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July 2023

New Import Regulations introduced in Gambia for Drugs – Pre Shipment Inspections – Product Testing related

The Medicines Control Agency (MCA), The Gambia has introduced the regulation of pre- shipment document verification, physical inspection, quality control testing and issuance of Clean Report of Inspection and Analysis (CRIA) for Pharmaceuticals to address issues related to substandard and falsified (counterfeit) medicines entering the country. This regulation requires all imported pharmaceutical products from India to be inspected and tested for conformity of quality standards prior to shipment from India. This is a mandatory process to be followed for all consignments imported into The Gambia from India. The MCA has appointed Quntrol Laboratories Private Limited, an independent verification, inspection and testing company, to carry out mandatory document verification, physical inspection, quality control testing and issuance of CRIA for all shipments. An importer shall in addition require a (CRIA) issued by Quntrol to clear their goods at the ports in The Gambia. Without this mandatory CRIA document, goods will not be accepted in the importation process. Quntrol shall conduct document verification, physical inspection of the consignment and sampling, for laboratory testing for each shipment. If conformity is established at all levels, Quntrol shall issue the mandatory CRIA document. If conformity is not established with regards to quality of the product, the shipment will be quarantined or seized by the MCA andthe necessary regulatory actions shall be taken. The regulation will be implemented from 1% July 2023. All shipments arriving in The Gambia with bill of lading dated on or after 1% July 2023 will be required to provide the CRIA for customs clearance at the ports of entry in The Gambia. Thursday 15th June 2023 Source: Medicines Control Agency

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Spices from India recalled; FDA issues import detention notice

The FDA has analyzed samples of three products, Everest Garam Masala, Everest Sambhar Masala, and Maggi Masala ae Magic, and the results showed the products were contaminated with Salmonella.  The products were manufactured in India and are not labeled for distribution in the United States. All three products were imported to the United States and the products were distributed to retail stores in Georgia, North Carolina, Ohio, Maryland, Tennessee, Texas, Mississippi, Florida, Virginia, New Jersey, and New York starting on March 16, 2023.  Amin Trading LLC initiated a recall on June 1, 2023, after test results showed the products were contaminated with Salmonella. All remaining product on hand with the recalling firm was destroyed under FDA supervision. Additional details regarding the recall can be found in the FDA’s Enforcement Report. There is concern that consumers may have the products on hand in their homes because of the long shelf life of spices. Consumers should not use the products and should throw them away, according to the warding from the Food and Drug Administration. No illnesses have been confirmed to date in relation to the products. The products can be identified by the following information Amin Trading Agency LLC purchased these spices, not labeled for distribution in the United States, at retail stores in India, and imported and subsequently distributed in the United States. The FDA has contacted the manufacturer of Maggi Masala ae Magic and they are investigating the situation. The foreign manufacturer of the two products, Everest Garam Masala and Everest Sambhar Masala, has been contacted and has issued a recall notice. The FDA has subjected the products to “Detention Without Physical Examination Of Food Products Due To The Presence Of Salmonella” under Import Alert #99-19. Friday, June 30, 2023 Source: FSN News

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US telemedicine platform ‘Drs.OnCalls’ enters India to offer consultation with doctors globally 24×7

