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Do Diagnostics Qualify as Drugs?

Do Diagnostics Qualify as Drugs?
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Above: A diagnostic centre in Mohali, Punjab/Photo:

The ICMR floating a National List of Essential Diagnostics could pave the way for more Indians to receive preventive care

By Dr KK Aggarwal

The Indian Council of Medical Research (ICMR) is in the process of formulating a National List of Essential Diagnostics on the lines of the National List of Essential Medicines, to ensure quality, availability and affordability of essential tests at all levels of healthcare. The list is scientifically designed and based on WHO’s list of essential diagnostics.

Articles 14, 15 and 21 of the Constitution give us the right to health without discrimination. But all the health requirements of a citizen are to be provided by the State (Article 47), subject to resources (Article 41).

The government can cap the prices of essential drugs, disposables, devices and diagnostics by invoking Section 3 of the Essential Commodities Act. With res­pect to drugs, this has already been done by drawing up a National List of Essential Medicines and bringing it under the DPCO (Drug Price Control Order, 2013). Diagnostics, like drugs, form an essential component of any treatment. Now, with the ICMR floating a National List of Essential Diagnostics, the doors will open to include them in the National List of Essential Medicines.

With this, the public mandate will be availability, capping of prices and ensuring quality of all essential investigations. Today, whenever there is an outbreak of dengue or chikungunya, the costs of diagnostic tests are sky-high. This can be curbed only by bringing in a list of essential investigations.

However, the ICMR is not an implementing authority and cannot fix prices of tests. The list will be considered by the committee that is in the process of developing the new national medicine list for 2018. If the diagnostics list is included, their prices will be regulated under the DPCO.

The government can include diagnostics as a drug under the Drugs and Cosmetics Act, which defines drugs to include “such devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government by notification in the Official Gazette, after consultation with the Board”.

The Heart Care Foundation of India and the Indian Medical Association have been asking the government to expand the definition of drugs to include all devices, disposables and diagnostics in its ambit. Only by making a National List of Essential Diagnostics and incorporating it in the definition of drugs can they make a dent in healthcare. This will ensure availability of essential investigations pan-India at various levels of healthcare facilities and help in reducing litigation, prevent non-essential investigations, and make healthcare more affordable and insurance companies viable.

Ever since the Consumer Act became applicable to the medical profession, there has been a trend of defensive practice which is investigation-oriented. The National List will help by differentiating an essential list from a non-essential one. Once these are incorporated as drugs, they will need to be classified as recognised indication and off-label indication. Any off-label indication investigation will need consent of the patient.

—The writer is President, Heart Care Foundation of India, and President-Elect, Confederation of Medical Associations of Asia and Oceania

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