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EDITOR'S EMULSION
Wishing all our readers and their family a Very Bright, Happy, Healthy and Prosperous 2023! May we step into this year with new hopes, renewed aspirations and magical dreams and the capacity to fulfil them all.
Welcome to yet another most pleasant Reading of our newsletter.
It is always my privilege to reach you on 1st & 17th of every month, since the last 11 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
DOSE OF THE DAY
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The CSR initiative is a great example of a holistic Govt approach.
The MoU will help in providing sustainable and equitable access to free high-quality TB treat-ment, care, and support services to the people of Uttar Pradesh and Chhattisgarh."
Together, we will make India TB free by 2025!
Dr. MansukhMandaviya
Minister of Health and Family Welfare; Chemicals and Fertilizers
Govt of India
Sponsor
Patient Safety Capsules
Ayush manufacturing units witness marginal decline in 10 years, GMP compliance registers growth
New Delhi, December 26, 2022: The number of licensed pharmacies which produce medicines under the Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa Rigpa and Homoeopathy (Ayush) has declined by almost 1.6 per cent in the last ten years, even as the ratio between good manufacturing practices (GMP) complied facilities and those which are non compliant has shifted significantly in favour of GMP compliance.
DCGI to undertake massive risk based inspections as WHO holds Indian co accountable for exporting contaminated drugs
New Delhi, December 27, 2022: The Drugs Controller General of India (DCGI) will soon undertake massive risk based inspections pan-India following the World Health Organization (WHO) holding Indian company Maiden Pharmaceuticals accountable for exporting contaminated medicines.
Drug Laws & Policy Injections
National Commission for Homoeopathy notifies BHMS regulations
New Delhi, December 10, 2022: The National Commission for Homoeopathy has prepared a regulation defining a structure to the Bachelor of Ho-moeopathic Medicine and Surgery (BHMS) course with changes including incorporation of a methodology to supplement modern advancement, research and technology in Homoeopathy (SMART-Homoeopathy). The regulation has come into force on the date of their publication in the Official Gazette.
DoP rejects IntasPharma’s review petition against ceiling price fixation on Globucel M
New Delhi, December 7, 2022: The Department of Pharmaceuticals (DoP) has rejected a review application by Ahmedabad-based Intas Pharmaceuticals for the review of the ceiling price fixed by National Pharmaceutical Pricing Authority (NPPA) for its brand Globucel M.
US FDA India accepts Karnataka DC department’s request for ‘observer’ role during plant auditsBengaluru, December 12, 2022: The US FDA India office has in principle agreed to the Karnataka drugs control department’s request for ‘observer’ role during the plant audits by the US FDA inspectors. The role as an observer would benefit making the audits more effective.
NPPA releases fourth list of draft ceiling prices for 15 formulations based on NLEM 2022
New Delhi, December 7, 2022: The National Pharmaceutical Pricing Authority (NPPA) has released the fourth list of draft ceiling price calculations for 15 more drugs, as part of fixing the ceiling prices of medicines under the National List of Essential Medicines (NLEM), 2022, which was amended into the Schedule-I of the Drugs (Prices Control) Order, 2013.
NPPA brings in changes in IPDMS 2.0 to improve ease of filing
New Delhi, December 9, 2022: The pharma companies which are looking at modifying the product or plant details in the Integrated Pharmaceutical Database Management System (IPDMS) 2.0 - except for the change of product category from scheduled to non scheduled and vice-versa
AIDCOC to hold EC meeting on Dec-10 in Hyderabad to reconstitute Central council & to make roadmap for 2023Hyderabad, December 9, 2022: The All India Drug Control Officers Confederation (AIDCOC) will hold its executive committee meeting in Hyderabad on December 10 to finalize decisions for the upcoming year and to reconstitute its Central council.
Pharma Injections
Gujarat FDCA witnesses drastic decline in non-compliance to Drugs Act and NDPS Act since 2019
Mumbai, December 7, 2022: The Gujarat Food and Drug Control Administration (FDCA) has witnessed a drastic decline in non-compliance cases related to Drugs Act and NDPS Act since 2020. It seized products worth Rs. 59,000 this year as against products worth Rs. 44.46 lakhs seized in the period of 2019 -2020.
IPC alerts healthcare professionals about norfloxacin induced skin hyperpigmentation
Mumbai, December 7, 2022: The Indian Pharmacopoeia Commission (IPC), which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI), has flagged drug safety alert revealing that antibacterial norfloxacin is associated with adverse event known as skin hyperpigmentation.
Some critical issues still persist which hamper ease of use in operating IPDMS 2.0.Mumbai, December 12, 2022: Even though the National Pharmaceutical Pricing Authority (NPPA) has resolved certain critical issues regarding Integrated Pharmaceutical Database Management System (IPDMS) 2.0, some critical issues still persist which hamper the ease of use in operating IPDMS 2.0.