Drs.OnCalls, a leading telemedicine platform based in the United States, has announced its strategic expansion into the Indian market. Having successfully established its presence in multiple countries, Drs.OnCalls brings a wealth of expertise and experience to India’s growing telemedicine sector. The company is committed to providing convenient, accessible, and high-quality healthcare services to individuals across the country. Drs.OnCalls distinguishes itself as the first telemedicine app in India to offer global real-time consultation services 24×7. Patients now have the facility to receive medical guidance from renowned experts worldwide, transcending geographical constraints and extending the availability of high-quality healthcare. This ground-breaking feature unlocks a multitude of possibilities, empowering patients with access to advanced medical expertise regardless of their geographic location. Founded by Mary Gorder in partnership with “Vichara Technologies’, a top wall street IT solutions expert, Drs.OnCalls platform leverages cutting-edge technology developed in collaboration with top healthcare specialists. Mary Gorder, founder & CEO, Drs.OnCalls, said, Our telemedicine solutions in India, aim to connect patients with top healthcare experts worldwide, round the clock. Our dedication to quality, accessibility, and innovation will transform healthcare delivery, empowering patients to make informed decisions about their well-being. We are committed to forging strong partnerships and collaborating with local stakeholders to create a lasting impact on the healthcare landscape in India”. The company provides seamless healthcare support anytime through its friendly app allowing users to connect with healthcare professionals around the clock. This ensures that individuals have continuous access to medical assistance, regardless of the time or location. To set up its footprints in India, Drs.OnCalls will execute targeted marketing campaigns to enhance awareness of its telemedicine services. They will actively pursue collaborations with local healthcare providers, hospitals, clinics, government agencies, and diagnostic centres to expand their network and offer comprehensive healthcare solutions, ensuring seamless integration and maximizing its impact on the Indian healthcare system. Friday, July 7, 2023 Source: pharmabiz.com

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South India’s premier pharma expo ‘Pharmac South’ to be held at Chennai Trade Centre on July 14 and 15

The pharma B2B event hosted by the Indian Drug Manufacturers’ Association Tamil Nadu chapter (TN IDMA) every year in Chennai will be held at the Chennai Trade Centre on July 14 and 15 this year with participation of a wide range of stakeholders of the sector. The business to business event ‘Pharmac South’ is the eighth in the series, but this year it coincides with the launch of the pharma cluster project (Tindivanam Pharma Park) of the Tamil Nadu government. The government on June 5 invited applications from the industry players for the allotment of land. More discussions on the project will be held at the seminars to be conducted as part of the Pharmac South expo, organizers informed.    While briefing Pharmabiz about the event, the chairman of the TN IDMA, J Jayaseelan said the expo is organized mainly to support the industries of drug manufacturing, API manufacturing, cosmetics and neutraceuticals to open up new market opportunities with the big players and pharma giants in the country. The event will showcase the latest innovations of pharmaceutical products, machineries, medical devices and new drug discoveries in addition to the display of latest industrial techniques. According to him, this year’s Pharmac South will be a unique platform for sharing knowledge, experiences, research & developments and other breakthroughs in the pharma sector for all the stakeholders in the industry. The trade fair will enable the MSME units in Tamil Nadu to reach out to hundreds of key industry stalwarts and potential customers from different parts of the country at one place. Jayaseelan said the health secretary and the MSME secretary of the Tamil Nadu government are also part of this year’s Pharmac South expo, so that the participant exhibitors will get chances to share their concerns with the government. Further, the entrepreneurs who want to invest in the pharma park project at Tindivanam can interact with the project officials and clear their doubts. In the presence of the government secretaries, this year’s pharma expo will be inaugurated at 10 am on Friday, followed by a seminar on sale strategies and B2B development will be held. In the afternoon, the motivational speaker, Swami Sukhabodananda from Benglauru will address the industry leaders and other participants of the event. The chairman of the Pharmaceuticals Export Promotion Council (Pharmexcil) Dr. SV Veeramani will preside over the inaugural session. Saturday, July 15, the program will start with a CEO Talk. A chief operating officer of a multinational pharma giant from Mumbai will deliver a speech on ‘how to make a successful B2B development in pharma’ at 10.30 am and followed by it a marketing conclave will be held. A seminar on exports will be held in the afternoon. K Sivanandan, organizing secretary of the TN IDMA said more than 200 exhibitors have already booked their stalls and this year 7,000 visitors are expected from all the south Indian states. He said Pharmac South is the premier high-powered pharmaceutical, neutraceutical and contract manufacturing exhibition in south India. Monday, July 10, 2023 Source: pharmabiz.com

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Import of medical devices to India declines 3.3% in 2022-23

