How to Achieve Effective Cleaning and Disinfection in Controlled Environments A good cleaning and sanitization program is very important in clean areas where pharmaceutical products are manufactured. It is required to stop microorganisms from contaminating the products. Sterile medicines can become contaminated by many things, such as ingredients, process water, packaging materials, the environment, equipment, and even the people working there. The rules called cGMPs (Current Good Manufacturing Practices) focus on having the right size and design of buildings. The materials used in construction and how things move inside the building should make cleaning and maintenance easy. This helps ensure proper and safe drug production. When disinfectants are used in the manufacturing area, care must be taken to make sure they don’t accidentally mix with or harm the medicine, because these chemicals can be toxic. In cleanrooms, the floors, walls, and ceilings should be smooth, nonporous, and easy to clean. The area should also have controls for dust, temperature, and humidity. Regular cleaning and disinfecting are needed to keep the area sterile. The cleaning and sanitization plan must: Meet the required cleanliness levels, Control microorganisms that can spoil the product, Prevent chemicals from getting into ingredients, equipment, packaging, or the final These rules also apply to non-sterile medicines. In those cases, microbial control is done by using the right ingredients, clean equipment, low water content, preservatives, and proper packaging. Apart from disinfectants, antiseptics are used to sanitize skin and body tissue before workers enter clean areas. Sterilants may be used to clean surfaces in the manufacturing and testing areas. Sterilants can also be used to sterilize the medicine itself. UV light may be used to clean surfaces too. Here we can understand how to choose the right disinfectants and antiseptics, how to test if they destroy microorganisms like bacteria, fungi, and spores, and how to safely use them in sterile drug manufacturing. “In GMP environments, precise cleaning and disinfection are critical to eliminating contaminants and ensuring the integrity of pharmaceutical products.” Breaking Down the Classification of Cleaning Agents Antiseptic—An agent that inhibits or destroys microorganisms on living tissue including skin, oral cavities, and open wounds. Chemical Disinfectant—A chemical agent used on inanimate surfaces and objects to destroy infectious fungi, viruses, and bacteria, but not necessarily their spores. Sporicidal and antiviral agents may be considered a special class of disinfectants. Disinfectants are often categorized as high-level, intermediate-level, and low-level by medically oriented groups based upon their efficacy against various microorganisms. Cleaning Agent—An agent for the removal from facility and equipment surfaces of product residues that may inactivate sanitizing agents or harbor microorganisms. Decontamination—The removal of microorganisms by disinfection or sterilization. Disinfectant—A chemical or physical agent that destroys or removes vegetative forms of harmful microorganisms when applied to a surface. Sanitizing Agent—An agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria. Sporicidal Agent—An agent that destroys bacterial and fungal spores when used in sufficient concentration for a specified contact time. It is expected to kill all vegetative microorganisms. Sterilant—An agent that destroys all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Sterilant are liquid or vapor-phase agents. Types of Chemicals and Their Antimicrobial Applications Type of Chemical Use Aldehydes Spore killer Alcohols (70% Isopropyl Alcohol) Disinfectant, Antiseptic Chlorine compounds (Sodium Hypochlorite) Sporicidal Phenolics (Chlorocresol, Chloroxylenol) General Disinfectant Ozone Sporicidal Hydrogen Peroxide Sterilant, Antiseptic Chlorhexidine (Diguanide) Antiseptic Peracetic Acid Sterilant Ethylene Oxide Vapor Sterilant Quaternary Ammonium Compounds (Benzalkonium Chloride) Disinfectant, Antiseptic β-Propiolactone Sporicidal Mastering disinfectant selection for effective GMP cleaning When choosing a disinfectant to use in a pharmaceutical manufacturing area, many important things must be considered: What kinds of microorganisms need to be controlled, and how many. Whether the disinfectant can kill a wide range of microorganisms (its spectrum of activity). If the product is approved as a sterilant (a strong disinfectant that kills all microorganisms). Whether it is registered and approved by the regulatory agencies. The right concentration (strength), how it is applied, and how long it needs to stay on the surface (contact time). The type of surface being cleaned and whether it can safely handle the disinfectant. If there is dirt or other materials on the surface that could reduce how well the disinfectant works. If it is necessary for the disinfectant to keep working (have residual activity) after it dries. Whether the disinfectant could damage equipment over time (corrosiveness). The safety of the workers who use it. If the disinfectant works well with other cleaning products or disinfectants. The rotation plan for using different disinfectants to avoid resistance. What steps must be taken to make sure the disinfectant does not contaminate the medicine. Disinfectants at work: Mechanisms that destroy microbial Life Disinfectant Microbial Target Formaldehyde, hypochlorite, and glutaraldehyde Cell wall Anilides and hexachlorophene Cytoplasmic membrane, action on membrane potential Hexachlorophene Membrane enzymes, action on electron-transport chain Chlorhexidine and ethylene oxide Action on ATP Ethylene oxide, glutaraldehyde, hydrogen peroxide, hypochlorite, and iodine Action on enzymes with −SH groups Alcohols, chlorhexidine, and quaternary ammonium compounds Action on general membrane permeability Chlorhexidine, aldehydes, and quaternary ammonium compounds Cell contents, general coagulation Hydrogen peroxide Ribosomes Hypochlorites Nucleic acids Ethylene oxide, glutaraldehyde, hydrogen peroxide, and hypochlorite Thiol groups Ethylene oxide, glutaraldehyde, and hypochlorite Amino groups Hypochlorite General oxidation How disinfectant challenge testing should be done – It is a common regulatory requirement, that chemical manufacturing companies must demonstrate the safety and effectiveness of disinfectants, sanitizers, sporicidal agents, and sterilants before these products can be marketed or used. To register these products, companies must: Provide the chemical ingredients of the product. Show safety data (toxicology) to prove the product is safe if used as directed. Show that the product kills the microorganisms it claims to (efficacy data). Provide proper usage instructions on the label. However, these instructions are often meant for general use and may not be fully useful in a pharmaceutical manufacturing environment. Disinfectant testing methods These include: Phenol-Coefficient Test
Life-Saving Drugs & Planet-Killing Waste: Why Pharma Must Go Green Now
