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02 March 2004
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Tuesday
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10 Muharram 1425
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PM approves draft law to regulate herbal drugs
By Nasir Iqbal
ISLAMABAD, March 1: Prime Minister Mir Zafarullah Jamali has approved a draft legislation for presentation to the cabinet to regularize and register traditional herbal and ayurvedic medicines.
An official source told Dawn that under the law a licensing and registration board would be set up, similar to the one which has been functioning under the Drugs Act 1976 to regularize allopathic medicines. In the absence of such a law, hundred of thousands of herbal medicines are being sold in the country without any regulation and quality check.
"This is true that a number of so-called 'Hakims' are playing havoc with the lives of patients by administering steroids-adulterated medicines," a senior official in the ministry of health said.
He said due to the absence of a law, advertisements or promotional statements through wall-chalking or pamphlets claiming, for example, to restore men's potency or other weaknesses, could not be checked despite the fact that these were against the law.
The objective of the proposed law, the source said, was to encourage export of good quality medicines, which some reputed manufactures have been producing but could not be exported despite being in demand due to non-existence of a regulatory and licensing body.
The board will be led by executive director National Institute of Health (NIH) while it would comprise representatives from the four provinces, homeopathy, Tibb, ministry of health, the NIH and academicians.
The draft was inked by a national advisory committee on traditional medicines after a series of meetings and suggestions and was sent to the provinces, ministries of finance, industry and law and justice for perusal.
After incorporating their inputs, the proposals in a shape of a bill was submitted to the prime minister, who approved the idea for its final endorsement from the cabinet, the source said.
The draft law asks for formation of a pharmacopoeia to have standard specifications of traditional medicines, after which the medicines would be registered gradually while the producers would be encouraged to implement good manufacturing practices in their facilities.
The law also suggests penalties for selling spurious medicines. Though there exists the Unani and Ayurvedic Act of 1965, it deals only with the registration of qualified Hakims to practise Tibb, but is silent about the quality of medicines a Tibb prescribes.
The source said after hectic meetings, led by former secretary health Ijaz Rahim, with leading manufacturers of herbal medicines in May 2003, the government had convinced the manufacturers to register their products so that their medicines could be exported after receiving quality certificates from the government.
Earlier, the herbal medicines manufacturers were reluctant to bring their products under any regulation, fearing exploitation from the government. However, the source admitted that from the date of amendments to the rules by the cabinet, the health ministry would require at least three to four years to register a sizable number of herbal medicines.
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