Imports of medical devices to India have registered a slight decline of 3.3 per cent during the financial year 2022-23 as compared to the previous year, with the imports from China declining almost 20 per cent. The imports of Covid-critical medical devices has seen a significant fall during the financial year, resulting in the overall decline in imports. According to data from the AiMeD, the umbrella Association of Indian Medical Industry covering all types of medical devices including consumables, disposables, equipment’s, instruments, electronics, diagnostics and implants, the medical devices imports to India stood at Rs. 61,179 crore during 2022-23, as compared to Rs. 63,276 crore during 2021-22. However, this is the second highest imports in the last five years starting from 2018-19, following the highest imports in these five years reported in 2021-22. In 2018-19, the imports were at Rs. 40,915 crore, which grew to Rs. 41,709 crore in 2019-20, and to Rs. 44,759 crore in 2020-21. Imports from China declined almost 20 per cent to Rs. 10,397 crore in 2022-23, as compared to the highest imports of Rs. 12,979 crore during the year 2021-22. The decline was owing to the drop in Covid-19 critical medical devices and the impact of Public Procurement Order (PPO) promoting the Make in India move by the government, said Rajiv Nath, Forum Coordinator of AiMeD. Imports of thermometers have declined more than 91 per cent from Rs. 1,480 crore in 2021-22 to Rs. 130 crore in 2022-23. Similarly, imports of oxygen therapy equipment fell 87.4 per cent from Rs. 1,975 crore to Rs. 248 crore, examination gloves 78.54 per cent from Rs. 2,275 crore to Rs. 488 crore, diagnostic test kits 41.56 per cent from Rs. 3,850 crore to Rs. 2,250 crore, and oximeters from Rs. 1,200 crore to Rs. 800 crore during the respective period. However, imports of ophthalmic surgical equipment (from Rs. 100 crore in 2021-22 to Rs. 1,500 crore in 2022-23), MRI (Rs. 1,400 crore to Rs. 2,200 crore), Surgical Instruments (from Rs. 900 crore to Rs. 1,200 crore), Artificial joints (from Rs. 950 crore to Rs. 1,400 crore), Intraocular lens (from Rs. 1,080 crore to Rs. 1,780 crore), and Cochlear implants (from Rs. 400 crore to Rs. 600 crore), reported a growth during the period. While imports from China have declined, the imports from the other top five countries from where India imports medical devices has reported a growth during the year 2022-23 compared to the previous year. Imports from the USA, Germany, Singapore and Netherlands, the top four other source countries, have registered the highest imports in the last five years, during the fiscal 2022-23, according to the data. Imports from the USA grew 16.7 per cent to Rs. 11,350 crore in 2022-23 from Rs. 9,724 crore in 2021-22. Imports from Germany reported a growth of 15.86 per cent to Rs. 6,411 crore as compared to Rs. 5,533 crore during the previous fiscal year. Imports from Singapore grew 26 per cent to Rs. 6,275 crore in 2022-23 as against Rs. 4,981 crore in the corresponding period of previous year. Imports from Netherland stood at Rs. 3,322 crore as against Rs. 2,451 crore during the comparable period, with a growth of 35.53 per cent. The various initiatives from the government including the National Medical Devices Policy (NMDP), 2023, the Production Linked Incentive Scheme, MedTech Park Schemes, the Indian Certification for Medical Devices by Quality Control of India (India), price caps on stents and knee implants, duty increase of five per cent on some devices as a cess for NHA, among others are part of the Make in India achievements in the sector, said Nath. Monday, July 10, 2023 Source: pharmabiz.com

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DCGI in talks with global consultants to rationalise drug regulations to ensure quality

