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Medical Voice 6th August 2019

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Dr KK Aggarwal    06 August 2019

Sports centres in Scotland ban energy drinks for children

All publicly-funded sports and leisure centres in Scotland have banned the sale of energy drinks to children under the age of 16. The move on high-caffeine drinks is the result of work by umbrella body Community Leisure UK and the Scottish government. In total, 1,300 sites have introduced the restriction. Public Health Minister Joe FitzPatrick welcomed the "leadership" they had shown in announcing the ban. The drinks, which can also have high levels of sugar, have been linked to health problems in children. The World Health Organisation has published research suggesting an association with headaches, sleep problems, irritability and tiredness.

Kirsty Cumming of Community Leisure UK said: "After working closely with both our members and colleagues at Scottish government, Community Leisure UK is delighted that all members in Scotland have chosen to ban the sale of energy drinks to young people under 16. "This is an important step in protecting the health of young people across Scotland and we are proud to support the Scottish governments promise made in the Diet and Healthy Weight Delivery Plan." (Source: BBC, Aug. 4, 2019)

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Government plans to roll out e-pharmacy project in 100 days

Mint- Teena Thacker

Formal recognition and regulation of online pharmacies is a step closer to reality, with health ministry officials set to meet industry stakeholders on 10 June to finalize the rules. The new government is planning to roll out the e-pharmacy project in its first 100 days, having released the draft rules for it last year. India’s online pharmacies that currently operate in a regulatory grey area, thanks to conflicting court orders, hope the new rules will bring much-needed clarity to the sector. According to the proposed e-pharmacy rules which were opened for public comments in September, only government-registered e-portals can sell medicines, and they must retain prescriptions and verify details of patients and doctors. However, the going has not been easy for online pharmacies. In December, the Delhi high court ordered all online pharmacies in the country to shut by 20 December. In the same month, the Madras high court suspended the ban, after a group of e-pharmacy companies filed an appeal. The order came as a respite for e-pharmacies, but the health ministry now wants to finalize the regulation.

No new pharma colleges for 5 years

Telangana Today - ANI

In view of the lack of quality education and shortage of qualified teaching staff, a government body under the Union Health Ministry has imposed restrictions on setting up new pharmacy colleges for the next five years. As per the resolution adopted by the Pharmacy Council of India (PCI), the restrictions would not be applicable to the North-Eastern parts of the nation, as that is the only area where there is a shortage of pharmacy colleges. The PCI, a statutory body working under the Ministry of Health and Family Welfare, was constituted under the Pharmacy Act, 1948 to regulate pharmacy education and the practice of the profession in the country by prescribing the minimum standards of education required to qualify for registration as pharmacists.

To ensure authenticity, APIs of drugs may soon get track-and-trace codes

The Indian Express - Prabha Raghavan

The Health Ministry may soon make it mandatory for companies to include codes to track-and-trace key ingredients used to make medicines in India, The Indian Express has learnt. If implemented, the move will potentially be the first step by the government to pinpoint the origin and movement of drugs manufactured here and ensure their authenticity. A draft amendment mandating quick response (QR) codes at “each” level of packaging of active pharmaceutical ingredients (APIs), used to give medicines their therapeutic effect, is ready and will be notified “soon”, said a senior Health Ministry official. The Indian Express has viewed a copy of this draft. “The basic drug is in the API. For a medicine to be effective, the API has to be effective. As a first step (to tracking and tracing medicines in the country), every API manufactured or imported in India will bear a QR code on its label at each level of packaging,” the official added. India is currently dependent on China for imports of APIs to make “certain” essential medicines, with around Rs 12,255 crore worth of these ingredients imported from the country in 2016-17, as per government data.

Six bodies registered with CDSCO to audit medical device manufacturing sites as per new MD Rules

Business Medical Dialogues

Trough a recent public notice, the apex drug regulatory body, Central Drugs Standard Control Organisation (CDSCO) has notified six bodies to carry out an audit of manufacturing site under the provisions of the Medical Devices Rules, 2017. New Delhi: In this connection, six bodies have been registered with CDSCO. These audit services providers include New Delhi-based Intertek India Pvt. Ltd which was established in the year 1997; TUV Rheinland India Pvt. Ltd located in West Wing, Electronic City in Bengaluru; TUV Sud South Asia Pvt. Ltd situated in Mumbai; Dnv GI Business Assurance India Private Limited, Mumbai; BSI Group India Pvt. Ltd, New Delhi and BSCIC Certifications Pvt Ltd situated in Faridabad. “The notified bodies registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out an audit of manufacturing site under the provisions of said rules,” reads the notice undersigned by the Joint Drugs Controller of India, Dr V G Somani. New Medical Device (MD) Rules 2017 were notified last year and has come into effect from the beginning of 2018 onwards in the country. MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate the manufacture, import, sale and distribution of the medical devices. New MD Rules 2017 cover medical devices, invitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.

ICMR releases policy on research integrity & publication ethics to maintain professional standards for health research

Pharmabiz India- Shardul Nautiyal

To ensure highest professional and ethical standards for bio-medical and health research at all stages, the Indian Council of Medical Research (ICMR) has released policy on research integrity and publication ethics. As per the policy document, research must follow applicable guidelines such as ICMR National Ethical Guidelines, Good Clinical Practices/Good Laboratory Practices (GCP/GLP) and other applicable guidelines and regulations. The policy is intended to also provide procedures to manage allegations of research misconduct to be processed fairly, confidentially and promptly. ICMR Bioethics Unit would provide needful support to ICMR network of institutions in establishing appropriate policies for declaration and management of conflict of interest (COI) at the level of researchers, ethics committee (EC’s) as well as institutions. The policy has been prepared by the committee headed by Chairperson Prof. Balram Bhargava, secretary, Department Of Health Research (DHR) and Director General (DG), ICMR, New Delhi. Dr. Roli Mathur, Scientist ‘E’ and head, ICMR Bioethics Unit, National Centre for Disease Informatics and Research (NCDIR), Bengaluru is the Member Secretary of the committee. Dr R Gangakhedkar, Scientist ‘G’ and head, Division of Epidemiology and Communicable Diseases (ECD), ICMR, New Delhi, Dr N C Jain, Scientist ‘G’ and head, Division of Human Resource Planning and Development (HRD), ICMR, New Delhi are members of the committee.

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