Life-Saving Drugs – Planet-Killing Waste: Why Pharma Must Go Green Now The pharmaceutical industry, historically known for its high energy consumption, toxic waste production, and reliance on harmful chemical solvents, has long been criticized for its significant environmental footprint. Traditional drug manufacturing processes often generate pollution, contribute to resource depletion, and introduce health hazards, both for workers and consumers. In response to these concerns, a growing movement within the industry is embracing green chemistry—a paradigm focused on designing drugs and manufacturing processes that reduce harmful environmental impacts. This shift is not only about environmental protection; it also aims to streamline operations, increase cost-efficiency, and ultimately safeguard public health. In this blog, we will explore how sustainability and green chemistry are reshaping the pharmaceutical sector, offering new solutions to age-old problems. “Pharmaceutical innovation must align with environmental stewardship—green chemistry is no longer optional, but essential. Sustainable drug manufacturing ensures therapeutic progress without ecological compromise.” What is Green Chemistry? Green chemistry, also known as sustainable chemistry, involves the design of chemical products and processes that minimize negative environmental and human health impacts. At its core, it aims to create products and processes that are efficient, sustainable, and environmentally friendly. The pharmaceutical industry’s adoption of green chemistry principles seeks to address the numerous challenges inherent in drug manufacturing, which traditionally consumes vast amounts of resources and generates significant chemical waste. Some of the fundamental principles of green chemistry include: Minimizing waste: Reducing by-products and chemical residues during the drug synthesis process. Using renewable resources: Transitioning away from fossil fuels and non-renewable raw materials toward renewable resources such as biomass. Eco-friendly solvents: Substituting toxic solvents with safer alternatives such as water-based solutions or supercritical CO₂, which is non-toxic and recyclable. Energy efficiency: Developing processes that consume less energy, minimizing environmental impact while optimizing production. By focusing on these core principles, green chemistry aims to improve the sustainability of pharmaceutical manufacturing by reducing pollution, conserving resources, and making drug production safer. Why Sustainability Matters in Pharma The pharmaceutical industry is an energy-intensive sector, with traditional manufacturing methods involving large-scale energy use, hazardous chemical inputs, and significant waste generation. Several aspects of traditional pharmaceutical manufacturing are particularly harmful to the environment, including: High energy consumption: Drug manufacturing often requires high temperatures and pressures, consuming considerable amounts of energy. Chemical waste generation: The synthesis of drugs, particularly complex ones, produces chemical waste that requires specialized disposal methods, which can be expensive and environmentally damaging. Toxic chemicals: Many pharmaceutical processes still rely on harmful solvents and reagents that pose risks to workers, surrounding communities, and the natural environment. The growing importance of sustainability in the pharmaceutical industry is driven by both environmental concerns and economic pressures. As governments and regulatory agencies introduce more stringent environmental regulations, pharmaceutical companies are recognizing that embracing sustainability not only helps them comply with these regulations but also offers economic benefits. Green chemistry provides a powerful framework for improving resource efficiency, reducing costs, and minimizing environmental impact. How Green Chemistry is Reshaping Pharma Manufacturing? Reducing Waste in Drug Synthesis- A hallmark of traditional drug synthesis is the generation of large quantities of chemical waste. This waste often requires expensive disposal methods, such as incineration or landfilling, which can contribute to environmental pollution. Green chemistry encourages the development of more efficient chemical reactions that reduce the generation of by-products, leading to less waste and lower environmental impact. For instance, by designing more selective and efficient reactions, pharmaceutical companies can avoid producing large amounts of side products. These advances not only help preserve resources but also save money by reducing the need for waste treatment and disposal. Sustainable Solvents- One of the major contributors to pollution in pharmaceutical manufacturing is the use of toxic solvents. Many traditional solvents are volatile, harmful to human health, and difficult to dispose of. As part of its sustainability efforts, green chemistry promotes the use of safer, more sustainable solvents. Some notable alternatives include: Water-based solvents: Water is a much safer and more environmentally friendly solvent than many of the organic solvents traditionally used in pharmaceutical manufacturing. Supercritical CO₂: Supercritical carbon dioxide is non-toxic, recyclable, and can be used as a solvent in pharmaceutical processes. It is especially useful in extractions, making it an excellent green alternative to organic solvents. By shifting toward eco-friendly solvents, pharmaceutical manufacturers not only reduce their environmental impact but also improve worker safety by decreasing exposure to toxic chemicals. Energy-Efficient Manufacturing Processes- The pharmaceutical manufacturing process is notoriously energy intensive. Traditionally, high temperatures, pressures, and long reaction times were required to produce active pharmaceutical ingredients (APIs). Green chemistry focuses on reducing energy consumption by developing more efficient manufacturing processes that operate at lower temperatures and pressures. This is not only beneficial for the environment but also reduces the overall cost of production. For example, some companies are experimenting with reactions that occur at room temperature, reducing both energy use and the risk of harmful emissions. These energy-efficient processes can significantly lower the carbon footprint of pharmaceutical manufacturing, making the entire production cycle more sustainable. Sustainable Sourcing of Raw Materials- Pharmaceutical manufacturing has historically relied on fossil fuels and other non-renewable resources for raw materials. However, green chemistry encourages a shift toward renewable resources, such as biomass, for the sourcing of key raw materials. Biomass—plant and animal-based materials—can be sustainably sourced and offers an eco-friendlier alternative to fossil-based chemicals. This shift in sourcing not only reduces the industry’s reliance on finite resources but also creates opportunities for more sustainable, circular supply chains. By incorporating renewable feedstocks, pharmaceutical companies can decrease their environmental footprint and contribute to the global transition to a sustainable economy. Recycling and Reuse in Drug Manufacturing- Green chemistry encourages the recycling and reuse of materials wherever possible. For example, many solvents, catalysts, and other chemicals used in drug production can be recycled or reused multiple times, reducing the need for fresh materials. Recycling not only cuts costs but also reduces waste generation, improving the overall sustainability of the pharmaceutical production
सस्ती जेनेरिक दवाओं की सच्चाई: क्या सच में असरदार और सुरक्षित हैं ?