In order to achieve quality, compliance and patient safety, the Central Drugs Standard Control Organisation (CDSCO) is rationalising the drug regulations in consultation with global regulatory experts. This, according to the Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi, will be done towards ease of doing business and developing a quality culture. Speaking on the sidelines of a panel discussion on Quality, Compliance and Patient Safety at the 9th International Pharmaceutical Exhibition (iPHEX) in Hyderabad, the DCGI said this is very much required as the pharma industry is projected as a US$ 500 billion opportunity by 2047. The event which was hosted by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry began on July 5 and concluded on July 7, 2023. “Regulations need to be designed in such a manner that it serves the purpose of quality for both big pharma and MSMEs. It has been observed that the compliance to drug regulations have been optimal for big pharma and sub -optimal for MSMEs. Besides that, it has also been observed that there has been non-uniformity in terms of interpretation and implementation of the law. Therefore, MSMEs will be supported by the CDSCO towards upgradation of skills to achieve global industry standards,” the DCGI said. “Creating a balance in terms of implementing the law is a challenge as the country’s compliance requirements are huge considering the size of the industry and the country. This is also very much required as India is witnessing and implementing global regulatory harmonisation with active participation of the US, Europe and Japanese pharmacopeias,” Raghuvanshi added. He further said that India story will continue to shine if we allow MSMEs also to move up the value chain by bringing in quality manpower and setting quality management systems (QMS). “In order to create an ecosystem of quality, the Indian Pharmacopoeia Commission (IPC) has developed Adverse Drug Reaction (ADR) reporting form as a part of the Pharmacovigilance Programme of India (PvPI) to effectively report adverse events due to the usage of a medicinal product. Over the past ten years of inception of PvPI, it has generated 13 signals which is big milestone to achieve and hundreds of drug alerts,” Raghuvanshi informed. Lakshmi Prasanna, director, Regulatory Affairs, Pharmexcil conducted the proceedings of the event. Monday, July 10, 2023 Source: pharmabiz.com

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Indian pharma industry to reach $57 billion by FY 25: CareEdge Ratings report

