Study of regulatory requirements for the conduct of bioequivalence studies in US, Europe, Canada, India, ASEAN and SADC countries: Impact on generic drug substitution.

In the last one decade, due to expiry of patented products as well as their exclusivity period, a drastic decline of branded pharmaceutical products and up streaming of generic drug market has been observed in developed as well as developing nations. This up rise in generic drug market is expected to rise in future till the arrival of new brand in market. This prevailing conditions could result in proliferation of generic drug manufacturing companies. The fact that generics do not undergo thorough extensive trials like innovator drugs, fuels further fears regarding their inferiority. Moreover, due to the hard competition amongst various companies to market their generics, the frequency of fraud and corruption have embarked doubts in consumers mind to reality. In order to blow away the doubts and re-establishing the credibility of generics in market, bioequivalence (BE) guidelines with stricter regulation should be the demand. The present study highlights the relevant regulatory guidelines for the conduct of bioequivalence studies in US, Europe, Canada, India, South Africa and South East Asian Nations. A comparative study of the differences in study design and specifications have also been addressed.

A Novel Approach for Innovative Pharmaceutical, Nutraceutical and Biocosmeceutical Products: Different Types of Combination Products and Co-activation of Natural Synergistically Acting Target-Receptors (CanSATs).

Traditionally, the main model of the pharmaceutical industry for developing new drugs has been based on monotherapies, new molecular entities (NMEs), and their underlying one-target-one-disease dogma. It is no surprise that closely related fields such as the cosmeceutical and nutraceutical areas, largely inspired by Big Pharma, have also mainly used that model. However, compelling evidence suggests that the time has come for these sectors of R&D activities to further explore more efficient, cost-effective and reliable approaches for innovative products. Among a few approaches proposed in recent years, there is one that is of particular interest – the ‘combination drug’ often referred to as the fixed-dose combination (FDC) products approach. It has been generally defined as two or more active ingredients that are combined in a single dosage form for either new effects or superior synergistic-like efficacy with less adverse effects. Both the World Health Organization (WHO) and the U.S. Food and Drug Administration (FDA) have recognized the great potential of FDCs for the future of innovation in those sectors. In fact, the development of FDCs has recently received substantial support for commercialization of new products – that is between three and five years of additional protection and exclusivity. Next-generation FDCs have already been identified. Indeed, FDCs that may be referred to as ‘variable-dose combinations’ (VDCs) products and, more specifically, ‘Co-Activation of Natural Synergistically-Acting Target-Receptors’ (CanSATs) products when applied to natural products if synergistic-like actions are found among active ingredients. Although VDCs and CanSATs have emerged mainly from the nutraceutical and cosmeceutical sectors, these approaches may perhaps also promote the development of promising new pharmaceutical products.