Just a few of the countries that have updated regulations governing generics include emerging markets such as Brazil, Mexico, Russia and South Africa. This leads to delays in generics approvals.

Recently, ANVISA (Agência Nacional de Vigilância Sanitária), the national health surveillance agency of Brazil, which is considered one of the most efficient in emerging markets, changed its approval process to include bioequivalence testing. This change has resulted in generics approval times in Brazil increasing from about 36 months to 48 months, according to industry officials.

In Russia, a new regulatory directive, which mandates clinical trials for generics, has created huge hurdles, according to one domestic firm. It has also led to firms, such as India-based Glenmark Generics, which is already conducting six to seven clinical trials in Russia, to declare that they do not expect any Russian generics approvals during 2013.

In the US, Indian companies, including Ranbaxy Laboratories and Wockhardt, have recently faced enforcement actions from the US Food and Drug Administration (FDA) for failing to meet regulatory and good manufacturing practice (GMP) requirements.  Wockhardt is also facing action in Europe.

In Europe, regulation of generics has been increased. The European Union introduced its Falsified Medicines Directive in 2013, requiring that countries certify that bulk drugs, or active pharmaceutical ingredients, meet GMP standards [1].

India, a major producer of generics, has also not got away without increased scrutiny of generics, and regulations are also being tightened in the country. The domestic drug regulator, the Drugs Controller General of India, has constituted several new drug advisory committees to oversee clinical trials, as well as new drug approval processes.

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. European Commission publishes new rules on falsified medicines [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 6]. Available from: www.gabionline.net/Policies-Legislation/European-Commission-publishes-new-rules-on-falsified-medicines

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