Wholesale Drug License in Kerala - Process, Fees, Documents

Wholesale Drug license registration is a critical certification required for wholesalers dealing in medicines and cosmetic products. Wholesalers are those who either sell or store such products in bulk. The Drug license is a mandatory compliance for all wholesalers operating in Kerala. The objective of issuing drug licenses to wholesalers in Kerala is to regulate the sale of generic and non-generic medicines and cosmetic products and enhance consumer trust in the existing market.

Drug license registration is an obligatory and mandatory compliance for businesses involved in selling, storing, or manufacturing medicines, as well as for other traditional drug-related businesses in Kerala.

Let's dive into the legal framework governing the wholesale drug industry and highlight the government's initiatives to support and regulate this sector in India.

Wholesale Drug License Certificate Sample

Form-20B
Form-21B

Table of Content

Wholesale Drug License in Kerala
Eligibility for Drug License in Kerala
Documents Required for Drug License in Kerala
Fee for Wholesale Drug License in Kerala
Process for Wholesale Drug License in Kerala
Benefits of Registration in Kerala
Conclusion
FAQs

Wholesale Drug License Registration In Kerala?

A wholesale drug license certificate is a type of authorization given to wholesalers of medicines and their allied products to sell and store in retail. It is an obligatory requirement by the government for businesses dealing in the wholesale market. As per the guidelines prescribed under the D&C act, applicants are required to apply under form 19AA and other relative forms with the central licensing authority to obtain drug license certification in Kerala.

Requirement to get a Wholesale Drug License

Space is required for a physical shop.
Must have a full-time qualified pharmacist or a competent person.
Submission of documents proving the ownership or legal occupancy of the premises.
Provide a detailed blueprint or layout plan of the premises.
Submit invoices for all necessary types of equipment.

These are the prerequisites required to start as a wholesaler in the pharmaceutical business in Kerala.

Classification of products under drug and controller act

Drugs are classified under the following categorie for sale in market

Medicines
Health Supplements
Nutraceuticals

Documents Required For Wholesale Drug License In Kerala

These are the following documents that are needed to be attached for Wholesale drug license application.

General Documents
Documents required for Manufacturing License

General Documents

Details of Applicant
Copy of proprietorship/ Company Incorporation certificate
Address proof and identity Proof of Proprietor/director

Documents required for wholesale License

Key plan and site plan of the premises
Affidavit of non-conviction regarding property respectively
Affidavit from the registered pharmacist or competent person
Proof of qualification is required
Experience certificate is required
Appointment letter and biodata of the competent person
Proof of premises such as sale deed, utility bills, or rent agreement if rented

Fee For Wholesale Drug License Registration in Kerala

The professional fee for a Wholesale drug license in Kerala is INR 24,999/- only. Applicants are required to pay a government fee during the registration process.

Note: The aformentioned Fees is exclusive of GST.

Procedure For Wholesale Drug License in Kerala

Step 1 - Account Creation for users

An online login user ID and password is created on the portal to initiate wholesale drug license registration process with central licensing authority for drug and cosmetics.

Step 2 - Documentation

After the creation of user login credentials, all the required documents for drug license will be verified by our expert before filing a formal application with the central licensing authority for registration.

Step 3 - Filing Application

Once documentation is completed a formal application will be filled under form 19A for Wholesale drug license along with other relevant forms in its entirety.

Step 4 - Issuance of Certification

A formal inspection will be held by licensing authorities for authorization for Wholesaler license. The registration process would take around 30 days to complete.

Benefits of Drug license certification In Kerala

Legal Compliance: Ensures compliance with the Drugs and Cosmetics Act, 1940, demonstrating a commitment to operating within the bounds of the law.
Quality Assurance: Involves a rigorous evaluation of products and the facilities where they are manufactured or stored, ensuring consumer confidence in the safety and efficacy of pharmaceuticals.
Consumer Trust: Legally approved and regulated products build consumer trust in terms of quality and safety, enhancing the brand's reputation.
Market Access: Many government tenders, hospitals, and medical institutions require suppliers to have a valid drug license, expanding market reach.
Export Opportunities: If you have aspirations to export pharmaceutical products, a drug license is often a prerequisite, facilitating entry into global markets.
Regulatory Support: Obtaining a drug license means you are part of a regulated industry, providing access to regulatory support and updates on industry best practices.
Business Credibility: In a highly competitive industry like pharmaceuticals, credibility is everything. Having a drug license adds a layer of credibility to your business, assuring partners, investors, and stakeholders of legitimacy.
Risk Mitigation: Operating without a drug license carries the risk of product seizures, legal penalties, and damage to your business's reputation. By obtaining a license, you reduce these risks and ensure the smooth operation of your pharmaceutical business.

Conclusion

A Wholesale Drug License is an important certification for the aggregator business model of drug and cosmetic products in Kerala. As the drug industry is highly regulated and deals with public health and safety, it is mandatory for all wholesalers of such products to get a drug license certification from CLA for their business in Kerala.

Frequently Asked Questions

How does the Wholesaler Drug License registration process in Kerala compare with Manufacturing Drug License requirements in Manipur?

In Kerala, the wholesaler license process focuses on verifying premises, documents, and adherence to state drug regulations. In contrast, Manufacturing Drug License in Manipur involves additional checks related to manufacturing compliance, technical staff qualifications, and GMP standards.