Updated on 14 January 2013
Of the 348 drugs listed in NLEM, about 30 are biologicals namely alpha interferon, filgrastim, dextran-40 and 70, fresh frozen plasma, factor VIII concentrate, factor IX complex, streptokinase, urokinase, atorvastatin, insulin injection (soluble), anti-D immunoglobin (human), polyvalent anti-snake venom, rabies immunoglobin and many vaccines like BCG, DPT, Hep B, rabies and so on, used in different therapy areas such as cytotoxic medicines, medicines used in palliative care, plasma substitutes, plasma fractions for specific use, antithrombotic medicines, hypolipidemic medicines, insulins and other anti-diabetic agents, immunologicals (diagnostic agents), sera and immunoglobins, and vaccines (for universal immunization).
Surprised with the names of biologicals included in the list, an industry veteran, who wished not be quoted said, "I do not see intravenous immunoglobulins (IVIG) among the plasma derived or immunological drugs category. Although filgrastim is not used for treating cancer, it is still in the supportive therapy. It is of course very useful, I just wonder if it is "essential". He further said, "Erythropoietin, used in kidney failure patients, is quite widely used, and I am surprised that it is not in the list and alfa interferon is in the list, but it is now hardly used, since its use in cancer was superseded by other drugs, and its use in hep-C was superseded by pegylated-interferon, which is not listed."
Sharing his thoughts about the biologicals listed in NLEM, Dr Ashok Kumar, president, Research and Development, Ipca Laboratories, said, "There could be several drugs used for life-threatening diseases that could be included, however, possibly, the expert committee who prepared this list could have omitted them because these drugs are not available in India. We need to note that the development of these biological drugs requires not only higher development cost but also very huge initial set-up costs for manufacturing these complicated molecules. This is not only due to complexity of manufacturing these biological, but also its quality requirements to match with innovator products in the market."
He further said, "This is a major hurdle for these biologicals to become commodity drug, and applying the Drugs Price Control Order (DPCO) policy when the drug is marketed in India does not justify the return for investment made by the developer. This is something the government needs to address. Therefore, the government should bring in funds to partly bear or cover the cost for development and set-up of manufacturing facilities by way of soft loans or other funding options for mass production of biologicals. Or we may need to bring in suitable mechanism for adequately covering the cost of development and setting up manufacturing facility for biologicals by Indian manufacturers. My opinion is that, this is the right time to take proper action in indigenous development of biological, as most of the essential biological drugs are going off-patent in coming years and promoting the development of these drugs would be beneficial to bring in all essential medicines for the Indians at large."
Reacting on the impact of the biologicals listing in NLEM on local companies, who have been manufacturing and offering the biologicals at an affordable price, Dr Ashok Kumar said, "The list contains biological that are well established in Indian market. So I do not consider a heavy impact on those manufactures currently marketing them. As and when the competition increases in the market, we do expect further price reduction in the biologicals area."