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Medical Voice 1st October 2019

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Dr KK Aggarwal    01 October 2019

Humans can get tuberculosis from deer, the CDC says

(CNN)The Centers for Disease Control and Prevention has found another unusual way animals can get humans sick. After two decades of hunting, a 77-year-old Michigan man came down in 2017 with a case of tuberculosis. The carrier, according to a new CDC report, was an infected deer (Notes from the Field: Zoonotic Mycobacterium bovis Disease in Deer Hunters - Michigan, 2002-2017. MMWR Morb Mortal Wkly Rep. 2019 Sep 20;68(37):807-808). The unnamed patient had hunted deer in the same area where two other hunters were infected more than 15 years earlier. In his case, he likely inhaled infectious pathogens of bovine tuberculosis, a mycobacterium that can sicken humans, while removing a dead deers infected organs, the CDC said.

Its the second report concerning disease-carrying animals the CDC has released this month. In the first, the problem was affection: Officials implored chicken owners to stop kissing, snuggling and sharing their homes with their fowl after a whopping 13% of people who contracted salmonella fessed up to smooching their birds.

Healthcare News Monitor

PIL against digital thermometer, BP monitor being notified as drugs: HC seeks Centres stand

ET Healthworld-PTI

Apart from seeking quashing of the notification, the association has also challenged the Constitutional validity of provisions of the Act. The Delhi High Court has sought the Centres response on a plea challenging its decision to notify blood monitoring devices, digital thermometers, nebulizers and glucometers as drugs under the Drugs and Cosmetics Act. A bench of Chief Justice D N Patel and Justice C Hari Shankar issued a notice to the Health Ministry whose notification has been challenged by an association representing manufacturers and traders of surgical and other medical equipment. The court asked the ministry to file its reply before the next date of hearing on December 11. The association, in its PIL, has contended that none of the notified devices have a drug component and therefore, bringing them under the ambit of the Act was an arbitrary decision. The petition, filed through advocates Harsh Kumar, Bhagya Yadav and Aditya Raj, claims that the notification would create an unwarranted burden of expenditure on importers, traders and manufacturers of these devices and consequently, it would be passed on to the consumers. It said notifying the devices as drugs will result in a substantial hike in their prices which would make them unaffordable for a large segment of society. Apart from seeking quashing of the notification, the association has also challenged the Constitutional validity of provisions of the Act.

Govt’s no price control move on drugs made from local APIs will be good for pharma

Financial Express

The government is mulling over excluding medicines made from locally manufactured active pharmaceutical ingredient (API)—the key raw material for the production of a drug—from price control. The move, according to a Mint report, is aimed at pushing manufacture of APIs in India to reduce import dependence. The move, if implemented and to the desired effect, would be a boost for Indian pharma. In FY19, Indian pharma companies imported bulk drugs and intermediates worth $2.4 million from China. The irony is the government had all along known how price control was affecting domestic manufacture. Indeed, Indian manufacturers had gotten more and more export focused, with their offerings in India accounting for an increasingly smaller portion of their revenues over the years. In the Draft Pharamaceuticals Policy 2017, the government had noted that PSUs were doing a good job of producing raw materials/intermediates in the 1950s-60s, and accepted that import dependence had grown because of its price controls—“the Drug Price (Display & Control) Order 1966 put 18 APIs (raw materials) under price control … from 1996 … imported APIs and Intermediates started becoming hugely lucrative as a price cap on drugs forced the manufacturers … to obtain the cheapest raw material with the basic minimum efficacy/quality”. And yet, it had called for price controls to stay citing high out-of-pocket costs for drugs. The government, in the draft policy, also rued the fact that pharma companies were more focused on generic formulations than R&D. It should have long realised that, unless price controls go summarily and companies’ profits grow, investment in R&D will remain thin. If the government is serious about Make in India for APIs and boosting R&D spending by pharmaceutical companies, it must shun price controls as a policy measure. To keep medicines affordable for the masses, it must subsidise through bulk purchases for its Jan Aushadhi and other outlets.

Bangladesh bans heartburn drug ranitidine over cancer fears

ET Healthworld

DHAKA - Bangladeshs drug regulatory authority on Sunday issued a ban on sales of popular heartburn drug ranitidine while it investigates a potential cancer-causing substance in the drug. The move comes after the U.S. Food and Drug Administration (FDA) warned that some of the pills contained small amounts N-nitrosodimethylamine (NDMA), which the regulator says is a "probable human carcinogen". "We have banned the import of raw materials, production and sale of ranitidine until further notice," said Khandaker Sagir Ahmed, a director of Bangladeshs drug regulatory authority, adding that the decision was taken a precautionary measure. Drug manufacturers across the world have begun recalling the widely taken heartburn drug, which is sold under the trade name Zantac among others, while the FDA and European drug regulators review whether low levels of NDMA in ranitidine pose a health risk to patients. Domestic companies affected include Beximco Pharmaceuticals and Square Pharmaceuticals, which produce ranitidine under the Neoceptin R and Neotack brands respectively.

Manufacturing of methylcobalamin badly impacted in Gujarat due to ambiguous nature of notification on its ban

Pharmabiz- Shardul Nautiyal

Manufacturing of methylcobalamin has been badly impacted due to the ambiguous nature of Food Safety and Standards Authority of India (FSSAI) ban on methylcobalamin in Gujarat. Methylcobalamine is an important pharmacopoeial ingredient used in drugs as well as in food supplements. It is prescribed to treat vitamin B12 deficiency in people with pernicious anemia. Gujarat manufacturers have stopped manufacturing methylcobalamin which is a form of vitamin B12 taken to regulate certain vital bodily functions like cell multiplication, blood formation, and protein synthesis. While state drug regulator maintains that it has been done to dissuade unscrupulous people to use it irrationally as a food supplement, the industry feels that the notification banning it is not justified more so as it is wrongly interpreted and need further amendment to achieve the desired purpose. Giving clarity on the issue, Gujarat Food and Drug Control Administration (FDCA) Commissioner Dr H G Koshia said, “Methylcobalamine can be used for manufacturing medicines but not for food supplements as per the notification.” A controversy began with whether methylcobalamin can be used in health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food after the notification passed in 2016 under the subject of direction under section 16[5] of Food Safety and Standards Act 2006 regarding operationalisation of standards of health supplements, nutraceuticals, food for special dietary use, food for special medical purpose, functional food and novel food.

Hike in government hospital charges revoked in Uttarakhand

The Times of India

DEHRADUN: Barely a month after Uttarakhand government announced a hike in the treatment charges at government hospitals, community health centres (CHCs) and primary health centres (PHCs), Dr RK Pandey, director general (DG) health, the state government did a U-turn on Saturday saying that it has been decided to continue with the old OPD charges instead of putting in place the enhanced rates. The step has been taken in view of the common man’s interest, Dr RK Pandey, director general of health, claimed. “We decided on this measure after we received complaints from several people of a delay in getting Atal Ayushman cards. Also, the state is grappling with a spurt in communicable and non-communicable diseases. We have urged the state government to continue the old rates until the situation is under control,” Pandey said, adding that the concerned authorities have been asked to speed-up the process of providing people with Atal Ayushman cards. Sources however said that the increase in expenses of medical treatment may have had an adverse effect in the panchayat polls for the ruling party which may have prompted the roll-back.

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