Wholesale Drug License in India

Making sure that everyone has fair and equal access to medicines and drugs is the primary goal of every government. However, the power to manufacture and market drugs and other medicines must be granted care. Therefore, the government has strict regulations for granting licenses to manufacture and sell medicines and pharmaceuticals. The Act regulating the complete process from manufacturing to selling drugs in India is known as the Drugs and Cosmetics Act 1940.

Companies that deal with medicines or drugs will require different licenses depending on the nature of their commercial activities. A regionally specific Drug License is required to be obtained by a single dealer with multiple locations in multiple states.

Drug Sale License 

The license that is granted to sell drugs. Drug Sale License is divided into two parts - A wholesale Drug License and a Retail Drug License.

• Drug Wholesale License - A drug wholesaler requires a wholesale license. Wholesale is the process of selling the drug to a retailer or individual for further sale.

• Drug Retail License - Retail licensing is necessary for the retail selling of prescription drugs. Retail sales refer to the sale of medicines or cosmetics intended for the final customer's consumption. Retailers may sell it to a hospital, dispensary, educational, medical, or research centre. Retailers selling cosmetics, pharmaceuticals, and cosmetics stand-alone pharmacies and ayurvedic shops require this license.

Drug Controlling Authority or Regulatory Authority

The authority responsible for drug control, also called the drugs controller as specified in the Drugs and Cosmetic Act, is accountable for the issuance of various licenses for drugs. The drug control authorities (licensing officials) are:

* State Drugs Standard Control Organisation (SDSCO) – Provide licenses for sales of the drug, drug distribution, and manufacturing regulated by state authorities.

* Central Drugs Standard Control Organisation (CDSCO) - CDSCO is responsible for the approval process and issuance of new drug licenses and clinical trials for drugs. It also oversees the quality of manufactured drugs and coordinates with SDSCO.

* State Drug Controlling Authority with approval from the Central License Approving Authority – Grants licenses to constitute blood banks and their components and products such as Vaccines, Sera, etc.

* Department of Ayush - Provide licenses for ayurvedic, Unani, Siddha homeopathic, and herbal remedies to be used in medical and cosmetic applications.

Wholesale Drug License

To begin a business involving cosmetics or drugs, it is necessary to get a Drug License. Without a wholesale drug license, it is impossible to conduct an enterprise that consists in selling cosmetics or drugs.

The process and requirements needed for obtaining a license to sell drugs are outlined in the Drugs and Cosmetics Act 1940. The laws that govern the sale and distribution of drugs and their production are covered under the mentioned Act, and the Rule is formulated under it. The existence of a pharmaceutical business that does not have the required license will be an offence. Any person, LLP, partnership firm, OPC, or company can request a drug license. The License can be renewed, and the license is in effect for a maximum of five years.

The Ministry of Health and Family Affairs released the Cosmetic Regulations in December 2020. The rules state that a prescription drug license is required to import cosmetics in India. To be an authorized dealer of cosmetics and drugs in India, any business or person must obtain a wholesale drug license to sell drugs. Wholesale drug licenses are issued by the licensing authority for the particular state. Wholesale refers to selling the drug to individual retailers for further sales of the drugs.

How to Apply for a Wholesale Drug License in India?

State Licensing Authority grants the wholesale license. The process is lengthy and can take between 30 and 60 days.

The following steps need to follow to get authorization to sell drugs wholesale at the authority responsible for licensing state-wide in the state that you reside in India:

• Make sure to ask your pharmacist/Competent person

• Preparation of documents is mandatory

• Portal Registration

• Registration of pharmacists on the portal

• Filling out applications

• Map of registered premise 

• The application process and fee payment

• Examination of the application

• On-site inspection of the Drug Inspector

• The grant of a license

Step 1: The initial step in the application for a license is to find the company’s pharmacist/competent person, who will be the technical director for the company. The pharmacist/competent person is accountable for all technical activities within the company.

Step 2: All required documents should be organized before filling out the application. The required document set is comprised of the following documents shown below.

• Layout plan for the concept

• Invoice of cold storage device If appropriate

• Documentation of the establishment

• GST certificate

• Lease arrangement or Purchase agreement

• Photograph of the applicant

• ID proof and address evidence of the applicant

• The applicant must have a qualification certificate

• Pharmacist/competent person qualification documents

• Ownership document

• List of directors

Step 3: After all required documents are completed, the online account needs to be set up on the website of the state food and drug authorityi.e ONDLS portal. As part of account creation, specific essential details must be provided by the person applying to create login credentials for the company.

Step 5: The final step of the portal following the pharmacist's registration is to complete the online form for the license to sell drugs wholesale. All mandatory information and supporting documents must be provided for their specific areas through the portal.

The company's details, as well as the details of the applicant, must be entered in the application form, and all documents should be uploaded in all relevant fields.

Step 6: the most critical aspect of filling out an application is to identify the pharmacist registered in the application by making use of the ID number that is unique to the application. Once the pharmacist has been successfully identified in the application, the application will be reviewed for the next step.

Step 7: The last step to fill out the application is to submit the application in the direction of the department and pay fees according to the guidelines. After the fees have been paid and the form is delivered to the department, the applicant will receive an acknowledgment or an online form that may be used for future references.

Step 8: After the application's submission and the government fees, the application is scrutinized by departmental officials. If there are any issues or discrepancies identified, the department is notified of the concerns online and requests that you respond online within the stipulated time with a resolution to the issue.

Step 9: After the department accepts the online application, a satisfactory answer will address all concerns.

A site-based inspection is carried out on the premises where the company's activities are conducted with the Drug Inspector's help. The inspector ensures that all the company details are identical to those listed on the internet on the form. In addition, he evaluates the competence of the pharmacist and determines whether he has the required knowledge.

After the officer is satisfied with the inspection, all checkpoints have been completed by the applicant during the inspection. The Drug Inspector sends the application to grant a license.

Step 10: After a satisfactory inspection, the DLA (Drug licensing agency) will issue wholesale licenses under the company's name. After the final license is granted, the applicant can begin working on the business. If there is a violation of the license's terms or conditions, severe sanctions can be imposed, including imprisonment.

Eligibility Criteria To Be Considered For A DrugWholesale License

The following people/entities can apply for a wholesale drug license: -

• Any business, LLP / partnership firm/person is eligible to apply for a drug license.

• A competent person (registered pharmacist with the council of state pharmacies) with previous experience is eligible to apply for the wholesale license.

Validity of Wholesale Drug License

A wholesale Drug License is valid for a duration of three years. The license must be displayed at the location of the business during working hours.

Conclusion

Medicines and drugs are essential products to maintain health. In recognition of their importance, the government has outlined an exact procedure for applying for the issuance of a drug license. The process of starting a wholesale drug business in India isn't difficult, but one has to plan for it. The formalities have to be met during the process of obtaining a license to distribute or sell drugs. This will ensure that wholesalers of drug products follow all of the regulations. To get permission for a wholesale drug license in India, the applicant must comply with the rules and regulations of the Drugs and Cosmetics Act 1940. The regulations ensure that a licensed and skilled person conducts the business of selling drugs.

Because the safety of people is the top concern, the government will ensure that the drugs don't put lives at risk. It is the Central Drug Control Organization (CDSCO) is the body that regulates medical devices and pharmaceuticals. CDSCO is accountable for formulating the guidelines for drugs and coordinates with the activities of the State Drug Control Organization (SDCO) by providing expert guidance to achieve uniformity in implementing the Drugs and Cosmetics Act regulations.