The Indian pharmaceutical industry is expected to grow at 7-8 per cent in FY24 to FY25 with prospects to reach $57 billion by FY25, after registering a Compound Annual Growth Rate of 6-8 per cent during FY18 to FY23, according to CareEdge Ratings. In a latest report, the knowledge-based analytical group said that the Indian pharma industry has grown from $35.41 billion in FY18 to $49.78 billion in FY23 and is likely to reach $57 billion by FY25. Globally, the Indian pharma industry has a strong footprint in the generics segment and the pharma exports and domestic market contribute equally to the overall Indian pharma industry. The growth during FY18-FY23 was contributed by 8% growth in exports and 6% growth in the domestic market during the same period. “The Indian pharma industry is expected to see a growth of around 7% to 8% over FY24-FY25 while the operating profitability of formulation companies to improve to around 23-23.5% and that of APIs/bulk drug companies to improve to around 19-20% during the same period,” said Krunal Modi, associate director at CareEdge Ratings. “The Indian pharma sector is expected to grow at a steady pace in the medium term due to structural factors such as ageing of the population, rising lifestyle or chronic diseases, healthcare awareness and insurance penetration apart from increasing government spending under various schemes,” said Modi. Further, changing world demography along with complex and specialty generic products are expected to drive the export growth of Indian pharma companies. The export growth would also be supported by patent expiry in regulated markets. Going forward, CareEdge Ratings expect higher export growth rates for emerging markets compared to growth rates of developed markets, it added. The Indian pharma market grew by nearly 5% on a year-over-year basis to $49.78 billion in FY23. The exports grew by just 3% while the domestic market continued to grow at a healthy rate of 7% in FY23 over FY22. Within exports, the emerging markets were largely flat while the developed market registered a growth of around 8% in FY23 on a y-o-y basis. The exports to emerging markets were impacted due to the Russia-Ukraine war and a shortage of foreign currency in many African countries apart from the significant depreciation of their local currencies. Regulatory headwinds and consequent lower ANDA approvals are likely to constrain the exports to developed markets. However, increasing focus on synthesis segment, complex and specialty products apart from easing of pricing pressure in US generics are likely to support the growth in the medium term. The US holds a prominent position as one of the largest export destinations for the Indian pharma industry, accounting for approximately 30-35% of total formulation exports. In recent years, the US generics market has experienced significant price corrections due to the consolidation of buyers and distributors. Despite these challenges, CareEdge Ratings has observed a notable increase in US export sales volumes, with expectations of sustained growth driven by upcoming patent cliff opportunities, said the report. In FY23, formulation exports to the US recorded a growth of 5.9%, primarily supported by sales volume growth of around 16%. However, this growth was partially offset by a price erosion of around 10-11%. The pricing erosion in the US generic market has eased to low single digit, a significant improvement compared to the high double-digit erosion witnessed in the past two years. “Looking ahead, there are substantial opportunities on the horizon, as approximately $188 billion worth of drugs worldwide are set to go off-patent during the period from Calendar Year 2023 to Calendar Year 2026. This presents a favourable landscape for the Indian pharma industry to capitalize on these patent expirations and expand its market share,” it said. During FY23, the Indian pharma exports stood at $25.39 billion which includes APIs/bulk drug exports of $5.32 billion. After witnessing sharp rise in APIs/bulk drug exports during FY21 due to Covid-19 led supply chain disruption in China, the exports of APIs/bulk drugs have remained subdued during FY22 and FY23. The export of bulk drug/APIs is likely to grow at around 5-6% over FY24- FY25; in-line with its historical average, it added. Despite sustained pricing pressures in the US generics market, formulation companies could sustain their margins to around 22% in FY23 due to focus on complex and specialty products. The operating margin of APIs/bulk drugs companies declined by nearly 170 bps on a y-o-y basis and stood at around 18% in FY23. CareEdge Ratings expects the growth in FY24-FY25 would be supported by 6% to 7% growth in exports and 8% to 9% growth in the domestic market during the same period. The credit profile of Indian pharmaceuticals companies in general has remained stable historically, due to their strong profitability and lower reliance on debt which is likely to continue. During the pre and post-Covid periods, the Indian pharmaceutical industry experienced significant changes in its operating profitability (PBILDT) margin. In FY21, due to the Covid-19 pandemic restrictions, there was a noticeable reduction in marketing, travelling, and conveyance expenses. Coupled with increased sales opportunities related to Covid-19, this resulted in a substantial increase in operating margins for the industry. However, the subsequent years, FY22 and FY23, presented new challenges for the pharma sector. Elevated input prices, rising freight costs, extended delivery timelines, and competitive pressures in the US generics market led to a moderation in operating margins. “As we look ahead, there are positive signs for the industry. Raw material prices are stabilizing, freight rates are normalising, and pricing pressure in the US generics market is easing. These factors are expected to contribute to an expansion of operating margins by approximately 100 to 150 basis points over FY24-FY25 compared to FY23. Furthermore, the industry’s continued focus on launching specialty and niche products in the US market is anticipated to provide further support to the profitability,” it added. Tuesday, July 11, 2023 Source: pharmabiz.com

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SaSPinjara sees Indian pharma needs ample guidance for China market entry going by regulatory approval challenges

