PHARMA LITERATI

Eminent genetic scientists from various countries, who assembled at the Sri Ramachandra Institute of Higher Education and Research (SRIHER) in Chennai last week observed that the emerging specialty in medical science, Precision Medicine which renders a new approach to medical treatment, has very big scope in treating and curing cancer diseases. They felt that precision medicine and individual therapy, especially for cancer patients, is becoming increasingly possible and the challenge is collection and handling of genomic data. In the near future, precision medicine approach will expand in many other areas of healthcare management. The genetic scientists of India and abroad held deliberations on the theme, “Advancing Healthcare through Genomics” at the three day annual meeting of the Indian Society of Human Genetics held at the Institute. ‘This approach will allow doctors and researchers to predict more accurately which treatment and prevention strategies for a particular ...

A multi-crore global drug racket was being operated through the dark web in the garb of online sale of medicines from a nondescript house tucked away in Alambagh area of the city. And the 21-year-old kingpin had dabbled in a failed online business before going fullthrottle into shipping contraband to Europe through Dark Net. Son of a retired PCS officer and hotel management graduate from Lucknow, the drug dealer, Dipu Singh, was arrested by Narcotics Control Bureau (NCB), Delhi, sleuths last week. At least 12,000 psychotropic tablets masked as medicine and fitness supplements were seized from his home and the cache is being examined for cannabis content. He skirted the law for over two years by accepting payment in cryptocurrency. The case was cracked after a consignment shipped to United Kingdom was seized by NCB, Mumbai, on December 9 last year. Investigations led to seizure of another consignment to Romania on January 17 this year. The cargo did not bear Know Your Cust...

As Indian pharma companies prepare to shift from supplying commodities to supplying innovations, technology is altering the way health care is imagined and delivered, according to an EY report, “Today for tomorrow: realizing the potential of Life Sciences 4.0”, released at BioAsia 2020 - Asia's largest Life-sciences & Health-tech convention. The accelerated technology and scientific advancement in the fourth industrial revolution, or life sciences 4.0, is changing the traditional model of health. The combination of smart devices and sophisticated AI-based algorithms has made it possible to remotely diagnose, monitor and treat disease, leading to a shift in health care delivery from hospitals and clinics to patients’ homes. People are now comfortable using wearables and sensors to track their health and fitness. Data generated from these devices empowers individuals to make their own health choices and fuels a shift from disease treatment to better management, and ult...

Alarmed by the coronavirus outbreak leading to lock downs in China resulting in stoppage of active pharmaceutical ingredients' (API) supply to India, NITI Ayog has called a meeting of representatives of drug industry on February 19 to take stock of excessive dependence of the country on China for APIs and key intermediates supply and plan to develop API parks in the country. In 2018-19, India imported bulk drugs and intermediates worth US$ 2.4 billion from China. In 2017-18 the import of bulk drugs and intermediates from China to India stood at US$ 2,055.94 million. At present, domestic drug makers have an inventory for a couple of months and pharmaceutical companies in Chinese regions mildly affected by coronavirus have resumed operation, except Wuhan region, the epicenter of coronavirus outbreak. The panic triggered by the spread of the coronavirus and extended shutdown in China have led to a steep rise in prices of several critical APIs in the country since Janua...

As the coronavirus outbreak shows, viruses are a constant threat to humanity. Vaccines are regularly developed and deployed against specific viruses, but that process takes a lot of time, doesn't help everyone who needs protection, and still leaves people exposed to new outbreaks and new viruses. Now, researchers at Massachusetts General Hospital (MGH) have uncovered a novel potential antiviral drug target that could lead to treatments protecting against a host of infectious diseases -- creating a pan, or universal, treatment. Their work suggests that the protein Argonaute 4 (AGO4) is an "Achilles heel" for viruses. AGO4 is one of a family of AGO proteins. Until now, there has been little evidence of why they are important. The researchers, led by Kate L. Jeffrey, PhD, and her collaborators found that AGO4 plays a key role protecting cells against viral infections. Specifically, this protein is uniquely antiviral in mammalian immune cells. The group studied ...

