Patient Safety Capsules
Health ministry soon to roll out eSanjeevani 2.0 across the country
New Delhi, February 18, 2023 : The Union Ministry of Health and Family Welfare is planning to roll out the next version of its national telemedicine initiative eSanjeevani, by launching an eSanjeevani 2.0 with enhanced telemedicine experience having new features both in terms of technology as well as innovation, making it more secure and scalable to undertake additional demands.
DCGI issues show cause notice to e-pharmacies for stocking & selling drugs in contravention to D&C Act
New Delhi, February 11, 2023: The Drug Controller General of India (DCGI) has issued a show cause notice to online pharmacies including Tata 1mg for allegedly stocking and selling drugs in contravention of the provisions of the Drugs and Cosmetics Act, 1940 and Rules, once again bringing back the long pending issue of lack of regulations on e-pharmacies under the existing drug regulations in the country, to the fore.
Drug Laws & Policy Injections
Centre finalising policy to catalyse R&D and innovation in pharma and med-tech sectors
New Delhi, February 8, 2023: The Central government is in the process of finalising the cabinet note on its Policy to catalyse R&D and innovation in the pharma med-tech sector in line with the budget announcement for the year 2022-23.
NPPA proposes ceiling price of 26 more scheduled formulations
New Delhi, February 18, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has released its 13th lot of draft calculation sheet for fixing and revising the ceiling prices of 26 formulations including some of the new additions to the National List of Essential Medicines (NLEM), 2022, as part of fixing the ceiling prices of the drugs under the Schedule I of the Drugs (Prices Control) Order, 2013.
CDSCO should sensitize manufacturers to implement registration process for class A&B medical devices: ExpertsMumbai, February 8, 2023 : The Central Drugs Standards Control Organisation (CDSCO) needs to sensitize manufacturers to implement registration process scheduled from October 1, 2022 for class A&B medical devices as per the mandate of new Medical Device Rules (MDR) – 2017, according to experts.
IDMA urges Centre to introduce prospective batch pricing towards compliance to DPCO guidelines
Mumbai, February 16, 2023 : The Indian Drug Manufacturers’ Association (IDMA) has urged the Department of Pharmaceuticals (DoP) that the applicability of ceiling prices should be done from the immediate prospective batch towards compliance to Drug Prices Control Order (DPCO-2013).
NPPA addresses the issue of inter brand price variation in new scheduled drugs while fixing ceiling prices
New Delhi, February 13, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has decided to cap the prices of new scheduled drugs from the same company with significant inter-brand price variation, at the price of the lowest brand or pack size plus 10 percent based on the existing reference under the Drugs (Prices Control) Order (DPCO), 2013.
AIOCD asks NPPA to streamline TMR in view of increase in WPI since introduction of DPCO -2013Mumbai, February 13, 2023: The All India Organization of Chemists & Druggists (AIOCD) has made a representation to the National Pharmaceutical Pricing Authority (NPPA) to streamline Trade Margin Rationalization (TMR) in view of the increase in Wholesale Price Index (WPI) which has been increasing consistently year on year since the introduction of Drug Price Control Order (DPCO)-2013.
Pharma Injections
NPPA refixes ceiling price of 400 scheduled formulations till Feb 6 with average reduction of 15.39%
New Delhi, February 11, 2023: The latest efforts by the National Pharmaceutical Pricing Authority (NPPA) to revise and fix the ceiling price of scheduled formulations has resulted in refixing the ceiling prices of 400 formulations till February 6 with an average reduction of 15.39 per cent in ceiling prices, says the ministry of chemicals and fertilisers.
Pharma exports to top 10 destinations decline 4.2% in FY 22
New Delhi, February 15, 2023: Pharma exports to the top 10 destinations for the industry have seen a decline of 4.2 per cent during the last fiscal year ended March, 2022, led by a decline in exports to countries including South Africa and United States of America, according to the Ministry of Commerce and Industry.
Medical hemp market propelled by Union govt’s notification lifting ban on scientific use of cannabisBengaluru, February 15, 2023: The Central government’s notification last year lifting the ban on medical and scientific use of cannabis derivatives has brought gradual recognition of hemp’s benefits and this has propelled the industry’s growth.
