New machine can keep livers alive outside body for one week

According to the researchers, including those from ETH Zurich in Switzerland, injured livers can regain full function under the support of the new technology for several days, with the potential to save the lives of patients suffering from liver disease, or a variety of cancers.

LONDON: Researchers have developed a novel machine which can repair injured human livers, and keep them alive outside the body for one week, an advance that may increase the number of available organs for transplantation.

According to the researchers, including those from ETH Zurich in Switzerland, injured livers can regain full function under the support of the new technology for several days, with the potential to save the lives of patients suffering from liver disease, or a variety of cancers. ....read more

US FDA announces more recalls of antacids containing traces of carcinogen

To remove confusion, every drug label must mention that this drug is NDMA-free

In the last few years, N-Nitrosodimethylamine (NDMA) has made more news. More and more drugs are being withdrawn due to the presence of this carcinogen. The pharma companies should voluntarily mention on the label that their said molecule is NDMA-free. ....read more

Healthcare News Monitor

DCGI directs state DCs to ask cos to get product licenses of 2,131 FDCs approved by Kokate Committee

Pharmabiz India - Shardul Nautiyal

The Drugs Controller General of India (DCGI) has directed state drug controllers (DCs) to ask manufacturers to get manufacturing licenses of 2,131 new fixed dose combinations (FDCs) approved by Prof. Kokate Committee and the DCGI. This is in continuation to the DCGI letter to state DCs dated December 12, 2018 whereby all the state DCs were requested to ask the concerned manufactures to follow the procedure for getting manufacturing licenses as stipulated by the Central Drugs Standard Control Organization (CDSCO) (FDC Division). As per the DCGI letter to the state DCs, in continuation to the said letter, it may be noted that apart from these 1,681 FDCs, further there are 450 more FDCs which have been declared as rational by the committee and report of the committee has been accepted by the union health ministry. Accordingly with approval of the Union health ministry, it has been now decided to follow a specific pathway for grant of product licenses by the State DCs for these FDCs. Manufacturers shall submit the requisite fees preferably through Bharatkosh for each FDC to CDSCO as specified under Drugs and Cosmetic (D&C) Act, 1940 and existing Rules thereunder.

DoP rejects Geltecs review petition against price fixation on ibuprofen capsule 400mg

Pharmabiz India – Neethikrishna

The Department of Pharmaceuticals (DoP) has rejected the review application filed by Geltec Private Limited against notification S.O. No.1485(E), dated 29.03.2019 issued by the National Pharmaceutical Pricing Authority (NPPA) for price fixation of its formulation ibuprofen capsule 400mg. Geltec had earlier filed the review application with the reviewing authority, DoP, under paragraph 4, 6 and 16 of the Drugs Prices Control Order (DPCO), 2013 against the NPPA S.O. No.1485(E), dated 29.03.2019 for price fixation of its formulation Ibuprofen 400mg capsules. The applicant had applied for separate retail price for its formulations ibuprofen 400mg capsules vide in its letter No.19 (1601)/2018/DIV II/NPPA, dated 04.01.2019 to follow the ceiling price of ibuprofen 400mg capsules as notified vide S.O 1687(E), dated 24.05.2017. The company stated that as per the calculation of ceiling price of Ibuprofen capsules, the NPPA considered formulations which are not available in the domestic Indian market, namely, Fenlong 400mg capsules and Brufen Softra 400mg capsules. Further the company said that the NPPA should fix the ceiling price for ibuprofen 400mg soft gelatin capsules as per the provisions of para 4 and 15 of the DPCO only after considering the formulations available in the market. In reply, the NPPA stated that the ceiling price fixed by the NPPA vide S.O. 1485(E), dated 29.03.2019 is based on wholesale price index (WPI) implementation under para 16 of the DPCO. Therefore, the issue raised by the applicant has to be examined in this context. During examination of the case, the DoP noted that as per the para 31 of the DPCO, any person aggrieved by any notification issued or order made under paragraph 4, 5 and 6 of the DPCO, may apply to the Government for a review of the notification or order.

Six infants die on intervening Jan 13-14 night in MP hospital

ET Healthworld-PTI

Six tribal infants have died at a state-run hospital in Madhya Pradeshs Shahdol on the intervening night of January 13 and 14, a senior official said on Tuesday. A probe has been ordered by Madhya Pradesh Health Minister Tulsi Silawat. "The infants, some of them one-day-old and others two-and-a-half-months-old, died on the intervening night of January 13 and 14," said Dr Rajesh Pande, Chief Medical and Health Officer (CMHO), Kushabhau Thakre district hospital. The exact cause of their death will be known after investigation, he said. "The infants were admitted in the Sick Newborn Care Unit (SNCU) of the hospital in a serious condition, and efforts to save them proved futile," he added. Dr Pande also said that authorities are also probing whether there is any negligence on part of the hospital staff. Four of the six deceased were identified as Shyam Narayan Kol, Suraj Baiga, Anjali Baiga and Subhash Baiga. State Rural Development and Panchayati Raj Minister Kamleshwar Patel also visited the hospital to take stock of the situation. "A high-level team will probe the incident and submit its report soon, based on which action will be taken against concerned staff," he said.

Bhopal: Medical equipment in govt hosps needs urgent upkeep

ET Healthworld- Jamal Ayub

Less than half of the 66,000 medical equipment in health centres or hospitals run by the state government are not under annual maintenance. Its no surprise then that 15,000 complaints of equipment malfunction was reported in the last year, according to state government data. Some 44 lakh people depend on health department-run hospitals for free treatment each year in Madhya Pradesh. Believe it or not, on paper, the oldest ECG machine, being used in a government-run hospital dates back to 1974. It is in used in a ward in the district hospital in Sehore. Of the 40 oxygen concentrators, date of purchase of only 14 machines is known. The device, mostly used in special newborn care units, concentrates the oxygen from a gas supply (typically ambient air) by selectively removing nitrogen to supply an oxygen-rich gas stream. Madhya Pradesh is the first state to map all medical equipment with a unique barcode. Annual maintenance contract makes it incumbent to have a problem fixed within a week. Also, non-reporting of equipment malfunction leads to action against the hospital incharge. Complaint can be made through a toll-free number, mobile application or system generated log. However, some of the equipment like mercury-based blood pressure instrument have been not covered under annual maintenance contract. Health department officials said that digital BP meters are being introduced as per directives of the NGT.