India is one of the top five generic drugs exporters and maintains a positive trade balance by meeting over 90 per cent of the country’s requirements. Indian generic exports, following suit of global branded generic market, is also making efforts to improve the foothold of traditional medicine exports. Viewing that, Indian generic market segment is headed for a significant spurt in growth.

It is also well-positioned to take the opportunity provided by blockbuster drugs going off patent in the next few years in Europe. Thus, Indian generics manufacturers can make huge gains from Europe, the world’s largest pharma market, and subsequently decrease pressure on the healthcare budget costs.

Furthermore, as the global companies are adopting cost-reducing strategies to increase the margins after the economic failure and striving to discover and develop drugs at lower costs by taking on outsourcing and contract research, it will help in bringing a boom in India’s price competitive research and manufacturing activities.

Generic Pharma Market overview in Europe-

According to US-based health care information and consulting company IMS Health, the global market for generics generated $83bn (€59.8bn )in the 12 months at the end of September 2009. The total European revenue for the initial generic drug segments of the pharma market in 2009 were approximately $43bn (€31bn). As reported by EGA (European Generic Medicines Association), generic drugs generate savings of €30 billion.

Europe is primarily dominated by branded generics with 50% volume share and 18% value of the total generic sales globally. Germany is the largest generic market in Europe accounting for 27% generic drugs sales and present sluggish growth between 5-6% whereas Italy and Spain are expected to register higher growth rates of generic drug sales between 18-20%.

Blockbuster drugs losing patent protection in Europe (2011-2017)-
Several patents of branded blockbuster drug (a drug generating >$1 billion of revenue for its owner each year) are about to expire in Europe thus providing an opportunity of unusual scope to pharmaceutical companies who worry about making profits as the generic competition enters the drug market. Calcium antagonists, anti-ulcerants and platelet inhibitors are the some of the generic drugs that are analyzed to face high generic competition.

Below is the list of blockbuster drugs that are likely going to be off patent in the next few years in Europe:

EMA approval requirements-

EMA stands for European Medicines Agency. It is a regulatory authority that grants market authorizations and conducts a scientific evaluation of the medicine’s efficacy (i.e. how well it works as measured in clinical studies), safety and quality. Generic medicines must obtain marketing authorization in Europe before they can be marketed, as for all medicines. The EMA is governed by the European Union, which helps to oversee approval for medications in Europe. Firm applying for generic drug selling must meet the following requirements for the EMA’s approval-

     A.  Generic medication manufacturers must show the exact composition of the active substances as well as information regarding their bioavailability. They must also provide data of impurities found in the active substances as well as bioequivalence studies, similar to FDA requirements.

     B.  European and Canadian guidelines require a minimum of 12 subjects for bioequivalence trials, while the US Code of Federal Regulations does not explicitly designate a minimum sample size.

       C.  Information must also be provided about the safety and efficacy of the active substances compared to the medication from which it is based, including alterations in salts, esters and/or isomers to demonstrate that the properties of the reference medication are not different from the generic drug when changes have been made.

      D. The EMA neither require clinical trial results to be released nor the results from pharmacologic or toxicological tests. Because of possible variations in the composition, and therefore the beneficial action, of generic drugs, it is important to consider the value of authorizing pharma-covigilance.

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