Generic pharmaceutical companies play a very crucial role in maintaining good public health. These companies provide affordable drugs to masses in a timely manner. There are many life saving drugs that cannot be afforded by masses if they are purchased at their original cost. The generic drugs providers help them in having an affordable healthcare.
Healthcare is expensive because of the amount of investment made in research and development of the pharmaceutical product. This is also the reason why a patent protection is conferred upon the person or entity that comes up with a pharmaceutical product. Once the patent for a drug expires, its open and free availability can boost pharmaceutical business and e-commerce as the generic pharmaceutical companies can provide affordable drugs in large quantity.
One of the aims of World Trade Organisation (WTO) and Trade Related Trade Related Aspects of Intellectual Property Rights (TRIPS) is to ensure a barrier free movement of life saving drugs across various countries. The Doha Declaration also recognises the importance of affordable drugs for saving lives of millions. However, policy decisions adopted by many countries may prevent this from happening.
For instance, recently the United States Food and Drug Administration (U.S. FDA) issued an Import Alert 66-40 titled Detention Without Physical Examination Of Drugs From Firms Which Have Not Met Drug GMPs (PDF). This alert deals with detention without physical examination of drugs from firms which have not met drug good manufacturing practices (GMPs). Many Indian pharmaceutical companies have been listed on this alert and import from them has been banned. In fact, Lupin is recalling 9,210 bottles of Suprax drugs for failure to pass purity test.
While maintaining appropriate standards by the generic pharmaceutical companies of India is need of the hour yet countries like U.S. should not be very strict when it comes to life saving drugs. If the generic drugs produced are not contaminated or sub standard, the countries importing the same must not unnecessarily create procedural and technical hurdles.