China Moves 30 Drugs OTC, Encourages Nonprescription Switches

China's State Food and Drug Administration assigned 30 drugs OTC status in a notice issued Jan. 11, reflecting the agency's interest in expanding availability of nonprescription drugs to help reduce health care costs.

Effective immediately, the notice covered cetirizine hydrochloride tablets and 29 other branded and generic drugs, including 13 chemical drugs and 17 Chinese proprietary medicines.

The 30 drugs include dispersible guaifenesin and dextromethorphan hydrobromide tablets, erythromycin and benzoyl peroxide topical gel, pseudoephedrine hydrochloride capsules, tinidazole vaginal effervescent tablets, nifuratel and Nysfungin vaginal soft capsules, butenafine hydrochloride sodium chloride eye drops, menthol nasal inhalation, crotamiton cream, carraghenates cream and benzocain gel.

SFDA has called on regional FDAs from all provinces, autonomous regions and municipalities to enact relabeling of these drugs, in accordance with the "standardization rules on non-prescription drugs leaflets" and other relevant provisions, according to the SFDA.

China encourages pharmaceutical enterprises to switch prescription drugs that are proved safe and effective to OTC status, Wang Xi, an analyst with Shanghai-based Industrial Securities, told PharmAsia News.

Wang said that because of increasing pressure on the China's public health expenditure, the government tends to promote self-medication and the use of OTC drugs.

Because the use of OTCs can reduce the cost of medical care, "encouraging OTC drug consumption is the most effective method to economize medical welfare spending," Wang said.

Pharmaceutical enterprises will also benefit from switches, he said.

Pharmaceutical companies can advertise an OTC drug in the mass media in China and expand their market in order to maximize profits, according to Wang.

"However, some OTC drugs are still listed on China's current national medical insurance directory," he said. If prescription drugs "are switched over to OTC category and are no longer listed on the national medical insurance directory," then consumers will have to bear the burden of the cost.

According to the trade group China Non-prescription Medicine Association, China's non-prescription drugs market is growing at 15 percent annually, the fastest rate in the world, to become the world's fourth largest OTC market.

China's OTC market was valued at 90 billion yuan in 2006, and is expected to exceed 100 billion yuan in 2007.

In 1997, the CPC Central Committee and the State Council on Health Reform and Development established a prescription/non-prescription classification system in order to enhance self-care and self-medication initiatives.

In 1999, SFDA issued the "prescription drugs and non-prescription drugs classified management approach," under which the agency is responsible for oversight of the classification system.

Drug supervision and administration departments at all provincial levels are responsible for management of the system. However, the State FDA is in charge of approving, publishing and restructuring the non-prescription drugs directory.

In 2004, SFDA began accepting and approving applications for Rx-to-OTC switches.

Domestic drug makers or imported drug distributors have to apply to provincial FDAs for any OTC switch. If the application is deemed eligible, the provincial authority will forward it to the SFDA's Drug Safety Supervision Division.

SFDA reviews the submitted application and organizes experts and relevant organizations to conduct a medical and pharmaceutical evaluation.

If the switch is approved, the SFDA publishes the drug under its list of prescription drugs switched to OTC.

-Ying Huang

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