Editor in Chief Dr KK Aggarwal, Padma Shri Awardee                                                                               Dated:20 November,2019

FDA clears first duodenoscope with disposable elevator piece, reducing the number of parts needing disinfection

The U.S. Food and Drug Administration has cleared for marketing in the U.S. the first duodenoscope with a sterile, disposable elevator component that will reduce the number of parts that need to be cleaned and disinfected (reprocessed) in between uses.

The Pentax Medical Video ED34-i10T2 model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems… (FDA, November 15, 2019)

Medical Devices should be regulated under a Separate Law eventually and not as a Drug beyond 5 years, Nor as amendment to Drugs Act

The Under Secretary (Drug Regulation),
Ministry of Health and Family Welfare, Government of India,
Room No. 414 A, D Wing, Nirman Bhavan,
New Delhi – 110011
Email drugsdiv-mohfw@gov.in

Subject: Comments on Draft Notification # GSR 797 (E) dated 18th October, 2019

Dear Sir,

The subject Draft Notification # GSR 797 (E) dated 18th October, 2019 has been reviewed by the Heart Care Foundation of India (HCFI). The comments of HCFI on the Notification are as follows:

1.Medical Devices should be regulated under a Separate Law eventually and not as a Drug beyond 5 years, nor as amendment to Drugs Act ....read more

How long can one fast?

As per allopathy, one cannot live without air or oxygen for more than 3 minutes, without water for more than three days and without food for more than 3 weeks.

According to the Chandogya Upanishad, food is responsible for the making of motor organs (Karma indriyas), sensory organs, Manas (mind, intellect, memory and ego) and Prana. The fiery foods are responsible for making the motor indriyas, earthy foods for sensory indriyas and manas and water for making Prana Vayu.

Therefore, it is possible for a person to live on water for up to few weeks because he will keep making Prana and keep breathing but absence of food on 14th day onwards will start affecting his Gnana indriyas and Manas. The person will start losing power of hearing, touching and tactile sensation and will start showing impairment in mental status, memory, intellect functions and egoistic behavior.

Healthcare News Monitor

Health ministry signs pact with Gates Foundation for support in innovation
Mint - Neetu Chandra Sharma

The Union ministry of health and family welfare on Monday signed a memorandum of cooperation (MoC) with Bill & Melinda Gates Foundation (BMGF). Under the MoC, Gates Foundation will provide technical, management and program design support through its grantees and other partners, with a special focus on innovation, best practices and enhancing performance management, while working closely with the government. The Foundation will support the ministry’s work towards strengthening the primary health aspects such as reducing maternal and child mortality, improving nutrition services and increasing the immunization reach. Efforts will be made to increase access to family planning measures amongst younger women and reduce the burden of select infectious diseases such as Tuberculosis, Visceral Leishmaniasis and Lymphatic Filariasis. The work will also include strengthening of supply chains and monitoring systems while focusing on budget utilization, management and skills of human resources for health, ultimately bolstering the entire health system. “The Ministry of Health has put forward an ambitious vision to improve the primary healthcare system in this country–especially for women and children. Our Foundation supports that goal, and we want to partner with India to achieve it," said Bill Gates, Co-Chair, BMGF.

Pharmacists to protest at Jantar Mantar against amendment of Schedule K of Drugs and Cosmetics Act
Business Medical Dialogues

The Indian Pharmacist Association (IPA) has decided to conduct a protest on November 29 at Jantar Mantar against the recent draft to amend Schedule K of the Drugs and Cosmetics Act to empower community health workers to store and dispense drugs which would allegedly lead to the end of the pharmacy profession. New Delhi: The protest will be backed by the National Level Associations and State Level Associations of almost all the states. The protest comes in a wake of the central government’s move to permit many allied healthcare practitioners including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors to store and dispense drugs without the need for license under the Drugs and Cosmetics Act, the pharmacist fraternity had seen red. As per the latest draft rules proposed by the Ministry of Health and Family Welfare (MoHFW) which was made public via Gazette Notification dated November 6 2019; In the Drugs and Cosmetics Rules, 1945, in Schedule K, against serial number 23, for the entries under the column “Class of Drugs”, the following shall be substituted, namely:? Drugs supplied by (i) Health Functionaries including Community Health Officers, Nurses, Auxiliary Nurse Midwives and Lady Health Visitors attached to Primary Health Centres/ Sub-Centres/ Health & Wellness Centres in rural and urban areas, (ii) Community Health Volunteers such as Accredited Social Health Activists (ASHAs) under the National Health Mission, and (iii) Anganwadi Workers.”

CDSCO mandates processing of applications of non-notified medical devices through Sugam portal
Pharmabiz India - Shardul Nautiyal

The Central Drugs Standard Control Organization (CDSCO) has directed manufacturers and state drug controllers (SDCs) to process applications of non-notified medical devices through SUGAM portal. This is applicable to products approved as medical devices which as of today comes under the ambit and definition of drug. SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. The system also builds up the database of approved drugs, manufacturers and formulations, retailers and wholesalers in India. As per CDSCO officials, processing of such applications will be done by new drugs division or import division of CDSCO. Centre for Development of Advanced Computing (C-DAC), Pune has been urged to make provision for the same in the SUGAM portal. CDSCO receives applications for grant of permission to import various products falling under definition of drug or new drug. “However the CMC, safety and efficacy data of the product should be submitted as per the checklist applicable for medical devices,” informed Drugs Controller General of India(DCGI) Dr V G Somani. Implementation of e-Governance at CDSCO through SUGAM portal has brought simplicity, transparency, reliability, accountability, timeliness and also simplified ease of business.

PWA urges Cipla to avoid dual trading policy and establish good distribution practices
Pharmabiz India - Yash Ved

Mumbai based Pharmaceutical Wholesalers Association (PWA) has written to Cipla urging the company to avoid dual trading policy and establish good distribution practices in the business interests of trade. PWA has been observing the trend of dual trading policy followed by companies including Cipla and has written to them to take up remedial action in the interest of trade. In a letter to Cipla, PWA president Dilip Mehta cautioned, "PWA regrets to inform you that goods of Cipla are freely available in the market in less than price to stockists (PTS) in Mumbai" PTS (Price to Stockist) is general term used by pharmaceutical companies to mention the price of particular product offered to stockist or distributor. PTS is inclusive of VAT to be paid by Stockist to the central government. Talking about the unethical practice of dual trading policy, Mehta further added, "We wish to extend full support to eliminate such activity in the interest of authorized stockists fraternity. We request you to investigate the matter relating to dual trading policy." PWA in its letter to Cipla indicated that dual trading policy is currently being followed in the form of special scheme, special rate to special stockist scheme as also in the form of discounts given to online pharmacy or hospital pharmacy. “There is also possibility of spurious goods circulating in open market,” Mehta argued. Established in 1935, Cipla is a global pharmaceutical company focused on agile and sustainable growth, complex generics, and deepening portfolio in our home markets of India, South Africa, North America, and key regulated and emerging markets. The company's strengths in the respiratory, anti-retroviral, urology, cardiology, anti-infective and CNS segments are well-known. Its 46 manufacturing sites around the world produce 50+dosage forms and 1,500+products using cutting-edge technology platforms to cater to our 80+ markets. Cipla is ranked 3rd largest in pharma in India (IQVIA MAT June’19) and is the 3rd largest in the pharma private market in South Africa (IQVIA MAT June’19).