क्या आप जानते हैं कि भारत में हर साल लाखों मौतें उन दवाओं की वजह से होती हैं, जो अप्रभावी या नकली होती हैं? जब दवाओं की बात आती है, तो सुरक्षा और प्रभावशीलता सबसे अहम होती है। हालांकि, बाजार में सस्ती जेनेरिक दवाओं का चलन बढ़ रहा है, लेकिन कई लोग आज भी ये मानते हैं कि ये दवाएं ब्रांडेड दवाओं जितनी प्रभावी और सुरक्षित नहीं होतीं। क्या सच में ऐसा है? दवाओं का इस्तेमाल हमारे स्वास्थ्य को ठीक करने के लिए किया जाता है, लेकिन इन दवाओं की कीमत और उनकी गुणवत्ता हमेशा एक बड़ा सवाल बन जाती है। जब हम दवाओं की खरीदारी करते हैं, तो हमारे मन में यह सवाल उठता है कि क्या जेनेरिक दवाएं (Generic Medicines) उतनी ही प्रभावी और सुरक्षित होती हैं जितनी कि ब्रांडेड दवाएं (Branded Medicines)? क्या जेनेरिक दवाओं की कम कीमत उनकी गुणवत्ता पर सवाल उठाती है? मेरे लिए, जेनेरिक दवाओं के प्रति पूर्वाग्रह कुछ सालों पहले तक था। जैसे ही मुझे किसी बीमारी के इलाज के लिए दवाओं की जरूरत पड़ी, मैंने हमेशा ब्रांडेड दवाओं को प्राथमिकता दी। मुझे हमेशा यह डर था कि जेनेरिक दवाएं उतनी प्रभावी नहीं हो सकतीं या इनकी गुणवत्ता में कोई कमी हो सकती है। मैंने सोचा कि ब्रांडेड दवाएं, जिनमें बड़े नाम और विपणन खर्चे होते हैं, ज़रूर ज्यादा प्रभावी और सुरक्षित होंगी। लेकिन जब मैंने फार्मास्युटिकल उद्योग में काम करना शुरू किया और इसके विभिन्न पहलुओं को समझा, तो मुझे एहसास हुआ कि जेनेरिक दवाएं भी वहीं प्रभाव डालती हैं जो ब्रांडेड दवाएं करती हैं, बशर्ते वे नियामक मानकों के तहत बनाई गई हों। मैंने अपने चिकित्सक से इस बारे में बात की, और उन्होंने बताया कि जेनेरिक दवाएं उसी सक्रिय तत्व का उपयोग करती हैं, जो ब्रांडेड दवाओं में होता है। इसके बाद, मैंने कई बार जेनेरिक दवाओं का उपयोग किया और पाया कि वे उतनी ही प्रभावी और सुरक्षित होती हैं, जितनी ब्रांडेड दवाएं। क्या जेनेरिक दवाएं आपके स्वास्थ्य के लिए उतनी ही सुरक्षित हैं जितनी कि ब्रांडेड दवाएं? इस ब्लॉग में हम आपको इस सवाल का उत्तर देंगे और बताएंगे कि एक्सपर्ट्स इस पर क्या कहते हैं। “ क्या सस्ती जेनेरिक दवाएं हैं उतनी ही भरोसेमंद जितनी ब्रांडेड ? जानिए उनके पीछे छुपे सच और विशेषज्ञों की राय ” जेनेरिक दवाएं क्या होती हैं? जेनेरिक दवाएं उन दवाओं को कहा जाता है, जो किसी ब्रांडेड दवा के समान सक्रिय तत्व (Active Ingredient) के साथ बनाई जाती हैं, लेकिन इनका नाम और पैकेजिंग ब्रांडेड दवाओं से अलग होता है। ये दवाएं ब्रांडेड दवाओं की तुलना में कम कीमत पर उपलब्ध होती हैं क्योंकि इनमें प्रचार और ब्रांडिंग खर्चे नहीं होते हैं। जेनेरिक दवाओं को समान प्रभाव (bioequivalence) के तौर पर प्रमाणित किया जाता है, यानी कि ये वही प्रभाव डालती हैं जो ब्रांडेड दवाएं करती हैं, लेकिन इनके उत्पादन में कम खर्चा आता है। जेनेरिक दवाओं का उत्पादन क्यों किया जाता है? दवाओं के उत्पादन में जेनेरिक दवाओं का उत्पादन एक बहुत बड़ा कदम है, जो स्वास्थ्य देखभाल की पहुंच को आसान और सस्ता बनाता है। जब कोई नई दवा पहली बार मार्केट में आती है, तो उसे बनाने वाली कंपनी उसे पेटेंट करवाती है। इसका मतलब है कि किसी और कंपनी को उस दवा का निर्माण करने की अनुमति नहीं होती। लेकिन पेटेंट खत्म होने के बाद, दूसरी कंपनियां उस दवा का उत्पादन कर सकती हैं, और उन्हें जेनेरिक दवा कहा जाता है। जेनेरिक दवाओं का मुख्य कारण स्वास्थ्य देखभाल की लागत को कम करना है। जब पेटेंट समाप्त होता है, तो अन्य कंपनियां कम कीमत में उसी सक्रिय घटक (Active Ingredient) का उपयोग करके दवा का उत्पादन करती हैं। इससे न केवल स्वास्थ्य सेवाएं सस्ती होती हैं, बल्कि लाखों लोग जिनके पास महंगी दवाएं खरीदने की क्षमता नहीं होती, उन्हें भी आवश्यक दवाएं मिल जाती हैं। ब्रांडेड दवाओं और जेनेरिक दवाओं के बीच अंतर ब्रांडेड और जेनेरिक दवाओं के बीच मुख्य अंतर उनकी कीमत और ब्रांड पहचान में होता है। ब्रांडेड दवाएं एक कंपनी द्वारा विकसित की जाती हैं और उस कंपनी का नाम उनके उत्पाद पर प्रमुखता से दिया जाता है। दूसरी ओर, जेनेरिक दवाओं के नाम पर किसी विशेष कंपनी का ब्रांड नाम नहीं होता, बल्कि यह दवा उस सक्रिय तत्व के नाम पर आधारित होती है जो दवा में मौजूद होता है। ब्रांडेड दवाओं की कीमत अधिक होती है क्योंकि इनकी बिक्री के लिए कंपनियां विज्ञापन, प्रचार, और रिसर्च एवं डेवलपमेंट (R&D) में भारी खर्च करती हैं। जेनेरिक दवाएं इसके मुकाबले सस्ती होती हैं, क्योंकि इनमें इन खर्चों को घटाया जाता है। हालांकि, दोनों प्रकार की दवाएं उसी सक्रिय तत्व का उपयोग करती हैं, जो बीमारी को ठीक करने के लिए जिम्मेदार होता है। क्या जेनेरिक दवाएं ब्रांडेड दवाओं की तरह सुरक्षित और असरदार हैं? यह सवाल एकदम सही है, और इस पर विशेषज्ञों की राय अलग-अलग हो सकती है, लेकिन सामान्यतः यह कहा जा सकता है कि जेनेरिक दवाएं ब्रांडेड दवाओं के समान ही सुरक्षित और प्रभावी होती हैं, बशर्ते कि वे नियामक मानकों के तहत बनाई गई हों। समान सक्रिय तत्व (Active Ingredient) जेनेरिक दवाएं और ब्रांडेड दवाएं दोनों में वही सक्रिय तत्व होता है, जो बीमारी के इलाज के लिए जिम्मेदार होता है। यह सुनिश्चित करता है कि दोनों दवाएं शरीर पर वही प्रभाव डालें। जेनेरिक दवाएं किसी ब्रांडेड दवा के पेटेंट की समाप्ति के बाद बनाई जाती हैं, और इनका उद्देश्य उसी प्रभाव को कम कीमत पर उपलब्ध कराना है। जैविक समानता (Bioequivalence) हर जेनेरिक दवा को जैविक समानता (Bioequivalence) के परीक्षण से गुजरना पड़ता है। इसका मतलब है कि जेनेरिक दवा का शरीर में अवशोषण और प्रभाव ब्रांडेड दवा के समान होना चाहिए। जैविक समानता के परीक्षण में यह जांचा जाता है कि दवा शरीर में कितनी तेजी से और कितनी मात्रा में अवशोषित होती है। यदि जैविक समानता के मानदंड पूरे होते हैं, तो यह प्रमाणित हो जाता है कि जेनेरिक दवा ब्रांडेड दवा जितनी प्रभावी है। गुणवत्ता की जांच जेनेरिक दवाओं की गुणवत्ता को सुनिश्चित करने के लिए, सरकारी नियामक एजेंसियां जैसे फूड एंड ड्रग एडमिनिस्ट्रेशन (FDA) और भारत में केंद्रीय औषधि मानक नियंत्रण संगठन (CDSCO) इन दवाओं की गुणवत्ता पर कड़ी निगरानी रखते हैं। इन
Fast, Cheap, & Global: China’s formula to lead the Biotech race
