Aleph Accreditation & Testing Centre Pvt Ltd.
DRUG LICENCE
DRUG LICENCE: Drugs are necessary for maintaining human health. Medicine is the only weapon that can be used to fight diseases. Drugs are different from other commodities, so the government has enacted strict regulations. The Drugs and Cosmetics Act of 1940 and the Rules adopted under it regulate the production, importation, distribution, and sales of drugs.
The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India. CDSCO is responsible for approving drugs, granting import licenses, conducting clinical trials, establishing drug standards, monitoring the quality of drugs imported into the country, and coordinating the activities of State Drug Control Organizations by providing expert advice to achieve uniformity in the enforcement of the Drugs and Cosmetics Act.
RESPONSIBLE AUTHORITY FOR DRUG LICENCE
State Drugs Standards Control Organization (SDSCO) - State Authority, in collaboration with CDSCO, is responsible for granting licenses to manufacturers and sellers in the business of drugs and cosmetics on a state level. A license is required for each location if the business operates in many states. The CDSCO, in collaboration with state regulators, is responsible for granting licenses for some specialized categories of vital drugs, including blood and blood products, intravenous fluids, vaccines, and sera.
TYPES OF DRUG LICENCES
1. Drug Licence for retail sale and wholesale of Drug
(a) License for the sale of Allopathic and homoeopathic medicines by retail
(b) License for wholesale of Allopathic drugs and homoeopathic medicine
(c) License for sale of the restricted drug by retail and wholesale
2. Drugs Licence for manufacturing of drugs
3. Import license for drugs
1. Retail Sale Drug Licence(Chemist Shop) and wholesale drug licence
The sale of drugs to the end-user is referred to as retail sales. Drugs can be sold to a hospital, dispensary, medical, educational, or research institute, among other places by retailers. A drugs license is mandatory for retailers or chemist stores by the Drugs and Cosmetics Act. The State's Drug Control Authority also provides a retail license. If a person sells drugs without a license, he shall be punishable for one to three years imprisonment as well as a fine.
A wholesale license is given to a firm, distributor, or independent agent, an authorized Indian representative for a domestic or foreign manufacturer. CDSCO issues wholesale drug licenses for those who deal in wholesale distribution of drugs.
2. Manufacturing Licence for Drug
State Authority, in collaboration with CDSCO, is responsible for granting licenses to manufacturers, sellers who are in the business of drugs and cosmetics on a state level. A manufacturing license is granted to the manufacturer of Allopathic and Ayurvedic drugs and cosmetic products by the concerned State authority.
3. Import Licence
Drugs and Cosmetics can only be imported into India only after getting an import license from CDSCO. CDSCO is responsible for approving drugs, granting import licenses, establishing drug standards, conducting clinical trials, monitoring the quality of drugs imported into the country.
DOCUMENTS REQUIRED FOR RETAIL/WHOLESALE LICENSE
The following document are required for drug licence:
- Receipt of Online fee deposit
- Application Form
- The premises' site plan and key plan
- Memorandum and articles of association Partnership deed, duly attested by Notary Public, in case of the partnership firm. Trust deed, in case of trust/society
- Photo ID proof of firm proprietor/partner/director
- Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940
- Affidavit from a licensed pharmacist or other competent people.
- For Sale at Retail
Proof of qualification for a registered pharmacist, such as a final degree certificate or a provisional certificate with mark sheets
Appointment Letter and Bio-data - Competent person For Wholesale License:
Final degree certificate / provisional certificate with mark sheets as proof of qualification
Experience Certificate
Appointment Letter and Bio-data
- Premises documents like a rent agreement, regd. Sale deed
BASIC REQUIREMENT FOR WHOLESALE AND RETAIL DRUG LICENSE
To grant retail/wholesale licenses, the applicant must provide an independent shop with sufficient space, as detailed below:
- For grant of a license, the premises are of an area of not less than 10 square meters for retail and 15 square meters for wholesale.
- The clear height of the sale premises must comply with the National Building Code of India, 2005, as revised from time to time.
- All documents must be self-attested by the applicant/authorized person for the sake of validity and to assure confirmation of having submitted the same.
- If a retailer is involved in the drugs business in more than one state, each state will require a separate license.
PROCESS TO OBTAIN DRUG LICENCE
The processes to obtain a drug license are as follows:
- Submission of application online with all required documents: Applicant has to apply online with all required documents. All the documents should be scanned in and then should be uploaded online.
- Inspection of the premises: Inspection of premises will be done by a drug inspector of the responsible authority. The audit is conducted by a drug inspector appointed by the authorities, who inspect the premises to see if the information provided by the applicant is correct.
- Scrutiny of all documents: The inspector will verify the original documents at the time of inspection. The license will be granted if he considers everything satisfactory. If necessary, the licensing authority may ask for additional documents.
- Grant of license: The Drug Control Department issues the Drug License if they are satisfied with all documents. Licenses/approvals with a valid e-signature and official seal will be sent to the applicant.
HOW TO OBTAIN A DRUG LICENSE FOR RETAIL AND WHOLESALE?
A drug license is required to open a drug store. For businesses, we provide drug license services as well as substantial regulatory support. Whether you are a retailer, distributor, or manufacturer of pharmaceuticals and cosmetics in India or overseas, you can contact Aleph INDIA directly for any form of drug license. Aleph INDIA guarantees that you will receive your license promptly. For pharmaceutical businesses seeking a license and testing facility in India, we offer a complete solution. Visit Aleph INDIA for further information.
For more queries, feel free to contact us at inbox@alephindia.in, info@alephindia.in
Telephone: 9990136656