Starting a drug manufacturing business in India in 2026 offers strong potential. Rising domestic demand, global export opportunities, and supportive government policies are the driving factors for this booming industry. However, success requires strict compliance with CDSCO licensing, GMP standards, and revised Schedule M guidelines. Moreover, you need to mandatorily secure the CDSCO drug manufacturing license to enter the pharma manufacturing industry.
Potential for starting a drug manufacturing business in India in 2026
- Expanding domestic market: India’s pharmaceutical market is projected to grow steadily, driven by rising chronic diseases, such as diabetes and cardiovascular conditions. Additionally, the demand for affordable generics and branded formulations is increasing across urban and rural areas. Moreover, government healthcare schemes are expanding access, thereby boosting consumption of essential medicines. Thus, this creates a strong baseline demand for new manufacturing units.
- Global export opportunities: India remains the world’s largest supplier of generics, exporting to over 200 countries. Regulatory harmonization and faster CDSCO approvals in 2026 make it easier to align with US FDA and EU standards. Emerging markets in Africa, Southeast Asia, and Latin America are heavily reliant on Indian drug exports. A new entrant can tap into these regions with cost-effective production.
- Policy and incentive support: The government’s production linked incentive (PLI) scheme continues to encourage domestic manufacturing of APIs and formulations. Budget 2026–27 emphasizes biopharma, AYUSH modernization, and export-oriented manufacturing. Simplified CDSCO rules now reduce approval timelines, thereby lowering entry barriers for startups. These policies collectively create a favorable ecosystem for new pharma manufacturing businesses.
- Cost and infrastructure advantage: India offers lower labor and operational costs compared to global competitors. Industrial clusters in states, like Gujarat, Maharashtra, and Telangana, provide ready infrastructure and logistics support. Access to skilled chemists, pharmacists, and engineers ensures a strong talent pool. This cost-efficiency allows new manufacturers to remain competitive globally.
- Innovation and diversification potential: Beyond generics, India is pushing into biosimilars, biopharma, and nutraceuticals. The Biopharma Shakti initiative supports advanced R&D and manufacturing capabilities. AYUSH and herbal medicines are gaining global traction, opening niche opportunities. Diversification into these segments can future-proof a new business against market shifts.
For starting a drug manufacturing business in India, you need to mandatorily have the CDSCO manufacturing license. In this blog, we have prepared a detailed guide on how to secure the CDSCO drug manufacturing license in 2026.
CDSCO drug manufacturing license
- Form 25 license: Form 25 is the CDSCO drug manufacturing license issued for manufacturing non-biological drugs in India. This encompasses a wide range of pharmaceutical products, including tablets, capsules, ointments, and other non-biological formulations. Manufacturers aiming to produce these non-biological medicines for sale or distribution must obtain the Form 25 license. It ensures that the production facility adheres to the standards set by the regulatory authorities. The license guarantees the safety, efficacy, and quality of the medicines produced.
- Form 28 license: Form 28 is CDSCO drug manufacturing license issued for manufacturing biological drugs in India. This license is for manufacturing, selling, or distributing biological products, which can include vaccines, blood products, and other biologically derived medicines in India. Form 28 license demonstrates the biological products are produced under stringent conditions. It indicates their safety, efficacy, and adherence to the quality standards set by the regulatory bodies.
Requirements for CDSCO drug manufacturing license
Document requirements
- Land registration certificate
- Partnership deed / article of association
- Owner’s ID proof
- Technical staff documents
- Fire NOC
- Pollution NOC
- Layouts
- Plant master file
- Fees challan
- Application form
Land requirements
- Minimum 10,000 sq mt
- Square or rectangle plot
Step-by-step guide to get CDSCO drug manufacturing license in 2026
- Preparation and site setup: Ensure premises comply with Good Manufacturing Practices (GMP) and revised Schedule M. These are basic and mandatory requirement for setting up a drug manufacturing facility and securing CDSCO drug manufacturing license.
- Register on the SUGAM Portal: Register as an applicant on the CDSCO SUGAM Portal for online submission.
- Product classification and documentation: Identify the drug category (biological or non-biological). Prepare the Plant Master File (PMF) and product technical dossiers.
- Application submission: File the application using the appropriate application forms along with the required documents and pay the prescribed fees.
- Inspection: The Drug Inspector or regulatory authority will inspect the manufacturing facility to check compliance with GMP norms.
- Grant of license: If the inspection and documents are satisfactory, the license is granted. The CDSCO drug manufacturing license will be issued on Form 25 or 28, as applicable.
Pharmadocx Consultants: Your trusted partner for easily obtaining the CDSCO drug manufacturing license in 2026
At Pharmadocx Consultants, we offer all-encompassing services tailored to the pharmaceutical industry. Our services include expert layout designing for optimal factory setup, meticulous documentation to ensure regulatory compliance, thorough audits to maintain the highest standards. Additionally, we provide insightful regulatory consultations and assistance in obtaining WHO-GMP certification. With our comprehensive approach and over 27 years of experience, we will help you easily obtain the CDSCO drug manufacturing license. Our services catering to the pharma industry are as follows:
- Factory layout design service: We will visit your premises, take measurements, and design an industry-standard layout. We design the facilities for efficient working with requisite cleanliness levels. Facilities designed by us will comply with GMP, revised Schedule M, and all industry standards.
- Documentation services: We will prepare all the necessary supporting documents required for the CDSCO drug manufacturing license application. Additionally, we will compile the dossier per regulatory guidelines.
- Machine selection: We understand that the right machinery is pivotal for optimal pharmaceutical production. Leveraging our deep industry knowledge and technical expertise, we guide pharma factories in selecting machines that best align with their specific use cases.
- Audit services: We offer specialized factory audit services tailored to ensure compliance with WHO GMP and government standards. Our goal is to identify areas of improvement, provide actionable insights, and ensure that your factory not only meets but exceeds the stringent standards set by global and local regulatory bodies.
- License application service: We will file the drug manufacturing license on your behalf as well as walk you through the application process.
- Regulatory liaison: We will act as a regulatory liaison between you and the CDSCO. Our team will provide accurate and timely response to the CDSCO queries.
- Post licensing support: We not only provide support till successful license grant but also provide post licensing support. Our team will help you with license renewal and staying updated with the latest guidelines.
Need help securing the CDSCO drug manufacturing license in India? Drop an email at [email protected] or call/Whatsapp on 9996859227 to avail our comprehensive service.
FAQs
Do I need a license to manufacture drugs in India?
Yes, you need to secure the CDSCO drug manufacturing license to manufacture drugs in India.
Is the CDSCO drug manufacturing license application process online?
Yes, the drug manufacturing license application process will be online on the SUGAM portal.
What is the Form 25 license?
Form 25 license is the CDSCO drug manufacturing license issued for manufacturing non-biological drugs in India.
What is the Form 28 license?
Form 28 license is CDSCO drug manufacturing license issued for manufacturing biological drugs in India.
Do I need to comply with revised Schedule M to setup a drug manufacturing facility in India?
Yes, you need to mandatorily comply with revised Schedule M to setup a drug manufacturing facility in India.
