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Kerala Ayush DCA to submit proposal to govt for framing new rule to regulate vendors of herbal raw materials
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Peethaambaran Kunnathoor, Chennai
October 15 , 2020
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Drug regulators, academic researchers and experts in Ayurveda in Kerala are preparing a comprehensive proposal to the state government urging for framing a new rule to regulate local vendors who procure, stock, distribute and sell herbal raw materials required for the manufacture of Ayush medicines by small and medium companies.
For want of a concrete clause of law, the Ayush enforcement officials are unable to inspect the sale premises of the raw material vendors and check the quality of the raw drugs they supply to the manufacturers. The raw material merchants do not need any sale licences of the government and they currently do not come under the purview of any regulations.
According to regulatory officials, many of the Ayurveda medicines available in the market today are not made of genuine raw materials. Adulterations and substitutes contain in most of the raw drugs distributed by local vendors.
The proposal to the government is made on the direction of the state government to the drugs control department which sought suggestions and opinions from experts and public in this regard. Earlier, a former drugs controller of the Ayurveda wing in Kerala had lodged a complaint with the state human rights commission to inquire into the genuineness and quality of the raw drugs collected and distributed by the local vendors. Accordingly, the commission sought a clarification from the government.
Information from enforcement officers of the Ayurveda department reveals the fact that more than ten thousand ayurvedic raw material wholesalers and retailers are there in Kerala, who collect and sell the products to local drug manufacturers. These vendors do not need any licences of the regulatory body, so no agency or authority has the right to inspect or check the quality of the herbs or minerals or metals they supply as raw materials for traditional medicines.
While Pharmabiz sought opinions of the authorities in the field of Ayurveda, they are of the view that it is high time for the government to bring a law to regulate the collection, distribution and sale of all raw drugs for herbal formulations.
Dr T D Sreekumar, principal of the Government Ayurveda College at Tripunithura, said the quantum of heavy metals in ayurvedic drugs is more than the required quantity and several studies have shown that lead, mercury and arsenic are in larger quantities in many ayurvedic formulations and such drugs will create unintended harm to the patients. He said he will forward his suggestions to the Ayurveda DCA next Monday.
Dr N Vimala, former drugs controller of Ayurveda in Kerala, said she had submitted a similar proposal to the government seeking requirement of sufficient guidelines for control over raw material sales five years ago. Since the government has come forward to reinvigorate the Ayush sector, Dr Vimala will forward the copy of her earlier proposal to the drugs control administration.
Regarding constitution of an expert committee, Dr P Jaya, the drugs controller in-charge of the Ayurveda DCA said government has asked her to invite all the former DCs to the committee along with scientists from botanical gardens, representatives from Ayurveda manufacturers and officials of the medicinal plant board.
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