State & Center Body

Drug Licence

The drug license application process in India entails a number of steps and documentation needs. The particular documentation required depends on the type of license—retail, wholesale, manufacturing, or import. For instance, paperwork including a rent agreement, proprietor's affidavit, ID proofs, and a plan layout of the premises are needed in order to get a retail drug license

Generally, the application procedure entails creating an account on the website of the relevant state's drug control authority, completing the application, and paying the relevant fees—which might change depending on the kind of license

Drug license registration is a need for pharmaceutical companies that deal with medications and cosmetics because the Indian pharmaceutical market is the third largest in volume and the fourteenth most significant in value.

It is crucial to consult the guidelines supplied by the relevant state's drug regulatory authority because the particulars and prerequisites for registering a drug license can differ depending on the state and kind of business.

Various drug licenses are granted by the Indian government, depending on the nature of the enterprise.

Here are the various kinds of drug licenses:

  • Manufacturing Drug License
  • Loan Drug License
  • Import Drug License
  • Multi-Drug License
  • Sale Drug License
  • Wholesale Drug License
  • Retail Drug License
  • Restricted License for Drugs

It is important to consult the guidelines provided by the state's drug regulatory authority as the particular documentation and requirements for obtaining each type of license can differ.


Validity

A drug license in India is normally valid for five years, unless the drug department suspends or cancels it. If you send in the renewal application, the necessary paperwork, and the renewal fee, you can renew it before it expires. Depending on the kind of drug license, the exact validity period might change. For instance, a wholesale drug license is supposed to be valid indefinitely unless the regulatory body suspends or cancels it.


Document Required

  • Completed Form 19
  • Proof of qualification
  • Registration of the Delhi Pharmacy Council or equivalent regional council for registered pharmacists
  • Appointment letter and bio-data for registered pharmacists or competent persons.
  • Proof of possession of the premises, such as a rent agreement or ownership document.
  • Blueprint of the plan layout of the proposed premises.
  • Electricity bill of the proposed premises.
  • Copy of the refrigerator bill.
  • Self-attested copies of education certificates and identity proof of the registered pharmacist or competent person.
  • Form 8
  • Form 8A
  • Form 9
  • Form 12
  • Proof of constitution of the entity
  • ID proof of partner/director/proprietor