Regulatory Aspects of Traditional Indian Medicines (TIM) in India and in International Purview.

Background: Regulatory affairs play a crucial role in the pharmaceutical industry and are incorporated in all stages of drug development. Objective: Approval criteria practices were developed as a resolution of the government's desire to create policies to protect public health by controlling the safety and efficacy of merchandise in areas including pharmaceuticals, complementary color medicines, veterinary medicines, medical devices, and even food products and cosmetics. Method: Herbal health products are in practices in all parts of the world under either their legal system's or expert council's or agencies' guides. They include botanicals, health supplements, health foods, complimentary medicines, traditional medicines or following pathies like Ayurveda, Yoga, Unani, Siddha, and Homeopathy. The requisite parameters for registration or recognition of products by various major global regulatory agencies were reviewed, and compiled under purview. Results: In India, licensing these products is under the act provisions and the rules known as the Drugs and Cosmetics Act, whereas globally regulatory provisions follow the guidelines of developed countries like the U.S. Food and Drug Administration, European Medicines Agency, the Therapeutic Goods Act, or the World Health Organization's regulations for herbal products. Conclusions: The present communication highlights the provisions of regulatory and/or licensing requirements related to corporates, product composition, specifications, quality parameters, manufacturing methodology, stability, safety, preclinical studies, clinical studies, etc. for herbal products and the respective guidelines at one site. Highlights: Ultimately, all regulatory agencies across the world highlight majorly the safety and thereafter the efficacy for any products under the category.

[The technicoregulatory situation in France for manufactured homeopathic medications]. / Situation technico-réglementaire en France des médicaments homéopathiques préparés par l'industrie.

Many homeopathic medications are marketed in France on the basis of old national regulations: homeopathic medications with a common denomination (unit or complex products) whose former approval was transformed into a marketing authorization in 1984; "normal formulations" with a special denomination, often dating from before 1941 (date when drug approval was instituted) including certain produces whose marketing approval was obtained under different mechanisms but still sold today. After the EEC excluded homeopathic drugs from the "medication" directives, in 1975 the 92/72/EEC directive stated that beyond the normal requirements for quality and safety, the same obligations could not be required for homeopathic and allopathic medications. A "registration" system was thus instituted for "traditional" medications en lieu of marketing approval. This included a dual obligation: 1) abstention from claiming therapeutic indications, 2) avoiding any formulation which could carry a risk for the patients (i.e. oral and topical formulations exclusive and degree of dilution guaranteeing safety). Beyond this restrictive framework, these medications have marketing approval, but, for the specific features of homeopathic medications, the directive leaves it up to the member States with a "homeopathic tradition" to apply special rules for evaluating the results of clinical trials designed to establish safety and efficacy. For the efficacy feature, traditional use can be used as an argument for marketing approval (article R5143 CSP). In order to create a more rational technicoregulatory environment, older products marketed before 1994 are being "validated" by group according to a calendar established in 2003 and which should run from 2004 to 2012. At the end of this validation procedure, all manufactured homeopathic products will either receive marketing approval or be recorder in compliance with general or specific European regulations. In conclusion, we make a few personal comments which should be helpful for the reader to distinguish between therapeutic efficacy and therapeutic interest.

The return of the pharmaceutical industry to the market of contraception.

In the 1980s and 1990s, the litigious climate in the US had a catastrophic effect on sales of many major contraceptives. Although oral contraceptives escaped controversy, the intrauterine device (IUD) and Norplant(R) were two targets of damaging litigation. The IUD was withdrawn from the market in 1985. Since 1994 when the attacks began against Norplant, its US sales have dramatically declined, even though no fault has been found in the method or its development. In general, pharmaceutical companies were extremely hesitant to develop new contraceptives during this period. The bleak outlook, however, began to shift in the late 1990s, as fertility rates began to decrease worldwide and contraceptive users increased. By 2025, 2500 million women will comprise the customer base for contraception. Global pharmaceutical companies are now participating in expanding markets overseas and have launched and continue to develop a range of new long-term reversible, and highly effective, contraceptive products outside the traditional oral contraceptive field. Two new contraceptives on the way to the US market are: Mirena, a levonorgestrel-releasing intrauterine system manufactured by Schering-Leiras; and Implanon, a single implant system manufactured by Organon of the Netherlands. Other birth control methods soon to be launched include: emergency contraceptives, the contraceptive patch, monthly contraceptive injections, mifepristone for medical abortion, and modified oral contraceptives.

