Whether you are operating a drug manufacturing business or an import business, obtaining a
drug license online in India is crucial. The regulations set forth by the Central Drugs Standard Control.
The organisation require the possession of a drug certificate. Furthermore, obtaining the drug
certificate is a legal obligation. The flourishing Indian market fosters significant development and
enhances credibility. As the market evolves, new entrepreneurs are emerging within it. Imagine
you enter the pharmaceutical industry but fail due to a lack of a certificate.
In many cases, the manufacturers get stressed due to the complex registration procedure and
hard legal requirements. But the challenge they face is not registering with the CDSCO for a
pharmacy license. Let’s dive into this blog to gain an understanding of the drug license
online procedure without dealing with challenges.
What is the Purpose of Drug Safety Certification?
For regulators and patients, the drug license serves as a mark of safety, quality, and efficacy.
Before the pharmaceuticals’ sale, production, and distribution, they are tested to ensure
standardisation. The further purpose of introducing the drug license online application mode is to provide market access only to registered manufacturers. The Drugs and Cosmetics Act, 1940, restricts the approval of those medications that are unregistered or have expired. Before the medication
enters the market, the product must align with government legal compliance requirements.
Through the drug licensing, the governing authority gets access to regulate the entire procedure
of pharmaceutical products’ distribution and manufacturing, as well as sale.
The drug license online process in India allows businesses to operate legally, preventing them from potential penalties. The organisations that are involved in the drug industry must understand the
regulatory authority guidelines and the standards that have been set in the Drugs and
Cosmetics Act. Before a medication is introduced to the market, it must comply with established
quality and safety standards.
Types of Drug Licenses Online in India
The drug safety certification is a compulsory step in India for manufacturers. But the drug
registration in India is categorized by its business nature. For example, if you are a
manufacturer, you need to secure a drug license online.
The types of certificates are:
● Manufacturing License: Manufacturers who produce drugs like allopathic,
homoeopathic and cosmetic medicines are required to obtain a manufacturing license.
● Loan License: The loan license is mostly obtained by businesses that don’t have their
manufacturing facilities. Well, in this situation, they use the registered, licensed
manufacturer.
● Import License: The products related to drug import in India for manufacturing or
retailing require securing an import license.
● Multi-Drug License: The businesses that are operating multiple pharmacy shops or
working for retail outlets under the same name need to secure the multi-drug license.
● Sale License: This license requirement is further divided into two licensing categories:
- Wholesale drug license: The businesses that sell the drugs to other retailers in bulk
need to secure a wholesale drug license. - Retail Drug License: The retail license is required by medical stores, pharmacies, and
other businesses, as their connection is directly to the consumers.
The Drug License Online Process in India
Whether you are a wholesaler, manufacturer, or retailer, securing the drug safety certification in India is critical. Well, since the online registration procedure has been secured, it also becomes seamless. Additionally, the online procedure involves the major documentation steps. For the drug registration, the applicant needs to be registered with the relevant authority. The online registration procedure is
Step 1. Determine the Type of Drug License You Need:
- Manufacturing License
- Wholesale Drug License
- Retail Drug License
Step 2. Understand State-Specific Requirements:
In India, every state’s drug regulatory authority is different. While their guidelines and requirements are also different.
The applicant understands the regulations and fee structure by visiting to official state portal. Well, the common regulatory authority, CDSCO, has its online portal.
Step 3. Essential required documents
The list of documents can vary, but the common required paperwork to apply for drug license online is:
- Select application Form 19, 19A, 19B, 19C, 20, 21, etc., according to your license type.
- The evidence of business registration like MOA, AOA, partnership deed, incorporation certificate, and PAN.
- The premises documents, like the ownership evidence, NOC, rental agreement (if applicable), business layout plan, and equipment facilities.
- Personal ID proof like an Aadhar Card or PAN card, including educational qualification certificates.
- Pharmacist/Competent Person Documents, such as certificates of qualification (degree/diploma certificates).
- The pharmacists must acquire the registration certificate from the State Pharmacy Council.
Step 4: Register on the CDSCO portal
Register on the state’s drug licensing portal or visit the CDSCO portal. Enter the mobile number or email ID to generate login credentials.
Step 5: Complete the application form
As per the license type, select the appropriate drug license online application form. Provide the details like business, personal, and premises.
Step 6: Attach the documents
Review all documents before submitting online. Documents must be in PDF form and written.
Step 7: Pay the registration fee
After the application submission, pay the government fee, which is compulsory. Save the fee receipt as proof of payment.
Step 8: Scrutiny and Inspection
The drug license online application will be reviewed by the Drug Licensing Authority (DLA). After that, the premise inspection will be conducted by a drug inspector to ensure compliance.
Step 9: The approval of the drug certificate
If the application and the facilities of the business meet the governing authority’s requirements, CDSCO confirms the approval via SMS or email. Need to respond early if any query is raised by officials.
Conclusion
Securing the drug safety certification in India is the gateway to gaining market access. The drug registration protects the health of patients from hazardous pharmaceutical products. During the drug licensing, appointing a professional expert is a beneficial step. The advisable legal seek from the CDSCO consultation can streamline the complex registration procedure. Meanwhile, the manufacturers can navigate the online drug certificate application procedure by following the above-mentioned steps.
