Drug License in India: Registration Process, Eligibility & Online Application

The Indian government is responsible for ensuring the sustainable distribution of medical drugs across states. It further includes the quality of drugs or the whole supply chain. But the manufacturers and retailers have the right to distribute the drug products accurately. To monitor such a supply chain, the relevant controlling authority has mandated compulsory drug license in India. Meanwhile, there are very strict rules in India for issuing the license for drug manufacturing, retailing, or selling. On the other hand, navigating the drug license registration process can be complex for a startup or new business. This comprehensive guide will explore the process for drug certification online, required documents, types of drug licenses, etc. 

1. What is a Drug License in India?

The businesses that monitor the manufacturing, selling, stocking, or distribution of medicines are first required to align with CDSCO’s standards. Having a valid drug license ensures that the businesses get the legal permission to manage the operation. Under the Drugs and Cosmetics Act, 1940, ensuring the drug quality, safety, and effectiveness is mandatory. It guarantees that the medicines are safe and will not harm consumers.  Licensing ensures that drugs are safe for consumers, thereby ensuring consumers will not be harmed as a result of using a particular drug. Licensing provides a legal framework under which drug manufacturers, wholesalers, retailers, and importers may operate. License also protects the public’s safety and health by prohibiting unsafe, substandard, counterfeit, and expired drugs from being sold.

2. Why is a Drug License Mandatory in India?

A drug license does not just establish a legal requirement; rather, it represents a vital component of a successful business that is related to the production and sales of pharmaceuticals to help ensure public health. In addition to protecting the quality, safety, and effectiveness of drug products through regulation, licensing also helps protect patients from harmful, counterfeit, improperly labeled, expired drugs, and other contaminants. Licensing is also critical for ensuring that pharmaceutical companies comply with all state and federal laws established under the Indian Drugs and Cosmetics Act of 1940. Here are the key reasons why drug license registration is compulsory:

• Legal Requirement: Licensing is a legal requirement under the Indian Drug and Cosmetics Act of 1940.  
• Quality Assurance: Quality Assurance (minimum acceptable standards) for storage, handling, and selling drugs is to be established and enforced in accordance with 2 to 6 different state and federal regulatory bodies that monitor and supervise the manufacturing process from production to sale at retail. 
• Comprehensive regulation: Comprehensively regulating the import and export of certain types of controlled drugs (for example, Schedule H drugs and Schedule X drugs). 
• Legitimacy—Investigating and verifying the legitimacy of a drug, business, or organization providing either services or products to the general public.

3. Types of Drug Licenses in India

There are several drug certifications, but it depends on the specific activity performed by the registered business. It depends on the drug type and the sales channel (whether it is a retailer or wholesaler). Here is the table for clear understanding:

4. Who Needs a Drug License in India?

To get legal recognition in competitive markets, the pharmaceutical industries are required to obtain a drug certificate in India. It generally allows the government bodies like CDSCO, State Drug Control Departments, etc., to monitor quality from raw material to consumers. 

Meanwhile, securing this crucial license has become mandatory for manufacturers who produce allopathic, ayurvedic, cosmetic, or other regulated products. It is compulsory for:

• Drug Manufacturers

• Drug Wholesalers & Distributors

• Drug Retailers
• Importers & Exporters
• Online Pharmacies
• Business Dealing with Cosmetics

In essence, any business that operates pharmaceutical products in any way in India is eligible for drug license registration.

5. Eligibility Criteria for Drug License Registration

Meeting the regulatory requirements is the primary step to be eligible for a pharmacy license. The industry generally requires providing the qualification, identity/business proof, etc. Meanwhile, the key requirement includes

1. Eligibility & Personnel

Pharmacists/technical staff must be registered with the Pharmacy Council Registration. 1 year of experience in medical wholesaling in relevant sales/marketing. Evidence of appointment for the pharmacist. 