SEC refuses to recommend Glenmark’s nasal spray for Covid-19 additional indication
New Delhi, February 16, 2023 : The Subject Expert Committee (SEC), which advises the central drug regulator on approval of drugs and clinical trials, has refused to recommend Glenmark Pharmaceuticals’ Nitric Oxide Nasal Spray (NONS) for the additional indication of prevention of Covid-19 infection, citing lack of strong evidence.
Recent trade agreements & other initiatives give wider market access for Indian pharma & medical devices
New Delhi, February 9, 2023 : The recent trade agreements signed by India along with various other initiatives taken by the Centre has given wider market access for Indian pharmaceutical products and medical devices, said Anupriya Patel, minister of state in the ministry of commerce and industry.
AstraZeneca’s Durvalumab gets CDSCO nod to treat locally advanced or metastatic biliary tract cancerFebruary 17, 2023 : AstraZeneca India announced additional indication approval from Central Drugs Standard Control Organization (CDSCO) for Durvalumab to treat biliary tract cancer (BTC) in India.
Drug Dopes
Aviation and aerospace medicines take centre-stage at Aero India 2023
Bengaluru, February 17, 2023 : Startups maximized the Aero India 2023 platform to showcase self-reliance research and technology development of wearable devices, medical diagnostics and monitoring equipment which are designed to function as point-of-care gadgets in remote, inaccessible terrains and war-fields. 
Virologists see US FDA guidance on monkey pox to speed up drug development for viral infectionBengaluru, February 14, 2023 : Virologists have noted that the US FDA guidance on monkeypox will speed up drug development for the viral infection. The guidance provides nonclinical, virology, and clinical considerations for mpox drug development programes, with a focus on recommendations to support initiation of clinical trials.
IRGMA asks Mundra Port Commissioner to prevent import of poor quality medical, surgical glovesMumbai, February 7, 2023 : The Indian Rubber Gloves Manufacturers Association (IRGMA) has sought immediate intervention of the Commis-sioner of Customs General, Mundra Port, Gujarat with respect to the poor quality medical and surgical gloves being supplied to government hospitals. It has asked for guidance to prevent import of spurious disposable examination gloves in India.
NPPA proposes to bring down price of dobutamine injection 50 mg by 81%New Delhi, February 14, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has proposed to bring down the ceiling price of anti-cardiac drug dobutamine injection 50 mg by around 81 per cent and snake venom antiserum by around 64 per cent through the ongoing process of revising the ceiling prices of scheduled formulations as per the revised Schedule I of the Drugs (Prices Control) Order, 2013.
Akums gets DCGI approval to launch Lobeglitazone for diabetes treatment in IndiaFebruary 6, 2023: Akums Drugs and Pharmaceuticals has launched an antidiabetic drug, ‘Lobeglitazone’, to improve pancreatic beta-cell function in type 2 diabetic patients.
Fix quality issues, the rest will fall in placeFebruary 6, 2023 : As Union Budget 2023 was Finance Minister Nirmala Sitharaman’s last full ‘parting shot’ budget before the general elections next year, the life sciences industry hoped that many of their long-standing demands would get addressed.
National Injections
DoP to hold 'Chintan Shivir' in Hyderabad on Feb 26-27 to build trust on Indian drugs, cosmetics & medical devicesBengaluru, February 16, 2023 : Union government is now giving an increased impetus to pharmacovigilance and materiovigilance through its 'Chintan Shivir' initiative. The effort follows close on the heels of the Gambian cough syrup tragedy and the ophthalmology medication resulting in vision loss in the US. The government has positioned 'Chintan Shivir' to increase confidence of India’s high quality standards of pharmaceutical exports and domestic market sales.
Karnataka to utilise Namma Clinics for free healthcare services to identify NCDs early
Bengaluru, February 10, 2023 : Karnataka will utilise its 108 Namma Clinics for free healthcare services to identify non communicable diseases (NCDs) early. This is because the state is among the highest in the country for diabetics and other life style disorders like high cholesterol, blood pressure and obesity, which is extensively reported among the rural population.
TN DCA issues circular asking pharmacists in medical shops to wear white coat and badges
Chennai, February 10, 2023 : Although provisions of the Pharmacy Practice Regulations (PPR) 2015 are not there in the Drugs and Cosmetics (D&C) Act 1940 but are framed under the Pharmacy Act 1948, the steps now being taken by the drugs control ad-ministration (DCA) in Tamil Nadu in a motive to strengthen the dispensing activities in pharmacies are completely agreeing with the provisions of the PPR.
