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EDITOR'S EMULSION
Warm Greetings!!!
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
Invited the global community to 'Make in India', 'Innovate in India' & 'Discover in India', while addressing the roundtable on “Opportunities in R&D and Innovation in Life Sciences”, at Davos. Indian Govt is committed to unlocking to true potential of Indian Life Sciences sector
Dr. MansukhMandaviya
Minister of Health and Family Welfare; Chemicals and Fertilizers
Govt of India
Sponsor
Patient Safety Capsules
Indian healthcare looks at Socially Assistive Robots as viable option for mental health assistance
Bengaluru, January 5, 2023: Indian healthcare looks at Socially Assistive Robots as viable option for mental health assistance. There are several start-ups engaged in the development of robots to interface with humans. Surgical robots are seen to be the biggest boon on the medical front.
Lack of pharmacovigilance infrastructure in hospitals impacts growth of clinical pharmacists: Expert
Bengaluru, January 7, 2023: The paucity of pharmacovigilance infrastructure in healthcare facilities in the country is impacting the growth of the clinical pharmacy professionals, said Prof Hanumanthachar Joshi, Principal, Sarada Vilas College of Pharmacy, Mysuru.
Drug Laws & Policy Injections
Regulatory push, multi stakeholder engagement required to address growing obesity rates
Mumbai, January 5, 2023: With growing obesity rates and under-nutrition in adolescent population in India a concern, regulating their food environment and promoting nutrition literacy for healthy and informed food choices is urgently required, according to the Public Health Foundation of India (PHFI).
NPPA looks into fixation of retail price of drugs under phase IV clinical trials
New Delhi, January 9, 2023: The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company's application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.
AIOCD to discuss issues like e-commerce policy & online pharmacies in its next national meet in PuneMumbai, January 9, 2023: The All India Organisation of Chemists and Druggists (AIOCD) will discuss festering issues like e-commerce policy and online pharmacies involving its 12 lakh members pan–India to arrive at a concrete and long term solutions on the same.
NPPA fixes ceiling price of 97 formulations, revises prices of 31 fixed in December
New Delhi, January 7, 2023: A meeting of the National Pharmaceutical Pricing Authority (NPPA) has approved the revised ceiling prices of 97 scheduled formulations as part of its efforts to fix the price of the formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013 based on the National List of Essential Medicines (NLEM), 2022.
Regulators concerned over quality of drugs being sold by chain pharmacies on huge discounts in Odisha
Chennai, January 17, 2023: Huge price discounts being offered by corporate retail pharmacy chains and online pharmacies in Odisha have shattered the conventional pharma trade in the state including wholesale and retail trades.
D&C Rules need revamp as there is no clause of compensation for ADRs: regulatory expertsMumbai, January 17, 2023: Taking into account the four main components of regulator, industry, trade and patient/consumer in a medicine value supply chain, the Drugs and Cosmetics (D&C) Rules, 1945 and D&C Act, 1940 needs an urgent revamp as there is no clause of compensation for ADRs in patients, according to drug regulatory experts.
Pharma Injections
NPPA revises proposed retail price for Abbott's Nervup Forte Plus upwards following DoP review order
New Delhi, January 18, 2023: The National Pharmaceutical Pricing Authority (NPPA) has suggested the retail price of Abbott Healthcare's nutri-tional supplement Nervup Forte Plus at Rs 12.23 per tablet following the Department of Pharmaceuticals' (DoP) order to review the price fixation the drug price regulator has carried out earlier.
BDCDA calls on its 3,000 pharmacy outlets to renew KSPC registration to avoid penalties
Bengaluru, January 18, 2023: The Belagavi District Chemists and Druggists Association (BDCDA) has called on the 3,000 pharmacy retail and wholesale outlets under its umbrella to renew their Karnataka State Pharmacy Council (KSPC) Registration. This would help the pharmacists to be in sync with good professional practices.
No provisions for extension of exemption period for new drugs with indigenous R&D beyond 5 years: NPPANew Delhi, January 17, 2023: The National Pharmaceutical Pricing Authority (NPPA) has opined that the provisions for exemption of new drugs developed through indigenous Research and Development (R&D) from the Drugs (Prices Control) Order, 2013 does not provide for extension of exemption period.
Pharmexcil to partner with AIBC to facilitate Indian pharma’s bilateral trade with Australia
Mumbai, January 16, 2023: The Pharmaceuticals Export Promotion Council of India (Pharmexcil) will partner with Australia India Business Council (AIBC) to facilitate Indian pharma industry realize its objective of resilient supply chain for active pharmaceutical ingredients (APIs) and faster regulatory approvals in Australia.
