In a view of various reports doubting the quality of drugs manufactured in India and sold in the domestic and export market, the Union Health Ministry has launched the largest ever sample survey of spurious, counterfeit and sub-standard medicines to analyse their quality. The move also aims to plug loopholes if any.
A senior official in the Ministry said that the top drug controller, Central Drug Standards Control Organisation (CDSCO) in collaboration with the Noida-based National Institute of Biologicals is all set to test over 42,000 samples of a range of drugs to test their quality. The last National survey of spurious drugs which was conducted in 2009 had tested 24, 136 medicines.
The drug samples would include popular brands as well as essential drugs of 15 therapeutic categories enlisted with the National list of Essential Medicine (NlEM) from retail pharmacy outlets from across the country. Over Rseight crore is being spent on the survey to be completed by July.
In 2009, samples of popular brands of oral solid dosage (OSD) formulations, belonging to 9 therapeutic categories (anti-infective, anti-malarial, anti-TB Drugs, steroids, antihistaminic, cardiovascular drugs, anti-diabetics, NSAIDs, and multivitamin preparations), were tested. The official said that though “surveys in the past decades have found the prevalence of spurious and sub-standard drugs at not more than .04 per cent and 4 to 5 per cent respectively, some unverified reports often magnifies it, putting it between 10 per cent-25 per cent”.
“Due to dire consequences on public health in view of circulation of spurious drug, the study is necessary to assess actual extent of spurious drug circulation in the community at large,” it said. He said that the 2009 national survey of spurious drugs had found, “The extent of spurious drugs in retail pharmacies of India is much below the projections made by various media, WHO, SEARO, and other studies. It is 0.046 per cent - 11 samples out of 24,136 samples tested.”
India is the largest manufacturer of generic drugs in the world, and the pharmaceutical industry is worth billions of dollars in both domestic and overseas markets. Consequently, there has been a major issue with counterfeits of popular drugs and production of sub-standard drugs with similar-sounding names, the official added.