March 2024

Mar 14,2024 Ionis Pharmaceuticals said on Wednesday its experimental drug to treat a type of fatty liver disease met the main goal of reducing inflammation of the critical organ in a mid-stage trial. The results come as companies race to bring the first approved treatment for the disease and tap into a global market expected to surpass $16 billion by 2030, according to market research firm Vision Research Reports. Akero Therapeutics last week reported its experimental drug significantly reduced scarring after nearly two years in a mid-stage study while the U.S. Food and Drug Administration is expected to decide on Madrigal Pharmaceuticals ‘ treatment by Thursday. The trial enrolled 160 metabolic dysfunction-associated steatohepatitis (MASH) patients with scarring or fibrosis at severity of stage two or three, Ionis said. The company said 32 per cent of patients who received a higher dose of the drug, called ION224, saw improved scarring in the liver by at least one stage as measured by a biopsy, or tissue examination, compared to 12.5 per cent patients on placebo. Ionis said 44 per cent of patients treated with a higher dose version achieved more than 50 per cent relative reduction in abnormal retention of fat when measured by a quantitative imaging biomarker compared to 3 per cent for placebo. The company studied the drug – designed to reduce the production of an integral membrane protein – for 51 weeks in a two-part trial. The condition, earlier called non-alcoholic steatohepatitis (NASH), affects around 5 per cent of the U.S. population. Ionis said a subgroup analysis indicated significant improvements in the main trial goal in patients with advanced liver scarring. The company’s shares were up 4 per cent before the bell on Wednesday. Source: Pharma

Mar 15,2024 Prices of essential medicines including painkillers, antibiotics and anti-infectives are set to see a minuscule increase from April 1. In line with the annual change in the wholesale price index (WPI), the government is set to allow a .0055% increase in prices of drugs under the National List of Essential Medicines (NLEM). After massive annual increases of 12% and 10% in prices on record last year and in 2022, this will be a meagre increase for the pharma industry. The adjusted prices will cover more than 800 drugs on the National List of Essential Medicines. Price changes for scheduled drugs are allowed once a year. The list of essential medicines includes drugs like paracetamol, antibiotics such as azithromycin used to treat bacterial infections, anti-anaemia medicines, vitamins, and minerals. Some drugs used for treating moderately to severely ill Covid-19 patients and steroids are also on the list. The industry has been demanding a substantial increase in prices as it has been battling rising input costs. According to industry experts, over the last few years, prices of some key active pharmaceutical ingredients have increased between 15% and 130%, with the price of paracetamol jumping 130% and that of excipients increasing 18-262%. Glycerine and propylene glycol, solvents used in every liquid preparation including syrups, oral drops, and sterile preparations have become costlier by 263% and 83%, respectively. Prices of intermediates have also increased between 11% and 175%. Penicillin G has become costlier by 175%. Earlier, a lobby group that represents more than 1,000 Indian drug makers also urged the government to allow prices of all scheduled formulations to be increased by 10% with immediate effect. It had also sought a 20% increase in the prices of non-scheduled drugs. However, an executive associated with an NGO said this will be a respite after the last two major hikes. “Drastic hikes distort price controls. After witnessing two massive hikes back to back, this will be a good move in the interest of maintaining the affordability of these drugs,” the executive said. Source: Pharma

Mar 13,2024 New Delhi: The Rouse Avenue court on Tuesday expressed its displeasure over obtaining an independent medical opinion on the condition of Amit Katyal without its order. The court seeking a response from the accused on the reply filed by ED extended interim bail of Amit Katyal till March 22. Katyal is an accused in the ‘Land for Job’ money laundering case. Special judge Vishal Gogne said that the Court, without expressing further, would only record that a rather peculiar and novel process has been followed by the ED in obtaining opinions from doctors when no direction has been issued by the Court. It is appropriate that a formal rejoinder is filed by the accused to the reply for better appreciation of the merits as well as the contentions raised today regarding the methodology followed by the ED, the court ordered. The court was hearing an application of Amit Katyal seeking an extension of Interim bail granted to him. The Enforcement Directorate (ED) filed its reply. The senior counsel for the accused submitted that the ED had followed an improper and illegal process in filing the purported “independent opinion” and statements of doctors from certain private hospitals under Section 50 PMLA alongwith the reply. On the other hand, Counsel for the ED submitted that there is no procedural impropriety and efforts had only been made to bring forth the medical condition of the accused by way of the said independent information and statements under Section 50 of PMLA. The court was also apprised that the order on the plea seeking cancellation of interim bail granted to the accused is pending before the High Court. Amit Katyal was granted interim bail on medical grounds for four weeks in February which was extended. He has been arrested by the ED in land for a job money laundering case. Senior advocate Vikas Pahwa argued on behalf of Amit Katyal. Source: Healthworld