2. Business & Legal Documents

Complete the application form in the format of Form 19, 19A, and 19B. For business proof, firm registration, and partnership deed, or MOA/AOA. All partners’/directors’/proprietors’ identity and address proof. For business registration proof, the GST registration certificate. 

3. Premises-Related Documents

Ownership documents or a rent agreement for proof of possession. A detailed layout/blueprint of the premises is required, along with the electricity/water bill for the premises. In addition, the area of the premises must be a minimum of 10 sq. meters (retail/wholesale) or 15 sq. meters (for both).

4. Declarations & Fees

Under the Drugs Act, required declarations of non-convictions, including compliance with local laws and pharmacist details. Pay the prescribed registration fees and the purpose bill for necessary refrigeration.

6. Documents Required for Drug License Registration

For drug license registration, multiple documents need to be provided. These major documents include:

• Application form (e.g, for a retail license, the Form 19)
• Applicant’s identity and address proof like Aadhaar card, PAN card, voter ID, driving license, and electricity bill, etc. 
• photographs and an affidavit on the stamp paper.
• For business constitution, the partnership deed, MOA/AOA, trust deed, and LLP agreement.
• Ownership deed, registered GPA, and rent agreement for premises proof.
• Complete plan of the premises.
• Storage proof and fee receipts
• Pharmacist/technical staff qualification proof and registration.
• Identity proof and appointment letter.
• Bio-data/Experience  in a prescribed format

How a Drug License in India Helps You Avoid Heavy Penalties

7. What are the Drug License Fees in India?

The fee structure of drug registration depends on the specific type of license (e.g, retail, wholesale, or manufacturing). In addition, it further depends on the state. But in general, it ranges from Rs 3,000 for retail/wholesale to Rs 5,000 or more for manufacturing. The government fee is distributed as follows:

8. Step-by-Step Drug License Registration Process in India

Follow this error-free and easy registration process: 

Step 1: Identify License Type & Authority

Determine which type of business you are managing. Clarify that you need a retail, wholesale, manufacturing, or import license and locate the relevant State Drug Control Department website or CDSCO for central licenses.

Step 2: Online Registration

Navigate the online portal for a fast registration process. Register on the portal and make an account on it by filling out the application form. If registering for retail sale, fill out the Form 20/21 and Form 24/27 for manufacturing.

Step 3: Upload Your Papers

To register your pharmacy, you need to upload scans of the following:

• Business Proof: Your incorporation certificate, partnership deed, and GST registration.
• Premises Proof: Your rental agreement or proof of ownership, site plan, electricity bill, and property tax receipt.
• Technical Staff Details: Qualifications, experience, appointment letters, biodata, and affidavits for full-time work (for qualified pharmacists/technical staff).
• Other Documents: Proprietor/Director KYC, photographs, and layout plan.

Step 4: Pay Fees

Use a particular payment method to pay the online registration fee. Use a particular payment method to pay the online registration fee. The cost may change depending on the state and type of license. The cost may change depending on the state and type of license.

Step 5: Submit Hard Copies

Within 15 days of your online submission, hard copies of your application and any supporting documentation must be sent to the District Drug Control Authority.

Step 6: Inspection

A drug inspector will come to your pharmacy and register it after confirming your paperwork and application. The size of your pharmacy, along with all other equipment and personnel, will be verified by the drug inspector.

Step 7: License Issuance

Once the Drug Controller has verified all information using the results from the inspection, you will receive your pharmacy license from the Drug Controller. Your pharmacy license will be available on the Online Portal.

9. Drug License Registration Online in India

Drug manufacturers no longer have to deal with physical document management. It was a waste of energy and too time-consuming. But it is not a more challenging part since the online portal has been introduced. For fast and hassle-free drug license registration, the applicants can use the State Drug Control Authority’s portal. The Online National Drugs Licensing (ONDLS) portal streamlines the registration process.

10. Timeline for Drug License Approval (How Long It Takes)

The drug license approval timeline varies significantly, depending on the license type. In short, it is typically timed by license. 

