Treatment of cancer is limited by affordability of patients in the many developing countries including India. Generic drug manufacturers have responded to this scenario by making drugs available at affordable costs, often at less than 10% the cost of the original brand. In our practice, it is found that there is a three-fold higher prescription of generic brands compared to innovator, accompanied by cost savings of up to 80% per prescription. Unfortunately, the regulatory environment prevailing in India is not geared to ensure satisfactory quality of generic products. The standards set by the regulatory agencies for establishing equivalence of generics vis-ΰ-vis the innovator product allow anticancer generics to enter markets without undergoing clinical evaluation. Many drug manufacturing units in India flout good manufacturing practice norms, which was evident during the center for drug evaluation and research classifications inspection in the year 2006. Inferior drugs have therefore, made their way into the Indian markets, compromising the quality of care. The system of drug manufacturing and marketing approval needs a major overhaul, including regular inspection of manufacturing facilities. Bioequivalence should be made mandatory for all oral formulations. Unless these measures are rigidly implemented, the benefits of generic substitution would be seriously undermined.
Development of drugs from plant sources (botanicals) for the treatment of cancer has not been successful in India, despite a plethora of medicinal plants and an equal number of experiments demonstrating anti-cancer activity of plant principles in vitro. There are several pitfalls in our approach to botanical drug development. Foremost is the lack of industry-academia collaborations in this field. Research goals in Indian academic institutions are generally short-term and mostly aimed at fulfilling the minimum requirements of a doctoral/MD or MPharm thesis. Secondly, quality assurance of herbal formulations is difficult to achieve and good manufacturing practices are expensive to implement. This could introduce bias during the biological evaluation of botanicals. A systematic approach covering a wide range of investigations including but not limited to mechanistic studies, potential herb-drug interactions, pharmacokinetics and bioavailability could help in the optimization of herbal formulations in the preclinical stage of development before they can be considered for clinical trials. Government initiatives such as Ayurveda, Unani, Siddha and Homeopathic have encouraged research in these areas, but are insufficient to promote focused and aggressive evaluation of potential herbs. Particular emphasis should be given to clinical pharmacokinetics, drug interactions and clinical trials in specific cancers for the evaluation of dosage, safety, efficacy and concomitant use with chemotherapy. Only such policies can result in meaningful evaluation of botanicals for cancer therapy.
5HT 3 antagonists are superior to other pharmacological interventions for the prevention of PONV in patients undergoing breast surgery under general anesthesia.
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