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National Single Window System (NSWS) Portal: An Overview
With the consistent rise in demand for medical devices and pharmaceuticals, a streamlined regulatory approval system was very necessary. Moreover, India is aiming to become the global hub for medical devices and pharmaceuticals. Thus, a platform for seamless and...
19 Common FAQs on Indian Regulations for IVDs
Invitro diagnostic devices have a vital role in the healthcare industry. Thus, the invitro diagnostic devices in India are stringently regulated to ensure patient safety. However, the Indian regulations for IVDs are confusing. Hence, we have curated some common...
14 Tips to Minimize Human Errors in Pharmaceutical Industry
Manufacturing pharmaceuticals is a complex process involving multiple steps. Additionally, strict compliance with regulatory guidelines, such as GMP, is required. The pharmaceutical industry is highly regulated to ensure the safety of the patients. Ideally, the...
The Need for Pharmacovigilance in Pharmaceutical Industry
Medicines and other healthcare products form the core of the healthcare industry and improve the quality of life of patients. Pharmaceuticals are used to treat, mitigate, and prevent diseases or disorders. However, pharmaceuticals may cause undesirable or...
11 Tips for Selecting the Best Suppliers for Pharmaceutical Industry
The quality of drugs being manufactured largely depends on the inputs and raw materials used for their production. Thus, suppliers of pharmaceutical industry raw materials have a critical role in the success of this industry. Hence, it is vital to evaluate the...
Schedule M Compliance: Mandatory for Pharma Companies
Mandatory Schedule M compliance is being enforced to establish India as a global pharmaceutical manufacturing hub. The Schedule M is aimed increasing the accountability of pharmaceutical manufacturers for the quality and efficacy of the pharmaceutical products. The...
What is Good Manufacturing Practices in Pharma Industry?
Good manufacturing practices in pharma industry regulate all aspects of the drug-production process for patient safety and improved patient outcome. In this blog, we have provided a detailed overview of GMP in pharmaceutical industry. Additionally, we have provided...
CDSCO Regulations for In-Vitro Diagnostic (IVDs) Devices in India
In this blog, we have presented the CDSCO regulations for invitro diagnostic devices in India. What are IVDs or In-Vitro Diagnostic Devices? In vitro diagnostics or IVDs are tests that are used to detect infections, diseases, and health conditions. The term ‘in vitro’...
Choosing a Pharmaceutical Contract Manufacturing Company
Pharmaceutical contract manufacturing is the outsourcing of the production of pharmaceuticals to third-party contract manufacturers. Outsourcing is beneficial for pharma companies, as it is cost effective and helps deliver the product in a timely manner. The contract...
Cleaning Validation in Pharmaceutical Industry: A Quick Guide
Pharma companies are required to consistently manufacture high quality, safe, and effective pharmaceuticals. When different drugs are manufactured in shared facilities, there is a high risk for cross-contamination. Hence, to consistently maintain the quality, safety,...
What is cGMP in Pharmaceutical Industry? The Need & Relevance
Current good manufacturing practices (cGMPs) are a set of guidelines for various products, including biologics, drugs, medical devices, and food. The specific cGMP regulations and guidelines vary depending on the specific product category. In this blog, we will focus...
How to start a Haemodialysis Solution Manufacturing Business?
Are you planning to start a haemodialysis solution manufacturing business in India? Well, you have landed in the right place. We have curated this detailed guide just for you. Dialysis: A life saving treatment for patients with kidney failure or ESRD If you want to...
Technology Transfer in Pharmaceutical Industry: What, Why, & How
Pharmaceutical industry technology transfer is vital to improve the quality of drugs available in the market. It is essential for drug discovery and development of new medicinal products. Herein, we have detailed what is technology transfer in pharmaceutical industry,...
How to Effectively Conduct Internal Audits in Pharma Industry?
The pharmaceutical industry is monitored and controlled by several regulations and standards. It is vital for pharma companies to comply with the regulations to continue functioning in this industry. Internal audits in pharma industry evaluate whether the company is...
Monitoring Regulatory Compliance in Pharmaceutical Industry
Regulatory compliance in pharmaceutical industry is complex yet vital for ensuring the safety, efficacy, and quality of drugs. Compliance with these regulations is not just a legal obligation but also necessary for protecting public health and fostering innovation....
What Are Good Distribution Practices for Pharmaceuticals?
Given the vital role of drugs in healthcare system, their quality and efficacy have to be regulated at every stage. Stringent guidelines are in place right from raw material procurement to the transportation of the finished product to the patients. Good distribution...
Selecting Pharmaceutical Manufacturing Equipment & Machinery
Setting up a pharmaceutical manufacturing company is a daunting task. To establish a pharma company, you need to set up a manufacturing facility equipped with various machineries and equipment. It is important to choose the appropriate pharmaceutical manufacturing...
How To Start a Pharmaceutical Manufacturing Company in India?
In this blog, we have curated a detailed guide for starting a pharmaceutical manufacturing company in India. Rise and rise of the Indian pharmaceutical industry Why should you consider starting a pharmaceutical manufacturing company in India? To answer this question,...
CDSCO Market Standing Certificate: Everything You Need to Know
Companies secure a market standing certificate to demonstrate the potential of their business. The CDSCO issues the market standing certificate for pharmaceutical and medical device companies. Read on to find out more about the CDSCO market standing certificate, its...
