Updated on July 06, 2024 06:25:00 PM
Drug license registration is a necessary certification for manufacturers of drug and cosmetic products in Kerala. It is obligatory for all drug manufacturers and producers. The primary aim of issuing a drug license for the production of medicines and cosmetics is to regulate and ensure quality control in the production of both generic and non-generic drugs nationwide. Additionally, it serves to instill trust among consumers in both local and international markets.
The drug license registration is a mandatory compliance for manufacturers of medicines, cosmetics, and other traditional drug-related businesses in Kerala. Given Kerala's position as a global pharmacy, it has become imperative for authorities to regulate this sector, ensuring the quality and credibility of the Keralan drug manufacturing sector on a global scale. Therefore, obtaining a drug license certification is a critical step for all medicine manufacturers.
Now, let's explore the legal framework that governs drug certification for manufacturers and highlight the government's initiatives to support and regulate the manufacturing sector in Kerala.
Manufacturing Drug License Certificate Sample
A Manufacturing Drug License certificate is a form of registration or permission granted to drug and cosmetic manufacturers in Kerala by drug control authorities. This certification is a statutory requirement under the Drugs and Cosmetics Act and Rules. Manufacturers need to submit applications under forms 24, 24A, and 24B for manufacturing drug licenses.
These prerequisites are essential for starting a drug/medicine and Cosmetics manufacturing in Kerala.
Drugs are categorized into the following:
General Documents
Documents required for Manufacturing License
The professional fee for manufacturer drug license with us is INR 49,999/- only. Applicants are required to pay a government fee during the registration process as required respectively.
Note: The aformentioned Fees is exclusive of GST.
An online login user ID and password are created on the portal to initiate the drug license registration process with the central licensing authority for drugs and cosmetics.
After the creation of user login credentials, our experts will verify all the required documents for a retail drug license before filing a formal application with the central licensing authority for registration.
Once documentation is completed, a formal application will be filed under the respective forms for a manufacturing drug license, along with other relevant forms.
Licensing authorities will conduct a formal inspection for authorization of the drug certificate for manufacturers. The registration process is expected to take around 30 days to complete.
At Professional Utilities, we leverage our industry knowledge and expertise to help businesses navigate complex regulations, minimize risks, and optimize operations for maximum efficiency and profitability.
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Manufacturers of drug and cosmetic products are mandated to obtain authorization from the Drug Controller General to commence operations in Kerala. This is a necessary procedure for drug and cosmetic manufacturers, requiring approval from the central licensing authority.
Yes, manufacturers of drug and cosmetic products are required to have a Drug license for manufacturing in Kerala.
The professional fee for manufacturer drug license is INR 49,999/-
It takes around 30 working days to get a drug license in Kerala.
Yes, as per the guidelines of D&C Rules 1945, any entity dealing in a list of scheduled drugs is required to have a drug license in Kerala.
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