What are the Drug License Rules in India and its Eligibility Criteria?

Gone are the days when people get sick in the old age only. Nowadays, everyone is dealing with some health issues. Considering the decaying conditions, each street of India has multiple drugstore or pharmacist. If you also want to start a medication business, then you must obtain a drug license and compel with the drug license rules.

As per statistics report of the Indian Retail Druggists and Chemists Association, in 1978, there were about 10,000 distributors and 125,000 retail pharmacies in India. However, presently, the total number of pharmacies has reached up to 550,000. Hence, the Indian retail pharmacy market has rapidly grown over the last few years, on an average of 18% per annum.

What is a Drug License?

The permission granted under the Drug and Cosmetic Act, 1940 to commence the business of the medicines/drugs or cosmetics is known as a drug license. To simply put, no individual can conduct or sustain the activities of selling drugs or cosmetics; unless he procures an appropriate license to do so.

Also, Read: Know the Complete List of Items for Drug License

The Purpose and Conditions of Drug License Rules

Drug and cosmetic industry serve the interest of a larger community, an Act to regulate its manufacture, import, sale, and distribution was passed in the year 1940. The drug license rules under the Drug and Cosmetic Act, 1940 are as follows:

• The person who wishes to acquire a drug license must have at least four years of practical experience in the distribution of drugs.
• A licensee can only manufacture any drug under the personal supervision of a registered pharmacist.
• Further, the retailer of the drug must keep a record in the register at the time of drug supply.
• The licensee ought not to sell or stock any drug after its expiry date.
• Also, the drugs can be sold to a minor (below 18 years).
• The medicine in a retail shop to cure animals should have a tag of “Not for human use, for treatment of animals only.”
• Every drug license holder should maintain a purchase record of the drugs sold by retail or intended for sale.
• Moreover, the act prohibits a licensee from storing any drugs at his premises which were intended for free sample distribution to a medical profession.
• Any medicine prescribed by a registered medical practitioner must be under the inspection of a registered pharmacist before retail supply.
• The drugs categorized in Schedule X or Schedule H has a validity of two years. Therefore, it should be supplied to all registered entities like dispensaries, nursing homes, Medical Practitioners and hospitals only in regards to a signed written order.

Note: If you have stored any expired drugs to claim a rebate from the Income Tax, then it will not be considered an offence under the Drug and Cosmetic Act, 1940, unless not intended for sale.

Eligibility Criteria for obtaining Drug License

Drug and Cosmetic Act has set a long list of requirements that every medical aspirant has to fulfil to procure a drug license. Here are the basic needs as per drug rules:

• The carpet area of a drugstore should be 10 Sq. and meter for retail or wholesale outlets. Besides, you need to have 15 square meters area for combined wholesale and retail.
• Any drugstore or pharmacy must have an air conditioner, sound ventilation system, and refrigerator.
• According to the act,  a person can only conduct the drug business in the presence of any of these persons:

1. Any Registered Pharmacist under State Pharmacy Council.
2. A graduate with a minimum of 1-year experience in drugs sales and marketing in a reputed pharmacy.
3. An individual with four years of experience in pharma marketing and has passed S.S.L.C.
4. Even a person approved by the department of drug control is eligible.

Documents Required to apply for Drug License

Before you apply for a drug license, keep a checklist of these documents:

• Certificate of the company’s incorporation.
• ID proof of proprietor/director/ partner as per the case.
• Address proof like the sale deed/rent agreement
• A valid affidavit which states about the non-conviction of director/proprietor/partner of the firm under the Drugs and Cosmetics Act, 1940.
• An affidavit issued from a competent person or registered pharmacist.
• In case of retail sale registered pharmacist, a qualification proof of the pharmacist is needed.
• Also, one has to submit an appointment letter for registration under the local pharmacy council.
• Further, provide a receipt of the online fee deposit.
• Site plan and key plan of premises as required in the respective state as per applicable rules.
• For wholesale drug license, provide proof of qualification of the competent person and his experience certificate along with his appointment letter.

Step by Step procedure to apply for Drug License

The Food Safety and Drug Administration Department governs the drug license rules. Therefore, it has enlisted a few simple steps for candidates of pharma business. However, the candidate needs to affix to have authorized documents along with his drug application. Here are the steps to follow:

•  Fill the application: the process of filing the drug application is entirely online, wherein the applicant can access it by paying the Government fee. Then, upload a scanned copy of all the documents at the time of applying.
• Visit by the Drug Inspector: On receiving the drug application, a drug inspector shall pay a visit to the applicant’s shop. The purpose of his visit is to verify the documents and validate the information provided.
• Issue of the Drug License: Once the Drug Inspector completes his interrogation or verifies the correctness of all the documents, then the controller of drugs finally grant the Drug License.

Conclusion

Opening a drugstore or pharmacy is a big responsibility that one needs to undertake. However, with the right assistance, you can have a hassle-free registration process. Since the drug license rules are stringent, you must take professional help from our team. We provide end to end drug license solution for everyone from importers to manufacturer and wholesalers. Moreover, we can draft your drug application and will follow up with the drug license department.

Also, Read: Complete Process to Apply for Wholesale Drug License in India