Generic Drug: What Does It Really Mean?

A generic drug is an equivalent/equal substitute to a branded drug in terms of same clinical benefit, safety, strength, quality and intended use. In fact, the dosage form and route of administration for a generic medicine is in the same way as it is for the branded medicine. Generic drugs are often manufactured and marketed after the expiry of patent rights of the branded medicine’s manufacturing company. Thus, the most advantageous part of the generic drug is the availability of these medicines at a lower price as compared to the branded ones. The production of generic medicines does not involve investments and cost (usually in billions of US$) associated with the research and development of new drug by any company. Further, multiple drug companies are approved to manufacture such products to increase competition in the market and lower the prices. Globally, generic medicines undergo rigorous review by Food and Drug Administration U.S. Generic Drugs Program for well-defined standards before the medicines are approved and sold in the market. In India, the quality, safety and efficacy of medicines are tested by NABL approved laboratories to meet the required standards, before being supplied to Pradhan Mantri Bhartiya Janaushadhi Kendra (PMBJK) for distributions to masses [8]. The procurement, supply and marketing of these medicines are undertaken by specially established cell named BPPI (Bureau of Pharma Public Sector Undertakings of India) under the Department of Pharmaceuticals, Government of India.

Current Scenario of generic drugs in India

Over the time, medical spending in India has increased to US$ 26-30 billion owing to urbanization and improved healthcare. Indian pharmaceutical firms supplies over 50% of generic drugs/vaccines to more than 100 countries. The government of India has taken the initiative to increase the number of Jan Aushadhi Stores in each district in order to reduce expenditure on medicines drastically.

How Does It Benefits the Patients?To improve transparency in the cost of the medicines, the rate contract of medicines with MRP which are currently available are given on the website of BPPI. BBPI has mentioned 50-90% savings to patients in the annual report 2016-2017 by selling generic medicines at its PMBJP Kendras across various states in the country. For example, branded Paracetamol 650 mg 15 Tablets costs Rs. 25.65 while the PMBJP’s generic substitute drug’s price for the exact amount is Rs. 8.03 which is 68% saving to the consumer. Although the introduction of generic medicines into the Indian market is the prime focus, availability of the same in the markets is found to be very low.

At present, BPPI is providing more than 700+ generic medicines and 154 surgical & consumables, covering various groups such as Diabetes, Respiratory system, Central Nervous system, Cardiovascular system, Genital-urinary system and other therapeutic areas including antibiotics and skin products.

Recognise A Generic Drug : Secret Lies In Labeling Order