Healthcare sector looks at govt for working capital and preferential funding support
Bengaluru, January 14, 2023 : Indian healthcare sector is now looking at the government for working capital and preferential funding support. This is because there are no incentives to stimulate the establishment of smaller hospitals and nursing homes in rural regions, making it difficult for firms to establish chains of smaller hospitals.
Size increase of medicine strips by manufacturers puts retailers as well as patients into quandaryChennai, January 12, 2023: The new business strategy being adopted by manufacturing companies for more sales and profits by increasing the size of medicine strips with multiplying the number of pills contained in it has put the retailers as well as the medicine consumers into quandary as both the traders and the patients are forced to waste a large number of cut strips and pills unnecessarily.
Drug Dopes
NABL suspends accreditation of 80 labs for non-compliance to norms
Mumbai, January 12, 2023 : The National Accreditation Board for Testing and Calibration Laboratories (NABL) has suspended accreditation of 80 labs in the country for non-compliance to norms. These include seven calibration laboratories, 58 medical laboratories and 15 testing laboratories. 
Med-tech sector scouts for export incentives under RoDTEP to boost R&D eco-systemBengaluru, January 14, 2023 : Indian med-tech industry now sees the increasing need for favourable policies in line with the current inflationary challenges. This along with export incentives under the Remission of Duties and Taxes on Export Products Scheme (RoDTEP) would boost R&D ecosystem in the sector.
Pharma & healthcare sectors look for supportive policies & simplified GST norms in Budget 2023Bengaluru, January 12, 2023: Indian pharma and healthcare sectors look for supportive policies, simplified regulations and GST norms. This according to them will give a fillip to the growth of these sectors. Hence they are looking up to the Union Budget 2023 to fulfil their expectations.
CDSCO issues medical device alert on Abbott's MitraClip Clip Delivery SystemNew Delhi, January 6, 2023 : The Central Drugs Standard Control Organisation (CDSCO) has issued a medical device alert on US-based healthcare and medical devices firm Abbot's heart valve repair device MitraClip Clip Delivery System, which is intended to treat a heart condition that tends the mitral valve on the left side of the heart not to close properly.
NPPA extends time limit for submission of production, price data till February 15New Delhi, January 3, 2023: The National Pharmaceutical Pricing Authority (NPPA) has extended the last date of filing statutory forms related to quarterly production and sales data for scheduled drugs and medical devices for the two quarters ended September and December, 2022, for a period of up to February 15, 2023.
PLI scheme for bulk drug witnesses commissioning of 21 projects in 2022New Delhi, January 5, 2023 : The production linked incentive (PLI) scheme for promotion of domestic manufacturing of bulk drugs has seen setting up of 21 projects including capacities for manufacturing of over 25,000 MT of para aminophenol and around 4500 MT of 1,1 cyclohexane diacetic acid (CDA) in the country, till the end of December, 2022.
National Injections
Delhi HC issues order favourable to Novartis in Ceritinib patent infringement case against Natco PharmaNew Delhi, January 14, 2023: In a new development to the long pending dispute between Swiss pharma major Novartis and Hyderabad-based pharma firm Natco Pharma, a single bench of Delhi High Court has issued an order restraining Natco, its manage-ment and distributors from infringing the patent rights of Novartis on its cancer drug Ceritinib, branded as Zykadia internationally.
Kerala DCA to crack the whip on erring medical shops to make the state completely antibiotic literate in 2023
Chennai, January 18, 2023 : As part of making Kerala a ‘completely antibiotic literate state’, the state health department has strengthened its action to curb OTC sale of antibiotics and directed the drug control administration to take strong action against pharmacies violating rules.
Pharma SSIs in Assam want state govt to bring out a separate pharma policy to support local manufacturers
Guwahati, January 6, 2023: The small scale pharmaceutical manufacturing companies (SSIs) in Assam will shortly prepare a proposal to be submitted to the government for bringing out a separate pharma policy for the state to support the local manufacturers.
Gujarat FDCA starts issuing RCs to medical devices manufacturers as part of transitioning to new MD regime
Mumbai, January 6, 2023 : The Gujarat Food and Drug Control Administration (FDCA) has started issuing Registration Certificate (RC) (MD-42) to medical device manufacturers in the state as part of the transitioning to new medical device regime in a smooth way.
