Andrey Stepaniuk’s Post

Will pakistan be able to increase their pharmaceutical share to the 1/3rd of indian pharmaceutical? Major challenges includes: - #DRAP lack of commercial understanding hinders exports - #Liquidity issues restrict #international_marketing - Protective duty on APIs makes Pakistani medicines uncompetitive - Unstable supply chain and raw material procurement - Government support crucial for #growth What one strategy would you implement to address regulatory, liquidity, and supply chain challenges? #pharmaceuticalexports #Pakistan #govtofpunjab #healthcare

Expedite decision on anti-dumping duty on substandard IPA import from China: Pharma Experts "The unchecked dumping of underpriced, substandard IPA from China threatens India's efforts towards Atmanirbhar Bharat. Local producers struggle to compete, risking our production capacities and self-reliance on essential pharmaceutical supplies," said Vikas Biyani, an expert in FDA regulatory compliance and manufacturing of injectables. #Chinaimports I #IPA I #DGTR_investigation I #IsopropylAlcohol I #anti_dumping_duty I #domesticproduction I #AtmanirbharBharat Read more: https://lnkd.in/gweVprJj

Alert: German Pharmaceutical Industry Association warns of potential API shortages. As per yesterday’s Euro news German pharmaceutical industry association (BPI - Bundesvergand der Pharmazeutischen Industrie) has raised a red flag over possible drug shortages following recent tightening of espionage laws in China. As China plays a crucial role in the global supply chain for active pharmaceutical ingredient (API), these new regulations could impact the availability of essential medications. Several German states have now cancelled routine quality-control trips to China by their inspectors as they're concerned, they could fall foul of the over tightened espionage law. The states say they can no longer guarantee the safety of their inspectors on visits to Chinese pharmaceutical factories. Some API certificates have already expired or near expiry. In Germany, most of API, especially, antibiotics import from China, according to BPI. Several foreign organisations have requested for more clarity over revisions to the law, particularly on what data is safe for foreign businesses to collect. Source of Information: Euro news. Key Impacts: Regulatory Impact: Could affect API export because of API certification expiry. Supply Chain Risks: Potential shortages may lead to delays and increased costs. Strategic Response: Companies need to explore alternative sourcing and enhance supply chain resilience. #PharmaIndustry #API #APISupply #China #Healthcare #GlobalHealth #Export #Import #Pharmaceuticals #IndustryAlert #SupplyChain #Espionage #Anti #Bill #Germany #Europe #Import

What are the requirements for exporting medicines from India? Exporting medicines from India involves compliance with stringent regulations and processes to ensure product safety and quality. The first step is obtaining a valid Drug Manufacturing License under the Drugs and Cosmetics Act, 1940. Additionally, exporters must register with the Directorate General of Foreign Trade (DGFT) and obtain an Import-Export Code (IEC). Exporters need to acquire Good Manufacturing Practice (GMP) certification, which guarantees that the medicines are manufactured following globally accepted quality standards. Another essential document is the Certificate of Pharmaceutical Product (CoPP) issued by the World Health Organization (WHO). It ensures that the medicines meet the regulatory requirements of the importing country. Additionally, a No Objection Certificate (NOC) from the Central Drugs Standard Control Organization (CDSCO) is mandatory for exporting certain medicines. The exporter must also comply with the importing country’s specific guidelines, including labeling, documentation, and packaging standards. Furthermore, exporters should ensure the medicines are listed under the HS Code for proper customs classification. With rising global demand for Indian pharmaceuticals, adhering to these requirements ensures seamless export while maintaining international standards. https://lnkd.in/gig4MtSD For more information, visit us on: https://lnkd.in/gm8ptJR4

Bangladesh's local pharmaceutical companies have thrived on producing low-cost generic drugs, meeting the country's pharmaceutical needs without relying heavily on imports. However, their export growth has been slow, with only a few countries contributing significantly to their export value. To expand globally, these companies must analyze market data, target specific countries, and tailor their strategies accordingly. Currently, their market share in key importing countries remains low, indicating a need for more focused and data-driven approaches.

