must interpret the rules and regulations of CDSCO Registration. In order to obtain a drug licence in India, companies have to comply with the provisions of the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 whether they are manufacturers, importers, retailers, or distributors.
Dueran Consultant Regulatory Services:
CDSCO Services
Registration Certificate and Import License
Under Rule 27A, a “Registration Certificate” is issued by licensing authority in Form 41 so that foreign manufacturers can register their premises for import of drugs into India. Moreover, the drug manufacturing facilities must be approved by the National Regulatory Authority (NRA) in Country of Origin.
Our experienced professionals will help you to get your Registration Certificate by completing Form 40 precisely.
Further, a drug import license is a licence in Form 10 to import drugs. If you need to import drugs specified in Schedule X, a licence in Form 10-A is required.
For importing drugs, the application shall be made to the licensing authority in Form 8 (excluding drugs specified in Schedule X). To cover drugs specified in Schedule X, Importers must submit an application in Form 8A.
Under the rules and regulations, an import drug license can be applied by a foreign manufacturer, having a valid wholesale license for the sale or distribution of drugs, or a manufacturer's agent in India, having a valid license.
New Drugs Approval
New Drugs and Clinical Trial Rules, 2019
While gaining knowledge of drug licensing in India, it is also vital to know New Drugs and Clinical Trial Rules, 2019. The Government of India introduced New Drugs and Clinical Trial Rules, 2019 on March 19, 2019, and has set specific requirements for the Conduct of Clinical Trials in India, Approval Process of New drugs and investigational new drugs, registration of Bioavailability and Bioequivalence (BA/BE) Centers, registration of ethics committee (EC) etc. As per the new rules, companies need to follow set of requirements and submit their documents accordingly to Central Licensing Authority (CLA).
By connecting with Dueran Consultant, you will find proper guidance to submit an application for importing or manufacturing new drugs for sale or to undertake clinical trials.
We also cover Investigational new drugs, which are defined as a new chemical entity or a product that has therapeutic indication but which has never been earlier tested on human beings.
Subsequent New Drug
According to CDSCO, a subsequent New Drug refer to a drug approved by CLA for specific claims and proposed to be marketed with modified or new claims that include an indication, route of administration, dosage, and dosage form. It also includes a new drug already approved in the country.
From our platform, get effective assistance to forward the application of a subsequent new drug license by completing its requirements.
Fixed Dose Combination:
Fixed dose combinations (FDCs) refer to the combination of two or more active drugs to form a single dosage Form. As per CDSCO, fixed dose combinations are products containing one or more active ingredients used for a particular indication(s). These products are further divided into four groups.
- The first group of Fixed Dose Combinations (FDCs) includes those in which one or more of the active ingredients is a new drug.
- The second group Fixed Dose Combinations (FDCs) includes those in which active ingredients already approved or marketed individually are combined for the first time, for a particular claim.
- It includes those Fixed Dose Combinations (FDCs) which is not marketed anywhere in the world but these drugs are already in use individually for the said claim.
- For any other such Fixed Dose Combinations (FDCs), which are not covers above.
- The third group of Fixed Dose Combinations (FDCs) includes those which are already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim.
- The fourth group of Fixed Dose Combination (FDC) includes those whose individual active ingredients (or drugs from the same class) have been widely used in a particular indications for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience. It will have to be demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.
There are specific rules defined under the New Drugs and Clinical Trials Rules 2019 to conduct clinical trials and approval of new drug. For more details on FDCs, our experienced professionals will share required information and help you to process your application properly.
Test License
An importer seeks a license in Form CT-16 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of Clinical Trial or Bioavailability or Bioequivalence Study or for examination, test, or analysis.
Under New Drugs and Clinical Trials Rules 2019, various rules are described that need to be followed to obtain Test License for importing the drugs.
Clinical Trials
A clinical Trial is a systematic study of any new drug(s) in the human subject(s) to generate data for discovering and/or verifying the clinical, and pharmacological, including pharmacodynamic and pharmacokinetic, and/or adverse effects with the objective of determining the safety and/or efficacy of the new drug.
Discover various rules and guidelines for getting a licence to conduct clinical trials in India with our professionals.
State License Authority Services
Manufacturing License
A drug manufacturing license is described under the purview of the Drugs & Cosmetics Act 1940 and shall be obtained from the State License Authority or Central License Approving Authority (CLAA).
We help you to file the correct documents with the required processing fee so that you can submit the application for a manufacturing license properly.
Form 29 for Test Batch
A license in Form 29 is obtained by the drug manufacturers for the purpose of examination, testing, or analysis of drugs if they do not hold a license in Form 25 or Form 28. If you need assistance, connect with our experienced staff to understand the complete process before submitting your documents.
Free Sale Certificate
A Free Sale Certificate is issued by the concerned Licensing Authority. At Dueran Consultant, we guide our clients to follow a step-by-step process from top to bottom for obtaining the certificate.
Market Standing Certificate
Market Standing Certificate issued by the Licensing authority, offers information about a company’s status and reputation in the market. If you want to participate in government tenders, enter into a joint venture, or demonstrate credibility to potential customers or clients, you are required to have Market standing certificate.
Non Conviction Certificate
A Non Conviction Certificate is used to certify the firm has not been convicted under Drug & Cosmetic Act, 1940. In India, drugs manufacturing or import is a subject to stringent regulations controlled by CDSCO. A NCC certificate reflects good manufacturing practices, public safety & consumer confidence, and international compliance. To know up-to-date information and requirements related to Non Conviction Certificate, do not hesitate to connect with us.
Neutral Code Certificate and Special Code Certificate
Neutral Code and Special Code Certificates are approved by concerned Licensing Authority. They are helpful when manufactures do not intend to reveal their name or address on the label of the product. In such a case, they need to seek the permission for special code or Neutral Code Certificate. In order to export of finished formulation and bulk drugs, we help companies to get Neutral Code Certificate/Special Code Certificate by filling the application along with required documents.
Retail License
Do you wish to go further for retail sale of drugs? If your answer is yes, then our knowledgeable experts will help to get retail license, which is required for the retail sale of drugs. By getting retail license, you can sale drugs to the users.
Wholesale License
A wholesale license will be granted in Form 20B or Form 21B, when the application is filled and satisfy the licensing authority by meeting the required conditions. The SLA is responsible for providing wholesale licenses in India.
Zonal Services
Dual Use NOC
Dual-use drugs are drugs that can be used in both pharmaceuticals as well as other industries, including the textile industry, food and packaging, chemical industry, and more. To import dual-use drugs, companies must have NOC (No Objection Certificate). Having a huge practical experience in handling drug regulatory requirements, we can help to obtain Dual NOC from zonal offices of CDSCO.
Drug License Online Application in India
Obtaining a drug license requires three important steps. While meticulously working on each application, we have acquired the understanding of completing the legal requirement for obtaining a drug license to comply with the Drug and Cosmetic Act, 1940.
Being an applicant, you should have the idea how to go ahead for submitting a drug license online application. You must know the type of drug license meet your business requirements.
Register on SUGAM Portal
To build extensive regulatory framework for the CDSCO registration processes, government of India has created a digital platform called SUGAM portal. You need to submit your application along with essential documents and fees for every process.
Onsite inspection
Once your application is received by the authority, they will appoint an inspection officer. He will visit your company premises or shop or the drug store in order to verify the documents and authenticity of your provided data.
Issuance the license
After the verification and inspection, Drug licensing authority will issue the license. From applying for a drug license online to obtaining the license, we make sure you will follow the right procedure.
