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HomeHealth4 patented HIV, hepatitis & TB drugs now on govt price control...

4 patented HIV, hepatitis & TB drugs now on govt price control list. Controversial ranitidine cut

The latest National List of Essential Medicines released Tuesday includes 384 drugs — 34 medicines have been added to the list, 26 dropped.

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New Delhi: Union Health Minister Mansukh Mandaviya Tuesday released the latest National List of Essential Medicines (NLEM), a periodically revised list of medicines brought out by the central government based on criteria such as how widely they are used and how safe they are. The medicines on the list have to be sold at controlled prices based on a list brought out by the National Pharmaceutical Pricing Authority (NPPA).

Of the 384 medicines on the NLEM this time, 34 have made it to the list for the very first time and, compared to the earlier list of 2015, 26 drugs have been dropped. The latter category includes, significantly, the controversial drug ranitidine. The sale of the antacid was suspended in many countries across the world in 2020 after it was found to contain carcinogenic compounds. Its sale in India has been a bone of contention ever since.

Four drugs still under patent — used to treat multidrug resistant tuberculosis (MDR TB), hepatitis and HIV/AIDS — have been included in the list. The HIV and hepatitis medicines are dolutegravir and daclatasvir, respectively. It is estimated that 0.5 to 1.5 per cent of Indians have hepatitis infection, with the number higher in states like Punjab.

Bedaquiline and delamanid — two drugs used in the treatment of TB — are also under price control now. Bedaquiline is used for the treatment of multidrug-resistant pulmonary TB. India has the world’s highest burden of MDR TB, but the cost of bedaquiline has prevented its widespread use by patients in dire need. Delamanid, too, is used in MDR TB.

It is estimated that 50 per cent of all MDR TB cases in the world happen in India and China which is why demands for bedaquiline prices to be brought down have been coming for a long time now from patients and TB activists.

While releasing the list, Mandaviya said that “essential medicines” are those that satisfy the priority healthcare needs, based on efficacy, safety, quality and total cost of the treatment.

“The primary purpose of NLEM is to promote rational use of medicines considering the three important aspects i.e., cost, safety and efficacy. It also helps in optimum utilisation of healthcare resources and budget, drug procurement policies, health insurance, improving prescribing habits, medical education and training for UG/PG, and drafting pharmaceutical policies,” he said.

“The independent Standing National Committee on Medicines (SNCM) was constituted by the Union health ministry in 2018. The Committee, after detailed consultation with experts and stakeholders, has revised the NLEM 2015 and submitted its report on NLEM 2022 to the Ministry of Health and Family Welfare. The Government of India has accepted the recommendations of the committee and adopted the list,” he added.

He also noted that the process of creation of the NLEM depends on the “feedback backed by scientific sources from stakeholders and inclusion/exclusion principle followed (sic).”

Also read: With hospital-based surveillance programme, ICMR looks to fix India’s big data gap on STDs

Criteria for deletion

There are several criteria that a drug must fulfill in order to prompt deletion from the NLEM. According to health ministry officials, these include a ban on the drug in India, reported concerns about safety, the existence of an alternative with better safety profile or efficacy, and an emerging resistance pattern in case of antibiotics.

The banned drug ranitidine is commonly sold over the counter under brand names such as Zinetac and Rantac. In 2020, the US FDA had asked for the removal of all ranitidine products from the market over concerns about the presence of a contaminant known as N-Nitrosodimethylamine (NDMA).

“NDMA is a probable human carcinogen (a substance that could cause cancer). In the summer of 2019, the FDA became aware of independent laboratory testing that found NDMA in ranitidine,” the FDA has said.

“Low levels of NDMA are commonly ingested in the diet, for example NDMA is present in foods and in water. These low levels would not be expected to lead to an increase in the risk of cancer. However, sustained higher levels of exposure may increase the risk of cancer in humans,” it added.

(Edited by Zinnia Ray Chaudhuri)

Also read: This World TB Day, a look at how an Indian PPP initiative made it to WHO list of best practices


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