Patient Safety Capsules
Health ministry amends NDCTR to include additional testing methods to assess safety & efficacy of iPSC
New Delhi, March 15, 2023 : The Union health ministry has amended the New Drugs and Clinical Trials Rules (NDCTR), 2019 to include additional testing methods under the non-clinical studies to assess the safety and efficacy of induced pluripotent stem cells (iPSC), the adult cells that are genetically reprogrammed to have an embryonic stem cell-like potential.
Union ministry of health & family welfare receives Porter Prize 2023
Mumbai, March 3, 2023 : In a significant achievement towards recognizing the efforts in health sector and especially Covid management, the Union ministry of health and family welfare has received the Porter Prize 2023. Prize recognizes the holistic strategy followed by the Government of India in control and containment of Covid-19.
Drug Laws & Policy Injections
CDSCO approves two more medical devices testing laboratories
New Delhi, March 13, 2023 : The Central Drugs Standard Control Organisation (CDSCO) has approved two more Medical Device Testing Laboratories (MDTL) to carry out tests or evaluation of a medical device on behalf of the manufacturers under the provisions of the Medical Devices Rules (MDR), 2017.
NITI Aayog soon to come out with final report on health coverage for the missing middle
New Delhi, March 14, 2023 : A multi-stakeholder committee of the central government’s policy think tank NITI Aayog is in the process of preparing the final report for a larger health insurance coverage to improve the healthcare affordability in the country.
DoP urges pharma cos to report overcharging cases to NPPA for making policy interventions for prospective batch pricingMumbai, March 10, 2023 : The Department of Pharmaceuticals (DoP) has urged the pharmaceutical companies to study the number of cases of overcharging and report it to the National Pharmaceutical Pricing Authority (NPPA) towards making policy interventions for prospective batch pricing.
NPPA fixes new ceiling prices for 33 scheduled formulations under revised Schedule I
New Delhi, March 8, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has released the draft ceiling price calculation sheets for 33 scheduled formulations under the Schedule I of the Drugs (Prices Control) Order, 2013, which has been revised last year with replacing the National List of Essential Medicines (NLEM), 2015 with the NLEM, 2022.
DoP revises guidelines for PLI scheme for medical devices to include investment into clinical trials in eligibility criteria
New Delhi, March 1, 2023 : The Department of Pharmaceuticals (DoP) has revised the guidelines of production linked incentive (PLI) scheme for promoting domestic manufacturing of medical devices (PLI MD) making the cost incurred by the applicants towards clinical trials of eligible products in India as an investment determining the eligibility to be selected under the scheme, though it would be capped at a maximum of 10 per cent of committed investment.
Govt soon to announce R&D policy for pharma sector to create an enabling R&D environment: Dr Vinod KotwalMumbai, March 3, 2023 : Research and development (R&D) policy will soon be out for the pharma sector to create an enabling R&D environ-ment which will include initiatives like creating centres of excellence and industry academia linkages for growth of all stakeholders, said Dr Vinod Kotwal, member secretary, National Pharmaceuticals Pricing Authority (NPPA).
Pharma Injections
NPPA fixes ceiling prices of 79 scheduled formulations, retail price of 74 new drugs
New Delhi, March 2, 2023 : The National Pharmaceutical Pricing Authority (NPPA) has revised and fixed the ceiling price of 79 scheduled formulations in the revised Schedule I of the Drugs (Prices Control) Order, 2013, based on the National List of Essential Medicines (NLEM), 2022.
Indian pharma sees immense relevance to US FDA norms for drug development for age-related macular degeneration
Bengaluru, March 4, 2023 : Indian pharma sees immense relevance to the US FDA norms for drug development for age-related macular degeneration. The condition is a serious vision loss which mandated the need for new drugs.
Pharma API Leaders Conclave’ discusses regulatory compliance, technology adoption & automationMumbai, March 4, 2023 : While discussing the growth prospects of the global active pharmaceutical ingredients (API) market, Pharma API Leaders Conclave held between March 2 and 3 in Mumbai discussed ways to address regulatory hurdles, intellectual property issues,
KDPMA and PCI partnership to accelerate implementation of robust processes to fill critical knowledge gaps
Bengaluru, March 9, 2023 : The Karnataka Drugs and Pharmaceutical Manufacturers Association (KDPMA) and the Pharmacy Council of India (PCI) have come together to accelerate the implementation of robust processes to fill critical knowledge gaps.
