CDSCO to scan drug samples across country to assess quality

In an attempt to counter the circulation of sub-standard and spurious drugs in the country, the Central Drugs Standard Control Organisation (CDSCO), an Union health ministry outfit, is planning to undertake a nationwide sample survey of drugs available in the market.

Only recently, Indian drug companies have come under the scanner of countries like Vietnam and Sri Lanka, which have barred a handful of Indian companies from exporting to their markets, claiming that the drugs were of poor quality or in other words, 'not of standard quality' (NSQ). Industry insiders point out on grounds of anonymity that some companies do not stick to strict quality norms when exporting to countries which source drugs at a cheaper rates, and hence the quality of the medicines suffer.

The initiative by the CDSCO is a step to ensure the quality of drugs across the country. A senior CDSCO official confirmed the development and said that the nationwide survey would be undertaken in association with the National Sample Survey Organisation (NSSO). "We had conducted a similar survey in 2009, which had found that the actual extent of spurious drugs in the country was quite low. However, there is a need to assess the actual extent of spurious as well as substandard drugs in circulation in a systematic manner," the official said.

The NSSO would collect samples from all across the country, get them analysed and then come up with a final report. This would take around three to four months time. State drug regulators have also been informed about that same, and they have been asked to provide information related to district-wise number of retail pharmacy outlets, central medical stores etc. H G Koshia, commissioner of the Gujarat Food and Drug Control Administration (FDCA) said that the CDSCO periodically collects data and samples from different zones for analysis.

In the 2009 survey, around 24,136 samples were collected, of which only 0.046 per cent were found spurious. Then again, the CDSCO had taken up a similar initiative in 2012, when it collected samples from manufacturing hubs or clusters. Of the total 1710 samples drawn during this survey, 26 were declared as NSQ. The CDSCO also conducts surprise checks with state drug controllers on a monthly basis, when samples were taken from government hospitals, retail and wholesale dealers and different pharmacological categories.

A Gujarat-based mid-sized manufacturer said, "The problem is not so much of spurious drugs, but of consistent quality of drugs across the quality. The current exercise is an initiative to boost quality control across the country."