Mar 08,2024 The National Pharmaceutical Pricing Authority (NPPA) has directed Bayer Zydus Pharma, a joint venture between Bayer and Zydus Cadila, to continue production and sales of various strengths and sizes of diagnostic agent Urografin for one more year as against the company’s application to discontinue the scheduled formulations. The drug price regulator, in the recent Authority meeting, considered the request of the company to discontinue four scheduled formulations – Urografin 76% -20 ml, 50 ml, and 100 ml and Urografin 60%-20 ml under Form IV as per the Drugs (Prices Control) Order, 2013. The Authority directed the company to continue production of these formulations till February 28, 2025, extending the order it has issued in January, last year. In the latest decision, the Authority asked the company to ensure that the production is not reduced by more than 25 per cent of the production level at the time of discontinuation application. The Authority, in January 11, 2023 directed the company to continue import or production and sale of these formulations till February 29, 2024. It may be noted that the meeting of the Committee on Discontinuation under the Authority, held on December 6, 2022 also recommended to invoke Para 3 in the matter for further one year considering the substantial market share of the formulation and large public interest. The Para 3 of DPCO, 2013 comprise directions to manufacturers of active pharmaceutical ingredients (API) or bulk drugs or formulations, under which the government may direct any manufacturer of any API or bulk drug or formulation to increase the production and to sell such ingredients to other manufacturers and to sell the formulations to institutions, hospitals or any other agency. “The Authority deliberated upon the matter in detail and decided to re-invoke Para 3 of DPCO, 2013 to direct Bayer Zydus Pharma to continue the production and sales of the subject scheduled formulations (i) Urografin 76%-20 ml (ii) Urografin 76%-50 ml (iii) Urografin 76%-100 ml and (iv) Urografin 60%-20 ml for a period of one year i.e. up to February 28, 2025 and to ensure the production is not reduced by more than 25 per cent of the production level at the time of discontinuation application,” said the Authority in its latest meeting. According to Bayer, the drug Urografin solution for injection is a contrast agent which contains iodine, used to clearly show the area of the body of the patient that the doctor requires to investigate, on x-rays. It is also used with CT Scanners and during angiograms in cardiac catheterisation procedures to assist the doctor, it says. Bayer Zydus Pharma is focusing on prescription products especially for cardiology and women’s health care and on specialty therapeutics in oncology, haematology and ophthalmology. The synergy between the partners is that Bayer brings in novel products and international standards of administration and sales, while Zydus Cadila brings in its marketing and sales expertise as well as distribution network. Source: Pharmabiz

