The journey from the birth of a concept to the approval of a product is a difficult one especially when faced with tough regulations.
Barrocyte Consultants offers a cost-effective and comprehensive method to make this journey smooth and easy.
Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of government. But the right to sell drugs and medicines has to be given cautiously. Hence the government has stringent rules for granting licenses for the selling of drugs and medicine. We at Barrocyte assist in getting hustle free grant of Drug License in the stipulated time line.
To obtain a drug license, the following conditions must be met: - **Pharmacist/Competent Person:** A qualified pharmacist is required for retail licenses, while wholesale licenses require a graduate with 1 year of experience or an undergraduate with 4 years of experience. - **Space Requirement:** Retail and wholesale premises must be at least 15 sq. meters; individual licenses require 10 sq. meters. - **Storage Facility:** Refrigeration is mandatory for drugs requiring low temperatures. - **Technical Staff:** Retail pharmacy staff must have in-depth knowledge; wholesale staff must have relevant experience.
Steps to obtain a drug license: - Apply online with a valid email, contact number, and PAN number. - Ensure all documents are updated and ready. - Upload the documents and pay the applicable fees. - Authorities will inspect the premises for compliance. - Upon successful verification, the drug license is granted.
The following documents are required: - Entity proof: MOA, AOA for companies; partnership deed for partnerships. - ID and address proof of proprietor/partners/directors. - Property documents: Ownership proof or rental agreement. - Site and key plan of premises. - Proof of cold storage or refrigeration facilities. - Affidavits of non-conviction for proprietor/partners/directors. - Affidavit of registered pharmacist/competent person.
Different types of drug licenses include: - **Wholesale Drug License:** Required for selling drugs to retailers or distributors. Forms: 20B & 21B. - **Retail Drug License:** Required for selling drugs to end consumers. Forms: 20 & 21. - **Restricted Drug License:** For general stores with limited drug sales. Forms: 20A & 21A.
| Category | Sale Type | Application Form | License Form |
|---|---|---|---|
| Drugs other than Schedule C&C (1) & X | Whole Sale | 19 | 20-B |
| Drugs other than Schedule C&C (1) & X | Retail Sale | 19 | 20 |
| Drugs other than Schedule C&C (1) & X | Restricted (General Store) | 19-A | 20-A |
| Drugs in Schedule C&C (1) but not in Schedule X | Whole Sale | 19 | 21-B |
| Drugs in Schedule C&C (1) but not in Schedule X | Retail Sale | 19 | 21 |
| Drugs in Schedule C&C (1) but not in Schedule X | Restricted (General Store) | 19-A | 21-A |
| Drugs in Schedule ‘X’ | Whole Sale | 19-C | 20-G |
| Drugs in Schedule ‘X’ | Retail Sale | 19-C | 20-F |
| Drugs from motor vehicles | Whole Sale (Non-Schedule C&C (1)) | 19-AA | 20-BB |
| Drugs from motor vehicles | Whole Sale (Schedule C&C (1)) | 19-AA | 21-BB |
| Homoeopathic Medicines | Whole Sale | 19-B | 20-D |
| Homoeopathic Medicines | Retail Sale | 19-B | 20-C |
Blood Transfusion Service is a crucial part of the National Health Service, with no substitute for human blood and its components. Advancements in transfusion technology have led to stricter quality control of blood and its products. While some countries delegate the management of blood transfusion services to NGOs like the Red Cross, the government remains responsible for ensuring high standards. Formulating a national blood policy with proper regulations is essential to maintain safe and effective services.
A licence for the operation of a Blood Bank or processing whole Human Blood for components shall be issued in Form 28-C, 28-E, 26-G, or 26-I, depending on the specific operation.
Before granting such a licence, specific conditions must be fulfilled by the applicant.
The functioning of the Blood Bank must be under the active direction and supervision of qualified technical personnel.
This includes a full-time Medical Officer with one of the following qualifications:
• A Postgraduate degree in Medicine such as M.D.
in Pathology or Transfusion Medicine.
• An MBBS degree along with a Diploma in Pathology or Transfusion Medicine, with sufficient knowledge in blood group serology and blood procurement principles.
An MBBS degree with one year of experience in a Blood Bank during regular service, also demonstrating adequate knowledge and experience in serology and component preparation.
The degree or diploma must be from a university recognized by the Central Government..
The Blood Bank licence in Form 28-C, Form 28-E, or renewed in Form 26-G or Form 26-I is valid for five years unless suspended or cancelled. The validity starts from the date it is granted or renewed.
Sanitary Import Permit (SIP) is a certificate stating the sanitary conditions listed by the Government of India for the importation of livestock and livestock products. It is not a license but a document that informs exporting countries to follow the sanitary conditions listed under the Livestock Importation Act. Traders can import the animal and animal products from the exporting country only through the seaports or airports of Bangalore, Chennai, Delhi, Hyderabad, Kolkata and Mumbai. We at Barrocyte assist you in getting the Sanitary Import Permit (SIP) in the stipulated time manner.
Proforma Invoice.
Packing List.
Product Catalogue.
Product Specification.
Microbial Data Sheet.
Process Flowchart.
Import-Export Certificate.
The validity of the permit varies depending upon the livestock products and from three months to one year. The importer can carry out as many shipments as required as per the quantity permitted by the SIP within the stipulated period. The Department may extend the validity of the permit on request from the traders.
All imported items—whether personal or commercial—must undergo customs clearance, with applicable duties paid before release. Imported cargo is held in customs-bonded areas until cleared. The process includes documentation, duty assessment, and cargo delivery.
Barrocyte Consultantsensures smooth and speedy customs clearance for consignments arriving by air, sea, or land, handling all trade compliance so you can focus on growing your business.
Our team of legal experts and network of customs clearing agents across India provide tailored solutions to optimize your time and reduce customs duties effectively.
We ensure compliance while minimizing delays.
We help you navigate complex import-export trade regulations.
Our team ensures that you follow the correct processes and documentation for smooth and compliant customs clearance.
With years of experience, we’ve worked with companies dealing in Drugs, Medical Devices, Cosmetics, Livestock, Chemicals, and more.
Our knowledge ensures that your goods are handled efficiently and compliantly.
From documentation consulting to mapping the most efficient cargo routes, we offer complete support for Import and Export Customs Clearance.
We are dedicated to enabling your business growth through reliable services.
Here’s what our clients say about us.
❝This service has completely transformed our logistics operations.❞
Co-Founder at xyz
❝Highly professional and always reliable for international trade needs.❞
Manager at xyz
❝We’ve saved time and money with their custom clearance solutions.❞
Founder / CEO at xyz
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