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Opinion | Prev


Traditional technique that enhances drug availability

M. Somasekhar

RESEARCHERS at the Regional Research Laboratory (RRL), Jammu, while studying Ayurvedic formulations, chanced on an unusual phenomenon. In nearly 200 medical formulations, falling under a generic category known as trikatu, they found a common ingredient - - pepper.

Black pepper, long pepper and, to a small extent, ginger were essential inputs that enhanced the efficacy of these formulations in curing a wide range of diseases. Excited by this common thread, the scientists set out to unlock the secret properties of t he trikatu (pepper) formulations.

Practitioners of Ayurveda approached by the RRL could not explain the reasons for the inclusion of this ingredient. Therefore, the scientists sat down to a thorough analysis of the trikatu formulations, which revealed that pepper had the property of bio- enhancing the availability of a drug in the human body by increasing the blood concentration. Making this possible was the active constituent, identified as `piperine', and found in both the black and long peppers.

The RRL team led by Dr K. L. Bedi and the former Director, Dr C. K. Atal, isolated the piperine from the pepper plant and purified it. They then replaced trikatu with piperine and repeated the experiments on rats. The results were similar, with enhanced plasma and blood concentrates in the body.

The next stage was to blend the trikatu (pepper) with modern drugs (antibiotics), especially sulpha drugs and tetracycline, with the intention of observing how they were accepted by the body. Initial experiments were done on rats to examine the availabil ity of the drug in blood.

Having achieved encouraging results the scientists targeted `Rifampicin', the main `workhorse' in the multi-drug regimen for combating TB. The efforts by the RRL team opened up exciting prospects, with the piperine helping in enhancing the availability o f Rifampicin.

This has important implications for, say, a TB patient who has to take a 450 mg dose of Rifampicin daily for 6-8 months. The new technology of bio-enhancing the drug's availability would ensure that taking just 200 mg would suffice, explained Dr Bedi.

The RRL scientists demonstrated that piperine, in combination with 200 mg Rifampicin, resulted in the same therapeutic effect as 450 mg of the antibiotic alone in tests carried out on animals.

Interestingly, when the same technique when used for the other anti-TB drugs, such as Ethambutol, Isoniazid and Pyrazinamide, there was a drug availability increase of just 15-20 per cent in the blood plasma. Based on these studies, the RRL scientists co ncluded that Rifampicin was the best option for bioenhancing.

The implications of the success of this technology, especially in the treatment of TB, are an overall reduction in the cost of treatment and a reduction in the risks of side-effects associated with the use of Rifampicin, especially on the kidney and live r.

In the last few years, independent studies on the bio-enhancers have been taken up by the Indian Institute of Sciences (IISc), Bangalore; the National Institute of Immunology (NII), New Delhi; and the University of Mumbai, said Dr G. N. Qazi, Director o f the RRL.

The RRL has obtained a US patent for demonstrating the use of piperine as a bio-enhancer in anti-TB and anti-leprosy drugs in 1995, as well as an Indian patent, which has now expired. The focus now is to develop drug therapies or agents which will help t he body assimilate the drugs well, and which results in a lower requirement of various drugs, he said.

Strangely, once the RRL demonstrated the technology in animal experiments for the anti-TB drug Rifampicin, instead of gaining recognition, its troubles began.

Despite the Ahmedabad-based Cadilla Pharmaceuticals entering into collaboration for conducting phase-3, multi-centric trials, several obstacles emerged with the Drug Controller of India posing several queries, which led to delays since 1996. This, in tur n, meant that Cadilla, which is manufacturing the formulation, could not complete the trials and market the product easily.

The initial opposition stemmed from the drug lobbies, especially those operating in the anti-TB and -leprosy areas, which felt that their business would be affected as an outcome of the lowered dosage needs, the RRL scientists said. At one point, the Dir ector-General of the Council of Scientific and Industrial Research (CSIR) also expressed disappointment at the delays stemming from the Drug Controller's handling of the drug trial procedure.

The success of this interesting experiment, growing out of the knowhow available in the indigenous systems of medicine, is of considerable importance as traditional systems of Indian medicine and modern allopathy have not had the best of relationships in the country. There has always been mutual suspicion among the practitioners.

However, with the increasing worldwide interest in herbal drugs and medicinal plants, there are symptoms of change. The preference for alternative medicines, especially those derived from natural sources, is on the increase among people of the developed world. Thus, there is growing interest in Indian medicinal systems, including Ayurveda, Siddha and traditional folk medicine.

Undoubtedly, modern drugs, especially antibiotics, have played a significant role in the control of a wide range of diseases. In the bargain, however, they have also ushered in new problems. For example, the side-effects. Second, over-use and abuse have in certain diseases led to drug resistance. And finally, long-term prescription of antibiotics for diseases such as tuberculosis mean higher costs, which are not affordable by large sections of the people.

It is no wonder, therefore, that large corporates, especially pharma majors, have turned their attention to studying medicinal plants in biodiversity-rich nations such as India, China, Brazil, and so on, in the pursuit of developing new drugs.

Even in India, several initiatives have been launched, including a 19-laboratory, Rs 100-crore venture by the Council of Scientific and Industrial Research (CSIR). The focus is to identify, analyse and finally come up with new molecules and drugs from me dicinal plants found in the biodiversity regions of the country.

Scientists at the Regional Research Laboratory (RRL), Jammu, who are playing an important role in the project, have in a unique venture brought together the rich knowledge base of traditional medicine and scientific methods of modern science to develop a new technology that promises to enhance the bio-availability of antibiotics.

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