Express Pharma

Ministry of AYUSH takes steps to assure quality of AYUSH drugs

The information was given by Sarbananda Sonowal, Minister of AYUSH, in Rajya Sabha, yesterday

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The Ministry of AYUSH has taken various steps for assuring quality control of AYUSH drugs in the country, Sarbananda Sonowal, Minister of AYUSH, informed Rajya Sabha, yesterday.

He said, “Under the National AYUSH Mission (NAM) from 2014-2021, apart from other services, grant-in-aid were also provided for strengthening of state government ASU&H pharmacies. At present, Central Sector Scheme for AYUSH Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) has been implemented for the year 2021-2026.”

He further informed that the components of the AYUSH AOGUSY scheme are strengthening and upgradation of AYUSH pharmacies and drug-testing laboratories to achieve higher standards, 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 the Bureau of Indian Standards (BIS), Quality Control of India (QCI) and other relevant scientific institutions and industrial R&D centres.

In addition, he notified that in 2021, Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), Ghaziabad, a sub-ordinate office of the Ministry of AYUSH, has signed a Memorandum of Understanding (MoU) with American Herbal Pharmacopeia, United States (US) for developing standards of Ayurveda and other Indian systems of medicine on international standards. Further, PCIM&H and Indian Pharmacopoeia Commission (IPC) have also signed an MoU for developing “One Herb One Standard.

Furthermore, to facilitate exports, Ministry of AYUSH has encouraged Certification of Pharma Products (CoPP), as per WHO Guidelines, for herbal products. Quality Certifications Scheme implemented by QCI for grant of AYUSH Premium mark to Ayurvedic, Siddha and Unani products on the basis of third-party evaluation of quality in accordance with the status of compliance to international standards. Twenty seven state drug-testing laboratories have been supported for strengthening their infrastructural and functional capacity. As on 13th December, 2022, 81 laboratories are approved or licensed under the provisions of Drugs and Cosmetics Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials, Sonowal mentioned.

Further to it, he emphasised that pharmacovigilance centres for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs set up in different parts of the country under the Central Scheme of the Ministry of AYUSH are mandated to monitor and report the misleading advertisements to the respective state regulatory authorities. A three-tier structure comprising a National Pharmacovigilance Co-ordination Centre (NPvCC), Intermediary Pharmacovigilance Centres (IPvCs) and Peripheral Pharmacovigilance Centres (PPvCs) is established. Objectionable advertisements are being reported to the respective State Licensing Authorities by PPvC at regular intervals.

“Total nine posts i.e. four posts of Drug Inspectors (one in each stream- Ayurveda, Siddha, Unani and Homoeopathy); four posts of Assistant Drug Controller (one each for Ayurveda, Siddha, Unani and Homoeopathy) and one post of Deputy Drug Controller (ASU&H) has been created for setting up of the office of the Central AYUSH Drugs Controller in the Ministry of AYUSH. The ministry has appointed its nine officers for the additional charge of the above-mentioned nine posts in addition to their normal duties in the Ministry of AYUSH, without any additional remuneration vide gazette notification S.O. 4562(E) dated 27.09.2022. The ministry is in the process of filling the nine posts created for setting up the office of Central AYUSH Drugs Controller on regular basis in consultation with the Union Public Service Commission (UPSC),” he said.

Apart from it, he also spoke about the AYUSH Grid Project that envisages digitisation of service delivery across six functional areas — health services, education, research, drug administration, medicinal plants, and Ministry of AYUSH oversight, along with capacity building and media outreach.

Some of the objectives of the project are enhancing access to AYUSH services like health services, education, research, etc. in India and at the global level; ensuring holistic coverage of the AYUSH sector by digital solutions; increasing digital collaboration and exchange of the best practices among AYUSH stakeholders and attaining highest possible level of health and well-being as per the National Health Policy 2017.




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