For example, the retail/wholesale license at the state level generally takes a 1-3 month timeline. Under this timeline, the inspection process follows, and on the other hand, it takes 35 days for some Schedule X. In addition, for a manufacturing license, it takes 4-7 months. For the CDSCO new drug approval, it takes 9-12 months, and 4-6 months for fixed-dose combinations. Including 6-9 months for import registration.

11. Inspection & Verification Process (What to Expect)

The Inspection & Verification Process is to follow a clear, systematic approach confirming that a product/item/document/service has conformed to certain standards, requirements, or regulations (i.e., has been properly authenticated). The specific processes may vary depending upon the context (i.e., document authentication; material handling; etc.); however, the general steps are as follows:

• Preparation: All documents must be ready and in an accurate format. Before the inspection, prepare all the supported documents.
• Self-Inspection: Conduct the visual inspection for a quick check to avoid damage or defects. 
• Compliance Determination: The drug inspector will evaluate the findings against predefined quality standards. Their last decision will confirm whether the item passes or fails.

12. Validity and Renewal of Drug License

In India, the drug license is valid for five years from the date of approval. From the 2017 amendment to the Drugs and Cosmetics Rules, 1945, the renewal of a drug license is referred to as “License Retention.” But sometimes the validity depends on the specific type of license. For example, a license for blood banks or narcotics might have a shorter validity period. The condition for it is that the license will be active unless it is canceled or suspended by the licensing authority. 

Renewal (License Retention) Process

For the continuous legal operation, the renewal of the drug registration license is critical. The process follows as:

Ensure Expiry Date: The application for retention must be submitted at least 90 days before the current license expiry. It helps to avoid a late renewal penalty.

Documentation: Gather all the necessary documents, which include,

• Current drug license copy 
• Good Manufacturing Practice for compliance proof
• Address proof of the premises
• Identity and qualification proofs of the license
• Records of stock management and sales.

Application Submission: Submit the completed retention application form to the respective State Drug Regulatory Authority.

Renewal Fee Payment: The fee structure for the license retention is similar to the original drug license registration fee.

Inspection (if applicable): Again, a whole premise inspection may be conducted by the State Drug Inspector.

Approval and Issuance: Upon successful approval by the controlling authority, the renewal (retention) application will be approved, and the validity of the certificate updated.

13. Amendment/Changes in Drug License (Address, Pharmacist, Firm Details)

For any amendments or changes to the drug license in India, the respective company or drug industry is required to confirm the controlling authority. You need to apply online via your state’s respective single window portal. 

For example, if you are looking to change the premises address. For the change in premises address, surrender the old license and apply for a new one with a new address. As prescribed, provide all the necessary documents accurately.

In case of a pharmacist change, update the technical details of the person by using the online portal. Meanwhile, an amendment to the firm’s details should be reported online to the controlling authority by visiting the page.

Note: To follow the state-specific instructions, navigate the official portal for your region (e.g., drugs.delhi.gov.in for Delhi or statedrugs.gov.in for the national portal link finder).

How a Drug License Protects Both Patients and Businesses

14. Penalties for Selling/Stocking Drugs Without a License

Selling or stocking drugs in India without a valid drug certification is marked as illegal and a serious offense. Under the Drugs and Cosmetics Act, 1940, whoever tries to sell or stock the drugs without a license will face stringent action. The penalties that an offender may face: 

Imprisonment: The law offender may face imprisonment, which extends up to three years. 

Fine: It will suffer from the monetary fine of not less than 5,000.

Aggravated Offense: If the seller is found guilty of distributing the fake drugs, they will be punished much more harshly.

In conclusion, the major aim of these stringent laws is to ensure that only safe and quality medicines are available in markets for the public. The license allows only authorized and verified channels in markets.