SaSPinjara Life Sciences, the technical and business consultation provider for the pharma business in the global market, now sees that for Indian companies, China regulation is still very complex. Only companies with experience in the Chinese market have a certain advantage. It will take at least five years from the establishment of a joint venture to the final launch of the product, as drug approval takes three years. Indian companies also need to develop drugs targeting the Chinese market, which is another challenge, said Sachin Marihal, co-founder and chairman, SaSPinjara Life Sciences. India’s top pharmaceutical companies have always regarded the United States as their main market and have been unable to open up trade in China for a long time, with government regulation being the biggest obstacle, he added. Agreeing with Marihal was Aravind P, chief technical officer, SaSPinjara Life Sciences who said that even after policy reforms by the Chinese regulatory authority, still companies from India face  challenges in registering into this market, as compared to the US and EU regions. China is currently a semi mature market compared to the United States.  Indian multinational pharmaceutical companies, entering the Chinese market now have a great opportunity. This is because a wide basket of medicine portfolio has entered the list of volume based centralized procurement in China, Marihal told Pharmabiz. There is a huge market potential in China. To this end, Pharmacodia Global Data base has initiated its state-of-the-art incubation center in China, which will help to provide land, ready facility, investment, government funding, market access, regulatory access, joint venture opportunity and all related support to international companies for better long-term strategy growth, noted Aravind. Currently, Saspinjara has positioned itself as a channel partner to enter China and has just opened business avenues for Indian pharma. The company has been in discussions with a couple of Indian pharma companies during the recent CPhI Shanghai 2023 held in mid-June to help them better understand China market, investment, regulatory, disease mapping and related access strategy. On how interested Indian pharma companies would be keen to invest in China with the ongoing Union government’s Make in India programme gaining momentum, Marihal and Aravind noted that the support provided varies in different regions of China. It is important to ensure that the interests of foreign investors are protected. This includes establishing a mechanism for optimizing the legal protection of the business environment, actively creating a fair market for domestic and foreign companies to compete.  There is need to ensure that foreign-invested enterprises have equal access to production factors such as human resources, capital, land use rights, and natural resources in accordance with the law, and participate in market competition fairly, they added. Compared to other regulated markets, China is the most stringent in regulations for pharmaceutical products and volume of products requirement is also high.  There are many different business models where several opportunities are available for foreign companies to utilise. Here the Pharmacodia Global platform can help companies to enter China, said Marihal and Aravind. Tuesday, July 11, 2023 Source: pharmabiz.com

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USP sets up a programme unit team on excipients with a mandate for fiscal 2024 on specific areas of DEG and EG

The United States Pharmacopoeia (USP) has set up a programme unit team on excipients with a mandate for fiscal 2024 on the specific areas of di-ethylene glycol (DEG) and ethylene glycol (EG). The plan envisages contributing in testing excipients and also helping enhance criticality of testing methods in collaborations with USP headquarters in the US. This comes close on the heels of the Central Drugs Standard Control Organization (CDSCO) office conducting massive risk-based inspections pan-India following the World Health Organization (WHO) holding Indian pharma companies accountable for exporting contaminated cough syrups in Gambia and Uzbekistan due to the presence of excipients like DEG and EG in the cough syrups. “Excipients have a direct correlation with patient safety so it becomes very important to test excipients. Traditionally, excipient testing was done keeping in mind the end use in the drug product but that has changed over the past several years. So ideally it should not be tested into the end product but it has to be built in the end product. Quality by Design (QbD) is the way to go when you formulate a particular product so that one can counter and mitigate the risks involved considering that excipients have a lot of functional role to play in several drug products,” said Girish Kapur, vice president (VP), India Site Operations and Site Head, USP on the sidelines of the 9th International Pharmaceutical Exhibition (iPHEX) held in Hyderabad organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil) with support from the Union commerce ministry between July 5 and July 7, 2023. “USP as a standard setting organization realized this change and the dedicated expert committees on excipients now focus on excipient characterization, excipient variability, performance and the composition as well. USP has several general chapters which very well elaborate on how you can test different excipients in the lab. Besides this, there are 500 plus excipient monographs in the National Formulary (NF). NF has the maximum number of monographs and more than 60% of them have physical reference standards as well,” informed Kapur.  He further added that Covid has taught us the importance of supply chain. Given that the excipient supply chain is very complex and now with the advent of complex generics in the pharma industry, more excipients which will now be novel and not the regular ones like starch, CMC and HPMC among others. This will make the supply chain more vulnerable for adulteration. It is also important because we will use the excipient in the drug product and this will eventually affect the drug quality. “USP is very well integrated with its US counterparts with a big lab set up in Hyderabad in India. As a standard setting organisation, USP believes that the public standard setting process has to be based on a robust public input system which can give feedback on monographs published in the USP and the NF. The standards in USP-NF are used to help ensure the quality of medicines and their ingredients, and to protect the safety of patients. USP is an official quality standard for medicines marketed in the US,” Kapur informed. USP–NF is a combination of two compendia, the United States Pharmacopoeia (USP) and the National Formulary (NF). Monographs for drug substances, dosage forms, and compounded preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. “Excipients form 90% of the dosage forms available in the market. The role of excipients is very important as they impart a lot of physical characteristics to the drug product in terms of flowability, compressibility, disintegration and controlling the drug release in the product. In some cases, they also influence the organoleptic properties like taste and texture among others. These are the important parameters for evaluating the drug product which is sold in the market,” Kapur concluded. Tuesday, July 11, 2023 Source: pharmabiz.com