Health ministry adds six rare diseases under NPRD, 2021
New Delhi, March 9, 2023 : The Union health ministry has included six rare diseases including Laron’s syndrome, Wilson’s disease and hypo-phosphatemic rickets among others into various groups of disorders under the National Policy for Rare Diseases (NPRD), 2021, enabling the patients of these diseases to avail financial assistance for treatment.
How cloud utilisation can transform the pharma industryMarch 10, 2023 : Raheel Shah, director, BDR Pharma analyses how cloud computing in the pharma sector has evolved to address significant privacy, security, and compliance issues that the sector faces and is now more than just a storage option
Drug Dopes
Programmatic platforms a boon for pharma marketers for advertising on medical portals with utmost precision: Experts
Mumbai, March 15, 2023 : Programmatic platforms have proven to be a boon for pharma marketers for advertising on medical portals with utmost precision. Such platforms are automated advertising technologies that use algorithms to target specific audiences like healthcare professionals (HCPs), according to experts. 
MedLern HeartCode helping vulnerable Indian population survive sudden cardiac arrestsMumbai, March 15, 2023 : MedLern HeartCode complete training is today helping vulnerable population survive sudden cardiac arrests which take a heavy toll on lives in India.
Indian pharma encounters challenges to recycle glass with lack of proper collection infrastructureBengaluru, March 11, 2023 : Indian pharma encounters challenges to recycle glass with lack of proper collection infrastructure. This is even as the country is emerging as a significant player in the global glass recycling market, with opportunities for exporting recycled glass to other countries, said Aneesha Kaur Sachdev, director, Abraclean (Asia Pacific) Pte. Ltd.
Health ministry to rope in state governments to establish medical devices testing laboratoriesNew Delhi, March 6, 2023 : The ministry of health and family welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.
Patent office refuses review petition of Sun Pharma for its anti-dengue botanical drugNew Delhi, March 10, 2023 : The Indian Patent Office has upheld its earlier decision refusing patent rights to Sun Pharmaceuticals for its botanical drug to treat dengue following a review petition, as the company representatives neither attended nor filed submissions against the hearing notice issued by the authority.
India is a primary market to penetrate and enable access to TB test cartridges: Dr Laurent BellonBengaluru, March 15, 2023 : India is absolutely a primary market to penetrate and enable access to tuberculosis (TB) test cartridges, said Dr Laurent R Bellon, senior vice president, operations, Cepheid, USA.
National Injections
Generic Aadhar to reach each & every corner of India by next year, plans to set up 1,000 outlets in TNChennai, March 14, 2023 : Generic Aadhar, the largest retail-chain generic stores in the private sector with a pan-India presence, is all set to reach each and every corner of the country by next year. The company also has plans to set up 1,000 outlets in Tamil Nadu in the next one year.
Homoeopaths to hold Vijnan Sammelan in Hyderabad on April 9 to deliberate on various problems
Chennai, March 11, 2023 : The homoeopaths across the country will assemble on a common platform at the IICT Auditorium in Hyderabad on April 9 to deliberate on various problems faced by the practitioners and to promote homoeopathic remedies for easy cure of diseases as well as to find ways to advance homoeopathy medical practices in all the areas of healthcare management in India, on the lines of other countries.
Odisha APTI accuses OPCA of financial embezzlement by not paying legitimate salaries to teachers
Bhubaneswar, March 8, 2023 : The national vice-president of the Association of Pharmacy Teachers of India (APTI) has accused the Odisha Phar-macy Colleges Association (OPCA) of ‘financial embezzlement’ by not paying the legitimate salaries to teachers despite sufficient students being admitted to each course in every institution.
Health ministry to allow drug imports through Gangavaram Port in Andhra Pradesh
New Delhi, March 6, 2023 : The ministry of health and family welfare (MoHFW) will soon allow import of drugs into India through Gangavaram Port at Visakhapatnam, in Andhra Pradesh, an all-weather deep-water port owned by Adani Ports and Special Economic Zone (APSEZ).
