Legal remedy
-
29/06/1997
-
Down To Earth
IN a significant judgement in the last week of May, the Supreme Court (SC) directed the government expert panel set up under the Drugs and Cosmetics Act, 1949, to examine as to whether Ayurvedic, siddha or unani drugs are meeting the set standards and are fit for consumption. The case has brought to focus several vital issues regarding the Rs 900-crore herbal medicine market.
Inadequate checks on efficacy and toxicity often lead to substandard drugs being peddled in the market where assortments of adulterated plant parts are being sold in the name of the genuine ones. Companies buy these with or without knowledge and manufacture them. "When we went to the market to purchase Saracca asoca - the real source of Asoka that goes into the preparation of the drug Asokarishta used for menstrual disorders - we were offered a choice between a substitute at Rs 20 per kg and the real thing at Rs 200 per kg," says S Mehrotra, a scientist at the National Botanical Research Institute, Lucknow, who has been working on the standardisation of herbal medicine preparations.
"We urgently need to have a regulatory body, if we are to utilise our traditional knowledge system in an effective manner," says Ranjit Roy Chaudhury, chairperson of the Scientific Advisory Committee on Traditional Medicine of the Indian Council of Medical Research.
But modalities for the standardisation have yet to be worked out. Armed with a 1983 amendment to the Drug and Cosmetics Act - which insisted on drug formulae in authentic texts in February 1983 - the Drug Controller of India banned the manufacture of ayurvedic injections and siddha medicines. The ban was subsequently challenged on account of violation of the business rights of Ayurvedic manufacturers. The sc said that the government cannot ban these drugs and injections unless they are proven substandard by the committee.
The advisory committee, however, has yet to get its act together. Government officials say that there is a shortage of facilities and humanpower to check on these indigenous medical systems. "The area of regulation of ayurvedic drugs is a sort of no man's land, where there is no regulation on the companies of these products," says Roy Chaudhury.
Inadequate checks on efficacy and toxicity often lead to substandard drugs being peddled in the market where assortments of adulterated plant parts are being sold in the name of the genuine ones. Companies buy these with or without knowledge and manufacture them. "When we went to the market to purchase Saracca asoca - the real source of Asoka that goes into the preparation of the drug Asokarishta used for menstrual disorders - we were offered a choice between a substitute at Rs 20 per kg and the real thing at Rs 200 per kg," says S Mehrotra, a scientist at the National Botanical Research Institute, Lucknow, who has been working on the standardisation of herbal medicine preparations.
"We urgently need to have a regulatory body, if we are to utilise our traditional knowledge system in an effective manner," says Ranjit Roy Chaudhury, chairperson of the Scientific Advisory Committee on Traditional Medicine of the Indian Council of Medical Research.
But modalities for the standardisation have yet to be worked out. Armed with a 1983 amendment to the Drug and Cosmetics Act - which insisted on drug formulae in authentic texts in February 1983 - the Drug Controller of India banned the manufacture of ayurvedic injections and siddha medicines. The ban was subsequently challenged on account of violation of the business rights of Ayurvedic manufacturers. The sc said that the government cannot ban these drugs and injections unless they are proven substandard by the committee.
The advisory committee, however, has yet to get its act together. Government officials say that there is a shortage of facilities and humanpower to check on these indigenous medical systems. "The area of regulation of ayurvedic drugs is a sort of no man's land, where there is no regulation on the companies of these products," says Roy Chaudhury.