The Drug Controller General of India (DCGI) may soon prohibit the use of liver extracts in place of vitamin B12 in vitamin formulations. According to sources in the DCGI office, although the state drug control authorities were told to restrict the preparations with liver extracts in a meeting held in Delhi recently, the DCGI is going to issue a circular prohibiting these products.
The DCGI has also informed the State DCs not to renew the product registrations unless the manufacturers reformulate their products replacing liver extracts with pure vitamin B12 as the former is found to be irrational and hazardous. Hence, in the interest of consumer health, their use may be banned under section 26A of the Drugs & Cosmetic Act, 1940, the sources at Central Drug Control Standard Organisation said.
Since liver preparations have no place in modern therapy as they are unsafe and irrational, the NGOs like Consumer Education and Research Centre (CERC), Ahmedabad, have been persuading the DCGI to ban these products in the country for quite some time now. The CERC, had in a letter to the DCGI, pointed out that the mammalian liver extracts not only irrational in therapy but also carry a serious risk of transmitting infections from animals to humans.
Mammalian Liver Preparations were prescribed before the development of folic acid and Vitamin B12 in pure form. Since then there is no mention of any liver preparation in any pharmocoepia or for that matter any standard medical text book. Liver preparations were official in BP 1948,USP XV 1955, and IP 1966.
Currently there are several liver preparations available in the Indian market, in combination with vitamins like B12, folic acid and minerals like Iron and Zinc.
Being unsafe and with no justification in therapy, the consumer protection agency had urged the government to withdraw all Liver Preparations from the market. Recently, the multinational pharma company and major player in the liver haematinics segment, had voluntarily withdrawn liver extract from its popular formulation brand Livogen in the wake of its finding on the hazardous effect of the ingredient.
Vitamin B12 is a dietary essential for the growth, cell reproduction, hematopoises and nucleoprotein and myelin synthesis. Cells characterised by rapid division -epithelia cells, bone marrow, myeloid cells-appear to have the greatest requirement of Vitamin B12. Vitamin B12 is necessary for the maturation of red blood cells.
Oral absorption of Vitamin B12 depends on the presence of sufficient intrinsic factor, a glycoprotein with a molecular mass of 59000 Dalton, secreted by parietal cells of the gastric glands in the stomach. The intrinsic factor binds with vitamin B12 in stomach and helps and it get absorbed.
Lack of intrinsic factor, results in inadequate absorption of the vitamin and causes, pernicious anemia. The body for some reasons produces antibodys against the intrinsic factor, which may be responsible for the destruction of the intrinsic factor. A number of intestinal disease or defects can interfere with the absorption of intrinsic factor B12 complex. Intrinsic factor deficiency causes pernicious anemia.
Vitamin B12 is available in pure form for injection or oral administration. It is given along with other vitamins and minerals for oral or parenteral administration. Although oral preparations may be used to supplement deficient diets, they are of relatively little value in the treatment of patients with deficiency of the intrinsic factor.
In the absence of the intrinsic factor, the preparation of choice for treatment of a Vit B12 deficiency state is cyanocobalamin and it is administered by intramuscular or deep subcutaneous injection.