The world is in a constant search for a better rehydration solution. India is at the epicenter of this surge in the demand for oral rehydration solutions. In order to provide the public with a high level of health security. It is necessary to understand the manufacturing process carried out by the ORS manufacturer in India. In this blog, the reader will learn about the process of ORS production, the Indian government regulations, and the importance of safety.
Locating a reliable ORS manufacturing company in India can help in the production of high-quality electrolyte rehydration solutions. The production of high-quality ORS can help save lives by providing the necessary treatment for dehydration in the country.
The ORS Manufacturing Journey: From Formulation to Packaging
Smart Sourcing of Raw Materials
Every ORS manufacturer in India uses high-quality raw materials, including sodium chloride and anhydrous dextrose. These raw materials are tested in the lab to ensure compliance with the Indian Pharmacopoeia.
Blending of the Raw Materials
The active ingredients of the ORS are blended in a large mixer to create a uniform blend of powder. ORS production relies on ingredient blending. The ingredients must be mixed in the correct proportions to provide the correct balance of electrolytes.
Granulation of the Raw Materials
The ORS manufacturer in India use the granulation process in the production of ORS. The granulation process involves the use of high-tech machines to create uniform granules. The use of the granulation process in the production of ORS can help in the improvement of the solubility of the powder.
Sachet Filling and Sealing
The powder from the blending process is filled into a sachet at high speed using high-tech machines. The sachet must be sealed properly to keep the ORS dry. The presence of moisture in the sachet can disrupt the chemical composition of the ORS. The sealed sachets are packed into outer cartons, which display their assigned batch numbers and expiry dates.
Regulatory landscape – FSSAI vs Drug License
The complex regulatory environment of India creates obstacles that businesses must navigate throughout their operations. The reliable ORS manufacturer in India are required to obtain either a food license from FSSAI or a pharmaceutical drug license. The latest directives issued in the month of October 2025 have prohibited the use of the term ‘ORS’ for non-medicinal food products. Therefore, a legitimate ORS drug manufacturer in India has to function in strict compliance with the ‘Drugs and Cosmetics Act.’
The drug license can only be obtained with substantial capitalization for the infrastructure. The initial capital cost for the setup of a small-scale pharmaceutical manufacturing unit can vary from ₹6 lakhs to ₹12 lakhs. In contrast, a third-party liquid orals manufacturer in India can charge about ₹2 lakhs for the initial production batch. The purpose of compliance is to ensure the product is a medicinal preparation rather than a sweet drink.
- The ORS manufacturing company in India has to hold a valid WHO-GMP-certified drug license.
- The product has to conform exactly to the WHO formula for the low osmolarity ORS.
- FSSAI products are no longer allowed to use the ‘ORS’ brand name.
- The labels must specifically show the percentage of all the electrolytes present.
- Audits by the state drug controllers must take place regularly for the operations.
Quality Control and WHO GMP Safety Guidelines for Production
Implementation of WHO GMP Standards
Every professional ORS manufacturer in India has to comply with the ‘Good Manufacturing Practices’ standards for ensuring a sterile environment for production.
Maintaining Controlled Humidity Levels
The ORS powder has high moisture sensitivity. The ORS powder clumps when exposed to the atmosphere. Therefore, the production units must maintain the humidity levels below 40% by using high-end HVAC systems.
Rigorous Batch Stability Testing
Stability testing is carried out by quality assurance teams to ensure that the product is stable and resistant to extreme temperatures. The ORS product is effective for a period of two years.
Microbial and Chemical Analysis
Analytical chemists conduct full microbial testing, which ensures complete elimination of hazardous bacteria from the salt sample. Scientists perform active ingredient testing to verify that sodium and potassium concentrations stay within their necessary limits.
Documentation of ethical sourcing practices
The main ORS company that produces oral rehydration solutions keeps digital records of all product batches they produce. The system enables organizations to conduct product recalls with speed and effectiveness when safety issues arise.
Conclusion:
To understand the ORS industry, it is necessary to delve into the scientific, legal, and safety aspects of the industry. We have observed a top ORS manufacturer in India who meticulously follows every step, from the initial combination to the final packaging. Each step is vital to the patient’s recovery. Nutravends offers helpful information regarding the pharmaceutical industry, providing businesses with the opportunity to connect with the best ORS manufacturers. With these processes in place, any reputable ORS company continues to be at the forefront of the global fight to eliminate dehydrating diseases.
Frequently Asked Questions:
Q1. What is the difference between FSSAI and the Drug License for ORS manufacturers?
Ans. The drug license is required for therapeutic ORS, which is effective in treating the symptoms of medical dehydration. FSSAI licenses are required for food products, but these cannot be labeled ORS anymore.
Q2. How does WHO-GMP certification benefit the ORS manufacturer in India?
Ans. The WHO-GMP certification is required to ensure the ORS manufacturer is providing a product that adheres to the standards set by the World Health Organization. This certification also provides the manufacturer with confidence that their product is safe for consumption.
Q3. Can a third-party liquid oral manufacturer in India provide ORS in sachet form?
Ans. Yes, a third-party liquid orals manufacturer in India has the capability to create ORS sachets because most manufacturers produce both liquid & oral solutions. This solution assists brands that want to enter the rehydration market by supplying them with affordable solutions for their ORS products.
Q4. What are the key ingredients used by the ORS manufacturer in India?
Ans. The ORS maker combines sodium chloride with potassium chloride and trisodium citrate, and anhydrous dextrose to manufacture a product. This is a solution that provides essential patient energy according to the low-osmolarity WHO standards.