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Delhi HC refuses to grant interim injunction in favour of Bayer Healthcare in patent dispute over regorafenib

The Delhi High Court has refused to grant interim injunction in favour of Bayer Healthcare LLC in a patent litigation against Natco Pharma and MSN Laboratories in which the former has sought interim injunction against the two Indian companies from infringing the patent rights of its anti-cancer drug regorafenib, branded in India as Nublexa and Resihance. The Court, considering the arguments, took public interest into consideration and noted the price difference between the patented product and the products from the Indian generic firms, and also that a genus patent technically covering the compound has already expired patent protection in the country, while rejecting the application for interim injunction. The drug, which is branded as Stivarga in countries such as United States, European Union, China and Japan, is an oral, prescription anticancer medication approved by the US Food and Drug Administration (FDA) for people with cancer such as colon or rectal cancer, a rare stomach, bowel or oesophageal cancer known as gastrointestinal stromal tumour (GIST) and a type of liver cancer called hepatocellular carcinoma. Bayer Pharmaceuticals, the Indian affiliate of Bayer Group, has obtained an import license on June 1, 2014 and has been selling the regorafenib under the brand names Nublexa and Resihance in India since 2015. Bayer claimed that it has a patent for the compound with a validity for 20 years from July 22, 2004. The company also had a genus patent approved for carboxyaryl substituted diphenyl ureas, covering a vast number of compounds and this expired in January 12, 2020. While regorafenib is not specifically disclosed in the genus patent by way of either chemical name, formula, or chemical structure, it is technically covered within the generic scope of the numerous compounds included in the Markush Formula disclosed in the patent, it said. Natco and MSN Labs argued that the patent under dispute is already disclosed in the genus patent as the salts and the compositions and Bayer had prior knowledge of the compound regorafenib at the time of filing of the genus patent. They argued that the company deleted many compounds including regorafenib while amending its description of IN ‘758, due to which the said compounds entered into the public domain. They argued that regorafenib being disclosed in the patent IN ‘758, which expired on January 12, 2020, any corresponding protection to the compound also expired on the same date and no injunction can be granted against Natco and MSN Labs. The Court, after hearing both the sides, observed that Bayer, having admitted that the patent under dispute is covered by the genus patent – though qualifying such admission by use of the world “technically” – whose term has admittedly expired, at least prima facie is not entitled to an interim order at this stage. “The public interest would also demand that such injunction be refused inasmuch as it is claimed that there is a huge disparity between the price of the product offered by the plaintiff (Bayer) and the defendant (Natco and MSN Labs) for a disease which is life threatening,” said Justice Navin Chawla in an order on July 5, 2023. In the present case, Bayer is selling their product at the range of Rs. 36,995 by importing the same into India, whereas, the defendants are manufacturing the product in India and selling the same at a cost of Rs. 9,900. “Undeniably, the products of the defendants are significantly cheaper than that of the plaintiffs. Public Interest would demand that large segments of population should have relatively easier and affordable access to an anti-cancer drug, which could be the difference between life and death for certain patients. Taking into account the nature of the disease and the drug it seeks to provide relief from, affordability plays a major role in its access to wide sections of the public. Therefore, it would not be appropriate to injunct the defendants from selling the said product, especially when a creditable challenge to the patent has been laid and the plaintiff has already enjoyed protection for its full term for IN ‘758, that is, the genus patent,” said the Court. In order to maintain the balance of convenience, the defendants were directed to maintain complete accounts of manufacture and sale of the products with the subject patent and file statement of accounts, on affidavits on a half yearly basis before the court. Tuesday, July 11, 2023 Source: pharmabiz.com

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