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.

Antibacterial, antitussive, antioxidant and toxicological evaluation of Joshanda lozenges.

Joshanda, a Greco-urban formulation comprising seven herbs has been used since centuries for the treatment of cold, cough and associated allergic reactions. Conventionally, it is used in the form of an extemporaneously prepared decoction. However, in the current scenario, lozenges happen to be the dosage form of choice for antitussive drugs. In case of polyherbal drugs, the dosage form assumes a great importance in order to ensure that all the phyto-components exert their pharmacological effect to the maximum. Based on the popularity of lozenges, conventional decoction form of Joshanda was formulated in the form of lozenges. Lozenges were evaluated for routine quality control tests. The most remarkable feature of the formulation was that excellent compression, hardness, friability and disintegration properties could be achieved without the addition of any external binder. The prepared formulation was subjected to in vitro antioxidant activity, antibacterial activity against common respiratory tract pathogens, in vivo antitussive activity and acute toxicity studies using Albino Wistar mice. Accelerated stability studies were conducted as per ICH guidelines. The performance of lozenges was found to be satisfactory in all the tested aspects. Our study proposes the use of lozenges as a preferred dosage form of the conventionally used decoction of Joshanda.