In recent years, China’s biotech industry has grown by leaps and bounds. Once known for copying Western drugs, Chinese companies now lead in innovation. According to Bloomberg, in the latest count, 1,250 novel drugs entered development in China—close to the 1,440 in the U.S., and far ahead of the EU (South China Morning Post). This is a tectonic shift, and the world is taking notice. Chinese biotech has also had strong stock market performance this year. The Hang Seng Biotech Index jumped nearly 62%, driven by Western interest in Chinese cancer therapies. This shows investors believe big things are coming from China. Before 2015, China produced only about 160 new compounds, less than 6% of the global total. But after that, China changed gears. Its drug regulator started approving faster, set higher quality standards, and opened the market. The “Made in China 2025” plan pushed biotech into one of ten priority sectors. Chinese scientists trained abroad returned home to launch cutting-edge startups. Daniel Chancellor from Norstella says China is not just catching up—they are poised to surpass the U.S. in coming years, based on the number of new drugs entering pipelines. “China’s biotech revolution is changing the game—faster and cheaper innovation is forcing the world to take notice.” Quality Over Quantity: Winning Regulator Confidence Developing more drugs is one thing—making top-quality ones is another. Chinese drugs are now earning priority review, breakthrough therapy, and fast track status from regulators like the FDA and EMA. In fact, China surpassed the EU in these fast-track reviews as of 2024. A Blockbuster Example: Ivonescimab The most striking example is ivonescimab—a cell therapy for deadly non-small-cell lung cancer (NSCLC). Developed by Akeso and partnered with Summit Therapeutics, this antibody targets both PD‑1 and VEGF. In a Chinese Phase III trial, it significantly outperformed Merck’s Keytruda. Patients lived about 11.1 months before progression, compared to 5.8 months for Keytruda. This success sparked global interest. After the news broke, Summit’s stock jumped 30–+37%. Western companies like Pfizer and Merck rushed to gain access to similar drugs. In a recent update, China’s National Medical Products Administration approved ivonescimab in April 2025, citing a 49% improvement in “progression-free survival” and a 22% reduction in risk of death. Fast and Cheap Clinical Trials One key reason for China’s biotech success is its fast, low-cost clinical trials. Finding patients takes half the time compared to the U.S., due to China’s huge population and interconnected hospitals. This allows companies to run many trials in parallel and accelerate development. By 2021, China was the world’s top location for clinical research. Western sponsors now often use Chinese data to fast-track drug deals. Western Pharma is Watching—and Buying Global pharmaceutical giants are increasingly turning their attention—and wallets—toward Chinese biotech innovation. Major players like Pfizer, Merck, AstraZeneca, and Roche have signed high-value licensing deals with Chinese companies, reflecting growing confidence in the country’s R&D capabilities. Pfizer paid $1.3 billion upfront, with up to $4.8 billion in milestone payments, to license 3SBio’s dual-action PD-1/VEGF cancer therapy. Merck struck a $3.3 billion agreement with LaNova Medicines to tap into their oncology pipeline. In a notable earlier deal, Summit Therapeutics paid $500 million upfront to license the antibody therapy ivonescimab, co-developed in China. Merck also joined forces with Hansoh Pharma to develop GLP-1 molecules, further expanding its footprint in the booming metabolic disease space. This surge in cross-border licensing points to a shift in strategy: Western pharma is not just observing China’s biopharma progress—it’s investing in it, betting on Chinese innovation to drive their global pipelines forward. But Challenges Remain Even with strong data, Chinese companies still face hurdles. The FDA often needs global trials, not just China-only data, to grant approval. Ivonescimab now has to prove its success in global Phase III trials running until 2027. Also, many Chinese firms play it safe by improving existing drugs instead of creating brand-new therapies. While this reduces risks, it means real innovation is still being led by the U.S., Europe, and Japan. Counting the Chinese Innovators From 2020 to 2024, 20 of the top 50 companies adding new drugs were Chinese—up from just 5 in the preceding five years. One major player is Jiangsu Hengrui, which shifted from generics to innovation after government price reforms. It is now the world’s top company for adding new drugs to the pipeline. A Growing Global Presence Chinese biotech is now a global presence. BeOne Medicines (formerly BeiGene) has R&D sites in both China and the U.S., and its cancer drugs are approved in China, Europe, and the U.S. Many Chinese drugs are biosimilar or next-gen iterations, but more novel therapies are emerging. Geopolitical Concerns and Responses China’s biotech boom is also political. U.S. leaders worry about losing their edge, comparing biotech’s importance to AI and electric vehicles. Some argue that the U.S. needs to reform FDA rules, speed up trials, and reduce bureaucracy to stay competitive. There are also calls for export controls, restrictions on scientific investment, and new policies (like HHS “SWAT teams”) to help American companies catch up. What This Means for Patients Faster drugs: Patients can benefit from quicker access to effective new treatments. Global access: Licensing deals mean Chinese drugs may soon be available in India, the U.S., Europe, and elsewhere. Lower costs: Faster, cheaper trials could reduce R&D costs, possibly leading to cheaper drugs. Safety concerns: China’s fast pace leads some to worry about trial quality and oversight. Key Takeaways China is on track:China is quickly catching up to the U.S. in biotech innovation. In 2024, more than 1,250 new drugs entered development in China—just short of the U.S. total of around 1,440, according to Bloomberg News. This shows how far China has come from its earlier image of copying Western drugs to becoming a serious innovator in global pharmaceutical research. Quality is improving:Chinese drugs are not just increasing in number—they are also gaining global recognition. Many of them now receive “fast track,” “priority review,” and “breakthrough therapy” status from top regulators like the U.S. FDA and European Medicines Agency. These labels are
India’s medicine exports will Double by 2030: A Bright Future
