Study says generic drugs are as effective as branded ones

A recent investigation by Chinese healthcare and drug regulators has found that generic drugs purchased through the country's bulk procurement programs are as effective as their original versions, and concerns about quality issues primarily stem from isolated cases or subjective experiences.

The National Healthcare Security Administration sent an investigation team to Shanghai in late January after media reports said several political advisers, most with medical backgrounds, had raised concerns over the efficacy of some medications procured through the national bulk-buy program, particularly drugs for high blood pressure, diabetes and anesthetics.

In a report published on its website, the administration said a real-world clinical study by Ruijin Hospital, affiliated with Shanghai Jiaotong University's School of Medicine, found that a generic version of the high blood pressure drug Norvasc was just as safe and effective as the original. The administration said claims suggesting the generic drug is less effective are based on personal experiences.

Additionally, anesthesiologists and hospital officials from various hospitals in Shanghai said the generic versions of the anesthetics they use produce the desired clinical outcomes. Interviews with them, along with a retrospective study at Ruijin Hospital, showed no significant dosage changes before and after the bulk procurement program.

Addressing concerns about bulk-buy laxatives used for endoscopic examinations, the administration said the bowel-cleansing solution selected for bulk purchase in late December has not yet been introduced in public hospitals.

Several hospitals in Shanghai reported no related complaints from clinical doctors, and a senior colorectal surgeon said domestically made laxatives have been used for two years without reports of reduced effectiveness.

The administration said concerns over the quality of bulk-buy generic drugs have largely stemmed from secondhand information or subjective impressions. Chinese drug regulators have established stringent evaluation criteria and methods to ensure the efficacy and safety of generic drugs before granting market approval, followed by continuous quality oversight after their release.

The agency said rigorous methodologies and processes are needed to produce scientific, fair and accurate assessments of drug efficacy. However, it noted that individual cases are easier to understand and tend to have a greater impact and spread more rapidly than scientific evidence.

In response to concerns that the centralized procurement program could squeeze original medications out of the Chinese market, the administration said bulk-buy drugs typically account for 60 to 80 percent of the total volume required by medical institutions, which are free to choose brands for the remaining portion.

To enhance oversight of bulk-buy medications, the administration said it is committed to conducting regular and random checks on drugmakers that win bids and will promptly address any issues.

It also said it will encourage frontline doctors to use a monitoring platform to report adverse reactions and potential drug problems and will support medical workers and institutions in conducting real-world studies comparing the effectiveness of original drugs and their generic counterparts.

Generic drugs contain the same active ingredients as their equivalent original branded drugs.