Warm Greetings!!!

Welcome to yet another most pleasant Reading of our newsletter.

It is always my privilege to reach you on the 1st & 17th of every month, for the last 13 years. Please do not hesitate to share your comments on this edition to enable us to constantly improve. Please feel free to get in touch with us. You may find our previous issues on our website jagograhakjago.com or in the NEWS ARCHIVE section of every issue of The Prescription, in case you’ve missed any of them. You may also look us up on Facebook.

Stay Healthy. Stay Protected.
Pyush Misra
Editor-in-Chief

“Brief Answers to the Big Questions”: Can we predict the future?

“I believe the answer is yes — we can” when it comes to the future of health, Gates said.

“I’m lucky that my work gives me a view of all the amazing discoveries in the works right now,” said Gates. “That’s why I’m able to predict the future.”

Bill Gates
CO-Founder of
Microsoft

July 28 2023, On Friday, an industry body of Indian medical device manufacturers, AiMeD expressed its gravest concerns over an Official Memorandum (OM) issued by the government to its various Ministries enabling the import of pre-owned or pre-used and refurbished medical devices in India from MNCs. Read More...

July 28 2023, In its latest drug safety alert, the apex drug regulatory body, the Central Drugs Standard Control Organization (CDSCO), flagged 48 medicine batches for failing to qualify for a random drug sample test for the month of June, while one drug sample has been declared spurious.. Read More...

27 July 2023, With the rule on printing barcode or Quick Response (QR) code on the label of top 300 brand drugs to be implemented from August 1, 2023, the drug regulator affirmed that any batch of brands of drug formulations as specified in its notification and manufactured on or after the stipulated date, irrespective of the manufacturing site, shall have the barcode or QR code on its label. Read More...

July 27, 2023, The Union Ministry of health and family welfare has said that it has mandated the Indian Council of Medical Research (ICMR), the apex body in the country for formulation, coordination, and promotion of biomedical research, to research the impact of Polypharmacy and others in geriatric population.  Read More...

July 26, 2023, In a step towards forcing the National Pharmaceutical Pricing Authority (NPPA) for fixing a uniform price system for all surgical instruments and products sold through private medical shops and hospital pharmacies, Read More...

July 27, 2023, India should try to formulate an arrangement with Australia to avail Pharmaceutical Benefit Scheme (PBS) towards selecting, listing and pricing processes of exported medicines, according to Sudarshan Jain, secretary general, Indian Pharmaceutical Alliance (IP Alliance). Read More...

July 25, 2023, Regulatory experts have recommended to the Indian pharma industry to bring to the US government’s notice the significant time taken for generic drug approvals and request expedited approvals in cases of product having established bioequivalence (BE) in other jurisdictions. Read More...

July 26, 2023, Hyderabad-based Natco Pharma Limited announced submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of erdafitinib tablets 3 mg, 4 mg, and 5 mg strengths. Read More...

July 27, 2023, Since a majority of the drugs exported by India to the US are generics, intellectual property (IP) experts have advocated the need to combat patent thickets and product hopping in the US through legislation and policy interventions to facilitate pharma trade and exports. Read More...

July 26, 2023, STADA Arzneimittel AG and Xbrane Biopharma AB are considering options, including out-licensing, for their co-developed ranibizumab biosimilar candidate in North America, Read More...

July 26, 2023, Boehringer Ingelheim and Eli Lilly and Company announced that the European Commission (EC) approved Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease (CKD).According to the list of NSQs released by the drug regulator for the month of June, 48 were declared as NSQs out of a total number of 1,273 samples tested during the month. Out of the total, 1,225 samples were declared as of standard quality. Read More...

On World Drowning Prevention Day this year, WHO is releasing an investment case on drowning prevention showing how just two actions – investing in day care for pre-school aged children and teaching basic swim skills to school-age children – could protect millions of lives. Each dollar invested in these actions can yield benefits up to nine times the original value.

Drowning is an under appreciated but lethal public health issue. It has caused over 2.5 million deaths in the last decade, with an alarming 90% of these fatalities occurring in low- and middle-income countries. Across all age groups, children aged 1–4 years and 5–9 years experience the highest drowning rates, highlighting the need for immediate action to protect future generations.

Jul 24, 2023,, According to officials, the government has approved the prosecution of S Eswara Reddy, a joint drugs controller for the Central Drugs Standard Control Organisation, clearing the way for the start of a trial against him for allegedly accepting a bribe to favourably recommend an insulin injection made by Biocon Biologics. Before a special court in this location, the CBI presented the sanction for prosecution given by the Director (Vigilance) in the Union Ministry for Health and Family Welfare. Read More... Read More...

Jul 23, 2023, The govt has granted the sanction to prosecute Central Drugs Standard Control Organisation's joint drugs controller S Eswara Reddy, clearing the decks for initiating a trial. Read More...

Pharmaceutical Quality Assurance is the assurance of quality requirements for a product or service in the pharmaceutical industry. Quality assurance aims to create and maintain customer confidence in the product, and the goal is to detect defects early or to prevent them.

July 26, 2023, Gilead Sciences, Inc. presented new data reinforcing the efficacy, safety, and tolerability profile of lenacapavir, including patient-reported outcomes (PRO) from the phase 2/3 CAPELLA trial. These latest findings underscore the role of lenacapavir, the first long-acting injectable HIV treatment medication administered twice-yearly, as a person-centric therapy option and its transformative potential impact on the future of coordinated HIV clinical care. The data were presented at the 12th International AIDS Society (IAS) Conference on HIV Science (IAS 2023), taking place July 23-26 in Brisbane, Australia. Read More...

July 25, 2023, Syndax Pharmaceuticals and Incyte announced positive topline data from the pivotal AGAVE-201 trial of axatilimab, an anti-CSF-1R antibody, in adult and pediatric patients with chronic graft-versus-host disease (GVHD) following two or more prior lines of therapy. Read More...

“PSM- India’s battle against menace of counterfeit medicines in India is worthy of valour and appreciation”.

‘I have been a consistent reader of PSM Newz for last couple of years and really like their performance’.

‘We feel that every aware educated individual should raise their voice against fake medicines as like PSM and stop anybody around getting affected by it’.

Dr. Anamika Wadhera 

BDS, MPH, MSW, MWMA

Director

Patient Safety And Access Initiative of India Foundation
B306, First Floor, C R Park, New Delhi -110019
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Disclaimer : Our newsletter endeavors to compile patient safety information from various sources . PSAIIF may not be held responsible for any article published in The Prescription.