Patient Safety Capsules
Centre notifies Ayurveda Aahara regulations for food prepared based on Ayurveda books
New Delhi, May 10, 2022: The Central government has notified the Food Safety and Standards (Ayurveda Aahara) Regulations, 2022, stipulating standards and regulations related to food prepared in accordance with the recipes or ingredients or process as per method described in the authoritative books of Ayurveda. The Food Safety Standards Authority of India will form an expert committee under the Ministry of Ayush to provide recommendations and others.
IPC releases Indian Pharmacopoeia 2022
Mumbai, May 9, 2022 : In a bid to promote the highest standards of drugs for use in humans and animals, the Indian Pharmacopoeia Commission (IPC) has released Indian Pharmacopoeia 2022 containing 92 new monographs, 21 vitamins, minerals, amino acids, fatty acids and 27 active pharmaceutical ingredients (APIs).
Drug Laws & Policy Injections
CDSCO extends timeline for importing of drugs with shelf life less than 60% by another six monthsNew Delhi, May 10, 2022: The Central Drugs Standard Control Organisation (CDSCO) has extended the permission it has granted to the industry to import drugs with residual shelf life less than 60 per cent for another six more months, in view of the representations received and due to the Covid-19 pandemic situation.
DCGI extends timeline till Oct-31 for companies to submit application to regularize 294 controversial FDCs New Delhi, May 2, 2022: The Drug Controller General of India (DCGI) has extended time to those manufacturers who have licenses from the State Licensing Authorities (SLAs) for their fixed dose combinations (FDCs), but did not apply to the central drug regulator, for submission of applications with the DCGI.
Centre notifies National Assisted Reproductive Technology and Surrogacy Board to regulate ART clinics and banksNew Delhi, May 6, 2022: The Department of Health Research, under the ministry of health and family welfare has constituted National As-sisted Reproductive Technology and Surrogacy Board (NARTSB) headed by the minister of health and family welfare as the chairperson.
No individual can be forced to undergo vaccination: SCNew Delhi, May 3, 2022: Upholding the right of an individual to refuse to get vaccinated for Covid-19, the Supreme Court on Monday said the government’s current vaccination policy to protect community health cannot be termed “unreasonable or manifestly arbitrary”.
Pharma department suggests allocation of funds by institutes to promote startupsNew Delhi, May 6, 2022: The Department of Pharmaceuticals has recommended allocation of a fixed percentage of not less than 1 per cent of annual budget of institutes to fund and promote innovation and startup-related activities in the sector.
Bharat Biotech seeks DCGI nod for phase 2/3 Covaxin booster trial among 2 to 18-year-oldMay 4, 2022: Bharat Biotech has sought permission from India's drug regulator to conduct a phase 2/3 study of its Covid vaccine Covaxin as a booster dose among those aged two to 18 years, sources told PTI.
Pharma Injections
Pharma exports hit Rs 1.83 lakh crore in 2021-22PTI, May 2, 2022: Pharma exports have touched Rs 1,83,422 crore in 2021-22 against Rs 90,415 crore in 2013-14, the commerce ministry said on Sunday.
Companies stare at huge losses as unsold Covid drugs pile upMumbai, May 2, 2022: During the two years of the pandemic, there were sky-rocketing sales of Covid-19 portfolio of drugs, sometimes even severe shortages. But now the industry is saddled with a huge inventory of raw materials and medicines used in Covid-19, and staring at potential losses and write-offs running into hundreds of crores.
No merit seen in including Paxlovid in Covid treatment: ICMR New Delhi, May 7, 2022: Experts from the Indian Council of Medical Research (ICMR) have not found a compelling reason to include Pfizer's antiviral drug Paxlovid in the national treatment guidelines for Covid-19.
Pharma exports register 3.9% growth in April New Delhi, May 9, 2022: Exports of pharmaceuticals for the first month of the new fiscal year 2022-23 has reported a four per cent growth compared to the same month last year.
Indian pharma sees US FDA’s electronic submission of IND safety reports to bring in competency and clarity Bengaluru, May 10, 2022: Indian pharma industry has noted that the recent US FDA’s electronic submission of IND (investigational new drug application) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) will bring in the much-desired competency and clarity.
