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India introduces regulations for making traditional medicines

BMJ 2000; 321 doi: https://doi.org/10.1136/bmj.321.7254.134 (Published 15 July 2000) Cite this as: BMJ 2000;321:134
  1. Rohit Sharma
  1. Mumbai

    The Indian government has drawn up regulations for good manufacturing practice for traditional Indian systems of medicine such as ayurveda, sidha, and unani, so that the industry can compete in international markets.

    The lack of regulation was “a serious shortcoming which has now been overcome,” said Shailaja Chandra, secretary of the Indian government's department of Indian systems of medicine. Her department had identified drug standardisation and quality control as the most important changes affecting the future of the Indian systems of medicines.

    The new manufacturing regulations are calculated to improve the quality and standards of medicines being manufactured in some 9000 licensed pharmacies. The manu-facturing rules prescribe essential infrastructure, staffing, and quality control requirements such as standard manufacturing processes and the use of authentic raw materials free from contamination.

    A transition period of two years has been given to existing registered units to comply with the new rules by improving infrastructure and quality. Registered practitioners of the Indian systems of medicine, called vaidyas, hakims, and sidhas, and teaching institutions have been exempted from the regulations.

    The Indian government is also planning to install and strengthen laboratories for testing traditional medicines, says Ms Chandra. She believes that this step will promote traditional medicines in national and international markets.

    Nationally, state dispensaries will be able to stock certified medicines, and the demand will grow. “Anybody abroad who buys our medicines, whether as food supplements or as medicines, would like to be assured that we as a country have certified the safety of these products,” says Ms Chandra.

    If the medicines have been tested in government approved laboratories, anybody who buys medicines could look for the good manufacturing practice certificate and be satisfied that some element of checking at a government level has taken place, she says.

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