The Gujarat Food and Drug Control Administration (FDCA)'s Vadodara based drug testing lab has tested the maximum number of 6,025 drug samples as part of a pan India spurious drugs survey to assess for the first time complete testing of not-of- standard quality (NSQ) drugs as per Indian pharmacopoeia and other pharmacopoeias.

This is followed by Central Drug Testing Lab (CDTL) Hyderabad which tested 5,461samples, CDTL Mumbai which tested 5,418 samples, CDTL Chennai which tested 5,257samples, CDTL Bangalore which tested 2,033 samples and Maharashtra which tested 186 samples.

Done at an estimated cost of Rs.8.5 crore, the Union health ministry had entrusted the job of National Drugs Survey in July 28, 2014 to Noida based National Institute of Biologicals (NIB) which compiled it in the form of around 400 pages of well documented evidence based study based on the pan -India sampled field data to the tune of 48,000 samples. It was recently submitted to the health ministry for review and suggestions.

Dr Surinder Singh, director, NIB, Noida, is the chairman of the committee which conducted the survey.

Only 10 per cent of the samples were tested during the pan-India study done in 2009.

For effective sampling of drugs by the drugs inspectors, around 224 molecules covering 15 therapeutic drug groups were assigned a unique sequence in the format developed through a statistical design. This ensured that the drug inspector can pick up samples only on the basis of statistical design and not on their own.

Around 1,000 drug inspectors were trained to execute the pan-India exercise to implement the study in the most transparent manner. The analysis and testing is facilitated through a specialised AKS software which helps in offering field data on spurious and NSQ drugs online on a consistent basis in a seamless and flawless manner.

The survey was done in collaboration with Indian Statistical Institute (ISI), Kolkata and Hyderabad and National Sample Survey Organisation (NSSO). CDTL in Chandigarh, Mumbai, Hyderabad, Chennai, Kolkata and Guwahati, state drugs testing labs at Gujarat, Karnataka Maharashtra and a lab at Indian Pharmacopoeia Commission (IPC), Ghaziabad were part of testing and analysis.

The Gujarat FDCA through its ongoing random sampling surveys at retail and wholesale stores, hospitals and manufacturing sites consolidated on an yearly basis across the state also registered a collection of 13,540 samples last year which is the highest in the country.

This is followed by states like Karnataka, Tamil Nadu, Andhra Pradesh, Maharashtra and Himanchal Pradesh.

Trends on sub-standard drugs based on a nation-wide study coupled with routine random- sampling exercises done over a period of one year also reveals that presence of sub-standard drugs in India has considerably come down from 8 per cent to 4.5 per cent.

Routine sampling and tests of drugs by Central Drug Standards Control Organization (CDSCO) usually check the quality of drugs using parameters like dissolution and assay.

The decrease in trend has been the key highlight of a risk-based assessment done in the country based on a statistically designed system which shows similar trends existing globally in terms of circulation of sub-standard drugs in India.

Substandard drugs are medicines that are of lower quality because of poor manufacturing, quality control, storage or packaging practices. Such drugs are different from spurious drugs, which are mostly imitations of genuine drugs and are often conspicuously labeled to deceive the patient about the ingredients, effects or manufacturer.