Mar 11,2024 The Drugs Technical Advisory Board (DTAB) has recommended affixing bar code or quick response (QR) code on all vaccine products, as part of obtaining the benchmarking maturity levels required under the upcoming World Health Organisation (WHO) Global Benchmarking of vaccines. It also recommended that the tracking mechanism be extended to all antimicrobials, and narcotic and psychotropic substances in a phased manner. The recommendation comes at a time when the Indian drug regulator is preparing for the WHO benchmarking, which is a process of assessment of National Regulatory Authority (NRA) based on Global Benchmarking Tools (GBT) done by a team from WHO. Global Benchmarking of vaccines is the tool followed by WHO that involves the implementation of various regulatory functions at relevant institutes of India including CDSCO as NRA. In India, the last NRA assessment was carried out by WHO in the year 2017. As a prerequisite of WHO prequalification programme of vaccine, the Organisation has communicated for benchmarking of Indian NRA and the Central Drugs Standard Control Organisation (CDSCO) and the State regulators in near future and the regulators has to prepare for the same at the earliest. A DTAB meeting held in January, this year, observed thawt marketing surveillance and control is one of the important function amongst the nine functions of WHO Benchmarking tool audited by WHO NRA assessment team and one of the indicator is regarding the legal provisions or regulations exist in the country for placement of product’s unique identification number (UIN) on its outer packaging. The Maturity Level 4 of the marketing and surveillance standards under GBT requires the NRA to make legal provision or regulations for affixing of UIN on outer packaging of each vaccine product. “DTAB deliberated the matter and agreed for the proposal to affix Bar Code or Quick Response Code on all vaccine products. Further the same may be extended to all antimicrobials, narcotic & psychotropic substances in a phase wise manner,” said the Board after the latest meeting. The Board also recommended that implementation of the existing system of QR code in the states for top 300 brands shall also be monitored. It may be noted that the government has already mandated affixing QR code on labels of 300 brands of different products through a notification in November, 2022 and it was implemented from August 1, 2023. “The manufacturers of drug formulation products as specified in Schedule H2 shall print or affix bar code or quick response code on its primary packaging label or, in case of inadequate space in primary package label, on the secondary package label that store data or information legible with software application to facilitate authentication,” said the notification. The list of 300 brands which has the QR code include seven vaccine brands including Pfizer’s Prevnar 13 injection 0.5 ml, Panacea Biotec’s Easy Six Prefilled Syringe 0.5 ml, GlaxoSmithkline Pharma’s Varilrix injection 0.5 ml, Synflorix injection 1, and Infanrix Hexa injection 0.5 ml, and Sanofi India’s Menactra injection 0.5 ml and Hexaxim injection 0.5 ml. However, to fulfil the requirements of sub indicator 1.05 of function “Marketing Surveillance and Control”  under Global Benchmarking Tools for Maturity Level 4, it is required to make legal provision/regulations for affixing of unique identification number on outer packaging” of each vaccine product, observed the DTAB. Source: Pharmabiz

Mar 13,2024 The Drugs Controller General (India) (DCGI) has directed the state drug regulators in the country to cancel the product permission granted by them for manufacturing and marketing of certain antibiotic drug combination meropenem and disodium EDTA for injection since it is a new drug and needs approval from the Centre also. DCGI Dr Rajeev Singh Raghuvanshi said that it has come to the notice of the Central Drugs Standard Control Organisation (CDSCO) that some manufacturers are involved in manufacturing and marketing of unapproved drugs which is not yet approved by his office for manufacturing or marketing in the country and falls under the category of new drug. “No new drug shall be manufactured for sale unless it is approved by the licensing authority as defined in Rule 3 of New Drugs and Clinical Trial Rules, 2019,” said Raghuvanshi in a communication to all State and Union Territory drug controllers. As per Rule 80 of the New Drugs and Clinical Trial Rules (NDCTR), 2019, a person who intends to manufacture new drug in the form of active pharmaceutical ingredients or pharmaceutical formulation, as the case may be for sale or distribution, shall make an application for grant of permission to the Central Licensing Authority in Form CT-21 along with a fee as specified in Sixth Schedule. “…you are hereby directed to convey the matter to all the manufacturers under your jurisdiction and cancel the product permission granted by you of the subject drug,” said the DCGI. The necessary information about the status and action taken in the matter may be intimated to the CDSCO at the earliest, he added. According to the online trading portals, the drug combination is sold by a manufacturer as an ultra broad spectrum antibiotic and claimed as effective and well-tolerated for the treatment of infections including bacterial meningitis, lower respiratory tract infections and used in treatment of certain types of cancer.  It may be noted that this is not the first time the national drug regulator takes up the issue of drug combinations and new drugs getting manufactured and marketed in the country without its approval, using the license issued by the state or UT drug regulators. Regulatory experts points towards the issues in proper communication between the regional and central drug regulatory mechanism, among others, as a reason for such mistakes. The Drugs Technical Advisory Board (DTAB) has recently suggested the Drugs Consultative Committee (DCC) to collect opinion from the States in the upcoming meetings on having a single licensing or approval authority in the country. The discussions for a centralised drug regulatory mechanism has been discussed in the past, especially after the incidents where the Indian made medicines such as cough syrups reportedly had an adverse impact and resulted in the death of many children overseas. The drug regulatory experts also suggested that there should be a single national portal where the state drug regulators could update the status of a drug license and quality test results, so that the information would be available to the national drug regulator for any reference. It may be noted that a national effort to take action against irrational fixed dose combinations in the country earlier has brought out the information that several FDCs were approved by the state or UT regulatory authorities without the approval of the Central drug regulator. Source: Pharmabiz

