Need 印度的藥品許可證 to Trade in Pharmacy?
We can help you get Drug Manufacturing License, Drug Import License, Drug Retail and Wholesale distribution and other 印度的藥品許可證.
Drug Licenses
Under the Drugs and Cosmetic Act of 1940, the competent authority awards a drug licence to conduct a business involving drugs/medicines or cosmetics. In other words, no one in India may establish or run a medication or cosmetics company without a licence from the relevant government. The Pharmaceuticals and Cosmetics Act of 1940 governs all forms of medications and cosmetics businesses, including allopathic, homoeopathic, ayurveda, and unani drugs. Maintaining the quality of medications and cosmetics is the duty of everyone who works with them. Assume that everybody who consumes or uses a medicine or cosmetic suffers injury as a result of the manufacturer’s or seller’s carelessness. In that situation, the same is an offence that is triable as a grave harm offence under the IPC. As a result, it is critical to follow the licence requirements.
Regulatory Authorities For Pharmaceutical Business
印度的藥品許可證 to sell or produce drugs and cosmetics, as well as to operate a blood bank, are granted and renewed by drug regulatory agencies. It authorises laboratories to conduct tests and analyses on behalf of the producers. If export registration is necessary, they will give free sale certificates, good manufacturing certifications, and export registration documentation, among other things. To compete in government bids, the company may additionally require a No conviction certificate, a Performance certificate, and a Market standing certificate from the regulatory authorities. There are numerous regulatory authorities that oversee the drug and cosmetic industries to assure their safety and efficacy.
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| Type of License | Regulatory Authority |
|---|---|
| 1. Allopathic Drugs License 2. Veterinary Medicines license 3. Cosmetic manufacturing license | State Drug Controlling Authority |
| 1. Blood Banks, 2. Blood components & 3. Blood Products like Vaccines, Sera and Parenterals, | State Drug Controlling Authority with an approval by the Central License Approving Authority |
| 1. Ayurvedic Medicines 2. Siddha Medicines 3. Unani Medicines 4. Homeopathic Drugs 5. Herbal Products For Medicinal and Cosmetic Use | Department of Ayush |
| 1. New Drug Approval, Investigational and Subsequent new drug 2. Clinical trial (test License) 3. Import of Drug and medical devices 4. Import of Cosmetics | Central Drugs Standard Control Organization (CDSCO) |
| 1. Proprietary food like Herbal Powder and Churna where no Medicinal Use is claimed | Food Safety and Standards Authority of India (FSSAI) |
Common Types of License for Pharmaceutical Business in India
Retail Sale Drug License
An applicant seeks for a Retail Sale drug licence to sell drugs at retail. The word “Retail Sale” refers to a sale for end-user consumption. It is not intended for resale by the buyer. As a result, the purchaser is not obliged to have a drug licence. The medicine might be sold by a retailer to a hospital, dispensary, medical, educational, or research facility, or to anyone else.
Import License
It is required to import drugs in India. The Central Drug Standard Control Organisation (CDSCO) grants import licences for drugs.
Manufacturing License For Drug
It is a drug manufacturing license. Any method or portion of a process for creating, changing, ornamenting, completing, packaging, labelling, breaking up, or otherwise treating or adopting any medicine with a view to its sale or distribution is referred to as drug manufacturing.
Wholesale Drug License
A wholesale Drug license is required for a wholesaler of the Drug. The term “wholesale” refers to the selling of a product to someone who would resell it; hence, the purchaser of these pharmaceuticals must have either a wholesale or retail sale 印度的藥品許可證. Third-party manufacture is an option for wholesale. Third-party manufacturing refers to medications produced by a licensed manufacturer in accordance with the specifications of its customer, i.e. a wholesaler. Before producing any medicine under the Wholesaler brand, such a producer will need to get a brand affidavit. The manufacturer (Marketed by) and the Wholesaler will be printed on the product packaging (Marketed by-).
Loan License
It is a permit to produce the medicine on the premises and facilities of other manufacturers. The producer who offers the facilities for the medicine’s manufacturing must have a valid 印度的藥品許可證 and excess manufacturing capacity.
Required Documents For Obtaining Drug License
| A. Entity Documents |
| 1. Registration Certificate, Memorandum of Association (MOA), Article of Association (AOA), Pan Card Copy of entity (in case of company) 2. Registration Certificate, LLP Agreement and PAN card copy of Entity (in case of LLP) 3. Partnership deed and pan card copy of the entity (In case of Partnership) 4. Any establishment proof in case of proprietorship (Not mandatory) |
| B. Each Director/proprietor/partner Documents |
| 1. Passport size Photograph 2. Pan card, Aadhar card, Address proof 3. Affidavits for directors/proprietor/partners |
| C. Premises Related |
| 1. Rental Agreement in the name of the entity. (Note*) 2. Ownership proof of the premises ie. Latest electricity bill, property tax paid receipt and sale deed(property papers) of the premises 3. Site plan and key plan of the premises with total area, dimensions, name of the firm, address mentioned on it. |
| D. Technical person documents |
| 1. Affidavit regarding non-conviction 2. All educational documents such as certificate and marksheet of graduation including 10th and 12th class documents. 3. ID proof & address proof including PAN , aadhar, and photo of the premises 4. Biodata and Appointment and consent letter in existing firm 5. Registration certificate and PPP card from state Pharmacy council in case of Registered Pharmacist. 6. Copy of experiences certificate of at least one year in case of experienced person. |
| E. Other documents |
| 1. List or details of directors/proprietor/director. 2. Board resolution or Authorization Letter |