INTRODUCTION

DRUG LICENCE : Throughout history, medical advancement has played a vital role in supporting the survival of human beings and curing life-threatening diseases. Medicine is the only weapon with mankind to fight diseases. But medicine is not an ordinary consumable product like chocolate because a particular drug can be used to cure a specific disease. Drugs should be taken with the consultation of a well-educated doctor so that he can advise about how to use when to use, what particular drug to be used to cure the disease; otherwise, it can lead to harmful side effects. The government of Indian has formed an Act which is known as “The Drugs and Cosmetics Act, 1940”. This act provides all the guidelines about the manufacturing, import, distribution, and sale of drugs and cosmetics. This act also covers all the regulations of Ayurveda, Siddha and unani drugs.

DRUG LICENCE DETAILS

Under“The Drugs and Cosmetic Act”, Central Drugs Standard Control Organization (CDSCO) provides the approval for drugs, clinical trials, lay down of the standards of drugs, quality control of drugs etc., with the coordination of the authority.
In December 2020, The Ministry of Health and Family Welfare published the Cosmetic rules 2020 that the licence is a must for the import of cosmetics into India.
“Drugs” -Inpharmacology, a drug is a chemical substance, typically of known structure, which, when administered to a living organism, produces a biological effect.

ISSUING AUTHORITY FOR DRUG LICENCE

State Drugs Standards Control Organization (SDSCO) –State Authority with CDSCO is responsible for the grant of licence who deals in the business of Drugs & Cosmetics on the state level. The business operates in different states, drugs sold or stocked for sale in more than one state, a licence is mandatory for each location.

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

1. Retail Sale Drug Licence(Chemist Shop) Retail sale refers to the sale of the drugs to the end consumer. Retailers can sell drugs to a hospital, dispensary, medical, education, or research institutes, etc. Under the Drugs and Cosmetic Act, a drugs licence is mandatory for the retailers of drugs or Chemist shops. And a retail licence is issued by the Drug controller Authority of the State.

In case any person sells drugs without the Licence, he shall be punishable with imprisonment for the term of not less than 1 year and may extend up to 3 years with a fine up to Rs. 5000.

Note –If a retailer is indulged in the drugs business in more than 1 state, then a different licence is required for the different state.

Basic requirements for obtaining Retail Drug Licence

1. Applicant premises should have an area of not less than 10sqr.mtrs.
2. A registered pharmacist shall always be present in the store throughout working hours.
3. Premises should have a refrigerator and air conditioner.

Document requirement for obtaining Retail Drug Licence

Rent agreement

1. Affidavit of the proprietor on stamp paper
2. Self-attested ID proof and educational certificate
3. Affidavit and ID Proof of registered Pharmacist
4. Plan layout of premises in a blueprint
5. Refrigerator Bill
6. 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.

Basic Requirements for obtaining wholesale Drug Licence

1. Applicant premises should have an area of not less than 15sqr.mtrs.
2. Applicant premises must have Air conditioner and refrigerator to store the vaccines, insulin injections, sera, etc.
3. Licence issues to the person who has degree or diploma in Pharmacy from a recognized university.
4. A pharmacist shall be a Graduate with 1 year of experience in drug dealing.
5. The licence shall be displayed on the premises.

Documents required for obtaining wholesale Drug Licence

1. Incorporation certificate, MOA or AOA, Partnership deed as applicable
2. Proof of the ownership
3. Cover letter with name and designation of the applicant
4. Challan of fees deposited for the license
5. Declaration form in a given format
6. Key plan and site plan of the premises (Blueprint)
7. The documents of possession of the premises
8. Affidavit regarding non-conviction under the Drugs and Cosmetic Act 1940, signed by proprietors, partners, directors as the case may be
9. 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 Ayurvedic drugs and cosmetic products; a licence is granted by the concerned State government of the manufacturer.

Types of manufacturing licence

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

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

Documents required for obtaining manufacturing Licence

1. Constitution of the Firm (MOA/AOA)
2. ID Proof of the partner/director/proprietor
3. Address proof of the owners
4. Copy of Property paper/Rent agreement
5. The site and key plans of the premises (Blue Print)
6. Invoice and details of Refrigerator and Air Condition Purchased for business use
7. Mention purpose of the application on Cover Letter
8. Self Attested of registered plant layout
9. List of technical staff with ID Proof, qualification, experience letter, appointment letter, and 3 photographs
10. Machinery list
11. Laboratory equipment
12. NOC of pollution control and fire fighting
13. 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.

THE PROCESS TO OBTAIN DRUG LICENCE

1. Documentation –Its process starts with the documents, as documentation depends upon the region and type of business like a retailer, wholesaler, manufacturer, and importer. Without documents, no application can be filed, or we can say without complete documents, no licence will be granted.
2. Submit application –After compiling the documents, submit the complete application with appropriate information with Drug Control Authority.
3. Inspection of the Premises –Drugs inspector appointed by the authority conducts the audit to inspect the premises in order to check whether details provided by the applicant are correct or not.
4. Scrutiny of application –Drugs inspector will verify the details of the application. If he finds everything satisfactory, then Licence will be granted. In case he raises the query applicant must reply within 3 days in an appropriate manner. Unsatisfactory reply can lead to cancellation of licence.
5. Grant of Licence –After getting satisfied with the documents, the Drug control department issues the Drug Licence.

TIMELINE

30 working Days

VALIDITY

Issued Licence is valid for 5 years

RENEWAL

Licence can be renewed by providing requisite documents for renewal, and authority will renew the licence for a particular time period.