India’s medicine industry is going through a big change. A new report by Bain & Company called “Healing the World: Roadmap for Making India a Global Pharma Exports Hub” says that by 2030, India’s medicine exports will double and reach $65 billion. This means India will sell medicines worth 65 billion US dollars to countries all over the world. Even more exciting is that by 2047, India’s medicine exports could grow to $350 billion. This will make India one of the top five medicine-exporting countries in the world. This growth shows that India is becoming a very important player in global healthcare, helping many people get affordable and effective medicines. India is famous for making generic medicines for many years. Generic medicines are cheaper versions of branded medicines. Indian companies supply these medicines to both developing and rich countries. Because of this, India is known as the “pharmacy of the world.” But in the future, India needs to do more than just make a lot of generic medicines. The report says India’s medicine companies should start making special generic medicines, biosimilars, and new innovative medicines. Special generics are complex medicines that are hard to make but sell for more money. Biosimilars are copies of biological medicines, which are made from living cells and need advanced technology. New innovative medicines mean completely new drugs invented by Indian scientists. This will help India become a leader in the global medicine market. India’s focus on advanced generics, biosimilars, and novel drugs is paving the way for its leadership in global pharma exports. Why India Needs to Change Its Approach For many years, Indian pharma companies made large amounts of affordable medicines. This helped patients all over the world, especially in poor and middle-income countries. But now, just making large quantities of cheap medicines is not enough. Other countries like China and some in Europe are also growing their medicine industries. To grow faster and compete with these countries, Indian companies need to make unique, patented, and advanced medicines. These medicines can be sold at higher prices and can be accepted in strict markets like the USA, Europe, and Japan. Sriram Srinivasan from Bain & Company says that Indian medicine companies should focus on making medicines that are different from what others make. Instead of just copying, they need to do research and develop advanced generics, biosimilars, and new medicines. For this, companies must invest more money in research and development, improve manufacturing quality, and follow international rules properly. If they do this, Indian pharma companies will become bigger global players and increase their exports. The report also talks about the importance of medicine quality and following regulations. Countries with strict rules only allow medicines that meet high standards. If India fails in quality, it will lose trust. So Indian companies must improve their quality checks and work closely with government regulators to follow global standards. Challenges and What Needs to Be Done Though the future looks good, India faces some challenges. One big problem is India depends on importing Active Pharmaceutical Ingredients (APIs) — the raw materials used to make medicines — mostly from China. To become self-reliant, India must start making more APIs within the country. The government is planning to build special areas called Bulk Drug Parks with good facilities like power, waste treatment, and transport to help API factories grow. Viranchi Shah, president of the Indian Drugs Manufacturers Association (IDMA), says that making more APIs and improving infrastructure is very important. Along with this, better roads, energy supply, and waste management will help make medicines cheaper and better. Without fixing these problems, Indian companies will find it hard to compete in the world market. Another important thing is innovation and skill development. India has many talented scientists and researchers, but they need better support like more funds, advanced labs, and chances to work with global companies. The government should encourage this by giving grants, tax benefits, and easier patent rules. This will make companies more interested in discovering new medicines and better ways to deliver them to patients. The Indian Pharmaceutical Alliance (IPA) also says that India’s pharma industry must be excellent in everything — from making medicines to marketing and exporting — to help India reach its economic goals. India wants to become a $30 to $35 trillion economy by 2047, and the pharma industry will play a big role in this success. The industry and government must work together to create good conditions for growth, exports, and innovation. India’s Pharma Growth and Its Global Importance India’s growing medicine exports will help the country’s economy and also improve healthcare worldwide. Indian medicines are already used in many countries, especially in Asia, Africa, and Latin America, where affordable healthcare is very important. As India makes more special and better-quality medicines, it can help patients with serious diseases like cancer, diabetes, and autoimmune disorders. This growth will create many jobs and bring more money for science and technology. Millions of people work in the pharma industry, from factory workers to scientists and sales teams. Increased exports will also help related industries like transport, packaging, and research services. As India becomes one of the top five medicine exporters, it will have more say in global health decisions. This will help India promote cheaper medicines worldwide and support global health efforts. During global health emergencies like pandemics, India’s ability to supply medicines and vaccines will be very important for the world. Conclusion: India’s Pharma Industry Has a Bright Future India’s pharmaceutical industry is at an important moment. Doubling exports by 2030 and reaching $350 billion by 2047 is possible, but India must focus on innovation, quality, and building good infrastructure. By making advanced generics, biosimilars, and new medicines, India can become a world leader in pharma. To reach this goal, India must overcome challenges like dependence on imports, strict regulations, and the need for more research. With the help of the government, industry groups like IPA and IDMA, and
