What is a Drug License in India?

The Drug License is granting a permission by the component authority under the act of drugs and cosmetics for carrying out the businesses related to pharmaceutical industries that deal with drugs, medications and cosmetics. Without a Drug License no person can do pharmacy business or even start to associate with any dealings. Doing so is a cognizable offence. Hence one must obtain an appropriate Drug License for conducting such activities under the drug and cosmetics act of 1940 under which all types of drugs and cosmetics businesses are covered which includes allopathic drugs, homeopathic drugs and even the Ayurveda or unani drugs.

The quantity of the drugs used and produced and packed in a dose is the responsibility of all the persons involved in the whole line of work. In case any consumer of these products suffers from any unmentioned harm, these persons will be held responsible and answerable to the event and is an offence of grievance which can go under trial under IPC. Hence vigilance is important.

To start a business of Drugs & Cosmetics in India, it is mandatory to obtain Drug License.

The provisions related to drug license are contained in Drugs & Cosmetics Act, 1940, and it extends to the whole of India. This act consolidates the other laws related to drugs & cosmetics. Drug Control Department is a regulatory authority which regulates the manufacture of medicines & cosmetics, storage, distribution and sale of medicines. The act was later amended in the year 1964 with the purpose of including Ayurvedic& Unani drugs. 

DOCUMENTS REQUIRED FOR ISSUE RETAIL OR WHOLESALE DRUG LICENSE

  1. Photo ID and address proof of Directors / Partners and an affidavit regarding non-conviction under the Act.
  2. Ownership Proof or Rent agreement of the premises, and a No objection the owner of the premises.
  3. Siteplan & Keyplan of the premises along with an affidavit that the premises is either commercial / mixed land use
  4. Appointment letter and qualification documents of Registered Pharmacist/Competent person employed.
  5. An affidavit duly sworn before notary of the pharmacist / competent person regarding full time working & Bio-Data
  6. Challan evidencing payment of fee, Invoice of Refrigerator and Air Conditioner & Duly filled application Form

Pharmacy is different from retail drug store or dispensary.

  • Pharmacy refers to the place where a medicine is prepared, preserved, compounded and later dispensed.
  • Retail drug store or dispensary merely carry out the procedure of dispensing or selling the drugs which are purchased from licensed stockists/distributors.
Prior Licensing

It is mandatory for drugs & cosmetics business to obtain a license as per the nature of business by applying with the controller of the drugs and cosmetics and that every drug & cosmetic business needs to comply with the conditions of the licence.

Is it important to obtain License for Each State?

In case a business is operating in more than two states, it has to obtain drug licence in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

Location Based License

If drugs are sold or stocked for sale at more than one place, a separate license is needed in respect of each such place. Similarly, in case of manufacturer, a separate license is required to manufacture same or different drugs but at different location

Commercial Premise Must

Licences for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose state drug office issues guidance which may be referred to.

Type of License

Based on the requirement of the business, an applicant must apply for issue of specific drug license. There are various licenses, for example, Manufacturing, Wholesale Drug License, Retail Drug License, Import of drugs or cosmetics.

Import of Drugs or Cosmetics

Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule X can be imported into India only after obtaining a License