Good Manufacturing Practices for Herbal Products

GMP

The Western countries are turning more and more towards using alternative or traditional forms of medicine due to their known therapeutic abilities. Besides, the use of herbal drugs is becoming increasingly popular due to increasing consumer awareness on ‘green’ initiatives. However, for the herbal drugs to gain widespread acceptability and use there is a need for laying down basic manufacturing standards for the herbal industry.

Good Manufacturing Practices for Herbal Drugs

In the manufacture of herbal drugs, specific plant parts are to be used in specific proportions. The initial testing of the manufacturer would be in regard to conformity of usage of the right amount and then the quality of the botanicals. As regards quality, the raw materials have to be ensured that they are free from contaminants and only then they should be taken to the labs. The concept of Good Manufacturing Practices herbal products comes into the picture here.

Good Manufacturing Practices for herbal drugs covers their growth in the farms to their preparation in varied formulations with the extract, crude powder or purified components. The aims of GMP for herbal drugs are normally laid down in terms of required achievements in different aspects of manufacture and control encompassing cultivation and collection. Various other regulatory aspects pertain to manufacturing operations, laboratory validation, personnel and facilities.

GMP is one part of quality control which is related to specifications, sampling, testing, organizing, documentation and release procedures. Good documentation is an essential feature of GMP as this ensures the traceability of entire history of a batch of herbal products and also the defined procedures in every stage of production.

Investment & Business Opportunities in Herbal Industry

The WHO has estimated that 80% of the rural population in developing countries depends on traditional plant based medicine for their basic health care needs. The global market for herbal drugs is poised for a steep growth and this will open the doors to huge business opportunities in herbal industry. International trade of natural plant products is expected to triple by 2020 and the herbal drugs expected to grow up to 20%.

India is a valuable store-house of diverse medicinal plant species and presents a vast scope for turnkey herbal product development. Hence, it is very essential for the manufacturers of herbal drugs in the country to follow GMP in order to tap the natural products business opportunities. However, this calls for additional investments on their part which may be difficult for the small manufacturers to fulfill. In this regard, it is the duty of the national health bodies to take necessary measures to promote and ensure the willingness of the manufacturers to adopt GMP. Several efforts are being taken by the governments at both the Centre and the State level to encourage entrepreneurs to set up herbal business in the country.

The Ministry of Agriculture has set up the Department of Agriculture and Cooperation to promote the integrated growth of herbal and aromatic plantations in India. It is also very active in framing schemes and policies for the sector.