A Comprehensive Guide for Manufacturing Blood Bags
Blood bags are lifesaving critical medical devices. In this blog, we have detailed the process of manufacturing blood bags. We have also provided an overview of the Indian blood bag market. This will help you determine whether you should start a blood bag business in...
Manufacturing Stents in India: Types, Demand, And Regulations
Stents form the backbone of various minimally invasive surgeries, such as angioplasty. Read on to find out about the demand for stents in India. We have also provided an overview of the steps involved in manufacturing stents. What are stents? Stents are small...
How to Select the Appropriate Medical Device Manufacturing Site?
The current Indian market is conducive for setting up a medical device manufacturing business. Selecting the correct location for setting up your medical device manufacturing facility is vital for the success of your business. This blog provides some tips for...
3 Way Stop Cock Manufacturing Business : A Guide
3-way stopcocks have a paramount role in the healthcare industry. Their pivotal role in the healthcare industry ranges from controlling the flow of fluids to facilitating efficient patient care. It is important to understand the role of this device before starting a 3...
Surgical Sutures: Manufacturing, Regulations & Demand in India
Surgical sutures are essential for performing most surgeries. These medical devices are designed to facilitate the healing process. Most surgical or traumatic wound closure would require sutures. The increase in number of surgeries performed in India is boosting the...
Surgical Drapes: Details, Manufacturing & Regulations
Patients are highly susceptible to infections and infection related complications during surgery. This can have detrimental consequences. Surgical site infection or SSI has to be prevented for improved patient outcome and a successful surgery. Surgical drapes are a...
Pulse Oximeter Manufacturing Process: A Vital Medical Device
Pulse oximeters are used to monitor patients’ oxygen levels and pulse rates. They are of use to both patients and healthcare professionals. In this blog, we will highlight the vital role of pulse oximeters in the healthcare industry. Additionally, this blog will...
Disposable Syringe Manufacturing: Requirements and Regulations
Previously, glass was used for manufacturing reusable syringes. However, the healthcare industry has switched to single-use sterile plastic disposable syringes. Disposable syringes are currently in very high demand in India. Medical device manufacturing companies can...
7 Commonly Used Medical Device Sterilization Methods: A Guide
While using medical devices to diagnose, monitor, and treat patients, they come in direct contact with patients. They may be used externally or internally. Thus, proper sterilization of medical devices is necessary to reduce chances of infection caused by these...
Technology Transfer in Medical Devices: The What and Why
The Indian medical devices industry is dynamic and evolving. India is witnessing an increasing demand for technologically advanced novel medical devices. Technology transfer increases local production, thereby increasing access to advanced medical devices. Medical...
SaMD and SiMD: The Differences and Applicable Regulations
New-age technology and software are revolutionizing healthcare. Currently, software is being used to monitor, diagnose, prevent, manage, and even treat diseases. Software used in healthcare industry are available in different types and forms. The two main categories...
CDSCO License Retention Fee: Mandatory for License Validity
In a recent circular, dated 15.5.24, CDSCO has issued a reminder for license or registration retention under MDR, 2017. This reminder for license and registration certificate renewal requirements is intended for medical device manufacturers, importers, and testing...
Medical Device Process Validation Assures the Device Quality
Regulatory bodies require medical device manufacturers to confirm whether the finished product meets the set regulatory benchmark. Manufacturers need to have strict quality control systems to ensure the devices being manufactured comply with safety and quality...
Start Medical Device Business in India Without CDSCO License
Medical devices form the backbone of the healthcare sector. They are used to perform real time diagnosis of medical conditions as well as treat and monitor them. Medical devices industry is a booming sector in India. There is a high unmet demand for affordable,...
Medical Device Grouping: Simplifying CDSCO License Application
Medical device grouping has been introduced to enhance the license application process in India. Grouping of medical devices expedites and simplifies the CDSCO registration and license application process. In this blog, we will delve into the grouping of medical...
Choosing an Indian Authorized Agent for Medical Devices: A Guide
Authorized agent for medical devices oversees a foreign manufacturer’s regulatory compliance and import operations in India. This blog will guide you on how to choose an “Indian Authorized Agent” for launching your medical device in India. Who is an Indian authorized...
Plant Master File for Medical Devices Registration
Central Drugs Standard Control Organisation (CDSCO) regulates the safety, efficacy, and quality of all medical devices in India. The aim of this regulatory body is to ensure substandard medical devices do not enter the Indian market. To market your medical devices in...
Quality Control in the Medical Device Assembly Process
With advancement in technologies, medical devices have become complicated and intricate with several parts. Manufacturers need to assemble various parts of the medical device to produce a functioning finished product. Hence, medical device assembly quality control...
CDSCO Registration for MRI machine in India
MRI machines play a critical role in enhancing patient care. They help take informed decisions by providing a non-invasive three-dimensional internal view of the human body. In India, awareness regarding the important role ofdiagnostic imaging in early detection is...
BIS Standard for Medical Devices: Everything You Need to Know
India is witnessing a rise in prevalence of chronic, lifestyle, and age-related diseases. The need for advanced and affordable healthcare delivery system and government support are fueling the demand for medical devices. Thus, the Indian healthcare market is thriving....
CDSCO Registration for PPE: Everything You Need to Know
The COVID-19 pandemic highlighted the potential of the Indian medical devices manufacturing sector. During the pandemic, India manufactured and globally distributed medical devices, such as PPE kits, PCR kits, thermometers, and N-95 masks. India’s transformation in...