DRUGS LICENCE
The Drugs Control Department regulates the manufacture and sales of drugs and Cosmetics. The Government has laid down various drug laws under which the State Drug Controller deals with the licensing of both manufacturing and sale premises of drugs & cosmetics. Section 3(b) of the Drugs and Cosmetics Act,1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes.
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Types of Drug License
Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of licenses:
- Manufacturing License
- Sale License
- Wholesale License
- Retail License
- Loan License
- Import License
- Multi-Drug License
How to get Drugs Approval in India? A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. In general, a drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs.
Registration process of Drugs Registration
The applicant must apply online for the license as per the line of business, for which he/she must have a valid email id and contact number. The next step is to keep all the documents updated. Next is to upload the documents and the form along with the applicable fees. Upon completion of the online process, an inspector will visit the site and verify the validity of documents. If all the above steps have been duly complied with, the authority will issue the drug license.
Regulatory Authorities For Pharmaceutical Business
The drug regulatory authorities grant and renew the licenses to sell or manufacture Drugs and Cosmetics and to operate a blood bank. It grants approval for the laboratories to carry out tests and analysis on behalf of the manufacturers. They issue Free sale certificates and Good Manufacturing Certificates and Export registration documents, etc., for export registration if required. The business may also need a No conviction certificate, Performance certificate, a Market standing certificate granted by the regulatory authorities to participate in Government tenders. There are various regulatory authorities to regulate the business of Drug and cosmetic to ensure its safety and efficacy. Below is the list of licences and its regulatory authority:
| S no. | Type of License | Regulatory Authority |
|---|---|---|
| 1. | Allopathic Drugs Licence Veterinary Medicines licence Cosmetic manufacturing licence |
State Drug Controlling Authority |
| 2. | Blood Banks, Blood components & Blood Products like Vaccines, Sera and Parenterals, |
State Drug Controlling Authority with an approval by the Central License Approving Authority |
| 3. | Ayurvedic Medicines Siddha Medicines Unani Medicines Homeopathic Drugs Herbal Products For Medicinal Use Herbal Products For Cosmetic Use |
Department of Ayush |
| 4. | New Drug Approval including investigational and subsequent new drug Clinical trial (test Licence) Import of Drug and medical devices Import of Cosmetics |
Central Drugs Standard Control Organization (CDSCO) |
| 5. | Proprietary food like Herbal Powder and Churna where no Medicinal Use is claimed |
Food Safety and Standards Authority of India (FSSAI) |
Drugs License: FAQ
Ans: Yes, before you start any business dealing in manufacturing of Allopathic Drugs, Ayurvedic, Homoeopathic and also Cosmetics, it is mandatory to obtain a manufacturing license as per the nature of business by applying to the controller. For Wholesale and Retail Business of Allopathic Drugs and Homoeopathic Drugs, licenses are required but for business of Ayurvedic and Cosmetic selling, no license is required.
Ans: Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use.
Ans: Based on the requirement of the pharmaceutical business, an applicant must
apply for issue of specific drug license. There are various licenses, for example:
1. Drug Manufacturing License
2. Wholesale Drug License
3. Retail Drug License
Ans: In case a business is operating in more than one states, it has to obtain drug license in every state in which business is being carried on. Drug licence is issued on premises / site specific, and hence within state also all premises / sites must have under separate licences
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