Viral safety in homoeopathic medicinal products.

To guarantee the safety of medicinal products as regards infectious agents, numerous national guidelines and recommendations have in recent years been included in the pharmacopoeia general monographs and have influenced the content of the substance monographs. Although the stipulations of the European Pharmacopoeia set out objectives, there is still a certain scope in how the requirements are implemented. This is reflected in the very different responses in Europe to the problems of safety from infection. Different traditions in the use of homoeopathic and anthroposophic therapy and varying levels of expertise among the regulatory authorities within the European Union have resulted in varying standard of assessment. The aim of this publication is to present a standard form of assessment for medicinal products in these therapeutic systems. Demonstrated hereunder is an approach that can be adopted to ensure that the high safety standard required is met for homoeopathic and anthroposophic medicinal products.

The global diversion of pharmaceutical drugs. India: the third largest illicit opium producer?

AIMS: This paper explores India's role in the world illicit opiate market, particularly its role as a producer. India, a major illicit opiate consumer, is also the sole licensed exporter of raw opium: this unique status may be enabling substantial diversion to the illicit market. METHODS: Participant observation and interviews were carried out at eight different sites. Information was also drawn from all standard secondary sources and the analysis of about 180 drug-related criminal proceedings reviewed by Indian High Courts and the Supreme Court from 1985 to 2001. FINDINGS: Diversion from licit opium production takes place on such a large scale that India may be the third largest illicit opium producer after Afghanistan and Burma. With the possible exceptions of 2005 and 2006, 200-300 tons of India's opium may be diverted yearly. After estimating India's opiate consumption on the basis of UN-reported prevalence estimates, we find that diversion from licit production might have satisfied a quarter to more than a third of India's illicit opiate demand to 2004. CONCLUSIONS: India is not only among the world's largest consumer of illicit opiates but also one of the largest illicit opium producers. In contrast to all other illicit producers, India owes the latter distinction not to blatantly illicit cultivation but to diversion from licit cultivation. India's experience suggests the difficulty of preventing substantial leakage, even in a relatively well-governed nation.

Viral safety evaluation of biopharmaceuticals and homoeopathic preparations of human or animal origin.

In order to meet the generally high quality requirements for the pharmaceutical manufacturing process, medicaments of animal or human origin specifically have to undergo a substantial viral safety test program. This procedure has been narrowly defined in numerous internationally valid guidelines; in addition, registration authorities are available in an advisory capacity. In order to bring about the experimental evidence, thorough planning, virological expertise and infrastructure, as well as close cooperation between process engineers and virologists, is necessary. Generally, generic studies are not accepted by the registration authorities. However, in coordination with the German Federal Institute for Drugs and Medicinal Devices (BfArM), a special arrangement for homoeopathic preparations could be agreed upon and the efficacy of selected production stages proven beyond doubt. Therefore, combined with the careful execution and evaluation of the validation studies, a high technical status for biopharmaceuticals including homoeopathic preparations guarantees a very high degree of viral safety.