Supplying over 20% of global generic medicines and approx. 60% of vaccines, India is one of the largest pharmaceutical industries in the world. With the spike in regulatory expectations and health awareness, the demand for quality entrusted medicines also increased. That demands outstanding pharmaceutical testing services to verify the quality and global standard requirements.
Drugs and Pharmaceutical Testing Services checks the medicines and guarantees the safety, efficacy, and compliance before they reach patients. If you’re looking for premium quality pharmaceutical testing services from a trusted source, we are here to help. Here are five critical things you should know about Drugs and Pharmaceutical Testing Services in India.
What Are Pharmaceutical Testing Services?
Every medicine is a hope, a prayer, and the beginning of a new life; Pharmaceutical Testing Services assures the quality, attributes, and properties it ought to have. It encompasses a wide range of scientific evaluations conducted on drug substances and drug products.
Premium quality pharmaceutical testing services include:
- Analytical Testing
- Chemical Analysis
- Instrumental Testing
- Stability and Shelf-life Studies
- Raw Material Testing
- Packaging Compatibility Studies
At ITC Labs, our goal is to ensure that every pharmaceutical product meets its intended quality standards, remains effective throughout its shelf life, and complies with national and international regulatory frameworks like FSSAI, NABL, ISO, WHO-GMP, and more.
In India, pharmaceutical product testing services are governed by agencies such as the CDSCO (Central Drugs Standard Control Organisation) and BIS (Bureau of Indian Standards). We take pragmatic steps to guarantee the quality, safety, and regulatory standards of medicines as per the national and international authorities.
Why Is Pharmaceutical Testing Critical?
When it comes to drugs & pharmaceuticals, quality assurance is a non-negotiable aspect. The slightest error in formulation, miscalculation of shelf-life period, or contamination through poor packaging can lead to dreadful consequences. Accurate testing ensures that the drug is safe and has no harmful contaminants, incorrect dosages, or side effects caused by impurities.
Pharmaceutical product testing services also help manufacturers to meet compliance requirements. Without robust pharmaceutical testing services, there are high chances of product recalls, license cancellations, or bans from international markets.
Another major factor that makes pharmaceutical testing critical is the international export requirements. Exporting to countries like the U.S., EU, and Southeast Asia requires certification from a Certified Drug Testing Laboratory List.
What Are Tests Typically Conducted For Pharmaceuticals?
With over three decades of industry leadership as a trusted pharmaceutical product testing laboratory, we at ITC Labs, carry out a wide range of safety & quality tests. The tests can be broadly classified into the following:
a) Dissolution, HPLC & Assay Testing
Assay testing ensures that the active ingredient is present in the right quantity, while content uniformity ensures consistent dosage in every unit. Dissolution determines the rate at which a pharmaceutical dissolves and helps in bioavailability studies.
These include tests for appearance, pH, dissolution, disintegration, and water content. Such tests are basic yet fundamental for understanding the drug’s physical and chemical nature.
b) Impurity Profiling & Residual Solvent Analysis
Impurity profiling and residual solvent analysis detect organic and inorganic impurities, including residual solvents, heavy metals, and degradation products. It is crucial for understanding the impurity level in drugs and ensuring the safety and stability.
c) Particle size analysis
Particle size analysis is integral for understanding the formulation consistency as it affects the dissolution rate, bioavailability, and stability of pharmaceutical products.
d) Extractables & Leachables
One of the major sources of contamination of pharmaceutical products is its own packaging material. Extractables and leachables tests ensure that the packaging material is of good quality and stays intact during external stress for the entire shelf-life period.
e) Microbiological Testing
At our dedicated microbiological labs, we conduct, testing for total microbial count, endotoxins, sterility, and specific pathogens like E. coli or Salmonella.
How to Choose the Right Pharmaceutical Product Testing Laboratory in India?
If you are a pharmaceutical manufacturer, you must know the struggles of finding the right partner for pharmaceutical product testing services. We are here to resolve that trouble for you. Abiding by the Indian Pharmacopoeia (IP), United States Pharmacopoeia (USP), European Pharmacopoeia (EP), British Pharmacopoeia (BP), and international guidelines for Nitrosamines detection and control, we are one of the top drug testing labs in India.
We are NABL-accredited and certified by the regulatory authorities to carry forward comprehensive testing solutions. Our team of testing experts, qualified chemists, microbiologists, and pharmacologists ensure that every sample we receive is tested to its fullest. With the most modern analytical testing equipment HPLC, GC-MS, FTIR, and UV spectrophotometers and digitalised operations with eLABSS LIMS, we offer timely and accurate results.
What is the Future of Pharmaceutical Product Testing Laboratories in India
India’s pharmaceutical industry is moving rapidly towards stricter compliance, digitisation, and internationalisation. With the rise of nutraceuticals, biosimilars, and personalised medicine, pharmaceutical product testing services are also adapting.
One major change happening in pharmaceutical testing laboratories as you read now is the shift from manual to digital. Apart from compliance requirements, laboratories are keen on having an effective and customised Laboratory Information Management System (LIMS) for traceability, faster reporting, and real-time analytics. Our lab is managed by eLABSS LIMS, one of the very few LIMS software with customisation options, a dedicated mobile application, and a customer portal.
At ITC Labs, we believe in providing the most reliable, tension-free and no-error testing solutions to our customers. Through this effort, we also aim to create a safer healthcare system for everyone.
Assuring Every Dose with Confidence
Pharmaceutical testing services always play a crucial role in the development of the ever-growing pharmaceutical industry. From verifying ingredient purity to testing stability and sterility, our services build the backbone of patient safety and public trust.
If you’re a manufacturer, healthcare stakeholder, or policymaker, choosing the right Pharmaceutical Product Testing Laboratory in India should be your key priority. And if you are wondering how to find a Certified Drug Testing Laboratory in India, you are in the right place. We offer reliable testing services at the most reasonable rates and deliver results in a short period.
Partner with us now to create a healthy, safe, and compliant world for everyone.