A large number of non-pharmacy outlets can now sell Class B OTC drugs.

Source: Pharmacy Manager

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Category B OTC sales are being significantly liberalized, and a growing number of non-pharmacies are set to enter the drug-selling market.

Category B OTC sales, widely liberalized

On June 19, the official website of the Hubei Provincial People's Government released the "Several Measures to Further Promote Commercial Consumption in Response to the Impact of the Epidemic" (hereinafter referred to as the "Measures"). The document comprises a total of 25 measures, covering areas such as cost reduction, burden alleviation, crisis support, fostering a favorable consumption environment, and optimizing regulatory services.

Among these measures, regarding the optimization of regulatory services, the "Measures" propose, "Simplify the approval process and application materials for retailing Class B over-the-counter drugs, reducing the approval time to within 2 days."

A growing number of non-pharmacy businesses will start selling medications.

So, what exactly does simplifying the approval criteria for retailing Class B over-the-counter drugs really mean? Based on market feedback, it doesn’t hold much significance for pharmacies that primarily focus on selling pharmaceuticals.

On the contrary, companies that have experience with other products, by allowing Class B OTC sales, will be encouraged to expand their sales channels and enter the pharmaceutical retail market. This demand is particularly high among non-pharmacy outlets such as convenience stores, supermarkets, health-focused shops, and health supplement stores.

At the end of last year, Jinhua City in Zhejiang Province also relaxed regulations on the retail sale of Class B over-the-counter drugs, allowing eligible businesses to receive their new licenses immediately on-site. Notably, prior to the reform, most of the 88 existing Class B OTC drug retailers in Jinhua City were primarily operated by large supermarkets, ginseng and medicinal herb shops, and other similar entities.

This example also shows us that general pharmacies typically don’t choose to carry only Class B OTC products—unless they face limitations in resources or fail to meet the necessary requirements, forcing them to make that decision. Moreover, a pharmacy that focuses exclusively on Class B OTC products has limited capacity, which in turn restricts the range of choices available to consumers.

Overall, simplifying the approval requirements for retailing Class B over-the-counter drugs—which also implies easing restrictions on pharmaceutical sales outside traditional pharmacies—will encourage non-pharmaceutical retailers to expand their product offerings and fully integrate drug-selling into their business strategies.

Convenience stores should fully roll out the sale of pharmaceuticals.

It is worth noting that when Hubei Province issued these measures, it emphasized the need to implement the spirit of the "Opinions of the General Office of the State Council on Accelerating the Development of Circulation and Promoting Commercial Consumption" (Guobanfa [2019] No. 42). Meanwhile, Article 4 of this opinion—titled "Accelerating the Development of Chain Convenience Stores"—also mentions launching a pilot program to streamline approval procedures for operating tobacco products and Class B over-the-counter drugs.

Meanwhile, the "Guiding Opinions on Promoting the Accelerated Development of Branded Chain Convenience Stores," jointly issued by 13 departments including the Ministry of Commerce, also stated: "Branded chain convenience stores may apply to sell Class B over-the-counter drugs according to relevant standards. Additionally, enterprises can centrally assign qualified personnel for quality management, streamline approval processes and application requirements, shorten approval timelines, enhance operational efficiency, and further reduce institutional costs for businesses."

Against this backdrop, similar documents have now been issued in regions such as Inner Mongolia, Gansu, Shandong, Beijing, and Jiangxi. Notably, the rollout of these measures has been further accelerated following the outbreak of the pandemic—prior to this, Inner Mongolia and Gansu had already released their respective documents.

On April 24 of this year, the website of the Inner Mongolia Autonomous Region Drug Administration issued a statement announcing that it would encourage and support branded chain convenience stores to apply for retail licenses to sell Class B over-the-counter drugs. According to the region's drug administration regulations, the region will provide support to these brand-name chain convenience stores in two key areas: not only relaxing the application and approval criteria, but also proactively assisting non-pharmaceutical retail businesses in addressing their professional shortcomings.

First, in terms of administrative approval, the district clearly aims to streamline the approval process and actively supports community-based, brand-name chain convenience store operators in applying to sell Class B over-the-counter drugs for retail purposes. Additionally, in line with local standards for establishing pharmaceutical retail businesses, the district will continue to optimize the licensing procedures, simplify application requirements, reduce processing times, and enhance overall efficiency.

Secondly, in terms of service guidance, we will not only assist brand-name chain convenience stores applying to sell Class B over-the-counter drugs in retail operations by strengthening training for pharmacy staff, but also provide guidance on establishing an internal quality management unit led primarily by the convenience store managers. Depending on the scale of their business, these units will appoint full-time or part-time personnel specifically responsible for pharmaceutical quality management.

On March 20 of this year, the Gansu Provincial Drug Administration issued the "Opinions on Promoting Innovative Development and Convenient Services for Pharmaceutical Retail Enterprises," which, under the section "Encouraging Convenient Services by Pharmaceutical Retail Enterprises," allows commercial entities such as department stores, supermarkets, and convenience stores to set up dedicated drug counters within their business premises, enabling them to sell Class B over-the-counter medications and thereby expanding public access to these products.

Meanwhile, regarding approval and filing procedures for Class B over-the-counter drugs and other related matters, we must streamline and optimize the approval processes, shorten processing timelines, enhance approval efficiency, and improve service quality—creating a favorable administrative environment that fosters innovation and convenience for pharmaceutical retail enterprises.