Govt brings two vaccines for animal use under NLEM

In order to tackle infectious diseases of zoonotic nature effectively, the Union health ministry has issued gazette notification to include two vaccines -foot and mouth disease (FMD) (Trivalent) oil adjuvant vaccine and brucella abortus (S19 strain) vaccine under National List of Essential Medicines (NLEM) for animal use by making amendment in Schedule-I of Drugs Price Control Order (DPCO) -2013.

To read / download the NLEM list for the year 2015, 2011 and 2003, click here

This is aimed at protecting humans from infectious diseases of animal origin. As per official sources, Centre has stated that the NLEM list covering two vaccines will be operational with immediate effect.

According to the gazette notification, in exercise of the powers conferred by Section 3 of the Essential Commodities Act, 1955 (10 of 1955), the Central Government hereby makes the following order further to amend the Drugs (Prices Control) Order, 2013.

In the Drugs (Prices Control) Order, 2013, in Schedule-I, after the serial number 31 and the entries relating thereto, the following serial number and the entries shall be inserted, namely:

32. Medicines for animal use-
32.1.Foot and mouth disease (Trivalent) oil adjuvant vaccine and
32.2 brucella abortus (S19 strain) vaccine, live freeze dried

As such, the meaning and list of essential medicines for animal use is not published by the national and international agencies. However, in the Indian context, the essential medicine may be defined as essential medicines for veterinary use are the medicines, which address the majority of animal or livestock health needs of the country based on the disease prevalence and objective evidence.

 

Brucellosis is an important contagious bacterial disease of livestock, which can be transmitted to humans. It is prevalent in many countries including India. Vaccination and biosecurity can reduce the prevalence of brucellosis. FMD is a severe, highly contagious viral disease of livestock that has a significant economic impact. The disease affects cattle, swine, sheep, goats and other cloven-hoofed ruminants.

 

The Government of India constituted a committee in October 2019 under the chairmanship of Dr R K Singh, director, Indian Veterinary Research Institute (IVRI), Uttar Pradesh (UP) for preparation of list of essential medicines for animal use.

The committee recommended two vaccines named foot and mouth disease (Trivalent) oil adjuvant vaccine and brucella abortus (S19 strain) vaccine, live freeze dried under NLEM for animal use in Indian context at this point in time.

As per the committee report, during the recent years majority of the infectious diseases has emerged from animals. Thus, it is logical to safeguard animal health for sustaining human health.

The essentiality of such medicines is generally based on safety, efficacy, and affordability in the context of the access of these medicines for veterinary use in the country.

The committee also mentioned that NLEM is a dynamic document and there is scope to explore the possibility to include other veterinary vaccines like camelpox vaccine, sheeppox vaccine, PPR vaccine, goatpox vaccine, orf vaccine, buffalo pox vaccine and poultry vaccines in the NLEM at the appropriate stage based on the deliberations and inputs of disease prevalence and objective evidences.

The government had last year in December had also launched a new scheme National Animal Disease Control Programme for FMD and Brucellosis with a financial outlay of Rs. 13,343.00 crore for five years (2019-20 to 2023-24) by vaccinating 100% cattle, buffalo, sheep, goat and pig population for FMD and 100% bovine female calves of 4-8 months of age for brucellosis to prevent loss of Rs. 50,000 crore to the government exchequer and also to increase the economic output of farmers.

The mission mode approach for eradication of these diseases is the biggest step any country of the world has ever taken either for human or animal vaccination programmes to control any disease. This programme combined with providing unique PashuAadhar to 535 million animals (cattle, buffalo, sheep, goat, and pig).

The committee in its first meeting held on February 14, 2020 deliberated on the issue concerning NLEM for veterinary use considering the prevalence of disease in the animal sector and to adopt a mechanism by which the veterinary drugs including veterinary vaccines can be made available to the stakeholders, and veterinary healthcare providers at affordable cost.

Many of the diseases bacterial diseases like brucellosis, tuberculosis, and glanders, as well as viral diseases like corona, influenza, Hendra and Nipah are of zoonotic significance. Beside them, several other viral diseases of animals in India, Viz., foot and mouth disease, bluetongue (BT), peste des petits ruminants (PPR), sheeppox, goatpox, camelpox, infectious bovine rhinotracheitis (IBR), malignant catarrhal fever (MCF) and bacterial disease like haemorrhagic septicaemia (HS), black quarter (BQ), anthrax, and Brucellosis are endemic and a few of them do have potential of crossing the continental boundaries.

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