Chennai DTL will soon be notified by CDSCO to test medical devicesChennai, January 4, 2023: The drug testing laboratory (DTL) under the department of drugs control in Tamil Nadu is likely to be certified soon by the government of India to carry out test and evaluation for medical devices (MDTL).
Homoeopathic market in India to grow 20-25% annually and resize itself to 1.08 billion: Dr Mukesh Batra
Mumbai, January 3, 2023 : Homoeopathic market in India is likely to grow 20%-25% annually and resize itself to US dollar 1.08 billion, informs leading homoeopath Dr Mukesh Batra adding that this can be attributed to the fact India has over 5 lakh registered homoeopaths and around 20,000 more are being added every year.
Global Injections
WHO announces plans to establish a TB Vaccine Accelerator CouncilJanuary 17, 2023: The World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus yesterday announced plans to establish a new TB Vaccine Accelerator Council.
AbbVie and Eli Lilly exit UK drug pricing agreement
January 17, 2023: AbbVie and Eli Lilly have withdrawn from Britain’s voluntary medicines pricing agreement, an industry body said yesterday.
Eisai files for approval of Alzheimer’s drug in JapanJanuary 17, 2023: Eisai said yesterday it had submitted a marketing authorisation application in Japan for its Alzheimer’s drug lecanemab, which was recently granted accelerated approval in the United States (US).
CDC probes possible safety risk for Pfizers new COVID shot
January 16, 2023: Throughout the whirlwind COVID-19 vaccine rollouts in the U.S., federal officials have kept a close eye on reports of adverse events. Now, after tracking potential stroke risk for Pfizer's new shot, the government is sharing its findings.
USFDA gives tentative approval to Zydus’s Levomilnacipran extended-release capsulesJanuary 16, 2023: The United States Food and Drugs Administration (USFDA) has given tentative approval to Zydus Lifes-ciences to market Levomilnacipran extended-release capsules, 20 mg, 40 mg, 80 mg and 120 mg, ac-cording to a company statement.
China allows sale of Pfizer oral drug as demand surges in wake of rising COVID casesJanuary 16, 2023 : China has given nod for the sale of Pfizer’s COVID-19 pill, Paxlovid, in the mainland. It comes after Beijing decided to move away from its stringent ‘zero-COVID’ policy in the wake of protests.
PSAIIF PILL
Government approves PMBI’s proposal to open JAKs in 651 districts
New Delhi, January 13, 2023: The Centre has approved Pharmaceuticals and Medical Devices Bureau of India’s (PMBI) proposal to open Jan Aushadhi Kendras (JAKs) in 651 districts across India. In this regard, PMBI is inviting online applications in different states and Union Territories (UTs).
Investments based on IEMs filed by pharma industry in first 10 months show decline
New Delhi, January 6, 2023: The pharmaceutical industry has reported investments to the tune of Rs. 2,828 crore in 19 projects in the first 10 months of the year, out of the investment intentions it has filed through the Industrial Entrepreneur Memorandum (IEMs) with the government. This is a decline compared to the Rs. 3,453 crore invested in 28 projects through implementation of IEMs during the same period of 2021, according to data from the ministry of commerce and industry.
Frequently Asked Questions
What to Eat (or Not) When Your Stomach Hurts
January 17, 2023: When your stomach hurts, cramps, or you feel like you might throw up, the last thing you want to do is eat something that makes it worse. It can be even harder to know what to try if you’ve been vomiting or have diarrhea. But some foods can give you nutrients you need without making you feel worse. Read More>>>
SUBSCRIBER'S SYMPTOM
The emphasis of the ‘Clean Approach’ on lifestyle
January 13, 2023: New year! A new challenge awaits! Bringing new hope to the world! A new sense of happiness! Thus, our New Year’s Resolution is born! We all secretly have some resolution, even if we deny it, and we work very hard during the first month to make it a reality! Slowly, our resolution also fades as time passes, and we all get busy with our daily routines.
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Blog Addicts
Caesar Mariet, Academician comments :
Good informative articles PSA India, but rather alarming condition of medicine counterfeiters across the Globe !
Dr. Pushpita Aggarwal, General Physician blogs Collective efforts of PSA-India and aware consumers of India can bring radical change in im-proving condition of health and medical care in India
Dr. Abhiroop Rawat, RMO Tweets:Praises for your interesting newsletter. Fetch us with more articles on how to cope up with in-creasing lifestyle NCDs in India!
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PSAIIF may not be held responsible for any article published in The Prescription.
