Drug License and cosmetic license, both are registration to be taken to carry out business related to drugs and cosmetics. Drug license is a license to be taken by manufacturer, trader, stockist of drugs and medicines. Similarly, cosmetic license has to be taken for doing business related to manufacturer, trader, re-packers, re-labellers and stockist of cosmetics. Health Department of state regulates the manufacture, sales and distribution of drugs in the state of Bihar and Jharkhand by implementation of regulation of Drug and Cosmetic acts and rules thereto. Control is exercised over drugs from the raw material stage during manufacture, sale, and distribution and up to the time it is passed on to a patient or consumer by a Pharmacist in retail pharmacy, hospital or a dispensary. In 1964, Ayurvedic and Unani drugs were also included under the Drugs and Cosmetics Act, 1940. Licensing is mandatory to carry out business in Drugs & Cosmetics in India. The provisions for this is in Drugs & Cosmetics Act, 1940 which is applicable to whole of India. It is an Act to consolidate all the laws relating to drugs & cosmetics, which established the Drugs Control Department. The Act was amended in 1964 to include Ayurvedic & Unani drugs. However, a specific and particular business entity may require different types of drug license based on their business and nature of business, you may contact us for consultancy on it.
Thus, Drug license has to be taken by:
b. Wholesale traders (Stockists, Re-packers, Re-Labellers)
c. Retail traders,
Based on the requirement and necessity of the business, one can apply for issue of specific category of license. There are various licenses, for example,
- Manufacturing License
- Wholesale License,
- Retail License,
- Import of Drugs or Cosmetics
- Import of Medical Equipment
- Export of Medicines and cosmetics etc.
What are Eligibility Criteria?
Any individual, proprietorship firm partnership firm, llp or company willing to open a retailer medical store or wholesale medical outlets, has to take drug license from Labour inspector of its jurisdiction. The applicant will have to provide shop or office of appropriate area with own refrigerator.
Documents required for Drug License:
1. Copy of Pan card and Aadhaar card of Proprietor/Partner/Director
2. Two passport Size photographs of Proprietor/Partner/Director
3. Copy of Registration Certificate, Deed, Bye-Laws, MOA, AOA of Firm/Company,
4. Copy of Electricity Bill and Rent Agreement
5. Copy of Work Experience in case of Wholesale Drug License,
6. Copy of Consent letter of Pharmacist in case of Retail Drug License
How to apply for Drug license and Cosmetic License:
The following are the steps to be taken for obtaining the license:
- The applicant must apply online or offline (as applicable in his or her state) for the license as per the nature of business,
- The drug inspector may visit the premise or shop or office of applicant,
- After finding all information correct, concerned authority may issue provisional license,
- After 15 days or end of specified period, final license is issued to final drug license or cosmetic license.
Validity of Drug License:
1. Wholesale Drug License is valid for 5 years,
2. Retail Drug License is valid for 5 years.
Renewal of Drug license:
An application for renewal of wholesale drug license and retail drug license has to be made before date of expiry of Drug license. After expiry, an application for issue of fresh issue may be made. Similar is the case with Cosmetic License.