In January-July of this year, #Azerbaijan imported $305.4 million worth of #pharmaceutical products. According to Iqtisadiyyat.az, this is 15.6% less than last year. Pharmaceutical products accounted for 2.83% of total imports during the reporting period. During the same period of 2023, Azerbaijan imported pharmaceuticals worth $362 million. Azerbaijan intends to reduce its dependence on imported #medicines by increasing local production. Thus, in March of this year, the board of the Ministry of #Health approved a list of #medications that will be produced in Azerbaijan. Approximately 70 types of #drugs will be produced locally under the decision. Economist Khalid Karimli believes that Azerbaijan's decline in drug imports is not due to increased production, but to the fact that after a surge in demand during the coronavirus pandemic, demand has now declined. “As a result of the pandemic, the state tried to create pharmaceutical stocks, so imports rose between 2020 and 2022. Azerbaijan is no longer in the midst of a drug boom and rush, which is why imports are declining," Karimli told Sputnik Azerbaijan. Furthermore, the expert noted, Azerbaijan can't replace imports through local production, since the country still has a limited capacity to produce medicines. As of now, there is only discussion about investing in this production sector and corresponding enterprises are being formed, according to the expert. A complete replacement of #pharmaceuticalimports with local production, according to Karimli, is also unrealistic in the future; only partial replacement can be achieved. It is also important to note that establishing local production in no way ensures better quality or cheaper products. #CIS; #healthcare

Most developing countries depend on imports for the supply of essential medicines. Many developing countries have been finding it extremely difficult to promote local production. But despite being a Least Developed Country (LDC), Bangladesh has succeeded in developing a pharmaceutical industry. The rise of the pharmaceutical industry in Bangladesh is attributed to the Drug Ordinance of 1982. This created a market for the local firms for simple generic formulations which were earlier imported or manufactured by the foreign firms. Local firms grabbed the opportunity and dramatic growth of the industry led by local firms followed. But manufacturing of active pharmaceutical ingredients was neglected. This did not constrain the growth initially with the availability of cheap supplies from India and then China. But this has emerged as a critical bottleneck today. Bangladesh, as an LDC abolished product patent protection in pharmaceuticals in 2008 and what the 1982 Ordinance did for generic products, the change in the patent regime has been doing for patented products. Bangladesh has introduced to the market a number of patented products at very low prices. This is a significant development. But the traditional sources of APIs, viz., India and China cannot officially export patented APIs to Bangladesh unless permitted to do so. Due to the difficulty of sourcing patented APIs, Bangladesh is unable to enjoy the full benefits of the absence of product patent protection. Some steps have been initiated for the growth of the API sector. For the efforts to succeed, the government needs to be more directly involved in developing the technological base of the industry.

𝐄𝐧𝐬𝐮𝐫𝐢𝐧𝐠 𝐒𝐚𝐟𝐞 𝐚𝐧𝐝 𝐒𝐞𝐜𝐮𝐫𝐞 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥 𝐏𝐫𝐨𝐝𝐮𝐜𝐭 𝐃𝐢𝐬𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧 𝐢𝐧 𝐌𝐚𝐥𝐚𝐲𝐬𝐢𝐚 Malaysia prioritizes public health by enforcing strict regulations for the distribution of registered pharmaceutical products. This system ensures that medications reach consumers safely and effectively, minimizing potential risks through the issuance of licenses. In Malaysia, manufacturers, importers, and wholesalers of registered drugs need NPRA licenses to operate. 𝗪𝗵𝘆 𝗟𝗶𝗰𝗲𝗻𝘀𝗲𝘀 𝗠𝗮𝘁𝘁𝗲𝗿: Licenses ensure products meet quality standards (manufacturers) and are authentic throughout the supply chain (importers & wholesalers). This protects consumers from risks. 𝗚𝗲𝘁𝘁𝗶𝗻𝗴 𝗟𝗶𝗰𝗲𝗻𝘀𝗲𝗱: Apply online via NPRA's QUEST system. Submit documents proving your qualifications and adherence to regulations. 𝗠𝗮𝗶𝗻𝘁𝗮𝗶𝗻𝗶𝗻𝗴 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: Renew licenses annually, update product lists, and keep COAs readily available for NPRA inspections. 𝗕𝗲𝗻𝗲𝗳𝗶𝘁𝘀: Licenses allow legal operation, build trust, and minimize legal risks. 𝗚𝗲𝘁 𝗟𝗶𝗰𝗲𝗻𝘀𝗲𝗱, 𝗦𝘁𝗮𝘆 𝗦𝗮𝗳𝗲: NPRA licenses ensure a safe and secure supply chain for registered products. Contact us today for comprehensive support in your NPRA license application. https://lnkd.in/gWyWbKMS

