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Ayush Ministry to amend D&C Rules to regulate retail outlets of ASU drugs
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Peethaambaran Kunnathoor, Chennai
November 18 , 2024
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The Union Ministry of Ayush (MOA) will soon amend rules to regulate the retail sale outlets of the Ayurveda, Siddha and Unani (ASU) drugs in order to ensure safety, efficacy and quality of these medicines.
An amendment in Drugs and Cosmetics Act, 1940 is imminent in this regard, and the ministry is now considering the recommendations of the expert committee drafted for presenting in Parliament, sources from the ministry informed Pharmabiz.
It is learnt that once the amendment is in force, the Ayurveda drug inspectors can inspect the ASU retail outlets and samples can be drawn for testing, as is being done by drug inspectors of the modern medicine system. Similarly, the people can use the traditional drugs supplied through retail pharmacies under medical supervision and verify the ingredients on the label. If any contravention is found, there will be provisions to report to the drug controlling authorities.
The sale outlets of the ASU drugs will become Ayush Pharmacies and the dispensing of the medicines will be carried out by qualified persons like Ayurveda pharmacists or doctors.
According to information received from the Ayush Ministry, the ASU Drugs Technical Advisory Board (ASUDTAB) under the ministry, in its last meeting, recommended to constitute an expert committee for registration of sale outlets of ASU drugs. In addition to obtaining sale licences from the Ayush drug control department, the retail shops will have to submit sale data of formulations containing ingredients mentioned under Schedule E (I) (Poisonous Substances) through e-Aushadhi portal.
To strengthen and expedite the process, the Ayush Ministry, on the recommendation of the ASUDTAB, constituted a committee to prepare necessary amendments in Drugs and Cosmetics Rules, 1945. The committee is working on the draft of the amendments, and once the process is completed it will be presented in Parliament to make it a law, sources informed.
Currently, the sale of homoeopathic medicines is already regulated under the provisions of the Drugs and Cosmetics Rules, 1945.
When Pharmabiz sought the responses of the industry and traders, positive supporting comments have come from everybody. According to Dr P Madhavan Kutty Varier, managing director of the Kottakkal Aryavaidyasala, sale licences for retail outlets of Ayurveda products is necessary to ensure its quality and safety. He said there should be a provision to dispense the medicines by competent persons, either Ayurveda pharmacists or doctors. The current system of allowing anybody to start an Ayurveda pharmacy has to be stopped and it should reach the hands of qualified persons. He welcomed the decision of the Union Ayush Ministry in its efforts to bring the retail sales under legal control.
Since there is no regulatory control for the retail outlets, no statistical data is available with any agency or government about the number of sales outlets and the source of procurement of medicines for sale. Approximately, there are about ten lakh retail shops of ASU&H operating across the country.
The MOA has taken various steps to ensure quality of Ayush drugs in the country. One Central Sector Scheme for Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented for the year 2021-2026. The components of the AOGUSY scheme include strengthening and up-gradation of Ayush pharmacies and drug testing laboratories (DTL) to achieve higher standards. It also includes pharmacovigilance of ASU&H drugs including surveillance of misleading advertisements, strengthening of central and state regulatory frameworks including technical human resource and capacity building programmes for Ayush drugs, and support for development of standards and accreditation/certification of Ayush products and materials in collaboration with Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centres.
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