Health Ministry guidelines for sputum samples potentially containing TB bacteria (Contd)

Steps to be taken in case of accidental damage or spillage

1.Do not accept if the outer packaging is found wet, soiled or broken.

2.In case of damage /leakage during transport, the transporter must inform sender/ receiver whoever is nearer.

3.In the event of exposure to any infectious substance, wash hands and affected part with soap and water.

4.In an unlikely event of spillage, do not leave the damaged/broken container unattended. Cover it with cloth/paper and immediately inform the nearest RNTCP laboratory for assistance and management.

5.Seek medical advice from Medical Officer (RNTCP)/ District TB Officer (DTO).

(Source: Central TB Division, Ministry of Health and Family Welfare)

Healthcare News Monitor

ICMR set to launch dengue vaccine in 2020

ET Healthworld

Kolkata: An indigenous dengue vaccine designed to counter the outbreak of the vector-borne virus — that claims hundreds of lives across the country every year — could be launched by the Indian Council of Medical Research (ICMR) in 2020. A dengue serotype survey has been done across 15 states, including West Bengal, to identify the prevalence of the disease. The vaccine could be launched in a region where the disease is more prevalent, ICMR director-general Balram Bhargava said. Revealing this at the inauguration of the National Antimicrobial Resistance (AMR) Hub in Kolkata on Monday, Bhargava said that demonstration projects to test the vaccine could be launched by the year-end. “It is not easy to counter dengue, which is why the launch of the vaccine was preceded by a serotype mapping of the virus. We have been doing it slowly but very systematically to identify the best possible areas for the launch. There are a couple of vaccines now, including a Japanese one. We are keeping fingers crossed for our own vaccine,” added Bhargava. He added that dengue has been a ‘common thread’ on a research platform of south Asian countries with WHO as a partner. “Every disease outbreak follows a pattern and dengue is no different. Apart from a vaccine, dengue outbreaks can also be prevented with the right management. Sri Lanka has been able to do it and bring down the number of casualties drastically,” said the ICMR director-general.

Rules set to keep track of doctors, make hospitals accountable for negligence

ET Bureau-Nidhi Sharma

New Delhi: The government would now maintain a complete record of all medical professionals — Indian and foreign origin — practising in hospitals or holding teaching and research assignments in medical colleges in India. Setting in motion the process of changing the landscape of healthcare in India, the Centre has framed part rules under the newly-enacted National Medical Commission Act. So far, two sets of rules have been framed — National Medical Commission (Submission of List of Medical Professionals) Rules 2019 and National Medical Commission (Manner of Appointment and Nomination of Members, their Salary, Allowances and Terms of Conditions of Service, and Declaration of Assets, Professional and Commercial Engagements) Rules 2019. Through the rules, the government has sought to set right the problems of now-defunct Medical Council of India in maintaining a national registry of all registered medical professionals in India. Now, the newly formed commission would need to maintain a database of all registered medical professionals in India and report it to the government bi-annually. So far, MCI and state councils would maintain data separately and it would not be updated in years. With the rules, the government has sought to address the problem of malpractice at the medical college level. The newly formed commission would be required to report data on doctors employed by colleges at teaching and research positions. The ministry has also made it mandatory for every hospital to report a person in-charge (usually medical superintendent) who would be held responsible (apart from the practising doctor) in case of legal issues pertaining to a case.

Hospitals to get gold, silver, bronze ratings based on facilities provided

ET Bureau-Nidhi Sharma

New Delhi In a bid to fill the gap of healthcare facilities in rural India for the poorest of poor, the Centre has now moved to ease accreditation norms for hospitals. In a first in India, hospitals would now get bronze, silver and gold ratings depending on the quality of healthcare facilities they provide. At present, the National Accreditation Board for Hospitals and Healthcare Providers (NABH) has an accreditation system which takes six-eight months for a hospital to get accredited. However, with healthcare infrastructure lacking in Tier 2 and Tier 3 cities and remote rural areas, the National Health Authority (NHA) has framed a new accreditation system which would help smaller hospitals also to get licences and operate in rural areas under Ayushman Bharat, the Modi government’s health insurance scheme for the poor.

Rather than rejecting accreditation of smaller hospitals, the Centre would give them a lower rating at a cheaper cost so that people know what facilities to expect. The accreditation system, developed with the help of Quality Council of India, would bring down the accreditation cost significantly from Rs 80,000-Rs 1.5 lakh to Rs 10,000. As the name suggests, bronze rating would be given to the lowest in the rung of healthcare provider. The government would introduce a self assessment process. Speaking to ET, Dr JL Meena, general manager (hospital networking and quality assurance), NHA, said, “The new system would be evidence-based self-assessment accreditation. After self-assessment, a desktop assessment would be done by QCI. This would be followed by external assessment after which a certificate would be generated. This would take 25-35 days as compared with six-eight months of NABH certification.” NHA has developed simple-to-follow guidelines which would demonstrate to hospital administration with photographs on the standards to be maintained.

CDSCO amends MD Rules to replace term “SLA” with “CLA” for effective implementation

Pharmabiz-Shardul Nautiyal

The Central Drugs Standard Control Organisation (CDSCO) has amended Form MD-10 of new Medical Device (MD) Rules 2017 to replace terms “state licensing authority (SLA)” with “central licensing authority (CLA)” to offer clarity in implementing the new MD Rules, which came into effect from January 1, 2018. CDSCO through a gazette notification stated, “After consultation with the Drugs Technical Advisory Board (DTAB), the central drug regulator has amended Form MD -10 in new MD Rules, 2017 in exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act (D&C), 1940 (23 of 1940). These rules may be called the Medical Devices (Fourth Amendment) Rules, 2019. In the MD Rules, 2017, in Form MD-10, for the words “State Licensing Authority”, the words “Central Licensing Authority” shall be substituted. It further stated, “The Union health ministry dated March 6, 2019 based on the draft medical device rules had invited objections and suggestions from public.”

The MD Rules, 2017 was published in the official gazette dated January 31, 2017 and was last amended dated the April 18, 2019. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others is supposed to be implemented effectively towards device or product safety. MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate manufacture, import, sale and distribution of the medical devices. The notified bodies registered with CDSCO under provisions of medical devices rules, 2017 are Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, Dnv GI Business Assurance India Private Limited, BSI Group India Pvt. Ltd and BSCIC Certifications Pvt Ltd. New MD Rules 2017 cover medical devices, in vitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices. As per the new MD Rules, 2017, SLA has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new rules. Class C and Class D category are audited by the CDSCO independently as per the new rules