An Overview of Drug License in Punjab

Any Government's primary concern is to ensure that everyone has equal & fair access to drugs & medicine, but the right to sell & manufacture drugs and medicines has to be given cautiously. That's why the Government has stringent rules for issuing licenses for selling & manufacturing drugs and medicine. So to sell & manufacture medicine and drugs, it is necessary to obtain Drug License. A Drug License is a legal certificate that is required to do businesses related to the pharmaceutical industry, Drugs & Cosmetics. If you want to obtain a Drug License in Punjab, then the Punjab State Pharmacy Council issues Drug License in Punjab. This department regulates the sale, manufacture, and distribution of drugs in Punjab by implementing relevant Central Drug & Pharmaceutical legislation in the State.

Different Types of Drug Licenses in Punjab

There are two different types of Drug License in Punjab:

• Manufacturing License: License issued to a business that manufacturers drugs inclusive of homoeopathy or allopathic medicines.
• Sale License: This Sale License is issued for the sale of drugs. Under this license, there are two more licenses:

1. Wholesale License: A drug wholesaler should obtain this license and wholesale means the sale of the drug to a person or a retailer to further sell it.
2. Retail License: This license is required for the retail sale of drugs which means the sale of drugs/cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, educational, research, or medical institute. Retailers involved in cosmetics, ayurvedic shops, stand-alone pharmacists, pharmaceuticals, etc., need to obtain a Retail License.

• Loan License: This license is granted to a business that doesn't own the manufacturing unit but uses the manufacturing facilities of another licensee.
• Multi-Drug License: This license is issued to businesses that own pharmacies in multiple states with the same name.
• Import License: This license is issued to any dealer importing the products for the manufacturing of drugs or is involved in the importing drugs business in India.

Conditions Should Be Followed to Obtain Drug License

For obtaining a Drug License in Punjab, there are certain conditions that the applicant will have to follow:

• A license Form 20A or Form 21A not be issued to any individual unless the authority is certified to issue the license.
• A license in Form 20, 20B, 21B, 20F, 20G, or 21 to sell, exhibit stock, or offer for sale or distribution of drugs shouldn’t be renewed or granted to any individual unless the authority empowered to grant the license.
• A License of Form 20C/Form 20D to four Homeopathic medicines shouldn’t be granted to any individual unless the authority empowered to issue the license.

Requirements for Obtaining Drug License in Punjab

1. Space Requirement: This is the most vital requirement for obtaining a Drug License in Punjab. For both Retail and Wholesale Licenses, the area of the unit or pharmacy should be 15 square meters. The obvious height of the premises of the sale shall be as per the guidelines listed under the National Building Code of India, 2005.
2. Technical Expert or Staff: The retail pharmacy staff must be experienced in the technical field. The staff of the wholesale pharmacy should be graduates with a minim of one year of experience or an undergraduate having 4 years of experience.
3. Pharmacist or Competent Individual: The pharmacist should be trained in the case of a retail business. In the instance of a wholesale business, the individual should be a graduate with one year of experience/an undergraduate with 4 years of experience.
4. Storage Facility: The other vital requirement is a storage facility since some drugs require to be stored in low temperatures, ACs, and refrigerators are a must.

List of all Vital Documents for Obtaining a Drug License in Punjab

Following is the list of vital documents for obtaining a Drug License in Punjab:

1. Identity proof of director or partner, or proprietor;
2. Board Resolution copy permitting obtaining of a license;
3. Key plan & site plan of the premises;
4. Declaration form in a prescribed format;
5. Constitution of the entity, MOA (Memorandum of Association), AOA (Articles of Association) for a company, LLP Agreement, Partnership Deed in case of LLP and Partnership;
6. Affidavit regarding non-conviction of partner or director or proprietor and the film;
7. Cover letter with name & designation of the applicant;
8. Qualification Certificate of the applicant;
9. Documents related to premises: Copy of ownership documents of property or rental agreement & No Objection Certificate (NOC) from the owner or proprietor of the rented premises as the case may be;
10. Challan copy (as proof of depositing fee);
11. Proof availability of storage space such as refrigerator, cold storage, etc.;
12. The affidavit from the competent individual or registered pharmacist;
13. For a pharmacist at a Wholesale Sale:

• Qualification proof;
• Experience Certificate;
• Appointment Letter;

14. For a Pharmacist at a retail sale:

• Qualification proof;
• Registration of local pharmacy council;
• Appointment Letter.

Application for a Drug License in Punjab

The drug controlling authority/the regulatory authority is accountable for issuing the Drug License in Punjab. The applicant must apply to the relevant drug controlling authority based on the license they require. Following is the process of obtaining the Drug License in Punjab:

Step 1: Visit the Official Website of the Respective Drug Controlling Authority in Punjab: The applicant must visit the respective drug controlling authority depending on the type of license the applicant is applying for since each drug controlling authority is accountable for the issue of different types of Drug Licenses.

Step 2: Filing of an Application: The applicant must file the application for Drug License online on the website. The applicant or candidate must fill in all the information asked in the application form.

Step 3: Upload Documents: After filing all the vital details on the application form, the next step is to upload all the vital documents and submit the application form along with the applicable fees. The applicant should keep all the documents updated before filing the application for Drug License.

Step 4: Inspection by Drug Inspector: After receiving the application form, the drug inspector will visit the company premises personally, shop or the drugstore for the verification of documents & correctness of facts stated in the application.

Step 5: Grant of the Drug License: After verification and inspection by the drug inspector, the Drugs Controller will issue the Drug License.

Validity of Drug License in Punjab

The new Drug License in Punjab issued to the repairer, dealer, or manufacturer is valid for a minimum of one calendar year period. The license can be further renewed for a period of 1 to 5 calendar years by the concerned office on the payment of a necessary fee as specified in the fee Scheduled X of the Punjab Legal Metrology (Enforcement) Rules, 2013.

Renewal of Drug License

You can also apply for the renewal of a Drug License in Punjab in the respective authority. You have to submit the license renewal form along with the requested documents. Then the renewal process will be completed upon the payment.