Mar 14,2024 London: The U.S. Food and Drug Administration’s staff on Wednesday raised concerns that it was unclear if Johnson & Johnson and Bristol Myers Squibb ‘s cell therapies would benefit blood cancer patients when given as early treatments. Regulatory approval for the therapies as earlier treatments could expand their use to a larger subset of blood cancer patients who are less sick than those treated with multiple therapies. The therapies – J&J’s Carvykti and Bristol’s Abecma – belong to class known as CAR-T. “I think there is a need for these therapies as patients are relapsing earlier,” said Eric Smith from Boston’s Dana Farber Cancer Institute. FDA’s staffers pointed to a pattern of early deaths in late-stage trials of the therapies, saying that it raised questions over the effectiveness of the treatments in extending the time patients live after receiving them. Carvykti and Abecma are approved by the FDA to treat patients with multiple myeloma who have received at least four prior lines of treatment. J&J partners with Legend Biotech for Carvykti, while 2seventy bio is Bristol’s partner for Abecma. Guggenheim analyst Kelsey Goodwin said the FDA’s stance was harsher-than-expected, but expects both therapies to gain approval. In late-stage studies, both the treatments helped extend the time patients live before their disease begins to worsen. About 8 per cent of trial patients died after receiving Carvykti or Abecma – a proportion higher than those being treated with standard of care therapies. While data for Carvykti does not clearly establish the need for an additional trial, further overall survival data from Abecma may not be sufficient to overcome the risk of early deaths, the reviewers said. J&J said it remained confident in the clinical profile of Carvykti. The meeting of FDA’s independent advisers set for Friday will be closely watched by investors to understand the regulator’s view on CAR-T therapies, after recent safety concerns over the treatments. Source: Pharma

Mar 14,2024 Zydus Lifesciences on Wednesday said it has launched olaparib, a PARP inhibitor, under the brand name IBYRA in India, making advanced cancer treatment accessible to all. PARP (poly-ADP ribose polymerase) is a protein that helps damaged cells to repair themselves. As a cancer treatment, PARP inhibitors block the PARP from doing its repair work in cancer cells and the cell dies. The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach, the company said in a stock exchange filing. The drug will target specific genetic mutations prevalent in certain types of cancers, paving the way for a more tailored and effective treatment approach. To help identify the right patients and facilitate access, Zydus has collaborated with MedGenome for comprehensive HRD testing . This along with a year-long treatment of IBYRA has been capped at Rs. 3 lakhs as compared to the cost of around Rs. 72 lakhs by the innovator. Out of 14 lakh newly diagnosed cancer patients in India, nearly 2.75 lakh patients are diagnosed with breast, ovarian, prostate and pancreatic cancers as per Globocan 2022 data. Amongst these patients, those who are diagnosed as HRD positive or with BRACA mutation need to be administered this PARP inhibitor which can delay the progression of the disease. IBYRA is a next gen targeted therapy for HRD-positive and BRACA-positive cancer patients. Source: Pharma

