CDSCO analysis reveals prevalence of substandard drugs in India

11-Mar-2014 - Last updated on 11-Mar-2014 at 13:37 GMT

Nearly a quarter of drugs made in Jammu & Kashmir and 10% of those produced in Himachal Pradesh are substandard according to new testing data published by CDSCO.

Last week the Central Drugs Standards Control Organization of India offered a first look at its analysis of drug samples taken from facilities located at various manufacturing hub/clusters/locations falling under jurisdiction of CDSCO zonal and sub-zonal offices.

The samples were collected and tested for their quality at the Drugs Testing Laboratories of CDSCO from the month of December 2012.

Uttar Pradesh, Madhya Pradesh and the ‘South Zone’ were the only regions to have no sub-quality drugs, though the sample sizes were all below 200.

As far as the worst regions, 17% (27/156) of drugs tested in Jammu & Kashmir were found to be not of standard quality, while 7% (7/97) were to be not of standard quality in Himachal Pradesh. Four percent of all drugs (7/161) tested in the ‘West Zone’ were found to be substandard.

Bangalore should perhaps stand as an example of a region where quality remains high, with just 0.6% (2/294) of drugs found to be substandard there. Hyderabad, which In-Pharmatechnologist.com visited in October, only had 1/70 found to be substandard.

Sampling bias?

The CDSCO findings are likely to be representative according to Roger Bate of conservative policy think tank the American Enterprise Institute, who told in-Pharmatechnologist.com “I think the data are probably fairly accurate, if a bit low on the substandard side,”

However, Bate told us that: “I wouldn’t be surprised if in some of the locations the samplings are biased by the providers of the drugs knowing who was doing the sampling” adding that “I have evidence this was the case historically, but no evidence this time.”

The figures remain preliminary for a number of regions where samples were collected but not yet tested for quality.

For the concerning regions, state drugs controllers were informed to stop the further distribution of drugs in the market and to take action against manufacturers under Drugs & Cosmetic Act.

Joint surprise checks were also conducted with state drugs controllers to check the quality of drugs on a monthly basis. Samples were drawn from government hospitals, retail & wholesaler dealers from April 2013.

“Perhaps the data say less than the release that comes with them, which is that they found no fakes/spurious meds,” Bate added. “I’d say they stress this because they think that that is what US is most interested in.”