Just as India is mulling to scrap provisions pertaining to the regulation of sale of drugs through e-portal and implement online pharmacy as proposed in the draft Drugs (Sale and Distribution) Rules, 2017, a study by the World Health Organisation (WHO) has asked the nations to be cautious as such ‘modern purchasing models’ can easily circumvent regulatory oversight.
In the study titled ‘Public health and socioeconomic impact of substandard and falsified medical products’ which was released recently, the WHO has estimated that “1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified.” That includes pills, vaccines and diagnostic kits.
“We have reports from all over the globe, from countries rich and poor, and reports on all types of products, both innovative or generic, expensive or not,” Suzanne Hill, who directs WHO’s department of essential medicines and health products had said in a statement here.
The findings are based on 100 peer-reviewed surveys on medicine quality from 2007 to 2016 spanning across 88 countries. The studies examined use of more than 48,000 drugs and found that 10.5 percent of the drugs sold in developing countries were either fake or of poor quality.
The WHO study has also highlighted in detail on the ‘internet gateway’ saying that risk-based surveillance, which focuses detection resources on the products and supply channels most at risk for falsification, indicates that in some high-income countries, medical products bought over the Internet from illegal or unauthorized websites, social media platforms or smartphone applications frequently fail to meet quality standards.
“Buying from the Internet is increasingly popular in middle-income countries, too. Besides being convenient, buying medical products over the Internet provides anonymity; that is often attractive to people wanting products relating to impotence or to treat stigmatised conditions.
“The inexorable growth in online sales provides criminals with a relatively easy entry point into even the best regulated markets. Authorities around the world are working to tackle this new challenge, but it is universally recognized to be a difficult task,” the study said.
It said that more research is needed to determine the proportion and impact of sales of substandard or falsified medical products. The WHO observation has come at a time when the Health Ministry has issued the Draft Drugs (Sale and Distribution) Rules, 2017 that proposes to set up an e-portal wherein all manufacturers, stockists and retailers are required to register themselves and enter data relating to sale of drugs with batch number, quantity and expiry date through both online and by using mobile phones.
However, the Indian Pharmaceutical Association (IPA) has been opposing the proposed move saying that the country’s poor IT infrastructure is a major roadblock to the implementation of e-portal. “Even cities have poor internet connectivity. Considering this, it will be difficult for most of the chemists to upload the details of the sale on the e-portal,” said Kaushik Desai, general secretary, IPA in a letter to the Health Ministry recently.