Mar 14,2024 Mumbai: Emcure Pharmaceuticals recently announced its entry into the over-the-counter (OTC) market with their product Galact. The product has been prescribed by healthcare professionals for more than 20 years to boost breast milk production for lactating mothers. Galact is enriched with the potency of Shatavari and six other herbs. Shatavari is known to enhance a baby’s weight, and sleep pattern, leading to better immunity, while a key ingredient, Yashtimadhu, helps enhance cognitive function, memory, and concentration, thereby assisting in improving a baby’s IQ, stated the company at the product launch event. Interacting with ETPharma, Namita Thapar, Whole-time Director, Emcure Pharmaceuticals, shared that the product has been well received by doctors and patients, which prompted the company to go ahead and bring their product into the market. Since the product is Food Safety and Standards Authority of India (FSSAI) approved, the company didn’t require additional approvals to launch the product over-the-counter (OTC). Thapar further mentioned that they are working on various products they intend to bring to the market, addressing women’s health in due course. She said, “My goal is across the spectrum, from womb to tomb.” She added that they want to be the trusted partner for women across her entire journey for all health conditions. Thapar envisions foraying into the women’s health market in phases, as there are gaps that need to be addressed for women’s health. She highlighted awareness, access, and affordability as the three main factors. She also highlighted that women’s health is overlooked due to various reasons, including the inability of women to speak about their health conditions, have open conversations on women’s health, and the taboos that surround women’s health. These are also the reasons why India is always in the bottom four or five of the World Economic Forum survey every year. This happens because women don’t prioritise their health. Commenting on the challenges that women face while breastfeeding, Thapar mentioned that during pregnancy, more importance is given to the delivery of the child and several other milestones during the nine months. When consulting with gynaecologists and paediatricians, parents don’t discuss breastfeeding; once the child is born, the decision has to be made instantly. Women are not aware of or educated about breastfeeding, which will increase their chances of success, or there is not adequate breast milk to feed the child. There are not enough conversations happening around breastfeeding, and there is not enough information on the same. There is a lot of misinformation and homemade concoctions for improving the quality of breast milk that don’t work. Breastfeeding is only addressed once the child is born and not during pregnancy. Thapar remarked that she is a pro-choice woman and she is not going to sermonise about breastfeeding; the decision to breastfeed solely depends on the mother. Thapar concluded by stating that breastfeeding has several health benefits that improve a child’s immunity and IQ; mother’s milk is best for the child. In women, it reduces the chances of ovarian and breast cancer. Source: Pharma

Mar 14,2024 Pharma lobby groups have welcomed the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) that aims to keep unethical Practices in check. Notification of the code establishes a framework for communication claims, educational activities, samples and other market initiatives within the knowledge-driven pharmaceutical industry, said Sudarshan Jain, secretary-general of the Indian Pharmaceutical Alliance (IPA). “It clearly lays down what activities are permissible and outlines a complaint procedure involving both industry associations and the Department of Pharmaceuticals. Indeed, it is a step forward towards industry advancement, prioritising superior patient care and adhering to established norms,” he said. “We welcome the UCPMP. It is a balanced order that ensures that there is a healthy and ethical engagement between the pharmaceutical industry and medical professionals,” Indian Drug Manufacturers’ Association (IDMA) national president Viranchi Shah said. “It also brings clarity in the domain and has been updated as per current industry practices. The IDMA has always been in favour of ethical marketing practices for its members.” The government on Tuesday notified the new UCPMP. Department of Pharmaceuticals secretary Arunish Chawla told ET that the modified UCPMP has been finalised after due consultations with the pharma associations and lobby groups. “The response of pharma associations has been positive and all honest players in this field and industry want everyone else to play by the rules,” he said. The new code, which is not voluntary anymore but is quasi-statutory, will have to be followed by all pharma companies irrespective of their size. “It will apply to all because the pharma associations covered the entire spectrum. There is the Indian Pharmaceutical Alliance which covers the large companies. Then there is an Indian Drug Manufacturers Association which covers the medium companies, the medium small companies and the OPPI (Organisation of Pharmaceutical Producers of India), which is a very old organisation and covers large companies, particularly companies which are multinational and working in India,” Chawla said. Pharma companies were earlier asked to explain why they need to offer gifts and free medicines as samples to doctors to promote their products, as part of a government’s move to review the regulatory framework on marketing practices in the sector. A high-level committee formed under Niti Aayog’s VK Paul also held meetings with the representatives of pharma lobby groups to review the matter. Members of the OPPI, IPA IDMA attended the meeting on November 4 last year. The panel was formed by health minister Mansukh Mandaviya after reports suggested that companies were spending exorbitantly on promotion of drugs. Source: Pharma