Benefits of the Wholesale Drug License

A wholesaler drug license in Form 20B or 21B is a prerequisite for selling or distributing drugs in India. This is because there are strict rules laid by the Drugs and Cosmetics Act,1940 for granting permission to sell and distribute drugs. It also lets the retailers and customers know that the product sold by the wholesaler does not pose health risks. In this article, let’s go through the different benefits a wholesaler has after getting a wholesale drug license.

Wholesale Drug License at a Glance

According to the Drugs and Cosmetic Rules provisions, wholesalers must obtain a wholesale drug license to sell, exhibit, stock, or distribute drugs in India. Individuals can issue wholesale drug licenses for products like drugs and  biologicals. 

The regulatory authority associated with this service is the State Licensing Authority (SLA). Individuals interested in a wholesale drug license must apply to the SLA. After the application, the Competent Authority carries out an inspection and grants a license.

Since the SLA provides a wholesale drug license, getting different licenses for the respective state where the wholesaler intends to do their business is essential. Conducting business without taking proper approval from the SLA can result in penalties.

List of Forms Involved in Obtaining Wholesale Drug License

The following forms are essential for availing the wholesale drug license in India:

• Form 19: This is an application form which the individual needs to submit for the sale or distribution of drugs 
• Form 20B:This form grants permission for the sale and distribution of drugs other than those included in schedule C, C (1), and X of the Drugs & Cosmetic Act and Rules
• Form 21B:This form grants permission for the sale and distribution of drugs for those included in schedule C, C (1), and X of the Drugs & Cosmetic Act and Rules

The wholesale drug license remains valid for a lifetime unless the regulatory authority cancels or suspends the license.

Benefits of a Wholesale Drug License

A wholesale drug license opens endless possibilities for wholesalers despite strict rules and regulations. Individuals can get the following benefits after having a wholesale drug license (Table 1):

• Executes drug-related activities
  The registered pharmaceutical companies must constantly remain updated about new developments and comply with the existing regulations. Though this may seem like a burden, it positively impacts the companies.
  A wholesale drug license helps pharmaceutical companies maintain a seamless supply chain. In addition, it allows wholesalers to continue their business without much difficulty and legal problems.
• Improves management and efficacy of drugs
  Remaining complaint with the rules laid down by the government authorities positively impacts a pharmaceutical company’s production efficacy. 
• Aids hygiene of drugs
  Since drugs can quickly get contaminated,the Central Drugs Standard Control Organization (CDSCO) provides guidelines under the Drugs & Cosmetic Act of 1940. These guidelines need to be followed by the wholesalers to maintain the best possible hygiene of the drugs.
  A valid wholesale drug license holder ensures that the drugs are properly stored and do not pose health risks to any individual. In addition, government authorities always send official notices to license holders about the changes in drug procurement procedures.
• Builds good relations with the retailers
  A wholesale drug license ensures that the license holder has followed every possible measure given by the government authorities. This provides transparency in business practices. Drug retailers are often concerned about the quality, pricing, and storage of the drugs they wish to purchase. Therefore, with a wholesale drug license, drug retailers do not have to worry about these attributes.
• Increases market exposure
  A wholesale drug license not only helps the license holder to sell, exhibit, stock, or distribute drugs but also increases their market reach. With increased visibility, companies can look for new opportunities to expand their business. 
• Boosts business credibility
  A wholesale drug license shows the consumers that strict quality standards have been followed while distributing drugs. In addition, remaining compliant with the Drugs and Cosmetics Act,1940 helps develop credibility and creates numerous business opportunities for sustainable growth.
• Act as an Indian Agent/Marketing Authorization Holder
  A company having wholesale license can also act as an Indian agent or Marketing Authorization holder for foreign manufacturers who wish to register their products to market in India.

Conclusion

Drug wholesalers typically purchase the product in bulk from the manufacturers and sell it to retailers, community pharmacies, and hospitals. In addition, obtaining a wholesale drug license needs many formalities without any mistakes. 

The rules laid down in the Drugs and Cosmetics Act, 1940 are stringent since drugs are essential in maintaining the health of individuals. Therefore, it is crucial to obtain a proper license to save the wholesale business from fines and penalties.

Short description:

The State Licensing Authority grants a wholesale drug license to wholesalers who wish to sell, exhibit, stock, distribute drugs in India.

Summary

• Individuals can apply for a wholesale drug license in Form 19, and they can get the license in Form 20B or 21B or Both
• The State Licensing Authority grants the license
• The wholesale drug license helps individuals execute drug-related activities, improve management and efficacy, maintain the hygiene of drugs, build good relations with retailers, increase market exposure, and boost business credibility

References:

1. https://cliniexperts.com/india-regulatory-services/drug/for-manufacturer/wholesale-license/
2. https://www.bizadvisors.io/wholesale-drug-license