Drug License

Drug License for Distribution and Sale

Drug license is an authorization granted by the authority under the Drugs and Cosmetic Act 1940 so as to perform the business of drugs/ medicines or cosmetics. The Drug license is issued through the State Drugs Standard Control Organization or the Central Drug Standard Control Organization.

The government has set down stringent law and guidelines for manufacturing and distribution of drugs and medicines within India. The registration of Drug License and everything identified with drugs is directed by the Drugs and Cosmetics Act 1940. Control is practiced over drugs from the raw material stage amid manufacture, sale, and distribution and up to the time it is given on to a patient or buyer by a Pharmacist in the retail drug store, hospital or a dispensary. Drug license is requisite to be taken for a wide range of drugs or cosmetics business which includes allopathic, homeopathic, ayurvedic or Unani drugs and so forth. The act also covers the Pharmacist actions, hospital or a dispensary utilization of drugs. The act covers the Ayurvedic and Unani drugs likewise in it.

Forms for Drug License for sale and wholesale of Drugs:

Drugs have varieties of categories, and for various categories, the different license is mandatory to obtain, by filing various forms as given underneath:-

  1. FORM 20 is for the sale of Allopathic drugs.
  2. FORM 20-A is for the sale of Restricted Allopathic drugs.
  3. FORM-20-B is for wholesale of Allopathic drugs.
  4. Form 20-C is for the sale of Homoeopathic medicines by retail.
  5. Form 21 is for Sale of Allopathic drugs specified in Sch C & C (1).
  6. Form 21-B is for wholesale of Allopathic drugs specified in Sch C & C(1).
  7. Form 21-A is for the retail sale of restricted Allopathic drugs specified in Schedule C (I).
  8. Form 20-F is for the retail sale of drugs specified in Sch. ‘X’.
  9. Form 20-G is for wholesale of drugs Specified in Sch. ‘X’.
  10. Form 20 BB & Form 21 BB R-62- D R  is for Sale of Drugs from motor vehicles (1) Drugs other than those specified in Schedule C&C (1) (2) Drugs specified in Schedule C&C (1).

Document Required for Registration

The lists of documents required for Drug License are:-

  • The corporation’s constitution (AOA/MOA).
  • The photograph identity proof of sole proprietor, partner or their director.
  • The papers of the owned property where the commerce would be carried out.
  • For rented property, the copy of the rent agreement is required.
  • The key plan and the site plan of the particular premises.
  • Drugs storage sometimes needs to be in the cold chain, therefore the particulars and invoice of the refrigerator in use.
  • An affidavit relating to compliance with MPD 2021 and if premises are situated on DDA residential flat or building or a plot then their affidavit.
  • An additionally exhaustive document is required for a registered pharmacist.
  • Qualification proof in the form of degrees as well as certificates or mark sheets ( wholesale license).
  • The certificate of registration with the state pharmacy council depending on the region.
  • An appointment letter as well as biodata ( wholesale license).
  • Any other additional wholesale documents for wholesale Drug Licensecompetent person.
  • Any type of experience certificate ( wholesale license).

Registration Process 

The standards and guidelines relating to drug license are governed by the Food Safety and Drug Administration Department of the respective State Government.

The process for obtaining the Drug license is-

Step-1: Online application filling for the drug License, with the payment of government fee.  The scanned copy of each and every document is uploaded at the time of filing the application.

Step2: On receipt of the application, the drug inspector would visit personally at the shop for verifying the documents and accuracy of the information provided.

Step3: On successful completion of the Inspection personal interview for by the inspector or such competent individual and depending on verification of every information and documents provided is correct the controller of drugs issues the Drug License.

The Drug Regulatory Body has made it compulsory for its authorities to attend as well as grant the licenses, whether retail or discount, within a period of 30 days, in the event that they satisfy all the necessary eligibility criteria.

We at Panomics Legal Mentors provide meticulous assistance to the clients incorrectly filing the drug registration as per the rules.

Panomics Legal Mentors is the professional tech-based online and legal services which help the clients to simplify the procedures of all kinds of drug license and registration, license, implementation, tax concerns and any additional legal compliances and services related to the pharmaceutical business in India.

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