Sophos sees global healthcare organisations grapple ransomware attacks and aggressively work on data recovery
Bengaluru, December 10, 2022: Sophos, a global leader in next-generation cybersecurity, has now seen that global healthcare organisations grapple ransomware attacks and aggressively work on data recovery.
DBT to support multi institutional CoEs for nano-vaccines and nano-adjuvants development
New Delhi, December 9, 2022: The Department of Biotechnology (DBT) is extending support to the institutions and scientists to set up Centres of Excellence in the country for nano-vaccines and nano-adjuvants, to treat cancer and other diseases.
DCGI gives nod to Serum Institute’s ebola vaccine for export to UgandaNEW DELHI, December 9, 2021: The Drugs Controller General of India (DCGI) has approvied India’s frstebola vaccine manufactured by the Serum Institute of India (SII) for export to Uganda, official sources said yesterday.
Drug Dopes
Specialty chemical manufacturers urge govt to make efforts to validate, implement NAMs replacing animal testing
Mumbai, December 10, 2022: In a bid to ensure proper product safety testing and maintain and respect animal and environmental welfare, specialty chemical manufacturers have urged the government to validate and implement New Approach Methodologies (NAMs) by aligning itself to global trends in developing alternatives to animal testing. 
21 projectswithinstalledcapacity of 33,895 MT commissioned under PLI scheme for KSM, DI and APIsNew Delhi, December 12, 2022: The Central government's production linked incentive (PLI) scheme for promotion of domestic manufacturing of critical key starting materials (KSMs), drug intermediates (DIs) and active pharmaceutical ingredients (APIs) has seen 21 projects, out of the 51 applications selected so far, being commissioned with an installed capacity of 33,895 MT.
Pharmacy college managements from southern states soon to start educational intuitions in J&K and LadakhChennai, December 12, 2022: Since the Pharmacy Act, 1948 is in force in the whole jurisdiction of the Union territories of Jammu & Kashmir and Ladakh, managements of educational institutions from the southern states of the country are showing interest to open pharmacy colleges in both the territories, according to sources close to the governments there.
PCI directs state pharmacy councils to expedite transfer of registration for phar-macists in Central govt jobNew Delhi, December 24, 2022: The Pharmacy Council of India (PCI) has advised the state pharmacy councils to expedite the process to transfer registrations within seven days especially with regard to those in the Central government departments having a transferable job.
Government should make IP certification mandatory for IPAs used in pharma industryMumbai, December 6, 2022: The Indian Pharmacopoeia (IP) certification should be made mandatory for isopropyl alcohols (IPA) used in pharma applications by the union government, as usage of imported IPA is fraught with risks.
India – the emerging hub of nutraceuticalsDecember 5, 2022: The Indian nutra industry is poised to realise the $100 billion dream, suggests a recent survey by Nutrify Today. 2016 turned out to be the year that the nutra industry began to take off in India and both the trajectory as well as the industry have since undergone a seismic evolution.
National Injections
Gujarat launches cosmetic manufacturing license portal to make licensing process transparent and less time consumingMumbai, December 27, 2022: Following a trial run of the online system which started from December 1, 2022 for nearly a period of one month, Gujarat Chief Minister (CM) Bhupendra Patel has finally launched the cosmetic manufacturing license portal to make licensing process transparent, accountable and less time consuming as part of Gujarat government’s good governance initiative.
Delhi High Court refuses to issue interim injunction on Dabur's glucose drink commercial
New Delhi, December 28, 2022: A single bench of Delhi High Court refused to issue an interim injunction against Dabur India Ltd's video advertise-ment for its orange flavoured glucose drink in a petition filed by the market leader Zydus Wellness Products, observing that the an advertiser have the freedom to make advertisements with generic comparison highlighting the features of its own product and if the same is done without an allusion to any market leader.
Manufacturers in southern TN grumble about local marking cos for not establishing business relationship with them
Chennai, December 27, 2022: The pharmaceutical manufacturers in the southern districts of Tamil Nadu are grumbling that the marketing companies in the south are not creating a supporting business relationship with the local manufacturing units for agreement for their supplies rather they like to have business dealings with companies in Pondicherry and Chennai.
Karnataka clears Startup Policy to recognise innovation & entrepreneurial skills across lifesciences sectors too
Bengaluru, December 27, 2022: The Karnataka Cabinet has approved the state Startup Policy 2022-27 which aims at stimulating the growth of 25,000 startups in the state by 2027. The policy has dedicated focus on promoting startups in emerging technology clusters 'Beyond Bengaluru' by creating a conducive environment and offering these an ideal ecosystem for their growth.
IDMA asks govt to exclude freebies to doctors from the ambit of IT in the Union Budget 2023-24Mumbai, December 23, 2022: The Indian Drug Manufacturers’ Association (IDMA) has strongly recommended to the Union Finance Ministry to exclude medicine samples and product reminders meant for doctors from the ambit of Income Tax. In its recommendation to the Union Budget 2023-24, IDMA has proposed restoration of weighted deduction to 200% on in-house R&D facility and has highlighted other issues related to direct and indirect taxes as part of Budget Recommendations.
