Generic drugs are bioequivalent to brand name drugs. They are basically copies of brand name drugs that have exactly the same dosage, safety, route of administration, strength, intended use and performance characteristics. Even though generic medicines are chemically identical to the branded drugs, they are sold at a much cheaper price as compared to the branded ones. According to one statistic, generic drugs saved about 150 billion USD in 2010 alone.
There is sufficient amount of checking on generic drugs as well, the drug companies need to submit their abbreviated new drug application (ANDA) for approval before they can market their generic drug. Due to the substantial difference in the prices of the generic and branded drugs, many people fear that the quality of both may not be same. They think that the quality and effectiveness of the drug might have been compromised to make them cheaper which is not the case. All the generic drugs are FDA approved and they have to go through the same standards and guidelines as the brand name drug. For FDA approval, a generic drug must:
- Have the same active ingredients as the brand name drug (Variation in inactive ingredients may occur).
- Identical in strength, dosage, safety and route of administration.
- Have the same usage indications.
- Be Bioequivalent.
- Must meet the same batch requirements for strength, purity and quality.
- Be manufactured under the same strict guidelines and standards laid out by FDA’s good manufacturing practice regulations required for innovator products.
Generic Drugs Industry In India:
With the recent surge in India’s Private Healthcare Sector, India is now counted in countries having one of the best healthcare infrastructures in the World. With world class doctors, latest medical technologies and well-equipped facilities, India’s medical sector is booming. Another Industry that India is now excelling is its Generic Drug Industry. Eight out of Top 25 Drug Companies in the World that makes up 28% of the Global Generics Market are from India.
Generics Drugs constitute up to 25% of the total pharmaceutical market of India which was valued at 962 Billion USD in 2012. This market is growing 2.4% with each passing year making it one of the most important Indian exports. India is now responsible for making and supplying lifesaving medicines for diseases like HIV AIDS and life threatening diseases.