Emcure partners with FOGSI for EmWocal campaign to raise awareness on anaemia Bengaluru, May 11, 2022: Emcure Pharmaceuticals along with Federation of Obstetrics and Gynaecologists of India (FOGSI) intends to maximize use of technologies like Augmented Reality (AR) and personal digital assistant for its EmWocal initiative.
Drug Dopes
Despite significant increase in infra and manpower, rural health reports manpower shortage in 2020-21New Delhi, May 7, 2022 : Even though the number of staff including doctors has increased significantly in the last 16 years, there is still a shortfall in terms of healthcare manpower in the rural India, according to the latest Rural Health Statistics 2020-21. The healthcare infrastructure has seen a significant growth during the period, it said. 
India’s life sciences industry confronts extensive cybersecurity and data security breachesBengaluru, May 11, 2022: Indian healthcare and life sciences companies are grappling with largest volumes of cybersecurity and data security breaches among all industry sectors. In 2021, specifically, the pharmaceutical sector reported the third-highest average cost of a data breach after healthcare and financial services.
Karnataka drugs controller issues circular warning pharmacists to refrain from taking up two jobs Bengaluru, May 7, 2022: In a major development to stall malpractices of submitting false affidavit and fake certificates by pharmacists for seeking licenses to set up medical stores, the Karnataka drugs controller has issued a circular on April 29 2022 stating that registered pharmacists should refrain from taking up two jobs with one pharmacy certificate.
Researchers find coronavirus can also spread through air Hyderabad, May 6, 2022 : A recent research study conducted in collaboration with Hyderabad based CSIR-Centre for Cellular and Molecular Biology (CCMB) and CSIR-Institute of Microbial Technology (IMT) at Chandigarh has revealed that the dreaded SARS-CoV-2, Covid-19 disease can also spread through air.
Facemasks can reduce Covid severity, pressure on health systems, study confirm PTI, May 10, 2022: Effective mask use can drastically slow the spread of COVID-19, reduce the magnitude of the pandemic peak by flattening the curve, and reduce the prevalence of severe cases, according to a study.
Unorganised sector workers to get ESIC health benefits; PMO asks body to tap reserve fundMay 2, 2022: All 380 million unorgansied sector workers may get treatment at Employees’ State Insurance Corporation (ESIC)-run healthcare facilities.
National Injections
NPPA fixes retail price of Emcure’s HIV drug combination following review order from DoP New Delhi, May 11, 2022: Bringing a two and a half year old dispute by the Pune-based Emcure Pharmaceuticals related to the price fixation of its HIV drug combination to a closure, the National Pharmaceutical Pricing Authority (NPPA) has revised the retail price of the same on par with the price it has fixed earlier for another manufacturer.
NCB nails online pharmacy for supplying psychotropic medicines to foreign countries from HyderabadHyderabad, May 11, 2022: The Narcotics Control Bureau (NCB) has nailed an online pharmacy store run by a private company which was involved in supplying psychotropic medicine to foreign countries like United States and other European countries from Hyderabad.
Telangana IPGA starts certificate course on medical coding and clinical data analysis for pharmacy graduates Chennai, May 7, 2022: Associating with Skillyaari, an SAS education partner, the Telangana state branch of the Indian Pharmacy Graduates Association (IPGA Telangana) is starting a certificate course on medical coding and clinical data analysis for final year students of graduate and post-graduate courses and for recently passed out pharmacy degree holders.
Healthcare associations oppose WHO’s Covid death data attributing 50% of excess deaths to India Mumbai, May 9, 2022: The World Health Organization (WHO)’s current stand on attributing 50 per cent of excess deaths to India due to Covid-19 has drawn flak from Indian healthcare associations.
USFDA finds lapses at Sun Pharma’s Gujarat plant Mumbai, May 11, 2022: Sun Pharma announced on Tuesday that the US drugs regulator — US Food and Drug Administration (USFDA) has issued a ‘Form 483’ after inspecting its Halol facility in Gujarat. The issuance of this form implies that the US regulator found certain procedural lapses at the plant and would seek corrective action from the company.
