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Any business in India must have the proper licences in order to operate. A drug licence is a valid government authorization to operate a business that sells medications and cosmetics. Each state requires a different licence if the business activity takes place in two or more states, and must obtain a separate licence if sold at more than one site. This is because drug licences are region- and location-specific. The drug licence covers both the production and selling of drugs.
In comparison to the global pharmaceutical industry's predicted growth of 5% from 2015 to 2020, the Indian pharmaceutical industry is expected to increase by nearly 16% annually. The Indian pharmaceutical industry has enormous potential, which provides opportunities for entrepreneurs and start-ups engaged in the pharmaceutical industry. According to the 1940 Pharmaceuticals and Cosmetics Act, a drug licence is required for any pharmaceutical businesses operating in India that deal with drugs, medications, and cosmetics. To lawfully conduct business in the pharmaceutical industry, including the sale of Ayurvedic and Unani medicines, one must get a drug licence.
Depending on the nature of your pharmaceutical business, different types of drug licenses are required.
A company that manufactures homoeopathic and allopathic medicines is granted a manufacturing licence.
Depending on the sort of activity the company engages in, the sale licence includes two subcategories - wholesale and retail.
A loan licence is given to the applicant who plans to manufacture their medications using the machinery, personnel, and equipment of another registered manufacturer.
If the applicant intends to bring drugs into India from any other country, they must apply for an import licence with CDSCO.
A drug license is required for any pharmaceutical businesses operating in India that deal with drugs, medications, and cosmetics.
To be eligible for a drug license, the applicant must meet the following criteria:
The following documents are required for drug license application:
The following is a concise description of the procedure for obtaining a drug license.
Get in touch with our experts to discuss your drug license requirements and business plan.
Register on the drug licensing portal. After registration, login information is sent to the registered email address or mobile number.
Update the information on qualified individuals and registered pharmacists on the portal.
Submit all requisite details and upload necessary documents. The application is submitted with required payments.
A drug inspector visits the location to authenticate the location and check the originality of documents. The inspection report is submitted to DLA.
Based on the inspection report, the final license is issued by the Drug Licensing Authority.
The drug manufacturing license is valid indefinitely, subject to compliance with periodic inspections and regulatory requirements. To maintain the license, businesses must:
We manage every step, document, and follow-up with the Drug Licensing Authority so you can focus on your pharmaceutical business.
We verify your eligibility and ensure all required documents are complete and valid.
Complete drug license application drafting and verification to ensure error-free submission.
Assistance in verifying pharmacist qualifications and registrations.
Guidance on preparing premises for drug inspector visits.
Complete application filing through the drug licensing portal.
We respond to all queries from the Drug Licensing Authority on your behalf.
Regular follow-up with DLA to ensure timely processing of your application.
Assistance with post-license compliance, renewals, and regulatory updates.
Help with preparing and organizing all required documents for the application.
Talk to a First Auditor specialist today — get a clear fee quote and document checklist before you start.
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