CDSCO Steps Up Quality Control In India
The Central Drugs Standard Control Organization (CDSCO) announced plans to survey a broad selection of drug samples available on the Indian market to counter recent complaints of substandard manufacturing, reports The Business Standard.
The survey will be conducted in a coordinated effort with the National Sample Survey Organization (NSSO) and will collect samples from a variety of companies from different parts of the country and analyze them for quality. The CDSCO anticipates the project will take three to four months.
Concerns about quality control in India have gained international attention and led many countries to institute company-specific bans. There have been some allegations that Indian drugs exported to low-income countries are not receiving the same standards of quality.
An article published by the Royal Society of Chemistry reports that the harshest criticisms have come from a report published by U.S. researchers, which found quality issues in drugs collected in African countries.
However, researchers argue that there might be any number of reasons for these quality issues. Improper Storage concerns and poor distribution could also contribute. The problems aren’t necessarily the fault of the manufacturer.
The CDSCO hopes that their analysis report can help quell some of the nervousness countries have about importing drugs manufactured in India.
A senior CDSCO official told The Business Standard that the organization had conducted a similar sample analysis in 2009 and found that instances of “not of standard quality” (NSQ) to be relatively low. Of the 24,136 samples collected in 2009, .0046 percent were found to be substandard.
He agreed, however, that constant vigilance needed to be maintained. He said, “There is a need to assess the actual extent of spurious as well as substandard drugs in circulation in a systematic manner.”
According to Business Standard, the CDSCO conducts unannounced tests on samples collected from a variety of sources, including hospitals and retail locations on a monthly basis.
Business Standard quotes a representative from a Gujarat-based mid-sized manufacturer, who says “the current exercise is an initiative to boost quality control across the country.”