Any pharmaceutical drug that expresses itself equivalent to a brand name product like quality, dose, strength, performance, method of administration and the use for which it is intended, is considered, a generic drug. This class of drugs gives priority to the chemical composition of the drug rather than the name of the brand under which the drug is being sold. The compliance with the federal food, cosmetics, and drug act is required for all the drugs, which are approved in the country. This must be regardless of the place where the drug is manufactured. The above act requires a manufacturing standard to be met by all drugs. This would ensure the quality of the drug and the product label requirement. Such generic medicines which are approved in the country are generally manufactured entirely overseas. However, this is not always the case. Unlike medications sold at healthprose.org, several of these drugs have only some foreign ingredients. A fast increase in the amount of foreign made drugs has been seen recently in the pharmaceutical market.
Patent’s Act regarding the manufacture of generic medications in foreign countries
The Government of India started encouraging manufacturing of larger number of drugs by Indian companies in the early years of 1960’s. This was followed by the Patent’s Act of 1970. This act ensured the removal of composition patents for drug and food supplies. Although process patents remained intact, these were reduced to a span of five from seven years. This further, led to a lack of patent protection. This led to a creation of a niche in the international as well as the Indian pharmacy market. The medical council of India, in the year 2002, issued a code of ethics, which dictates the physician to prescribe drugs to their patients, only by their generic name. This law however is widely violated by the active medical community of the country, exposing the shortcomings and loopholes in the section of government dealing with the medicine and healthcare system of the country. The Chinese pharmaceutical market too has been found to be lacking a decent administrative protection of the patents. This, however, has improved after the countries entry into World Trade Organisation.
The late 1980 have brought a major change in the pharmaceutical history :
The confidence of the general public in the generic medicines was greatly shaken in the late years of 1980’s. This was after a series of controversies revolving around manufacturing of generic medicines. Many cases were reported, of pharmaceutical companies, who were using branded medicines in the tests (conducted in their laboratories) instead of their own patented products. A further investigation found many cases of corruption, in which employees were found to be accepting bribes to improve the application of some generic companies and denying and/or delaying the application of other companies.
Know something about the measures taken:
Many detailed safety regulations have been implemented and enforcement bodies have been set up by the government to ensure the adequate research and circulation of the generic drugs in the free market.
Routine inspection of the domestic and foreign medicine manufacturing factories takes place to ensure the compliance with the enforced regulations. Samples from every retail stores, warehouses and manufacturing plants are routinely collected and subjected to standardised testing procedure. Along with this, complaints from consumers, medical community and other bodies are vigorously evaluated. The database of information, thus created, assists the enforcing body to identify the various requirements for surveillance, research, research and enforcement.
The responsible enforcement agency has to address the massive challenge of ensuring the safety of generic drugs, as well as other related products. The foreign generic drugs are subjected to comparison with the domestic equivalence of the same drug. The agency often enters into pacts with its foreign counterpart authorities to create a platform for sharing and discussing information about drugs. This improves the agency’s ability to safeguard the consumers from unsafe generic drugs manufactured outside the country. The agency also establishes working and research branches and posts officers in certain foreign countries to increase the area of discussion over generic medicines and their regulations.