Pakistan's pharmaceutical industry is significantly contributing to GDP, achieving sales of Rs. 916 billion (USD 3.3 billion) in FY24, marking a 22% year-on-year growth[1][2]. This sector is organized and led by skilled professionals, yet it faces challenges in export facilitation. The government must prioritize collaboration with the industry and reduce heavy taxes on APIs and machinery to foster growth[3][4]. Unlike India and Bangladesh, which have FDA-approved plants, Pakistan needs to enhance its regulatory framework and seek international consultancy for FDA approvals to boost its top manufacturers[5]. DRAP Consultancy Services ServicesDrugregulatory Drugregulatory Export PakZulfiqar OmerSyed Haider AliDr.Aman Ullah Khan Sources [1] Price deregulation: Pakistan's pharma sector sales hit $3.3bn in FY24, 22 ... https://lnkd.in/eWUCdFPJ [2] Pakistan's pharmaceutical industry sees record 22% growth in FY24 https://lnkd.in/enzEaVkq [3] [PDF] PAKSTAN PHARMACEUTICAL SECTOR REPORT - VIS Credit Rating https://lnkd.in/eyznwSKw [4] Pharmaceutical industry in Pakistan - Wikipedia https://lnkd.in/ecfAD7uB [5] Unleashing the Potential of Pharmaceuticals in Pakistan https://lnkd.in/e4-UPFQb [6] [PDF] Pharmaceutical Industry - Pacra.com https://lnkd.in/eRZZuKnJ [7] [PDF] Pharmaceutical - ICAP https://lnkd.in/euK5N8-C [8] Pharmaceuticals - Pakistan | Statista Market Forecast https://lnkd.in/eh6iAr5h .

🌍 India's Pharmaceutical Export Growth: A Strong Start to 2024 Exciting news for the Indian pharmaceutical industry as it kicks off 2024 with robust export growth! 🚀 1. Exports Surge: India's pharmaceutical exports are expected to reach $27 billion in FY24, marking a significant increase driven by a rising demand for generic drugs, vaccines, and biosimilars globally. 2. Government Support: The Indian government is set to enhance its Production-Linked Incentive (PLI) scheme and provide further tax breaks and funding for innovation. These measures aim to bolster R&D and promote the manufacturing of high-quality pharmaceutical products. 3. Addressing Challenges: Despite regulatory and logistical hurdles, including compliance with international standards and infrastructure limitations, Indian pharma companies are investing in technology and quality improvements to maintain their competitive edge. 4. Future Outlook: With a focus on innovation and quality, the Indian pharmaceutical industry aims to grow to $120-130 billion by 2030, making significant strides in the global healthcare sector. The collaborative efforts between the government and the private sector, along with strategic investments in R&D and infrastructure, are paving the way for sustained growth and leadership in the global pharmaceutical market. I'm always looking to connect with professionals in the pharmaceutical industry for strategic partnerships and how we can work together! Let's collaborate and share insights on supply chain innovations and challenges. Feel free to connect, engage and share your thoughts and experiences on these updates! RAYCE PHARMA #PharmaExports #IndiaPharma #HealthcareInnovation #GlobalMarket #2024Trends #PharmaBuyers #PharmaSuppliers #PharmaProcurement #PharmaSourcing #PharmaDistribution #PharmaLogistics #PharmaNetworking #PharmaTrade #PharmaSales #PharmaWholesale #Globalhealth #Pharmaceuticals #API #Excipients #Intermediates #Export #Import #Buyers #Suppliers #CPHI #Pharmexcil #Health #Logistics #RaycePharma