The newly-found corbomycin and the lesser-known complestatin have a never-before-seen way to kill bacteria, which is achieved by blocking the function of the bacterial cell wall. The discovery comes from a family of antibiotics called glycopeptides that are produced by soil bacteria. The researchers also demonstrated in mice that these new antibiotics can block infections caused by the drug resistant Staphylococcus aureus which is a group of bacteria that can cause many serious infections. The findings were published in Nature . " Bacteria have a wall around the outside of their cells that gives them shape and is a source of strength ," said study first author Beth Culp, a PhD candidate in biochemistry and biomedical sciences at McMaster. "Antibiotics like penicillin kill bacteria by preventing building of the wall, but the antibiotics that we found actually work by doing the opposite -- they prevent the wall from being broken down. This is critical for...

Sourse:  http://www.ipc.gov.in/news-highlights/724-skill-development-programme-on-pharmacopoeial-standards-for-pharmacovigilance-for-medical-products-pvm-2020.html

Union health ministry has notified that all medical devices will now be regulated under the Drugs and Cosmetics (D&C) Act, 1940 with effect from the April 1, 2020 for effective compliance. The ministry after consultation with Drugs Technical Advisory Board (DTAB) has further notified to amend the Medical Devices Rules, 2017 and has specified that these rules may be called the Medical Devices (Amendment) Rules, 2020 and shall come into force on April 1, 2020. According to a Gazette Notification dated February 11, 2020, after consultation with DTAB, the health ministry hereby specifies that all medical devices intended for use in human beings or animals will be regulated as drugs with effect from the April 1, 2020, which includes all devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals...

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Indian drug manufacturers are to a large extent dependent on China for sourcing their drug ingredients or the active pharmaceutical ingredients, as the industry words it. This is largely for drugs like antibiotics - crucial among them being penicillin G (and other products based on it such as amoxicillin and ampicillin), tetracycline - and for vitamins such as vitamin C and D. All of these are based on drug ingredients made using the fermentation-based process, an area where China has achieved global dominance. Now, the coronavirus scare has added a new dimension with an air of uncertainty around how the supply situation from China will unfold. Currently, the Chinese government has extended the New Year holidays. They were to be from January 25th till February 3rd but will now be till around mid-February. However, if these get further extended then, Indian drug manufacturers, mostly formulation plants, which use the drug ingredients and make the tablets and capsules that we consume...

The Union health ministry has released the draft Drugs and Magic Remedies (Objectionable Advertisements) (DMR) (Amendment) Bill, 2020 for effective compliance. The ministry’s initiative in this regard comes close on the heels of concerns raised at several quarters on implementation and effectiveness of the DMR Act, 1954. The proposed draft bill clearly defines Advertisement, Penalty and the disorders covered under the ambit of the Act which shall be called the Drugs and Magic Remedies (Objectionable Advertisements) (Amendment) Act, 2020. As per a notice, “Ministry of health and family welfare, Government of India proposes to amend the Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 in order to keep pace with changing time and technology. In this regard, a draft bill has been prepared and released to solicit suggestions, comments, objections from the public or stakeholders with regard to the said draft Bill.” “The suggestions, comments or objections ma...

The Indian Council of Medical Research (ICMR) has received the Central Drug Control Organisation (CDCSO) emergency approval to use a combination of anti-HIV drugs- 'Lopinavir and Ritonavir' tablets for the treatment of novel coronavirus (nCoV) patients in India. ICMR says, ''it is an “experimental repurposed drug” and should be used only in cases where there is documented evidence of the person suffering from infection''. “There are no large studies done so far on the treatment of coronavirus. However, as an alternative, ICMR may recommend these drugs for treatment of coronavirus,” said a senior health ministry official. "We did our own docking studies and found that this could be a potentially useful drug against nCoV," an ICMR official said. "The DCGI has given a no objection for the restricted use of this drug combination -- Lopinavir and Ritonavir — in case of a public health emergency on patients affected by nCoV as per the ...