MP seeks PM’s intervention to reduce prices of breast cancer drugs
New Delhi, December 23, 2022: A Parliamentarian has sought Prime Minister NarendraModi’s intervention to take measures, including invoking relevant sections of the Patent Act, to facilitate generic availability of the three high priced drugs for treating breast cancer.
Global Injections
USFDA approves Roche’s lymphoma therapyDecember 26, 2022: The US health regulator has approved Roche’s therapy for treating a type of rare cancer called follicular lymphoma. The US Food and Drug Administration’s (USFDA) approval for Lunsumio was based on an early-to mid-stage study that showed the drug cleared signs of cancer in patients
UK researchers call for nasal spray vaccine to fortify protection against COVID-19 infection
December 23, 2022: Antibodies produced in the nose decline nine months after COVID-19 infection, while antibodies found in the blood last at least a year, a new study has found.
FDA approves Gilead's long-acting HIV injectable SunlencaDecember 22, 2022: Four decades after the start of the HIV epidemic, patients whose virus has become resistant to multiple therapies have a new treatment option.
Nasal Cell Damage Linked to COVID Loss of Smell: Study
December 22, 2022: Researchers now know why some people recover their loss of smell after COVID-19 and some do not. A new study, published Wednesday in the journal Science Translational Medicine, shows that for some people, their body’s immune response becomes dysregulated, even after the virus can no longer be de-tected by laboratory tests. Specifically, COVID-19 can cause a prolonged and damaging inflammatory assault on nerve cells in the nose that are responsible for the sense of smell.
Nepal bans import of medicines from 16 Indian companiesDecember 23, 2022: Nepal’s Department of Drug Administration has published a list of 16 Indian pharma companies, including Divya Pharmacy that manufactures Yoga guru Ramdev’sPatanjaliproducts, that failed to comply with the World Health Organization’s (WHO) good manufacturing practices.
Germany sends first batch of BioNTech COVID-19 vaccines to ChinaDecember 23, 2022 : Germany has sent its first batch of BioNTech COVID-19 vaccines to China, a German government spo-kesperson said recently.
PSAIIF PILL
NPPA releases draft calculation sheet for ceiling price revision of 35 formulations
New Delhi, December 28, 2022: The National Pharmaceutical Pricing Authority (NPPA) has released the draft calculation sheet for ceiling price revision of 35 formulations, based on their prices in July, 2022, under the revised Schedule I of Drugs (Prices Control) Order (DPCO), 2013. The list includes downward price revision proposed for some of the major drugs which have a moving annual total (MAT) of over Rs. 100 crore.
Two more AYUSH institutes get NABH and NABL accreditations
New Delhi, December 23, 2022: Two of the institutes under the Central Council for Research in Ayurvedic Sciences (CCRAS) of the Ministry of AYUSH, namely, Central Ayurveda Research Institute (CARI), New Delhi, and Central Ayurveda Research Institute, Jhansi, Uttar Pradesh, have been accredited with NABH and NABL accreditations, respectively.
Frequently Asked Questions
Do we need a climate-friendly diet?
December 11, 2022: Diet plays a very important role in climate change. Whether one consumes dairy, meat or other food products, a consistent dietary shift can cut down greenhouse-gas emissions, cropland, and pasture re-quirement, enhance biodiversity protection, and reduce mitigation costs. Read More>>>
SUBSCRIBER'S SYMPTOM
Explainer: India and Omicron BF.7 Covid risk
December 26, 2022: The BF.7-led Covid-19 surge in China has fanned concerns in India about this viral sub-variant. However, DrGagandeep Kang, who was involved in India’s Covid-19 decision-making in the early months of the pandemic, has said India has little reason for worry. Sarthak Ray takes a look at what the data and ex-perts are saying
Consumer Online Foundation: The first and only organisation certified as per international standard ISO 9001:2015 for Consumer Complaint Redressal Services
First and the only organization in India to be certified on 21st September 2021 as an ISO 9001:2015 on Consumer Complaint Redressal Services. We are proud to share our achievements with our readers and supporters. Thanks for your continued support and guidance for more than 35+ years of service to the consumers in India and abroad.
Blog Addicts
Dr Vivek Parikh, MD
"The Prescription" helps give me my monthly dose of current pharma news which I ea-gerly look forward to in order to keep myself abreast as a more aware reader. Keep up the good work.
Ms Supriya Singh, ProfessionalWant to commend the PSA India publication team for all the good work they do in bringing out this bi-monthly newsletter. Well done.
Mr Ramamurthy Iyer, Pharma ExpertVery beautifully and aptly captures important news in the Pharma domain. Excellent work.
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