MSD Pharmaceutical invests $16.1 million in Pune centre May 11, 2022: MSD Pharmaceutical has launched a new centre in Pune that will house a number of its divisions — in-cluding the commercial biopharma data and analytics organisation, Human Health Insights Analytics and Data (HHIAD).
Global Injections
Nasal Sprays for COVID Vaccine Being DevelopedMay 9, 2022: Scientists are working on COVID vaccines delivered through nasal sprays that could stop the coronavirus from invading the body at its most common entry point, the mucous membrane of the nose and throat.
Alabama Criminalizes Transgender Medical Treatments For MinorsMay 9, 2022: Alabama became the first state to make it illegal for doctors to provide gender-affirming medical care to transgender people under the age of 19, The Associated Press reported.
Most Americans Want Federal Law for Legal Abortion, Poll Shows
May 9, 2022: The majority of Americans want Congress to pass a federal law that makes abortion legal nationwide, according to a new poll by CBS News/YouGov.
US FDA issues Form 483 with 10 observations to Sun Pharma’s Halol unit
May 10, 2022: Listed multinational pharmaceutical entity Sun Pharmaceutical Industries on Tuesday informed the ex-changes that the US FDA has issued Form 483 with ten observations to the company’s Halol unit.
Gland Pharma launches generic cancer treatment drug in US
May 4, 2022: Gland Pharma on Wednesday said it has launched cancer treatment drug Bortezomib for Injection in the US market. The company has launched the product in the US market through its partner which received the approval from the US Food & Drug Administration (USFDA), the drug firm said in a statement.
US faces baby formula 'crisis' as shortage worsens
May 10, 2022: CVS and Walgreens are among the big chains to have imposed limits in recent weeks on how many cans customers can buy at a time.
PSAIIF PILL
Doctors call for more attention to plight of thalassemia patients
Mumbai, May 10, 2022: Over 10,000 children are born in India with thalassemia every year, but only a handful receive the curative treatment of blood stem cell transplant. The rest are forced to struggle to manage the disease with regular blood transfusions, leading to the risk of iron overload in the body and serious health complications, doctors have said on the occasion of the World Thalassemia Day which took place on May 8, 2022.
PETA India calls on researchers to stop using monkeys in vaccine development
Mumbai, May 6, 2022: People for the Ethical Treatment of Animals (PETA) India has called on researchers to stop using monkeys in vaccine development as it causes extreme suffering to monkeys and these monkey-tested vaccines have failed to work in humans.
Frequently Asked Questions
Well Being: How fat is your liver?
Fatty liver disease occurs when there’s too much fat accumulating in the liver. Fat triggers inflammation (leading to injury of liver or hepatocytes) and results into healing by fibrosis (scarring) and ultimately end-stage liver disease called cirrhosis. Childhood obesity has been rising over the past two decades and it’s also directly correlating with simultaneous rise in paediatric fatty liver disease. Parents are unaware that obesity has a direct relationship with diabetes (type 2) and metabolic syndrome, which is also a perfect recipe for fatty liver disease. The main reason behind this is a sedentary lifestyle and unhealthy eating habits (fast food or preserved foods). However, not all fatty liver diseases are related to obesity; there are also some genetic mutations that can lead to fatty liver (mainly related to cholesterol homeostasis).. Read More>>>
SUBSCRIBER'S SYMPTOM
Study Supports Colonoscopies for Women Under 50
May 10, 2022: Colonoscopies in younger women can significantly cut their risk of colon cancer, a new study claims. "While there's been an alarming increase in the incidence of colorectal cancer in recent decades in younger individuals, screening has largely been focused on people over 50," noted senior study author Dr. Andrew Chan, a gastroenterologist and epidemiologist at Massachusetts General Hospital.
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Blog Addicts
Dr. Harish Tripathi, MBBS "The Prescription" helps give me my monthly dose of current pharma news which I eagerly look forward to in order to keep myself abreast as a more aware reader. Keep up the good work.
Ms Susheela Singh, ProfessionalWant to commend the PSAII India publication team for all the good work they do in bringing out this bi-monthly newsletter. Well done.
Mr Ramamurthy Iyer, Pharma Expert
Very beautifully and aptly captures important news in the Pharma domain. Excellent work.
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