15. Why Choose LegalRaasta for Drug License Registration?

Drug License Registration through LegalRaasta offers a unique online experience at an affordable price, with quick service and a dedicated team of experienced professionals providing complete guidance throughout the process (consultation throughout the life of the business), committed to providing the best customer experience possible and enabling businesses to fully comply with all legal requirements, while minimizing any potential fines or penalties for non-compliance. The key reasons why you must choose LegalRaasta for drug license registration:

• Provide expertise and support, including handling complex legal requirements.
• Offers end-to-end assistance from application to approval
• For a paperless process, it uses digital platforms
• Offers cost-effective service and provides real-time updates.
• Not only drug registration, but their service also includes GST, MSME registration, and CDSCO registration. 

16. Frequently Asked Questions (FAQs)

What is a drug license in India?

Ans. A drug license in India is a core document that is important for getting the legal permission from the state or central authorities. It provides the authorization to businesses or individuals for manufacturing, selling, stocking or distributing medicines across India. 

How to apply for a drug license online in India?

Ans. To apply for drug certification, the applicant must navigate the state’s Drug Control Authority Portal. In addition, you need to fill out the specific application form with scanned documents and prescribed fees.

Why is a drug license required in India?

Ans. Through the drug registration, the controlling authority gets access to control the safety and effectiveness of medicines. It helps to prevent counterfeit or harmful drugs from reaching consumers.

Who needs a drug license in India?

The businesses or individuals who are managing the manufacturing, selling, importing, or distribution of drugs are eligible for drug registration.

What is the difference between a retail drug license and a wholesale drug license?

Ans. Both a retail drug license and a wholesale drug license are required for different purposes. In detail:

• Retail Drug License: It allows pharmacists to sell medicines directly to the end consumers, like patients. 
• Wholesale Drug License: It permits the wholesalers to distribute the medicines in bulk to other businesses like hospitals, pharmacies, and clinics.

Is a registered pharmacist mandatory for a retail drug license?

Ans. Yes, being a registered pharmacist is a legal requirement for obtaining the retail drug license in India.

What documents are required for drug license registration online?

Ans. For online drug license registration, you need to provide:

• Application form 
• Address and identity proof
• Affidavits and board resolution 
• Challan as payment proof
• ownership proof and NOC
• Qualification and pharmacy council registration
• Appointment Letter & Bio-Data
• Experience certificate
• ID proofs & photos

What is the government fee for Drug License registration in India?

Ans. In India, the fees associated with obtaining a Drug License through the government depend upon the state and the type of license you are applying for (retail, wholesale, or manufacturing).  In general, however, these costs will typically be between ₹1500 and ₹7500 for the application and initial registration and may have separate inspection fees as well.  All drug licenses also must be renewed every five years, which generally involves the same range of fee amounts.

How long does it take to get a Drug License approved in India?

Ans. In India, typically, a retail or wholesale drug license takes 15 days to 2 months for approval (dependent on inspection and the state). A manufacturing drug license can take anywhere from 4 to 7 months to approve, and complicated approvals, such as importing medical devices, can take between 6 and 9 months, depending on the type of license, document completeness, adherence to each state’s laws, and the scheduling of inspections performed by the Central Drugs Standard Control Organisation (CDSCO).

Is inspection compulsory for Drug License registration?

Ans. Yes, a physical inspection by a drug inspector is mandatory and compulsory for Drug License registration in India. It is required to verify the business premises, documents, and compliance with the Drugs and Cosmetics Act. Furthermore, it ensures proper safety, storage, and qualified personnel before the license is granted. 

17. Final Thoughts—Drug License Certificate Registration in India

Ultimately, registering for a drug license is an extensive process including several distinct levels of registration that go beyond simply obtaining the legal right to distribute drugs. The Drug Control Department’s website is the central point for registering for drug licenses, as is CDSCO’s ONDLS. Completing the registration will verify that your company meets, among others, the statutory requirements of compliance with Good Manufacturing Practices (GMP). While preparing for the final submission, make sure that you have provided accurate and complete information to avoid being denied. For the latest updates, check www.legalraasta.com.