A comprehensive set of rules is essential to regulate research and facilitate commercialisation in biotechnology. Patricia Sierra Blzquez , director of the Centre of Molecular Immunology (CIM), Cuba, talks to Vibha Varshney on the growing importance of biotech products in the present day health scenario
What is the need of regulating biotechnolgy?
Biotechnology products have acquired a special significance today as they can be used to cure diseases where conventional drugs have failed. Unfortunately, despite a growing demand for these products, the existing regulations are not comprehensive enough to address the market needs adequately.
What kind of guidelines should be formulated in this field?
Though standards for use of biotech products have been set by World Health Organisation (who) and International Commission of Harmonisation (ich), they are not adequate. The main problem is that the two bodies have followed different criteria while laying down their guidelines.
It is, therefore, imperative that each country lays down rules and regulations that clearly outline its own requirements. It is also necessary that while framing them, demands of the market is kept in mind. For example, if a country is targeting Japan for its products, it should adhere to ich rules which are applicable there.
What are the other factors to be considered while drafting these rules?
It is important to ensure that the rules formulated are logical, keeping in mind the limitations of biotech products. For instance, toxicity of conventional drugs can be tested by studying the breakdown products in the body. But such a test cannot be carried out in the case of biotech products like novel proteins, where the breakdown process is not understood. Moreover, it is not possible to determine how these drugs would behave inside the body.
Thus, only the relevant tests should be carried out and this can be decided in technical discussions between the producers and the regulatory body. As the field is relatively new, it is necessary that both parties keep an open mind about these tests. Discussing each case separately would be a good way of understanding the intricacies involved in testing the product.
What are the regulations in Cuba on use of biotechnology products?
To ensure that the product is acceptable in the country buying it, we strictly adhere to the international standards. Since we are not catering to the needs of Cuba alone but are actively exporting the antibodies to other countries, we follow both who and ich rules depending upon the market.
How is biotechnology being used in the present day health scenario?
The technique is currently being employed in preparation of monoclonal antibodies (antibodies derived from a single cell which are identical and targeted towards a specific disease) Antibodies are normally produced in response to an external stimulus such as a disease causing organisms. If multiple copies of specific antibodies, directed towards a pathogen can be prepared, they can be used to boost the immune system. Biotechnology is being used to prepare such copies. Initially, monoclonal antibodies (mabs) were developed using mice and these had undesirable side effects like the production of anti-mouse antibodies in humans. To counter this and increase the efficacy of the antibody, different techniques are now being employed to prepare antibodies that are similar to the original structures found in humans. One of the ways is by inserting human antibody producing genes in mice and suppressing those of the rodent.
Can biotech products be used for treating cancer?
mabs have been considered to be magic bullets in case of cancer treatment and this can be gauged from the fact that 51 per cent of the clinical trials using these antibodies have been carried out in this particular field. cim has developed h-R3 -- a receptor against the epidermal growth factor (egf) responsible for the spread of cancer. Clinical trials using these are being carried out in Cuba and Canada. So far, the mab has been tested in patients with certain types of advanced tumors. Different amounts of the antibody were given to 12 patients through a single intravenous infusion. While the patients did experience tremors, nausea, fever and hypertension, there were no allergic reactions or signs of liver damage. The antibody was then tested on patients suffering from advanced head and neck cancer in combination with radiotherapy. Patients were given six-weekly doses of the antibody and the cumulative dose ranged from 300 to 2400 milligramme. It was found that the treatment worked well in combination with radiation therapy.
What are the problems facing the Indian biotech research?
The main problem here is the lack of infrastructure. I am sure there must of thousands of antibodies that are available in India but there is no way that this research can be carried forward and commercialised. In Cuba, the biotech centres take care of all the aspects such as research, production and commercialisation. Also there is a lot of effective networking within the centres. For example, when a drug is developed, it is sent to special centres, which are authorised to carry out toxicological studies on animals and this helps in time and resource management. Such a collaboration would be extremely useful in India.
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