Tdap vaccine can be given instead of Td

The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention, in a unanimous 14-0 vote, in a policy change, recommended either tetanus, diphtheria, and acellular pertussis (Tdap) or tetanus and diphtheria (Td) vaccines can be used in situations where currently only the Td vaccine is currently recommended: decennial (every 10 years) Td booster, tetanus prophylaxis for wound management, and a catch-up immunization schedule for people age 7 and older, including for pregnant women. There were no substantive safety concerns … (Medpage Today)

Healthcare News Monitor

Delhi remains road fatalities’ capital, 3 metros show slide

TNN-Dipak K Dash

NEW DELHI: Kolkata, Chennai and Mumbai saw minor decline in road deaths in 2018 as compared to the previous year but Delhi recorded an increase of 106 fatalities in the same period, accident data received from different city traffic police showed. Data showed that the decline in road deaths was maximum in Chennai where 1,260 people died in accidents last year as compared to 1,299 in 2017. In Kolkata, fatalities stood at 294 in 2018 against 329 the previous year. Mumbai recorded a minor reduction from 490 roads deaths in 2017 to 475 last year. Comparatively smaller cities like Patna, Agra, Surat, Allahabad, Jodhpur, Nasik, Rajkot, Bhopal and Thrissur saw significant increase in road fatalities last year. These pushed the total road deaths close to 17,700 last year. In 2017, the number of lives lost in 50 million-plus cities was around 17,000. Road safety experts said more deaths in road accidents in non-metro cities indicated the need to put a stronger enforcement mechanism and there was a need to come up with interventions to improve the safety of vulnerable road users, which include pedestrians, cyclists and two-wheeler riders. “These (smaller cities) are fit cases to go for technology-based enforcement and we need to carry out detailed investigation to zero in on the exact cause of fatal accidents. Some believe that increased congestion on roads may have reduced the number of fatalities in some cities but it’s not true considering that the number of deaths on Delhi roads has increased,” said K K Kapila, former president of International Road Federation. The recently passed Motor Vehicles (Amendment) Act has made provision for wider adoption of technology for monitoring violation of traffic rules and the transport ministry has set up working committees to finalise the rules to implement the amended law.

NITI Aayog wants IITs to regulate medical devices, which are now covered by 1940s law

The Print- Himani Chandna

New Delhi: The Modi government is looking to involve the premier Indian Institutes of Technology (IITs) to check the efficacy and safety of medical devices, ThePrint has learnt. This as the government’s think-tank, NITI Aayog, has rejected the Ministry of Health and Family Welfare’s proposal to empower the Central Drugs Standard Control Organisation (CDSCO), India’s apex drug regulator, to regulate all medical devices as well. The union ministry had issued the draft notification in October. Two senior officials — both at NITI Aayog — confirmed that the think-tank had advised the ministry to build a separate ecosystem for the testing of medical devices in India instead of regulating them under laws meant for medicines and cosmetics. “Notifying medical devices as ‘drugs’ is an unhealthy way of regulating the segment that is growing by leaps and bounds. It’s a temporary solution,” a senior official at Niti Aayog told ThePrint. “Clearly, CDSCO lacks the expertise and ecosystem to effectively regulate the sector.” The NITI Aayog has instead recommended that the government involve the IITs to check the safety profile of the medical devices. The IITs have high-class labs that can test the electronic, electro-magnetic and biochemical-run medical devices. “In our view, IITs should be involved. With around 16 IITs, we can have at least 16 labs to test medical devices,” the official said. “We can also invest in these labs to raise their standards as per our requirements. “We have no law to check the safety profile of medical devices in India. Also, there is no clinical trials system for devices like we have for medicines,” he added. “NITI Aayog believes that labs at IITs can be used for the purpose until we create a separate infrastructure. Marginal additional investment can be done at IITs as we already have trained, scientific manpower there.”

