Drug License In India: Application, Documents, and Forms

Securing a drug license is not merely a legal formality but an indispensable cornerstone of public health. In India, the pharmacy sector is the lifeline for the healthcare business. As the demand for quality healthcare continues to surge, the significance of a well-regulated pharmacy industry cannot be overstated.

Considering the numerous incidents of misuse that have occurred the government imposes strict regulations for the production and distribution of drugs and medicine. Thus ensuring the need for a drug license when engaging in this business.

To sell drugs in India, a Drug license must be granted by the government or State Drugs Standard Control Organization (SDSCO).

In this article, we will explore the different types of licenses issued by the SDSCO furthermore the essential steps their prerequisites, and the application procedure involved in obtaining a drug license, in order to start a retail pharmacy. 

Drug Regulation In India

In India, there are two major regulatory bodies for drug regulation.

1. Central Drugs Standard Control Organization(CDSCO) 
   • The regulatory body grants licenses for specific specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, and Vaccines. To start a pharmacy franchise you need to get a drug license approved by this organization.
2. State Drugs Standard Control Organization (SDSCO)
   • The responsibility for issuing licenses to pharmacists, wholesalers, and retailers, as well as the complete drug manufacturing to the sales process, falls under the jurisdiction of the Drugs and Cosmetics Act, of 1940, and is regulated by SDSCO.
   • This act also covers the licensing of importers of drugs, cosmetics, Ayurvedic, Siddha, and  Unani medicines.

Drug license in India is area explicit. So pharmacy units that operate in multiple states must obtain drug licenses for each state in which they conduct business.

Types Of Drug Licenses Issued

According to the type of pharmaceutical business you are associated with you should have any of the following licenses.

1. Manufacturing Licence
   • License issued to entities for manufacturing drugs including allopathic, homeopathy medicines, and cosmetics to sell in India. The SDSCO officials will issue a license after inspecting the manufacturing facility.
2. Wholesale License 
   • Individuals or firms operating a wholesale drug business require a wholesale drug license to distribute drugs to retailers or hospitals.
3. Retail Pharmacy License
   • The license acquired by retailers enables them to market drugs or cosmetics intended for end-user consumption. Required for retailers involved in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, and similar businesses. To obtain this license, the applicant must submit an application to the SDSCO along with the required documents and fees,
4. Loan license
   • The type of license granted to an applicant who does not have their own manufacturing unit but plans to utilize a manufacturing facility owned by a different licensee.
5. Multi-drug-licence 
   • The type of license required for pharmacies that have multiple units operating under the same name across different states.
6. Import license
   • Licenses are issued for a specific duration to entities engaged in the import of drugs into India. Including those importing products for drug manufacturing and other businesses involved in drug importation.

Prerequisites For Obtaining A Pharmacy License

• Infrastructure Requirements
  • To obtain a license, most importantly a pharmacy that operates as both a retail and wholesale business must have a pharmacy unit of at least 15 square meters. For a retail pharmacy or medical shop, a minimum area of 10 square meters is required. A commercial building, with an electricity supply, and no direct sunlight.
• Storage requirements 
  • It is mandatory to have a refrigerator and an air conditioner in the uni. Since some medicines and vaccines must be stored in low temperatures storage requirements should be met.

• Technical/Staff Requirements
  • A registered pharmacist must be present during the pharmacy’s working hours to sell drugs in a retail pharmacy. Similarly, a registered pharmacist must also be present in a wholesale store. 
  • However, in a wholesale store, the sale of drugs can be carried out by,
    • A person who has a graduate degree with one year of experience.
    • A person who has completed SSLC and has four years of experience approved by the drug control department.

• Building
  • The pharmacy unit should be a commercial building with the following rent agreement.
    • The rent agreement should be in the proprietor’s name if the pharmacy unit is under proprietorship.
    • If the pharmacy unit is under a partnership rent agreement should be in the name of the managing partner on whose behalf the drug license is obtained.

Drug License Application Procedure

The applicant must apply to the respective drug controlling authority based on the license he/she requires as each drug controlling authority (SDSCO, CDSCO, or Ayush)  is responsible for issuing different licenses

1. Step 1 – Filing application
   •  Obtain the necessary drug license application form online from the respective drug controlling authority website. (https://dc.kerala.gov.in/en/online-licensing/) The applicant must fill out all the necessary drug license application forms.
2. Step 2  – Attach documents 
   • Upload your documents along with the filled application form and applicable fees. Applicant should make sure all documents are updated
3. Step 3 – Drug inspection
   • Upon receiving the application, the relevant authority will inspect your company’s premises to verify the authenticity of the information provided in the application form.
4. Step 4 – License issued 
   • If the inspection is successful you will be issued a drug license to operate your business.

List Of Essential Documents

1. Duly filled application form
2. Fee receipt or copy of challan as proof of payment
3. Documents regarding the company premise – ownership document of property / rental agreement 
4. ID proof of every partner along with a copy of the partnership deed.
5. Applicant’s qualification certificate
   • Registration certificate issued by pharmacy council
   • Education qualification certificates 
   • Appointment letter
   • Affidavit of pharmacist
   • Building/shop   Ownership certificate
6. Copies of the layout plan
7. Proof regarding the availability of storage space and necessary electrical appliances
8. Copy of  Constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP.
9. Copy of board resolution permitting a company to obtain a license
10. Cover letter of the applicant with the name, signature, and designation of the applicant and the intent of the application
11. Details of the staff and the registered personnel.
12. Building tax receipt
13. Corporation/ panchayat license

 List Of  Application  Forms required 

Conclusion

By obtaining the appropriate license and adhering to regulatory requirements, the pharmaceutical industry can ensure the safe and ethical distribution of medicines in India. Pillsbee can make the online application process less stressful for you by offering free assistance and covering the application fee for your new drug license.

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