A drug license is a legal permit issued by the government for businesses related to drugs and cosmetics. Drug License ensures that everyone has equal and fair access to drugs and medicine is the government’s primary concern. But the legal right to manufacture and sell drugs and medicines has to be provided carefully.
Therefore, the government has stringent rules for licensing of the manufacture and sale of drugs and medicines. The Drugs and Cosmetics Act, 1940 is the act regulating the process from manufacture to sell drugs in India.
Types of Drug License Mentioned Under Drug License under Drugs & Cosmetic Act, 1940
The below discussed are the types of drugs license requires by individual to run a pharmaceutical business in India.
Manufacturing License
Manufacturing License granted to a business that involves in the process of manufacturing drugs inclusive of homeopathy medicines/ allopathic.
Sale License
Sale licenses granted for the purpose of sale of drugs. Sale license have the below mentioned ramifications:-
- Wholesale Drug License
- Retail Drug License
- Restricted Drugs License.
Loan License
License is granted to a business that does not own the manufacturing unit but uses another licensee’s manufacturing facilities.
Import License
License granted for the purpose of the import of drugs.
Multi-Drug License
License authorized to businesses that own pharmacies in multiple states with the same name.
Terms & Conditions to Obtain Drug License
The below-mentioned are the terms & conditions to obtain drug license under Drugs & Cosmetic Act, 1940;
- An applicant to obtain drug license must have at least four years of practical experience in drug distribution.
- A drug licensee can only manufacture a drug under the supervision of an experienced pharmacist.
- It is forbidden by the law to stock or sells any drug after its expiry.
- A drug retailer cannot provide any drug to a minor or a child below 18 years.
- The drug retailers should make entry in the register each time they sell any drug to maintain the record for future reference.
- The medicaments to cure animals must be labeled as “Not for human use, for treating animals only.”
- Drugs that fall under Schedule H or Schedule X classification or have a validity of period of 2 years. Thus, such drugs should only be supplied to registered medical centers such as nursing homes, dispensaries, hospitals, and medical practitioners. Moreover, it is important to sign a written permission to supply such drugs.
- A drug licensee cannot be preserved any drugs at his place intended for the free sample distribution to a certified physician.
- If a medical practitioner suggests any medicine, it should be under the supervision of a registered pharmacist before its supply or retailing.
Point to Remember
In case the licensee has preserved any expired drugs to claim a rebate from the Income Tax Department, then it shall not be considered an offence under the Drug and Cosmetic Act, 1940[1], unless not intended for sale.
Prerequisites for Obtaining a Drug License
The below stated are the prerequisites to obtain a drug license
Pharmacist/Competent Individual
1. An individual can only conduct the pharmaceutical business activities in the presence of competent person.
- Any Registered Pharmacist under State Pharmacy Council.
- An individual must be a graduate with a minimum of 1-year work experience in drugs sales and marketing in a reputed pharmacy.
- A person who have four years of work experience in pharmaceutical marketing and has passed S.S.L.C (Secondary Level School Certificate).
- In case an individual get approval by the department of drug control, he will be eligible to do drug business.
2. For wholesale business activities, the individual must be a graduated with 1-year work experience or an undergraduate with 4 years experience.
Area
The other essential requirement is space that is the area of the pharmacy unit.
- 15 square meters area is required in the case of wholesale and retail license.
- 10 square meters area is required in all other cases.
- The height of the sales premises will be as per the guidelines provided under Drugs & Cosmetic Rules, 1945
Storage Facility
The other essential requirement is storage facility since some drugs need being stored in low temperatures; refrigerators and air conditioners are a must.
Documents Required To Obtain Drug License
The documents essential for obtaining a drug license are as follows:-
- Form: For wholesale form no. 19/ retail form no. 19/ restricted form no. 19A
- Challan: For wholesale Rs. 1500/ retail Rs. 1500/ restricted Rs. 500
- Affidavit of proprietor on stamp paper of 20Rs.
- Educational certificate copies of proprietor (Self attested)
- Self attested copies of Identity proof of applicant ( Domicile/ Driving license/ Voter ID card)
- Affidavit of Regd. Pharmacist.
- Educational certificate copies of registered Pharmacist (Self attested)
- Self attested copies of Identity proof of registered Pharmacist (Domicile/ Voter ID card /Driving license)
- Blue print of Plan layout of premises /proposed area.
- Electricity bill of proposed area/premises.
- Copy of Refrigerator bill.
- Rent agreement ( 50 Rs. Stamp paper)
- Property document justifying the ownership of that premises including the copy of tax receipt of proposed area/premises.
- Covering letter.
- Photo 5-5 each of Regd. Pharmacist and proprietor.
List of Application Forms
| Form 19 | Application for authorized or renewal of a license to stock, sell, offer for sale or exhibit , or supply drugs apart from those specified under the category of Schedule X. |
| Form 19A | Application for authorizing or renewing a restricted license to stock, sell, offer for sale, exhibit , or supply drugs by retail via dealers who don’t engaged in the service of a qualified individual. |
| Form 19B | Application for license to sell, stock, offer for sale or exhibit, or supply Homoeopathic Medicines. |
| Form 19C | Application for authorize or renewal of a drugs specified under the category of Schedule X. |
| Form 24 | Application for either authorize of a license or for the renewal of a license for distribution of drugs or to manufacture for sale other than those drugs which are specified under the category of [Schedule C, C (1) and X]. |
| Form 24A | Application for either the authorize of a loan license or renewal of a loan license to manufacture for sale or distribution of drugs other than those specified under the category of Schedule C, C (1) and X. |
| Form 24B | Application for authorize or renewal of a licensee to distribution of drugs or repack for sale , being drugs other than those specified under the catego0ry of Schedule C and C (1) excluding those specified in Schedule X. |
| Form 24C | Application for granting or renewal of a license to manufacture for sale [or for supply] of Homoeopathic medicines or a license to manufacture potentize preparations from back potencies by licensees holding a license in Form 20-C |
| Form 24F | Application for authorized for renewal of a license to distribution of drugs or manufacture for sale specified under the category of Schedule X and not specified in Schedule C and C(1). |
| Form 27 | Application for authorized or renewal of a license to distribution of drugs or manufacture for sale or specified under the category of Schedule C and C (1) excluding those specified in part XB and Schedule X |
Concluding Remark
As we knew that the drug license is a legal permit provided by the central and state drugs association governmental bodies. The said License is allotted after evaluating several mandates points and guidelines furnished under the said codified act of drugs. The drug is a boon for humankind, and sometimes it becomes a curse for humans if it is usually handled negligently.
These central and state drug bodies have their own well-established parameters to find the eligible person to circulate the standard quantity of drugs among a Nation’s subjects. Being the responsible individual, we must follow the mandated rules and perceptions established by such bodies to create harmony in public safety, such as a Nobel cause. Kindly contact our Corpbiz experts to know more about the process to obtain a drug license.
Read our article: A Complete Overview on Drug License Rules in India