Global drug trade faces shake-up as U.S. eyes new tariffs
On July 9, 2025, former U.S. President Donald Trump announced plans to impose import tariffs on pharmaceuticals, saying the rates could go as high as 200%. This is serious news for countries like India, which is a major supplier of affordable medicines to the U.S. In FY25, India exported nearly $10 billion worth of pharmaceutical products to the U.S., which is about 40% of its total pharma exports. A sudden increase in tariffs could hurt Indian companies badly and also make healthcare more expensive for American patients. In this blog, we explain how Trump’s proposed tariffs could affect India’s pharma industry, the global medicine trade, and what companies and governments can do about it. A broad consensus among leaders urges careful consideration of pharmaceutical tariffs, citing risks to patients, supply chains, and innovation. Pharmaceuticals Under Review in U.S. Trade Policy Shift Trump has always used import tariffs as a tool to protect U.S. businesses and reduce dependency on foreign goods. After already increasing duties on steel, aluminium, and now copper, he now wants to focus on semiconductors and pharmaceuticals. Speaking at a recent Cabinet meeting, he said that companies bringing medicines into the U.S. may face tariffs of up to 200%, but they will get one year to “get their act together” — meaning either move production to the U.S. or make other adjustments. Though he didn’t name any specific countries, it’s clear that India and China are the main targets, as they supply most of the generic medicines and active pharmaceutical ingredients (APIs) to the U.S. India – The Pharmacy of the World India is known worldwide for its low-cost, high-quality generic medicines. The U.S. is India’s largest market, with pharma exports reaching $9.8 billion in FY25, up from $8.1 billion the previous year. If a 200% tariff is implemented, Indian drugs could become too expensive in the U.S. market. This may force American buyers to look for more costly options from domestic or other global suppliers. The impact would be huge: Medicines in the U.S. could become more expensive Indian pharma giants like Sun Pharma, Cipla, and Dr. Reddy’s may lose market share Global pharma supply chains may need to be restructured For Indian companies, which have worked hard to follow U.S. FDA rules and keep prices competitive, such tariffs are not just a trade issue — they are a serious threat to their business survival in the U.S. Why Indian Drugs Matter to the U.S. Ironically, the same Indian pharma sector that Trump wants to hit with high tariffs is critical to keeping U.S. healthcare costs under control. About 1 out of every 3 pills taken in the U.S. is made in India. Indian companies also supply many essential and life-saving medicines — including cancer, heart, and diabetes drugs — at prices that are much lower than branded alternatives. These drugs support not just private buyers but also U.S. government programs like Medicare and Medicaid. If Indian drugs become expensive due to tariffs, the U.S. healthcare system may face: Higher treatment costs Shortages of affordable medicines Pressure on government health budgets At a time when the world is still recovering from COVID-related supply issues and inflation, this could create big problems for patients and hospitals alike. One-Year Deadline: Chance or Challenge? Trump has said companies will get about 12 to 18 months to adjust before the new pharmaceutical tariffs are applied. But his message — “get your act together” — sounds more like a warning than an opportunity. What does this mean for Indian pharma companies? Should they open factories in the U.S. to avoid tariffs? Can they change their supply chains fast enough? Will India be able to negotiate special rules or trade exemptions? Smaller Indian firms may find it hard to invest in U.S. manufacturing. Larger companies might look at buying U.S.-based plants or entering into partnerships with American firms to continue supplying medicines without facing huge tariffs. BRICS and the Dollar: Another Angle to the Story Trump also spoke about BRICS — the group of emerging economies that includes Brazil, Russia, India, China, and South Africa. He called BRICS “not a serious group” but admitted it’s trying to challenge the U.S. dollar in global trade. He repeated his idea of putting a 10% tariff on all BRICS countries. This puts India in a tricky spot. On one hand, BRICS offers India a way to trade more with other large markets and reduce its dependence on the West. On the other hand, the U.S. is still India’s most profitable pharma customer. If India shifts more toward BRICS countries, it could help in the long run. But in the short term, it might reduce earnings from U.S. exports. What Could Happen Next for Indian Pharma India’s pharma sector is used to handling global challenges — whether it’s U.S. FDA inspections, price caps, or supply chain shocks during COVID. But a 200% tariff on U.S. exports could cause widespread disruption. Some likely impacts: Revenue loss: Since 40% of pharma exports go to the U.S., even a partial drop could reduce profits. Stock market impact: Pharma shares may see high volatility. Job cuts: Thousands of jobs could be at risk in India’s pharma sector. Market shift: Companies may try to focus more on Europe, Africa, and Southeast Asia. What Indian Pharma Should Do Now To deal with the risk of high U.S. tariffs, Indian pharma companies — along with the government — must prepare smart strategies: Set Up U.S. Manufacturing Units Big players should explore building or buying plants in the U.S. This will help them avoid tariffs and maintain access to the American market. Find New Markets India should grow its pharma exports to countries in Africa, Latin America, and Southeast Asia, reducing its dependence on the U.S. Invest in R&D Firms should move beyond basic generics to specialty drugs, biosimilars, and complex formulations that bring better profits and are less sensitive to price wars. Trade Diplomacy India must use
Covid Vaccines and Heart Attacks: Is there really a link?
