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India’s Bid to Create Essential Diagnostics List Gains Momentum

The Indian government’s efforts to create the national essential diagnostics list (EDL) are gaining momentum as top scientists and industry stakeholders have arrived at a general consensus on catalogue of tests and initiatives to strengthen diagnostic infrastructure, it is learnt. The government is currently drafting an India-specific EDL, a set of tests for detecting common morbid conditions and priority diseases, along the lines of the National List of Essential Medicines. It will be based on a global EDL unveiled by the World Health Organization (WHO) in April. The effort is spearheaded by Indian Council of Medical Research (ICMR), the country’s apex medical research body. The list, expected to be ready by the end of the year, would help drive down cost of disease detection and treatment substantially.

At the second consultative meeting organized by ICMR on August 20, experts including top health ministry officials, clinicians, microbiologists and medical device manufacturers got down to the nitty-gritty of the plan. “I would say the initiative is progressing quickly and is on schedule. We will adopt the WHO list as a model and include additional tests in it to address India-specific infection patterns and diseases,” Dr Kamini Walia, a senior scientist with the ICMR, told Pharmabiz. The EDL unveiled by the United Nations health agency concentrates on in vitro tests. It contains 113 items – 58 tests are listed for detection of a wide range of common conditions, providing an essential package that can form the basis for screening of patients. The remaining 55 tests are designed for the detection, diagnosis and monitoring of priority diseases such as HIV, tuberculosis, malaria, hepatitis B and C, human papillomavirus and syphilis.

“The second consultative meeting was a brainstorming session where the officials concerned and industry stakeholders voiced ideas and opinions. We’ve discussed additional tests to be added to the WHO catalogue and measures to strengthen diagnostic infrastructure. The Indian list would include tests for hemoglobin, thyroid function and other non-communicable illnesses. Vector-borne diseases such as dengue and chikungunya would also be there,” an official said. The proposed EDL is significant as it is expected to influence the government’s price control policies. It will also help streamline procurement of essential diagnostics required at primary healthcare centers and encourage local companies to manufacture these products to ensure adequate and uninterrupted supply.

While emphasizing that affordable diagnostics is the cornerstone of treatment, Walia, who was on the WHO expert panel that drafted the list, said the country needed to develop its diagnostics infrastructure to achieve its healthcare goals. “It is a massive task. The policymakers have to weigh up issues of accuracy, affordability, human resources and regulatory challenges. We are glad that the WHO list is available. It is a guidance document for us,” she added. The WHO is now soliciting applications for including new diagnostic test categories for future iterations of the EDL. The global health agency is also setting up a new strategic advisory group on in vitro diagnostics to update the list of essential IVDs. – PharmaBiz

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