Medical devices need their own law

Financial Express - Rajiv Nath

Thirty years have gone by since the first medical device was regulated as a drug. A comprehensive regulatory framework is nearly in sight with the Draft Medical Devices (Safety, Effectiveness & Innovation) Bill from NITI Aayog to be shortly proposed as a separate law. India currently imports 80-90% of medical devices, of which the vast majority is unregulated for quality and safety. While many of these products may have regulatory certifications in other countries, the reality is that a considerable number of them are being exported from countries that do not regulate their exports. The medical devices market in India is over $15 billion (`105,000 crore) and projected to grow to $50 billion by 2025, and is the fourth-largest in Asia. Our policymakers in the health ministry were surprisingly undecided, and seemed to be in no urgency to usher in a ‘Patient Safety Medical Devices Law’ to protect patients, even after the recent ICIJ implant files or J&J incident, or the most recent ban on Trans-vaginal Pelvic Mesh by USFDA. As Ministry of Health & Family Welfare (MoH&FW) had been surprisingly very reluctant to draft a separate law, and CDSCO has a conflict of interest to empower itself, the industry watchers are waiting with anxiety the details of the draft Medical Devices Bill that NITI Aayog is reportedly working upon in consultation with other stakeholder departments and ministries to address the regulatory vacuum & the national patient safety concerns.

Eat carrots to avoid pollution-related harms: Health Minister Harsh Vardhan as Delhi chokes

India Today

As the pollution level in Delhi peaked to a three-year high on Sunday, Union Minister for Health Harsh Vardhan took to Twitter to impart tips on how to stay away from pollution-related diseases. Harsh Vardhan said that eating carrots would help a body get required nutrients to avoid polluted-related harms to health. "Eating carrots helps the body get Vitamin A, potassium, & antioxidants which protect against night blindness common in India. Carrots also help against other pollution-related harm to health," Harsh Vardhan tweeted. The Central government on Sunday reviewed the situation with the governments of Delhi, Haryana and Punjab and announced that Cabinet Secretary Rajiv Gauba would monitor it on a daily basis. After Delhi, all schools up to Class 12 were also closed in the National Capital Region (NCR) till November 5 following a spike in the pollution level in the region. The heavy smog caused a major disruption at Delhi airport as 37 flights were diverted and more than 250 departures and 300 arrivals delayed due to poor visibility, officials said. According to the Central Pollution Control Board (CPCB), the national capitals 24-hour average air quality index (AQI) stood at 494 at 4 pm on Sunday, the highest since November 6, 2016, when it was 497.

Licenses for cold storage delivery vehicles for drugs not issued in five years despite online licensing system

Pharmabiz India - Shardul Nautiyal

Ever since the introduction of XLN online licensing system by the Maharashtra Food and Drug Administration (FDA) in 2014, licenses for vehicles having cold storage for delivery of medicines at retail drug stores have not been issued in the past five years as the online system neither has provision nor any format on the same. There is a provision for obtaining 20 BB and 21 BB licenses under Drugs and Cosmetics (D&C) Act for bulk drug delivery through vehicle license. As per the provision, the state drug regulator can keep an oversight of the drug supply chain right from the wholesaler and C&F agents authorised by pharma companies to the retail drug store for patient safety. The XLN system is considered as a boon for manufacturing units across the state as system delivers online approvals for over 6 certificates required by pharma manufacturing units. The online XLN system was introduced in 2014 across the state in order to accomplish timely disposal of renewal licenses, testing licences, licences for additional products, performance certificate and free sale licences among others but the online system has no format and provision for online application of cold storage licenses for delivery vehicles which is an indispensable part in drug supply chain system.

Karnataka govt keen to put systems in place for reducing AMR through sustainable antibiotic manufacturing

Pharmabiz India - Nandita Vijay

The Karnataka government is keen to have systems in place for sustainable antibiotic manufacturing. The intent is to reduce levels of antibiotic emissions by pharma companies into the environment and establish a common framework for managing antibiotic discharge. This is even as the UK-based ShawView Consulting which initiated RATSAM (Reducing AMR Through Sustainable Antibiotic Manufacturing) a programme where it intends to rope in the Karnataka Drugs and Pharmaceutical Association to implement a pilot project in the state to adopt AMR Industry Alliance’s Common Manufacturing Framework and Discharge Limits. From a national perspective, the Central Pollution Control Board has issued a draft recommendation on this and DBT and UKRI are eager to provide grants on the research and development of sustainable manufacturing of antibiotics. Moreover, the government has launched a major study to check antibiotic resistance in the river Ganga among other similar water bodies in the country. The need of the hour is to build capacity of local companies to meet new global procurement standards and adhere to the domestic environmental regulations to monitor antibiotic manufacturing, said Brendan Shaw, Principal, Shaw View Consulting, UK.