Real photos from the factory Generic drugs
Generics are widely known as alternatives to costly drugs, based on the identical to original medication active ingredient. The production of generic preparations can be launched by any manufacturer once the patent protection period of a brand-name drugs expires.
Despite the widely spread myth that generics are almost non-regulated in US, FDA thoroughly monitors the state of affairs and acts accordingly on the legislative level.
To be legally available in the US market, a generic medication must be approved by FDA, contain the same active ingredients and the comparative efficacy. It must be produced in the same dosage form and must imply an identical administration as in the original drug.
FDA is a huge, dynamically acting entity that can change the rules of the game at any moment. Thus, e.g. on March, 31 the organization announced it is finalizing an amendment to its guidelines that implies changing labels if new safety information is received.
According to FDA statistics, around 40% of domestic drugs consumption accounts for imported products, and it’s not a secret the local market attracts dozens of huge players from South-Eastern Asia and India. Such giants as Ranbaxy Laboratories, Cipla and Dr. Reddy’s Laboratories are supplying huge volumes of erectile dysfunction drugs, but there’s still a myth that Indian companies produce drugs in poor conditions. Well, you may want to take a look at their facilities:
The fact should be underlined that FDA initiates around 6,000 of quality control audits of local and overseas companies, approved for sales in the local market. So if some violations are revealed, the sanctions are inevitable: from huge fines to license cessation.
Dr. Reddy’s Laboratories
So why do generics cost less?
Apart from way more affordable manpower, generic drugs manufacturers do not invest in development, research and promotion of new products like Big Pharma companies do. Pfizer or Johnson&Johnson invest up to $1-1.5 bn. into pushing their product to the market, and this process may take up to 15 years. Of course, the entire process is not about formula creation. Evaluating the efficacy and side effects of the newly produced medication is crucial: firstly, the experiments were carried on the cells, then in rats and rabbits, and only the final stage involves human volunteers. 80% of the price of the original drug is precisely the costs of these studies and advertising campaigns. The synthesis of the drug substance accounts for 20% of the expenses.
The average term of the patent equals around 15 years. Accordingly, during the remaining 5-10 years after all the necessary investigations manufacturer must recoup their costs and make a profit.
Generic companies just focus on synthesis, while their advertising budgets are extremely tiny against the background of huge companies. The relative cheapness of generics is also explained by the market competition: the more companies produce drugs with the same active ingredient, the lower the price is.
There are more nuances. In general, analogs differ from a proprietary formulation in auxiliaries (including excipients, preservatives, dyes) which may affect the color, shape, size, and sometimes the taste of the drug. However, the original drug patent applies solely to the composition of the active substance, not the method of its production. For example, the original tablet formulation is made by spraying of layers, allowing the drug to be released uniformly into the blood, maintaining a certain concentration for a long time. A generic drug can be made by conventional pressing.