Barrocyte - Drugs services

Drug Regulatory Services

FOR MANUFACTURER

At Barrocyte Consultants, we help manufacturers overcome the barriers in preparing strong regulatory strategies and unambiguous dossiers for filing applications for various drug products approval. Experts from our team represent our clients at the SEC meetings to obtain unanimous approvals and permissions. Our constant guidance, thorough follow-up, and other services like clinical trial management, medical writing, etc., enable our clients to obtain successful approvals/permissions smoothly and apply for licenses.

CENTRAL – CDSCO

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Investigational New Drug (IND)

Investigational new drug” means any new chemical entity or substance which is under investigation in a clinical trial to assess its safety and efficacy. We help ease the manufacturer’s journey in the process of receiving approvals for new drugs under investigation that are waiting to be introduced in the Indian market.

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New Drug Approval (NDA)

We provide comprehensive solutions for new formulations, API, FDCs, new indication for existing drug, new dosage form, modified release dosage form, veterinary products, and for vaccines, recombinant DNA (r-DNA) derived products, monoclonal antibodies, stem cells, gene therapeutic products, and xenografts.

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Subsequent New Drug Approval (SND)

‘Subsequent new drug’ is an officially accepted term by CDSCO for new drug products of the same therapeutic class or different class for a new indication, strength, dosage form, or route of administration. Our regulatory experts guide you through the entire approval process.

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BE NOC for Export

The requirements for BE NOC depend on the drug, disease, and study type. Our experienced team provides end-to-end consultation on BE NOC requirements to ensure compliance with regulatory needs.

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Special Code/Neutral Code for Export

If you have an exported product that requires a special code on the label authorized by the Licensing Committee, we can obtain NOC for you. This applies to finished formulations, bulk drugs, narcotic drugs, and psychotropic substances.

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SEC Meetings

The Subject Expert Committee (SEC) evaluates clinical trial and new drug applications. Our team assists in preparation, presentation, and representation during SEC meetings to ensure smooth approval.

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Toxicity Studies

Toxicity testing assesses adverse effects of chemical and physical agents on biological systems. We ensure studies adhere to GLP and CDSCO guidelines, providing expert assistance in toxicity study needs.

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BE Studies

Bioequivalence (BE) studies assess therapeutic equivalence between two drug products. Our team provides comprehensive support to conduct BE studies smoothly and efficiently.

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Clinical Trials

We help clients obtain regulatory permissions from DCGI for clinical trials across Phases I, II, and III. Our team guides clients through approvals, protocol amendments, and required notifications.

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Medical Writing

Medical writing plays a critical role in therapeutic product development. Our services include literature searches, Periodic Safety Update Report (PSUR) writing, and full-scale medical documentation support.

STATE – FDA

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Manufacturing License

For manufacturing of Allopathic drugs/products, a Manufacturing License is required as per D & C Act, 1940. To obtain a manufacturing license, filing of correct documents as per the State Licensing Authority (SLA) and/or Central License Approving Authority (CLAA) is required, whichever is applicable.

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Form 29 for Test Batch

Test license in Form 29 is a license to manufacture drugs for the purpose of examination, testing, or analysis of drugs. At Barrocyte Consultants, we guide you throughout the licensing process to file the appropriate documents for obtaining the license glitch-free.

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Wholesale Drug License

A Wholesale License is required for sale or distribution of drugs in Form 20B & 21B or its renewal in Form 21C by the manufacturer or any others who want to sell, stock, exhibit or offer for sale or distribute drugs. It is issued by the State Licensing Authority (SLA) in India. Barrocyte Consultants ensures a smooth and timely licensing process.

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Wholesale License Details

Wholesale License for sale or distribution of drugs under Drugs and Cosmetics Rules in Form 20B & 21B or its renewal in Form 21C is issued to the manufacturer or any other entity. Wholesalers purchase products in bulk and resell them at discounted prices to retailers. Wholesale Drug licenses (Form 20B; Form 21B; Form 21C) remain valid for 5 years from the date of issue.

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Retail Drug License

A retail license is required for the retail sale of drugs. A retail sale means selling drugs or cosmetics directly to the end consumer. Retailers, such as dispensaries, hospitals, medical institutes, and stand-alone pharmacists, require this license. Retail Drug licenses are issued in Form 20 & Form 21 and are valid for 5 years from the date of issuance.

ZONAL – CDSCO

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Test License

A Test license is issued for the purpose of examination, test or analysis of a drug in small quantities which is otherwise prohibited under section 10 of the D & C Act and Rules, 1945. This license is issued in Form 29 for Manufacturers from State Licensing Authority (SLA). We provide end-to-end consultation services to obtain Test License in a hassle-free manner.

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Export NOC

A manufacturer holding a valid license copy as per the Form-25 and Form-28 can obtain a No Objection Certificate (NOC) from Zonal/Sub Zonal offices of CDSCO for export purposes only for approved / unapproved new drug / banned drug in India. The process of obtaining these NOCs requires proper filling of documents. The process of obtaining the required NOCs can be eased by consulting a team of experts at Barrocyte Consultants.

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Dual NOC

A Dual NOC is required for the import of drugs and items capable of dual use in pharma and non-pharma industry. The permission has to be obtained from the Zonal Offices of CDSCO. Barrocyte Consultants can guide you throughout the process for obtaining the NOC for drugs with dual use.

Forms of Licences to Sell Drugs

Forms of Licenses to Sell Drugs

A licence to sell, stock, exhibit or offer for sale or distribute drugs other than those specified in Schedules C, C (1) and X and by retail on restricted licence or by wholesale, shall be issued in Form 20, Form 20-A or Form 20–B, as the case may be. A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted licence or by wholesale shall be issued in Form 21, Form 21-A or Form 21-B, as the case may be. A licence to sell, stock, exhibit or offer for sale or distribute drugs specified in Schedule X by retail or by wholesale shall be issued in Form 20-G as the case may be. Applications for the grant or renewal of a licence to sell, stock, exhibit or offer for sale or distribute drugs, other than those included in Schedule X, shall be made in Form 19 or in the case of drugs included in Schedule X shall be made in Form 19-C.

SR. NO	Form NO	Purpose
1	Form 19	License to sell, stock, exhibit or offer for sale, or distribute drugs apart from those in Schedule X.
2	Form 19A	Restricted license for dealers without a qualified individual to sell or distribute drugs.
3	Form 19B	License to sell, stock, exhibit, or distribute Homoeopathic Medicines.
4	Form 19C	License to sell, stock, exhibit, or distribute drugs specified in Schedule X.
5	Form 24	License to manufacture for sale or distribution of drugs except those in Schedule C, C (1), and X.
6	Form 24A	Loan license for manufacturing drugs except those in Schedule C, C (1), and X.
7	Form 24B	License to repack for sale or distribution of drugs excluding those in Schedule C, C (1), and X.
8	Form 24C	License to manufacture or distribute Homoeopathic medicines or potentized preparations.
9	Form 24F	License to manufacture drugs specified in Schedule X but not in Schedule C and C(1).
10	Form 27	License to manufacture drugs specified in Schedule C and C (1) excluding those in part XB and Schedule X.

Drugs License Service

Drugs License

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.

Drug License Requirements, Process & Categories

Overview of Drug Licensing in India

Prerequisites for Obtaining Drug License

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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.

Application Process for Drug License

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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.

Essential Documents Required

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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.

Types of Drug Licenses

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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.

Forms for Application

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