Drug License Renewal

Drugs and medicines in India are regulated by the Drugs and Cosmetics Act, 1940. Any person who intends to manufacture, sale or distribute any type of Drugs or Pharma products or import any Drugs in India for the purpose of carrying out the business in pharmaceutical industry are required to obtain a License from the Government of India.

The government has set down stringent laws and guidelines for the 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 alsocovers the Pharmacist’s actions, hospital or dispensary utilization of drugs. The actcovers the Ayurvedic and Unani drugs likewise in it.

Requisite
• Application form in the prescribed format
• Proof of ownership of the premises
• Proof of constitution of the business (Incorporation Certificate / MOA / AOA / Partnership Deed)
• KYCs of Directors / Partners / Proprietor / Authorized Signatory
• Key-plan (Blueprint) for the premises
• Site plan (Blueprint) for the premises
• Covering Letter with the intent of the application signed with name and designation of the applicant
• Affidavits as prescribed
• Declaration form in the format prescribed
• Additional documents as may be applicable on case to case basis.

Additional

1. Duly filled Form 19/19A/19AA/19C.
2. Original Treasury challan after depositing the requisite fees.
3. Original affidavit of proprietor/authorized partner/authorized director or authorized person of Pvt Ltd or Ltd Company or Trust or Society regarding no change in Name of the firm, Constitution (in case of Proprietorship or
Partnership firm), premises since granting of the license.
4. Documents related to Registered Pharmacist.
5. Copy of Diploma Pharmacy; Registration Certificate from Pharmacy Council of a particular state; Copy of renewal of Registration; Copy of Appointment and Joining Letter.
6. Original affidavit of Pharmacist.
7. Documents related to a Competent Person (For wholesale licenses).
8. Copy of Educational qualification certificate(s) including the High School Certificate.
9. If the competent person is a registered pharmacist then all the documents as enlisted.
10.Original affidavit of Competent Person.

Key Points:

1. The License is valid for 3-5 years depending upon the type of license which has been applied by the applicant. Thus, it is very important to renew the license to continue carrying on the business operations to avoid penalties
later on.

2. License is required to be renewed within a period of 6 months from the expiry of the license.

3. If the license is not renewed within the time frame allowed penalty shall be applicable on the same.
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: –

• FORM 20 is for the sale of Allopathic drugs.
• FORM 20-A is for the sale of Restricted Allopathic drugs.
• FORM-20-B is for wholesale of Allopathic drugs.
• Form 20-C is for the sale of Homoeopathic medicines by retail.
• Form 21 is for Sale of Allopathic drugs specified in Sch C & C (1).
• Form 21-B is for wholesale of Allopathic drugs specified in Sch C & C (1).
• Form 21-A is for the retail sale of restricted Allopathic drugs specified in Schedule C (I).
• Form 20-F is for the retail sale of drugs specified in Sch. ‘X’.
• Form 20-G is for wholesale of drugs Specified in Sch. ‘X’.
• 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).

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