India among countries where 10% of drugs are substandard: WHO
New Delhi: Approximately 10.5% of medicines in low and middle income countries including India are sub-standard and falsified, a report released by World Health Organization (WHO) on Tuesday showed.
The study titled Public health and socioeconomic impact of substandard and falsified medical products also pointed to increasing antimicrobial resistance. It said up to 72,430 childhood pneumonia deaths across the world can be attributed to the use of substandard and falsified antibiotics, if there is reduced antibiotic activity. Further, this number may increase up to 169,271 deaths if substandard and falsified antibiotics have no activity.
The WHO researchers reviewed 100 papers, published between 1 January 2007 and 31 December 2016. The papers in question reported on testing of 48,218 samples of medicines collected from 88 countries, including India. In addition, data from one publicly accessible database maintained by United States Pharmacopeia, known as the Medicines Quality Database (MQDB) was included in the review and accounted for 13,909 of the 48,218 samples – about 28.8% of the total.
The MQDB collates results of testing performed under a US government funded programme which supports governments in Africa, Asia and Latin America in their efforts to secure the quality of the medical products in the national supply chain.
The review of literature found that around 5,094 samples failed quality tests out of 48,218 samples. “The aggregate observed failure rate of tested samples of substandard and falsified medicines in low and middle income countries is approximately 10.5%. Substandard and falsified medical products from all therapeutic categories are reported from every region, including high, middle and low-income countries, and a significant proportion of the cases reported to the GSMS the WHO Global Surveillance and Monitoring System (GSMS) concern antimicrobials, with anti-malarials and antibiotics being the most frequently reported medicines,” the report said.
“Studies that focus exclusively on antimalarials, by far the most common among the 100 papers reviewed, provide a combined observed failure rates of 11.8% for substandard and falsified samples,” the study said.
According to the study, the failure rate for commonly used antiepileptic medicines was very high at 65% and for genito-urinary and sex hormone drugs, the observed failure rate was 56%.
The study said the majority (about 60%) of samples were from a mix of public and private outlets, followed by about 29% of samples coming from only private outlets (licenced/registered outlets or “not for profit”).
The WHO findings are in conjunction with a recent study done by National Institute of Biologicals (NIB) commissioned by Union health ministry.
The ministry had drawn around 47,954 samples from 2014 to 2016 and found that around 10% of the drugs in the government supply chain were not of standard quality.
Also, recently, some of the most common medicines such as Combiflam and D-Cold consumed in India were declared as sub-standard by Central Drugs Standard Control Organization (CDSCO). Specific batches of 60 drugs failed quality tests in sample-based screening, the apex drug regulator said. “Substandard medicines are a major issue in India and we are looking out for ways to tackle the problem. As quality regulator, we are developing proper mechanisms to stop manufacture and sale of counterfeit drugs so that they don’t reach the patients,” said G.N. Singh, Drug Controller General of India.
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