For an enterprise/distributor/autonomous agent to be a legalized Indian agent for a local/overseas manufacturer at Central Drug Standard Control Organization (CDSCO), they ought to possess a valid Wholesale Drug license in Form 20B and 21B. State Licensing authorities reserve the right to grant the wholesale drug license to the applicant. One can find the provision for the same in the Drug and Cosmetic Act, 1940 to understand the required documents for wholesale drug license.
Overview of the Drug License in India
The Drug and Cosmetic Act, 1940 enclose all the laws related to drugs & cosmetics, which founded the Drug Control Department. If the drugs/medicines are stocked at one place for sale, the application should be made without exception and a license has to be issued.
The applicant after obtaining the required license must stay in a complaint with the relevant by-laws related to the wholesale business of drugs. All the documents, forms, and records ought to be managed in the way prescribed by the licensing authorities. In this write-up, we would look into the documentation aspect and explain about Documents required for wholesale drug license.
Qualification & Eligibility for Availing the Wholesale Drug License
The given list exhibits the qualification criteria for obtaining the wholesale drug license in India.
List of Documents Required for Wholesale Drug License (Fresh Application)
- Form-19 properly filled by the applicant. Copy of the web-based receipt of the Challan worth Rs. 3000 credited in the government account.
- Affidavit of the owner/proprietor that must be outlined on the stamp paper of Rs 20.
- Photocopies of the Educational certificate of the proprietor (Self-attested).
- Self-attested copies of the identification proof related to the proprietor (Domicile/Voter ID card/Driving License)
- Affidavit of the Registered Pharmacist.
- Photocopies of the educational certificate of the qualified individual (Self-attested).
- Self-attest photocopies of the identification proof of the qualified individual (Domicile/Voter ID/Driving License)
- Experience certificate of the qualified individual (an individual having an intermediate level of qualification must have experience certificate of 4 years after schooling; meanwhile, individual holding graduation degree must have experience certificate of 2 years after completing graduation).
- The original floor plan of the proposed area clearly highlighting the dimension of the key areas.
- Utility bills such as water bill, electricity bill, or gas bill of the proposed area.
- Photocopies of Refrigerator bill.
- Rent agreement on the stamp paper of Rs 50/.
- Document related to the ownership of the premises inclusive of a copy of tax receipt.
- Covering letter
- Photograph of the qualified individual & proprietor – 5 items
Documents Required for Wholesale Drug License for Renewal Purpose
The registered individual seeking the renewal of a wholesale drug license must have the following documents in place. Keep in mind that the renewed wholesale drug license serves the validity period of 5 years subjected to the norms prescribed in the Drugs and Cosmetic Act, 1940.
- Form-19 properly filled by the applicant.
- Copy of the web-based receipt of the Challan worth Rs. 3000 credited in the government account.
- Self-declaration of the applicant properly validate by the Notary Public.
- Affidavit on behalf of the eligible individual properly validates by the Notary Public, where the applicant is not serving as a registered pharmacist.
- Registration certificate of the Pharmacist (not been in the expired state) issues by the Pharmacy council.
- Photo identification such as PAN, Aadhaar, Voter ID, etc.
- Copy of the latest certificate of renewal.
In case of alteration or addition: Revised layout plan in detail of the proposed establishment clearly exhibiting the dimension of the shops, adjacent areas, detail about the fixtures and furniture provided, location in the building, if any.
In case of alteration in the premises: Evidence of the possession/ownership of the proposed establishment i.e. updated copy of the allotment letter/rent deed/agreement in case of rented/allotted accommodation.
Points Worth Considering Before Availing Wholesale Drug License
- The Act that governs the Drug license demands ample space from the applicant to get into the business of wholesale drugs. Space must stay compliant with dimensions mentioned under the Drug and Cosmetic Act, 1940[1].
- Nearly every drug commodity is prone to bio-molecular damage. Make sure you have adequate resources such as air conditioners and refrigerators for their protection. Any contravention to this requirement will create a hindrance in order to obtain said license.
- The applicant must take care of the hygiene and cleanliness of the place that is supposed to be transformed into a storage house for the drug.
- The rejection rate for the drug license is considerably higher than other forms of registration. Make sure to go through the eligibility criteria related to qualification and other important parameters in detail before making an application.
Conclusion
Drugs are distinctive commodities and widely used to cure human diseases. That is the reason why the government has laid down strict norms and regulations for its manufacturing, distribution, and selling. The drug license is granted to the entity for governing and regulating the manufacturing and selling of drugs.
Drug license is issued by the competent authority under the Drugs and Cosmetic Act, 1940 to engage with the business of medicines/drugs or cosmetics. Those who seek wholesale drug license must have aforesaid documents in place. Get in touch with CorpBiz helpdesk for getting precise information on documents required for wholesale drug license.
Read our article: Purchase of Drug Patents by the Pharmaceutical Companies in India