Young people are dying from heart attacks. …. Is it because of their lifestyle? Or their family history? Or could it be something new, like Covid or the vaccine? These days, there is a lot of discussion and confusion among people about the sudden rise in heart attacks, especially in young and seemingly healthy individuals. Many are asking: Could Covid-19 or the Covid vaccine be the reason behind this? Some people worry that there might be long-term effects of Covid or the vaccine that we don’t fully understand yet. Others say that the real cause is our unhealthy lifestyle—like high blood pressure, diabetes, smoking, lack of exercise, and stress. This debate became even more active after a government expert panel in Karnataka studied heart attack cases and clearly said there is no link between heart problems and Covid-19 infection or vaccination. In fact, they said the vaccine might help protect the heart in the long run. Still, some people are not fully convinced and believe more research is needed. As a result, this topic continues to be discussed widely—in homes, hospitals, and even in politics. “Life-saving or risky? Exploring the connection between COVID vaccines and heart health.” Karnataka Panel Finds No Link Between Heart Attacks and Covid or Vaccines An expert committee in Karnataka has found no connection between heart problems and Covid-19 infection or vaccination. The panel studied recent heart attack deaths in Hassan district and said that common health issues like high blood pressure are more likely to be the cause. In fact, the report says Covid-19 vaccines may help protect the heart over time. The committee has suggested strong public health steps, including early heart health checks and better tracking of sudden heart-related deaths. An expert committee set up by the Karnataka government has said that there is no link between early heart disease (like heart attacks) and a person’s past Covid infection or Covid vaccination. In fact, the panel said that getting vaccinated helps protect the heart in the long run. This committee, led by Dr. Ravindranath, Director of Jayadeva Institute of Cardiovascular Sciences and Research, was formed to study the recent deaths due to heart attacks in Hassan district, where more than 20 people had died. The committee gave its report to the government on July 2. It said that current data does not support the idea that “long Covid” is the reason for the increase in sudden heart attacks among young people. Instead, the rise in common risk factors like high blood pressure, diabetes, smoking, and high cholesterol is a more likely reason. The study done at Jayadeva Hospital also found no connection between early heart disease and previous Covid infection or vaccination. This finding is also supported by similar studies from other countries. On the other hand, the report said that Covid vaccination actually helps reduce the risk of heart problems in the long term. Recently, Chief Minister Siddaramaiah had said that the vaccine drive might be linked to the deaths in Hassan and that the vaccines were approved too quickly. His statement was criticised by BJP leaders and Biocon founder Kiran Mazumdar-Shaw. The expert panel explained that there is no single reason for the rise in heart attacks. Many factors – like lifestyle, genetics, and environment – may be involved. After recovering from Covid, there may be a temporary increase in heart problems due to inflammation in the body, but this risk doesn’t last long. The pandemic ended three years ago, so this is not a current issue. The expert committee carefully studied 251 patients who were below 45 years of age and had come to Jayadeva Hospital with heart-related problems between April 1 and May 31, 2025. Each patient was personally interviewed by hospital staff. They collected full details about the patients’ health history—such as whether they had any past illness like Covid-19, if they were vaccinated, which vaccine they took, how many doses, and whether they had any side effects after vaccination. After going through all this information, the committee found that most of these patients had common health problems like high blood pressure, diabetes, high cholesterol, or a habit of smoking—these are already known to increase the risk of heart disease. But surprisingly, some patients had none of these risk factors. This means that there might be other, less known or new reasons that are also causing heart issues in young people. So, more studies are needed to understand these unknown causes properly. New Measures Suggested to Understand and Prevent Sudden Heart Deaths The expert committee has advised the government to take several important steps to protect people’s health, especially to prevent sudden heart-related deaths. They said that just giving reports is not enough—now action is needed. First, they recommended creating a proper system to keep a close watch on sudden heart deaths, especially among young people, so such cases can be tracked and studied better. Second, they suggested that whenever there is an unexpected heart-related death, an autopsy (post-mortem) should be done. This will help doctors understand the exact reason for the death. Third, the committee said that heart check-ups should begin at an early age—starting in schools itself—so that any heart problems can be caught and treated early. Lastly, they said that big research studies should be done across different parts of the country. These studies should look at the long-term effects of Covid infection and Covid vaccines on the heart. By doing this, we can get a clearer and more complete picture of what is really affecting people’s heart health in the long run. What We Still Don’t Know About Covid, Vaccines, and Heart Risks Right now, there is a lot of confusion and debate about whether Covid-19 infection or vaccination causes heart problems, especially in young people. Some people worry that vaccines might be linked to sudden heart attacks, while others believe it is mainly due to common health issues like high blood pressure, diabetes, or unhealthy lifestyles. Because of this uncertainty,
The AI-Driven Pharmaceutical Future
The use of Artificial Intelligence (AI) and Machine Learning (ML) in pharmaceutical manufacturing in India and globally is showing great potential to improve efficiency, product quality, and adherence to Good Manufacturing Practices (GMP). But when these technologies are applied in regulated environments, they bring several challenges—like how to validate their use, ensure data accuracy and integrity, manage risks properly, and meet strict regulatory rules. This article looks at the current rules and guidelines related to AI/ML use in GMP areas, points out the gaps that still exist, and suggests what should be done in the future to improve the policies. It also highlights important regulatory bodies such as the US FDA, European Medicines Agency (EMA), and the UK’s MHRA, along with real examples and case studies where AI/ML has been successfully used under strict regulatory supervision. In today’s pharmaceutical manufacturing, Artificial Intelligence (AI) and Machine Learning (ML) are being used more frequently to improve batch production, predict machine maintenance needs, monitor product quality in real-time, and control processes more efficiently. As the use of AI/ML grows in this field, regulatory authorities have started creating guidelines to maintain a balance between encouraging innovation and ensuring patient safety and high product quality. However, since AI/ML systems often behave unpredictably and their risks are still being studied, regulatory bodies remain cautious and are moving forward carefully. “The future of AI is not about replacing humans, it’s about augmenting human capabilities.” — Sundar Pichai, CEO of Google The US FDA is actively working with the pharmaceutical industry to use AI and ML in manufacturing. It started the Emerging Technology Program (ETP) to study and guide such new technologies. In 2021, it also launched a special program called FRAME to focus on AI/ML in pharma. By June 2025, the FDA plans to use AI in all its departments. In early 2025, they successfully completed their first pilot review using AI, showing a big step forward in using AI in regulatory work. In 2021, the EMA released a paper discussing how AI can be used in pharma manufacturing and the rules around it, focusing on maintaining GMP standards and data accuracy. With the 2024 EU AI Act, any AI used in pharma will now be considered high-risk, needing strict checks and human supervision. EMA has also prepared an AI action plan until 2028 to manage AI’s future role in medicine manufacturing. The UK’s MHRA started a program called AI Airlock to safely test AI in healthcare settings. It also supports AI systems for quality control in pharma, but they stress the need for proper validation and managing changes carefully. Through its Innovation Passport scheme, the MHRA gives faster regulatory support to new AI-based pharma technologies. The ICH gives global guidelines that support quality control and risk management in pharma, which fit well with AI/ML use. Its Q9 guideline promotes advanced tools like AI for managing risks. Also, the Q13 guideline supports AI in continuous manufacturing by setting clear rules for process monitoring and control that work well with AI systems. Main Regulatory Challenges Validation and CheckingOne big challenge in using AI/ML in pharma is checking (validating) the system properly, because these models keep learning and changing. Unlike old systems, AI does not stay the same. So, rules now ask companies to make proper plans for how and when the AI system will be updated. New ideas like “dynamic validation” and “predetermined change control protocol (PCCP)” help in keeping track of the AI system’s performance over time. Data Integrity (Honesty and Accuracy of Data)AI systems must follow ALCOA+ rules, which make sure the data is correct, complete, and can be checked later. Some AI works like a “black box,” which means we can’t easily understand how it made a decision. This makes it hard to track and audit data. That’s why “explainable AI” methods are being used so the AI can show how it reached a decision in a simple and clear way. Understanding and Clarity (Explainability and Transparency)Regulators want AI systems to be clear and easy to understand, especially when they affect product quality or safety. Tools like SHAP and LIME are helping to make AI decisions more visible and understandable. Companies are advised to build AI models that are easy to explain from the beginning, so people can trust and check their results. Managing Changes in AISince AI models keep learning and changing, there must be a system to manage these changes properly. Authorities expect companies to make a full plan for the AI’s life—from development to regular updates, checking, and control. A method called “progressive validation” helps in updating the model while following all rules without creating problems. Ethical and Legal IssuesAI systems can sometimes be unfair or biased. For example, if the data used to train AI is not balanced, it can give wrong or unfair results. Regulators now want companies to check for bias and make sure AI works fairly for all. Companies must take responsibility for the results their AI models give and make sure they are honest and fair. Easy Ways to Follow Rules While Using AI in Pharma Use Risk-Based ThinkingRegulators suggest using AI based on how risky the work is. If AI is used in something very important like medicine quality or patient safety, then it should be checked very strictly. But if AI is used in small jobs like making schedules, then it doesn’t need too much checking. Keep Full RecordsAll details about the AI model—how it was made, what data was used to train it, how it performs, and what changes are made—must be written and saved properly. This is very important for audits and approvals by the regulators. Human Checking Is Still ImportantEven if AI is doing most of the work, people must still check what it is doing. Experts must be there to see AI’s results, understand them, and stop or change things if needed. AI should help humans, not replace them. Set Up AI Monitoring TeamsPharma companies should make special
Why is India known as ‘Pharmacy of World’ ?
