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The Ayush drug manufacturing industry in the country, which has been treading a robust growth path, has received a booster dose as the Central government has ordered all Central and State agencies not to ask for analytical test reports at the time of submission of tenders or rate contract applications for the public procurement of medicines.
Obtaining analytical test reports of Ayurvedic, Siddha, Unani and Homoeopathic (ASU&H) medicines is an expensive and laborious exercise for micro, small and medium enterprises (MSMEs) and the ministry intervention will prove a boon to hundreds of firms that are keen on taking part in the procurement process.
Safety of herbal medicines is a major concern for health authorities worldwide and the World Health Organisation (WHO) has come out with a set of guidelines to address the issue and promote the efficacy and quality of traditional drugs. Several laboratories approved by the Indian government and accredited by National Accreditation Board for Testing and Calibration (NABL) have facilities to test raw materials, excipients and finished single herb as well as poly herbal formulations. They also carry out microbiological and physicochemical testing, tests for aflatoxins and other mycotoxins, chromatographic fingerprinting and non-genetically modified organism certification.
“However, these tests are quite expensive. Moreover, not all small manufacturing companies have access to these facilities as many of these labs are located in South Indian states. The government has finally cleared the air on this issue. It is indeed a welcome step,” Sanjay Srivastav, Director of Maharishi Ayurveda Products, a Delhi-based Ayush drug manufacturer, told Pharmabiz.
To rectify the anomaly, the Ayush ministry has directed all central and state procurement agencies not to ask for analytical test reports of ASU&H medicines quoted in the tender document. Henceforth, the manufacturers have to submit the test report or Certificate of Analysis only for the batch or lot of medicines actually delivered by them to dispensaries or hospitals under the rate contract.
“This will be a feasible alternative to the current method. The requirement of analytical test report at the time of tender submission is illogical. When we take part in the tender process, we have no guarantee that our products will qualify or get shortlisted for the contract,” an industry representative pointed out.
India has more than 9,000 units engaged in the manufacture of Ayush drugs. The government’s decision to make things plain is expected to help many of these companies take part in the public tendering process without feeling the pinch in their pockets.
With a wealth of 6,600 medicinal plants, the country is the second largest exporter of Ayush and herbal products in the world. The export of Ayush products is also on the rise with shipments, including extracts of medicinal herbs, crossing $403 million in 2016-17. The industry is expected to touch Rs.1.4 trillion by 2020 and might grow in double digits by providing direct employment to one million and indirect jobs to 25 million by 2020. The product market itself is worth about Rs.40 billion with over-the-counter products such as digestives, health food and pain balms constituting 75 per cent of the segment.
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