Q BioMed, a commercial stage biotech company, announced that its research partner Mannin Research (Mannin) is developing new therapeutics to treat a variety of vascular diseases, including the new coronavirus which originated in Wuhan, China, with a rapidly rising number of deaths and confirmed cases. Coronavirus has been declared a Global Health Emergency by the World Health Organization (WHO). Mannin is developing a unique set of therapeutics that target a variety of vascular diseases. Its lead research platform targets the activation of the Angiopoietin-Tie2 signaling pathway. While Mannin is not generating a vaccine against infectious diseases, it is developing a new class of therapeutics that may increase the survival rate of patients by reducing endothelial dysfunction and severity of infectious and other diseases through enhancement of host-directed therapeutic response. " We are working closely with our technology research partner Mannin to develop a potential ad...

India’s plan to focus on two national-level programmes to build genomic data of the population and crops is expected to help the country in developing personalised drugs, tackle disease and increase yield in crops, experts said. It is also an attempt by the country to build genomic data of South Asians, who are largely under represented in the databases existing in the world. Vijay Chandru, CEO of Strand Life Sciences, said initiatives around genetic data mapping by the government took shape in 2018 when K Vijay Raghavan, principal scientific advisor to the prime minister, had requested for pre-proposals from researchers in India. Chandru was a part of the team that drafted one of the first pre-proposals, which was presented to the the Prime Minister's Science, Technology and Innovation Advisory Council. He said the proposals had possibly lossevolved into a  national scheme and this could be an early announcement of funding support to the scheme. “ There is a resolve ...

GSK Pharma has decided to sell its state-of-the-art tablet facility at Vemagal (Karnataka), taking a financial impairment of Rs 640 crore in the third quarter ended December 31. The decision was taken on account of the financial impact of voluntary recall of popular heartburn medicine ranitidine, Zinetac in India. The company had recalled the medicine in September last year, following investigations by USFDA which raised a global alarm over the presence of a cancer-causing substance—NDMA (N-Niteosodimethylamine) in certain ranitidine medicines. The decision is due to under-utilisation of GSK India’s manufacturing facilities, and Rs 97 crore on account of other related assets / costs, a company statement said. As part of this strategic review, GSK India will explore future options for the Vemgal facility including a potential sale of the site, it said. GSK had invested around Rs 1000 crore staggered over a period 2012-13 and 2017-18 in the facility, which was to be inaugurated t...

The Ghaziabad-based Indian Pharmacopoeia Commission (IPC) will organise a workshop themed “Promoting Medical Devices Safety and Surveillance in India - Stakeholders Summit" on March 20 in New Delhi. The objective of the workshop is to sensitise manufacturers, importers, distributors and other stakeholders about the safety of medical devices and in-vitro diagnostics (IVDs) and their post marketing requirements in India. The workshop will majorly cover topics like safety and vigilance of medical devices, challenges in developing indigenous database for medical device safety, medical devices and IVDs online registration in India- procedures and requirements, reporting tools for medical device vigilance and practices among others. It will also help in strengthening post-marketing surveillance mechanism and help bridge the gap between stakeholders and regulatory authorities towards ensuring safety of medical devices in India. IPC is an autonomous institution of the un...

The Biotechnology Industry Research Assistance Council (BIRAC), under its National Biopharma Mission (NBM), will organise a training programme on “Operation and testing of medical devices' from February 24-28, 2020 at Central Scientific Instruments Organization (CSIR), New Delhi. Last date of receipt for the training programme application is January 31, 2020. The discussion will focus on day one is introduction to medical devices, testing and measuring instruments, and safety aspects in biomedical instruments as per IEC60601 guidelines. The topic for the day two is electrical safety, principle operation testing of ECG machine and defibrillator. The topic for the day three is principle operation testing of BP machine, pulse oximeter, multipara monitor, electrosurgical unit and infusion device. Another area of discussion will focus on day four is principle operation testing of infusion device, calibration & traceability, hands-on: testing & calibration o...