FACTS ON GENERIC DRUGS TO MEET OUT WORLDWIDE CHALLENGES FOR IMPLEMENTING GENERIC MEDICINE RELATED POLICIES OF HEALTH SCHEMES

Global market of generic drug has been propelled by new government initiatives to produce generic drugs and to promote the use of generic drugs; thus the use of generic pharmaceutical products represents over half of the total volume of pharmaceutical products used worldwide. India is the world’s largest exporter of cost effective generic medicines and leading Indian generic companies are generating more than fifty percent revenue from the export business of generic drugs. After the expiry of patent or marketing rights of the patented drug, generic drugs can be marketed. Generic drugs are available at affordable prices with assured quality and therapeutic value. The decision on drug approval is taken only after being assured of its pharmaceutically equivalent and bioequivalent properties. According to an estimate from the World Health Organization (WHO), the percentage of population without adequate access to essential medicines is less than 1% in high-income countries, 24% in middle-income countries, and 39% in low-income countries, due to their high cost. Recently Govt. of India has launched a campaign ‘Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)’ to promote the availability of generic drugs at affordable prices for all. It has also been decided to create a database of generic equivalents of branded medicine, paving the way for mandatory prescription of generic drugs along with brand names, to bring down the healthcare budget of every citizen of India. Branded versus generic medicines is an ongoing topic of debate and discussions among physicians, pharmacists, drug users, drug regulators, and policy makers across the world. Considering this aspect, the present article is an attempt to produce facts on generic drugs and focusing on the worldwide challenges through the major stakeholders of generic medicine.