Status and Application of Recombinant DNA Therapeutic Products Used in Clinical Practices: An Indian Scenario

Abstract

Recombinant DNA (r-DNA) technology or Genetic Engineering is an umbrella term for a set of experimental techniques that empower specific genes and DNA sequences to be manipulated resulting in genetically modified organisms (GMO) and therapeutic products. There have been many potential applications of r-DNA in medicine, agriculture, and industry. Conventionally proteins and other biological products, processed from human or animal serum or tissues, often are of low purity. Production of therapeutic products by the r-DNA technology has several advantages such as provision of drugs that could not be produced by conventional methods, manufacture of adequate quantities of drugs and provision for manufacture of safe drugs. In India, nine products have been approved for marketing – insulin (diabetes drug), alpha interferon (cancer drug), hepatitis B vaccine, Granulocyte-macrophage colony-stimulating factor (GM-CSF), Granulocyte-colony stimulating factor (G-CSF or GCSF),blood clotting factor 7, erythropoietin (drug used in kidney failure), streptokinase (drug administered in heart attacks), and human growth hormone. All these products except Hepatitis-B are being imported. The four major recombinant products with high market potential in India are human insulin, alpha interferon, and erythropoietin. In India, technology has been developed in different centers like International Center for Genetic Engineering and Biotechnology (ICGEB), (insulin), IMTech Chandigarh (streptokinase), and Bharat biotech. This review focuses on the scenario of Indian manufacturers, biotherapeutics approvals in India and important aspects that need to be precisely analyzed and resolved from the Indian perspective to facilitate implementation of r-DNA technology, bio-similar products, to best serve the public health needs of the developing countries. The study is beneficial to biotechnology scientists, medical institutions, pharmaceuticals, and doctors.