China Plus One strategy augurs well for Indian pharma as industry propels new capex expansionBengaluru, March 3, 2023 : China Plus One strategy augurs well for Indian pharma as industry propels new capex expansion. The sector has only gained from the China+1 factor, said S Venkat, founder, Practus, a global management consulting practice.
TN SPC unable to conduct council election due to case pending with high court
Chennai, March 4, 2023 : The Tamil Nadu State Pharmacy Council (TN SPC) has completed the work for the preparation of the State Phar-macy Register 2023 (SPR 2023) to conduct election for six members to the council as soon as the court verdict comes out in this regard.
Global Injections
Pfizer agrees to revise COVID vaccine contract with EU: ReportsMarch 15, 2023: Pfizer will be extending its COVID-19 vaccine contract from 2023 to 2026 with the European Union, as reported by the Financial Times. The company has offered to cut the number of doses being supplied by 40 per cent and delay delivery of the shots.
VAV Lipids earns appreciation from US Pharmacopeia
March 8, 2023: Certificate of Appreciation noted that VAV Lipids’ contributions have added significant public benefit to the standards-setting process in support of the USP mission
Long road ahead for non-statin therapies in Australia dyslipidemia treatment space: GlobalDataMarch 15, 2023: Esperion Therapeutics’ non-statin therapy “bempedoic acid” has shown modest results in reducing the risk of major cardiovascular events in statin-intolerant patients in the cholesterol-lowering via bempedoic acid, an ACL-inhibiting regimen (CLEAR Outcomes) trial. As a result, there is substantial room for im-provement in this space as a potential approval is expected in Australia in the near-term based on these results, says GlobalData.
Alembic Pharma gets USFDA nod for Fluorouracil Injection USP, 2.5 g/50 mL pharmacy bulk vial
March 6, 2023: Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluorouracil Injection USP, 2.5 g/50 mL (50 mg/mL) Pharmacy Bulk Vial. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Fluorouracil Injection, 2.5 g/50 mL (50 mg/mL), of Spectrum Pharmaceuticals, Inc. (Spectrum).
Zydus gets final US FDA approval for Vigabatrin for Oral Solution USP, 500 mgMarch 3, 2023: Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Vigabatrin for Oral Solution USP, 500 mg (USRLD: Sabril® for Oral Solution).
USFDA accepts Eisai’s sBLA and grants priority review for approval of LEQEM-BITM Alzheimer’s treatmentMarch 6, 2023 : Eisai and Biogen announced that the US Food and Drug Administration (FDA) has accepted Eisai’s sup-plemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
PSAIIF PILL
Expert panel recommends action against Panacea Biotec for launching Easy Six vaccine without price approval from NPPA
New Delhi, March 11, 2023 : The Multi Disciplinary Committee (MDC) of Experts which advises the National Pharmaceutical Pricing Authority (NPPA) has suggested that necessary action might be taken against vaccine maker Panacea Biotec Ltd, for launching its vaccine Easy Six without price approval of the Authority.
IDMA urges IPC not to consider implementing revising of DT time for soft gelatin capsules to avoid supply disruption
Mumbai, March 11, 2023 : The Indian Drug Manufacturers’ Association (IDMA) has made various representations to the Indian Pharmacopoeia Commission (IPC) to refrain from the implementation of the British Pharmacopoeia (BP) standards with reference to the Disintegration Testing (DT) time for soft gelatin capsules to avoid short supply of products in the market.
Frequently Asked Questions
Endometriosis: Can it affect beyond pelvis?
Endometrium is the tissue that forms the inner lining of the uterus. The presence and growth of these cells outside the uterine cavity causes the disease condition called endometriosis. The cause and rea-sons for its growth outside the uterine cavity is unknown. However, the disease per se is a common and painful one. It also has a moderate genetic predisposition. Which means if your mother or sister has suf-fered from it, there is a likelihood that you would too. Read More>>>
SUBSCRIBER'S SYMPTOM
Are you suffering from eye stroke? Here are the symptoms
An eye stroke is a dangerous condition that occurs due to a lack of sufficient blood flow to the tissues in the front part of the optic nerve. According to experts, having an eye stroke may be an indicator that the person might be at the risk of a serious stroke.
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Blog Addicts
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Excellent articles being published every edition. Very enjoyable.
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Ms (Dr.) Niloufer Ramadoss, MBBSPresented very beautifully and aptly captures important developments in the Pharma space
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