Advisory on Medical device Standards

Public Notice on Medical Devices Standards from Department of Pharmaceuticals

Public notice on Medical Devices from Department of Pharmaceuticals on what Standards industry and stakeholders have to follow, refer while dealing with Medical Devices.

Medical Device Sector is brought under 100% Regulation which means that it’s well defined framework , structure and has well established regulatory protocols .

Healthcare Services should understand more about the Supply Chain Quality – understand the Regulations, Standards , Certifications , Testing , Inspection norms that are prescribed for the market players.

Unless the supply chain quality is understood correctly, Service providers delivery can’t have the necessary assurance to users .

Procurement teams, QA teams in healthcare services should know about National, International Conformity Assessment practices, norms for Healthcare Products.

Since Users, Patients, stakeholders etc are always seeing Global Quality Campaigns while introducing, prescribing Products, it’s important to respond to queries on the same when asked.

Source: Public Notice No.31026/83-2021-MD dt. 01.02.2022 issued by Department of Pharmaceutical

Heal in India

Heal in India – Govt plans interpreters, special desks at 10 airports for ease of overseas patients

‘Heal in India’ – Government is likely to announce the initiative on August 15 2022.

The ‘Heal in India’ initiative aims to positioning the country as a global hub for medical and wellness tourism.

Interpreters and special desks at 10 airports, a multi-lingual portal and simplified visa norms are going to be the highlights of the government’s ‘Heal in India’ initiative to boost medical tourism.

The government has identified 44 countries, predominantly African, Latin American, SAARC and Gulf countries from where a large number of people visit India for medical purposes. The 10 identified airports — Delhi, Mumbai, Chennai, Bengaluru, Kolkata, Visakhapatnam, Kochi, Ahmedabad, Hyderabad and Guwahati — see higher footfalls of patients from these 44 countries

The Health Ministry, in collaboration with the National Health Authority, has developed a multi-lingual portal which would be a one-stop shop for services provided by medical travel facilitators and hospitals with an interface for foreign patients. The portal is also likely to be launched on August 15.

The portal will display standardized package rates based on the classification of hospitals and different systems of medicines including modern and traditional systems. It will also have a grievance redressal section as well as an option to submit patient feedback.

There will also be a mechanism to track patient journey by creating a unique health ID under the Ayushman Bharat Digital Mission framework and monitor service delivery in identified health facilities in India

Source:https://m.timesofindia.com/business/india-business/heal-in-india-govt-plans-interpreters-special-desks-at-10-airports-for-ease-of-overseas-patients/articleshow/93408941.cms

NHA Joins hands with QCI to Accredit ABDM Compliant Healthcare Solutions

National Health Authority (NHA) joins hands with Quality Council of India (QCI) to accredit ABDM compliant healthcare solutions like HMIS/LMIS

The National Health Authority (NHA) has onboarded the Quality Council of India (QCI) for six months to accredit and rate HMIS (Health Management Information System)/ LMIS (Laboratory Information Management System) solutions that have integrated with Ayushman Bharat Digital Mission (ABDM).

NABH will undertake the responsibility of accrediting and rating the ABDM compliant solutions on various parameters, including ease of usage, user interface, pricing, number of modules/features and value for money/pricing so that prospective purchasers may get credible information.

The purpose of this initiative is to encourage innovations by streamlining delivery of health tech services in a significant way. To develop a framework to ensure that ABDM compliant digital healthcare solutions are accredited and rated and to adequate information is available to consumers for choosing one solution over another.

Accredited health tech solutions will help healthcare organizations manage their patient journeys and business more methodically in accordance with ABDM standards. And ultimately, this initiative will help the citizens of India get better and more timely healthcare and help India become one of the leaders in digitization of healthcare in the world”

This accreditation exercise will be conducted in a phased manner. Phase I shall focus on accreditation and rating of HMIS solutions successfully integrated with ABDM. Subsequent phases shall include other subjective parameters and other categories of healthcare solutions like LMIS, Health Lockers, Health Tech,PHR (Personal Health Records) apps etc.

Source : Posted On: 04 AUG 2022 6:12PM by PIB Delhi

Pharma Sector Global Standards

Government of India launches scheme for pharma sector to step up capacity, upgrade to global standards

Move from Volume to Value

Support to Pharma clusters and MSME units to enhance quality and technology improvement

In the launch event of DoP’s Strengthening of Pharmaceuticals Industries – Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare urges the Pharma Industry to make India a global leader in pharma sector and utilize the scheme to upgrade MSMEs to high standards.

On July 21, 2022, Dr. Mansukh Mandaviya, Minister for Chemicals & Fertilizers and Health & Family Welfare formally launched the scheme of Strengthening of Pharmaceuticals Industries at Dr Ambedkhar International Convention Centre, Janpath, New Delhi, in the presence of  Minister of State for Chemicals & Fertilizers and New & Renewable energy Shri Bhagwanth Khuba amidst the strong presence of pharma MSME industry players and representatives of major Pharma Associations. 

The initiatives under the scheme are aimed at further enhancing India’s capabilities in the pharmaceuticals sector with an objective to make it much more competitive in terms of both quality and cost and also aimed at making Indian pharma MSMEs, a part of Global supply chain by incentivizing them to acquire Schedule M and WHO GMP certifications.

The Scheme provides for credit linked capital and interest subsidy for Technology Upgradation of MSME units in pharmaceutical sector, as well as support of up to Rs 20 crore each for common facilities including Research centre, testing labs and ETPs in Pharma Clusters. SIDBI will be the Project management Consultant for implementing the scheme.

The Chemicals and Fertilisers Ministry rolled out the schemes under the banner of ‘Strengthening Pharmaceuticals Industry’ (SPI). SIDBI will be the project management consultant for implementing the scheme

Union Minister for Chemicals and Fertilisers Mansukh Mandaviya said the schemes envisage technology upgradation, setting up of common research centres and effluent treatment plants in clusters for the pharma MSMEs and Small companies should be able to upgrade their facilities to global manufacturing standards.

The scheme has three components:

 Assistance to Pharmaceutical Industry for Common Facilities (APICF) – would strengthen the existing pharmaceutical clusters’ capacity for sustained growth. It provides for an assistance of up to 70 per cent of the approved project cost or Rs 20 crore, whichever is less.

 Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS) – would facilitate pharmaceutical MSMEs with proven track record to upgrade their technology. The scheme has provisions for a capital subsidy of 10 per cent on loans up to a maximum limit of Rs 10 crore with a minimum repayment period of three years or interest subvention of up to 5 per cent (6 per cent in case of units owned by SC/ST) on reducing balance basis

 Pharmaceutical and Medical Devices Promotion and Development Scheme (PMPDS), would involve preparation of study reports on topics of importance for the Indian pharma and medical device industry. The scheme is aimed at creating a database of pharma and medical device sectors

Information Source : https://www.moneycontrol.com/news/trends/current-affairs-trends/government-launches-scheme-for-pharma-sector-to-step-up-capacity-upgrade-to-global-standards-8862561.html

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