Promotion by the British pharmaceutical industry, 1983-8: a critical analysis of self regulation.

Since 1958 the Association of the British Pharmaceutical Industry (ABPI) has attempted to regulate the promotion of prescription medicines through its code of practice. This regulation is described and analysed for the six years 1983-8 using the reports on 302 complaints considered by its code of practice committee and annual reports. The complaints came mainly from doctors (143, 48%) and competing companies (103, 33%). The committee found a total of 379 breaches of the code in 192 (63%) of the complaints. Additional breaches were detected by informational scrutiny of advertisements by the ABPI secretariat. Analysis showed that 270 (71%) of these breaches involved possible breaches of the Medicines Act. The rules that forbid misleading or unsubstantiated information and misleading claims or comparisons were broken most often. The committee found the most frequent offenders to be Organon (32 breaches), Smith Kline and French (23), Glaxo (21), A H Robins (18), Bayer (17), Merck Sharp and Dohme (17), and Lederle (16). Often the promotion of one product led to several breaches. The promotional wars over histamine H2 receptor antagonists accounted for 33 breaches. It is estimated that in 1983-8 about 100 breaches of the code were detected a year. In the 18 years 1972-88 the Medicines Act was breached probably over 1200 times. Health ministers, by not enforcing the regulations controlling promotion, have abrogated their responsibility to the ABPI, but the evidence suggests that the code has failed to deter promotional excesses. The ABPI's wish to secure compliance with the code seems weaker than its wish to pre-empt outside criticism and action: its self regulation seems to be a service to itself rather than to the public. It is suggested that the code of practice committee should become publicly accountable, that the majority of its members should represent the health professions and the public, and that effective sanctions are needed.

Under pressure: homeopathy UK and its detractors.

Though homeopathy has been in successful and continuous use for well over 200 years, in the United Kingdom it is under growing pressure, from scientific detractors and sections of the media. As such, homeopathy's free National Health Service provision is threatened because it is derided as 'unproven', 'unscientific', and even 'deadly'. While refuting these and other detractions, this paper considers possible reasons for the current plight of homeopathy UK. Thus, the current attacks against homeopathy should be viewed more in the context of the globalised pharmaceutical industry which is itself in crisis, and a succession of UK governments seemingly supine in the face of legislation originating from the European Union.

[The regulatory framework for complementary and alternative medicines in Europe]. / Europäische Gesetzgebung zu besonderen Therapierichtungen.

Medicinal products from complementary and alternative medicine are in Germany a regular part of the health care system. Herbal, homeopathic, anthroposophic and traditional medicinal products are highly accepted by the population. The German Medicines Act obliged the competent authorities to consider the particular characteristics of complementary and alternative medicines. The European regulatory framework defined the status of herbal medicinal products, traditional herbal medicinal products and homeopathic medicinal products within the directive 2001/83/EC. The committee for herbal medicinal products (HMPC) was established at the European Medicines Agency in London (EMEA); for homeopathic medicinal products there is a specific working group established by the Heads of Medicines Agencies. Harmonisation of medicinal products from complementary and alternative and traditional medicine in Europe was enforced by implementation of directive 2001/83/EC in national legislations of member states. The provisions of this directive will substantially influence the development of the European market during the forthcoming years.

Opium and infant-sedation in 19th century England.

Infant cordials containing opium were commonly used in Victorian England to quieten babies and young children. The cordials were freely available and sold under a variety of brand names. JANET BRIAN describes the slow progress towards legislative control of the sale of opium and its use in infant cordials, in which opposition from the pharmacy lobby and government reluctance to lose income from the lucrative opium trade played a major part.