A few years ago, while working with an Indian multinational pharmaceutical company, I had the opportunity to tour its subsidiary company in Europe. I learned that manufacturers acknowledge India as a strong supplier of affordable generic medicines and active pharmaceutical ingredients (APIs), which play a key role in reducing healthcare costs across Europe. Indian pharma companies are seen as efficient and cost-competitive manufacturing partners, helping European companies reduce production costs through outsourcing and contract manufacturing. India is often called the “pharmacy of the world” because it supplies a large share of generic medicines to many countries, especially in developing regions like Africa and Latin America India holds a leading position in the global generic medicine production industry. It is the largest provider of generic medicines worldwide, supplying over 20% of global generic drugs by volume. India is also the third-largest pharmaceutical market by volume and plays a crucial role in making affordable medicines accessible to millions across the globe. Indian pharmaceutical companies are known for their large-scale manufacturing capacity, high-quality standards, and cost-effective production, which have helped India become a major hub for generic drug exports. Generic drugs are medicines that have the same active ingredients, strength, dosage form, and effectiveness as brand-name drugs but are usually sold at lower prices. They are approved by regulatory authorities once the patent on the original brand-name drug expires, allowing other manufacturers to produce and sell these equivalent versions. Generic drugs help make healthcare more affordable and accessible. Ranbaxy Laboratories, once one of India’s largest pharmaceutical companies, made its name by producing high-quality generic medicines. After the patents on many brand-name drugs expired, Ranbaxy developed and manufactured equivalent generic versions, offering them at much lower prices. This helped increase access to important medicines for patients both in India and around the world. For instance, Ranbaxy produced generic versions of popular drugs like atorvastatin (used to lower cholesterol), which was originally sold under the brand name Lipitor. By making these generics affordable, Ranbaxy contributed to the reputation of India as the “pharmacy of the world.” What are the key factors driving India’s rise as a growing power in the pharmaceutical industry? Let’s explore. India’s pharma success isn’t accidental—it’s the result of strategic policy, strong science, and sustained commitment. Policy transformations In 1970, India passed a special patent law. It allowed companies to copy the process of making a medicine, but not the actual product. This meant Indian drugmakers could figure out new ways to make the same medicines and sell them at lower prices. This clever move helped India become a world leader in making cheap, high-quality generic drugs. India Joins Global Rules in 2005:By 2005, India had to follow new international rules under the WTO’s TRIPS agreement. It started giving patents for drug products too. Even then, the country had already built a strong generic medicine industry, and Indian companies began supplying affordable medicines all over the world. Pharmaceutical manufacturing in India is much cheaper Inexpensive Infrastructure and Running Costs:Building factories and running them is much cheaper in India. Things like electricity, water, land, and other basic needs for running a pharma company cost less here than in countries like the USA or Europe. This helps companies reduce overall expenses. Easily Available Raw Materials:India can get many of the raw materials needed to make medicines from within the country itself, especially bulk drugs (also called APIs – Active Pharmaceutical Ingredients). Because of this, companies don’t have to depend too much on other countries. This saves money and time. Large-Scale Production Saves More Money:Many Indian pharma companies make medicines in very large quantities. When you produce more at once, the cost of making each unit (like each tablet or bottle) becomes lower. This is called ‘economies of scale’. It helps Indian companies sell medicines at cheaper prices and still earn profit. Government Support Helpful Government Policies:The Indian government has started many good programs to support the pharmaceutical industry. For example: Pharma Vision 2020, A program launched by the Department of Pharmaceuticals. The objective was to make India a global leader in end-to-end drug manufacturing. This program focused on encouraging research, infrastructure, and quality manufacturing, and helped attract foreign investments and support Indian pharma exports. The Central Drugs Standard Control Organization (CDSCO) has made approval processes faster and more transparent. Make in India encourages companies to manufacture medicines in India instead of importing. PLI (Production Linked Incentive) Scheme gives rewards to pharma companies that produce more and invest in innovation. These policies help Indian pharma companies grow stronger and more competitive. Government offers tax benefits and grants for research and development in biotech and pharma.Earlier, it used to take a lot of time to get approvals and clearances for making or selling medicines. But now, the government has made the rules simpler. With faster approvals and easier compliance, it’s now less stressful for companies to start and run pharma businesses in India.India is building special places like Pharma Parks and SEZs (Special Economic Zones) with top-class facilities like clean water, good roads, electricity, labs, and transport links. These help pharma companies set up their factories faster and export medicines easily to other countries. Capacity Building Many FDA and WHO-Approved Factories:India has more than 300 factories approved by the US FDA (Food and Drug Administration) – the highest number outside America. Many of these factories are also approved by WHO (World Health Organization). This shows that Indian factories follow strict international quality standards. Because of this, Indian medicines can be exported to strict markets like the USA and Europe. Can Make All Types of Medicines:Indian pharmaceutical companies are experts in making many different kinds of medicines. They make tablets, capsules, syrups, injections, vaccines, and even advanced medicines like biologics. This variety helps India supply medicines to countries with all types of health needs. Making APIs and Medicines Together:India is one of the few countries where companies make both the main ingredient (called API – Active Pharmaceutical Ingredient) and the final medicine (formulation) in the same