Register Your Drug License

Introduction

A drug license is a legal authorization granted by regulatory authorities to individuals involved in the manufacture, distribution, sale, or storage of pharmaceutical drugs, medicines, or substances. It is crucial for ensuring the quality, safety, and efficacy of drugs and pharmaceutical products in the market. The Central Drugs Standard Control Organization (CDSCO) provides approval for drugs, clinical trials, and quality control. In December 2020, the Ministry of Health and Family Welfare published the Cosmetic rules 2020, making the license mandatory for cosmetic imports into India.

ISSUING AUTHORITY FOR DRUG LICENCE

The State Drugs Standards Control Organization (SDSCO) is a state authority with CDSCO that grants licenses to businesses operating in Drugs & Cosmetics at the state level, requiring a license for each location where drugs are sold or stocked.

TYPES OF DRUG LICENCE

Drugs licence is the permission granted by the Drug controller to deal in drugs. Kinds of the licence depend upon the type of business as follows.

1. Sales Drug Licence

Types of sales Licence are as follows

• Rent agreement
• Affidavit of the proprietor on stamp paper
• Self-attested ID proof and educational certificate
• Affidavit and ID Proof of registered Pharmacist
• Plan layout of premises in a blueprint
• Refrigerator Bill
• 5 Photographs of proprietor and pharmacist

2) Whole Sale Drug Licence -

A wholesale licence is issued to the company/distributor/independent agent who can be an authorized Indian agent for the local or foreign manufacturer. Or we can say that the wholesale licence is issued to the manufacturer and authorized Indian representative. Whole Sale Drug Licence is issued by the CDSCO for those who deal in wholesale distribution of Drugs.

• Applicant premises should have an area of not less than 15sqr.mtrs.
• Applicant premises must have Air conditioner and refrigerator to store the vaccines, insulin injections, sera, etc.
• A pharmacist shall be a Graduate with 1 year of experience in drug dealing.
• The licence shall be displayed on the premises.
• Incorporation certificate, MOA or AOA, Partnership deed as applicable
• Proof of the ownership
• Cover letter with name and designation of the applicant
• Challan of fees deposited for the license
• Declaration form in a given format
• Key plan and site plan of the premises (Blueprint)
• The documents of possession of the premises
• Affidavit regarding non-conviction under the Drugs and Cosmetic Act 1940, signed by proprietors, partners, directors as the case may be
• Appointment letter on being appointed as a full-time registered pharmacist

3) Restricted Licence for Drugs:

Under Form 20A and 21A, this licence is issued to those applicants who want to sell drugs without the supervision of a competent individual.

• 2. Manufacturing Licence for Drug:Manufacturing licence is granted to the manufacturer of Allopathic and Ayurveda drugs and cosmetic products; a licence is granted by the concerned State government of the manufacturer.
• 1) Test Licence for Manufacturing:Form -29, this licence is issued by the Zonal Office and State licencing authority for the purpose of examination. Testing and analysis of drugs in small quantities and also given for the import of small quantities of drugs for examination, testing and analysis.
• 2) Post successful clinical trial manufacturing licence:Form -46, Licence permitted to manufacturing for sale of medical devices which are new in the market, and a clinical trial is not done.
• 3) Notified medical devices manufacture licence:Form -28 Form - 27This licence is issued to the manufacturer of disposable hypodermic syringes and needles, cardiac stents, catheters, IVD Devices for HIV, HBsAg, HCV, etc.

Basic Requirements for obtaining manufacturing Licence

• Factory premises should be according to the standard schedule M.
• The factory should be well equipped, have adequate space for machinery.
• Should have well qualified to carry out the analysis at the testing centre.
• Should have adequate laboratory equipment for testing.
• Adequate drug storage arrangements should be made.
• Conform to Good Manufacturing Practices standards.

Documents required for obtaining manufacturing Licence

• Constitution of the Firm (MOA/AOA)
• ID Proof of the partner/director/proprietor
• Address proof of the owners
• Copy of Property paper/Rent agreement
• The site and key plans of the premises (Blue Print)
• Invoice and details of Refrigerator and Air Condition Purchased for business use
• Mention purpose of the application on Cover Letter
• Self-Attested of registered plant layout
• List of technical staff with ID Proof, qualification, experience letter, appointment letter, and 3 photographs
• Machinery list
• Laboratory equipment
• NOC of pollution control and fire fighting
• Nominate authorized Indian Representative

3. Loan Drug Licence

According to the drug and cosmetic act," A loan license means a license which a licensing authority may issue to an applicant who doesn't have its own arrangement of manufacturing but who intends to avail himself of the manufacturing facilities of a licensee.

4. Import Licence

Under Schedule X, Drugs & Cosmetics can be imported to India only after obtaining a Licence. Not only drugs shall be registered, but the manufacturing unit should also be registered for import purposes.

5. Multi-licence for Drug

This licence is for those applicants who operate their business in more than one state. Without a multi-drug licence, you cannot sell drugs in more than one state.

Time and Validity:

• The time taken to obtain a drug license is 30-40 days or varies depending on factors such as the type of license, regulatory requirements, and the efficiency of the application process. Typically, it can take 30- 40 days to complete the licensing process.
• The validity period of a drug license also varies based on the type of license and regulatory jurisdiction. It may range from one to five years, after which renewal is required to continue operating legally.

Renewal Process:

• Renewal of a drug license is essential to ensure continuous compliance with regulatory standards and maintain legal authorization for pharmaceutical activities.
• The renewal process typically involves submitting an application for renewal along with the necessary documents and fees to the regulatory authority within the specified timeframe before the expiration of the current license.
• Failure to renew the drug license on time may lead to penalties, fines, or suspension of pharmaceutical operations.

Why Choose Promunim for Drug License Registration:

ProMunim offers expert drug license registration and compliance services, ensuring smooth and hassle-free processes. With years of experience in the pharmaceutical industry, they handle documentation, submissions, and follow-ups. Promunim prioritizes regulatory compliance, staying updated with industry standards. Their renewal services simplify the process, tracking expiration dates and providing timely reminders. Their top priority is customer satisfaction, delivering prompt, reliable, and customer-centric services.

Frequently Asked Questions