Traders in TN demand ‘One Molecule --One Price’ for all medicines in the country
Chennai, February 18, 2023 : The Tiruvarur District Chemists and Druggists Association affiliated to the Tamil Nadu Chemists and Druggists Association (TN CDA) wanted the government of Tamil Nadu to urge the Central government for implementing a policy of ‘One Molecule – One Price’ for all the drugs that are made with similar chemical composition.
US FDA-Gujarat FDCA Regulatory Forum meet discusses broad ranging issuesMumbai, February 3, 2023 : The US FDA-Gujarat Food and Drug Control Administration (FDCA) Bilateral Regulatory Forum held recently dis-cussed broad ranging issues related to quality audit for compliance to Good Manufacturing Practices (GMPs) and capacity building among other relevant subjects.
Maharashtra leads in having maximum number of 1,302 NABL accredited labs
Mumbai, February 4, 2023 : Maharashtra leads in having the maximum number of 1,302 National Accreditation Board for Testing and Calibration Laboratories (NABL) accredited labs in the country.
Global Injections
US govt to procure 1.5 million more doses of Novavax COVID-19 vaccineFebruary 14, 2023: The US government has agreed to buy 1.5 million more doses of Novavax COVID-19 vaccine, the company said. It also informed that the modified agreement includes funds for the development of an updated vaccine by fall this year.
NATCO announces ANDA filing for generic olaparib tablets in US
February 13, 2023: NATCO Pharma has 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 Olaparib Tablets 100 mg and 150 mg.
Sun Pharma recalls 34000 bottles of Diltiazem Hydrochloride extended-release capsules from USFebruary 13, 2023: Sun Pharma is recalling over 34,000 bottles of a generic medication, used to treat high blood pressure, in the US market due to failed dissolution testing.
Lupin gets USFDA approval for Glycopyrrolate Injection, USP
February 9, 2023: Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Glycopyrrolate Injection USP, a generic equivalent of Robinul Injection, 0.2 mg/mL of Hikma Pharmaceuticals. The product marks the first approval from Lupin’s new injectable facility in Nagpur, India.
FDA accepts NDA and grants priority review of Zuranolone from Sage Therapeutics, BiogenFebruary 7, 2023: Sage Therapeutics and Biogen announced the US Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for zuranolone in the treatment of major depressive disorder (MDD) and postpartum depression (PPD).
Celery Seed-Derived Medicine May Improve Stroke OutcomesFebruary 17, 2023 : Butylphthalide, a new medication that comes from celery seed, could improve outcomes after a clot-caused stroke when given in addition to prompt treatment for the clot, according to a new study.
PSAIIF PILL
DoP asks pharma companies to go for QR code instead of SMS code for track and trace of medicines
Mumbai, February 18, 2023 : The Department of Pharmaceuticals (DoP) has directed the pharmaceutical companies to go for quick response (QR) code instead of using an SMS code for tracking and tracing of medicines. This will ensure quality and efficacious medicines reach the consumer and the patient in a timely and cost-effective manner.
Ayush practitioners hail Budget for providing stimulus for growth
New Delhi, February 3, 2023: The practitioners of Ayush system in the country observe that the Union Budget 2023-24 provides stimulus for growth and it comprises several positive schemes to promote the role of Ayurveda in the health systems of India.
Frequently Asked Questions
Understanding Cholesterol Problems: Symptoms
A high level of cholesterol in the blood doesn't have obvious symptoms, but it can increase your risk for conditions that do have symptoms, including angina (chest pain caused by heart disease), high blood pressure, stroke, and other circulatory ailments. Soft, yellowish growths or lesions on the skin called xanthomas may suggest elevated levels of cholesterol. Read More>>>
SUBSCRIBER'S SYMPTOM
The Heart Attack You Didn't See Coming
Rita Conrad was saying goodbye to friends in the parking lot of a Mexican restaurant when she started feeling fatigued and uncomfortable. It was 10:30 on a Thursday night, so she assumed it was the late hour or maybe the enchiladas. But when she got home, she started to feel discomfort in her back, shoul-ders, and chest.
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