The health care sector in India is regulated by the Drugs and Cosmetics Act, which requires businesses to obtain a Drug License from the appropriate authority. State/Central Drug Standard Control Organizations are responsible for issuing licenses.

Drugs play an important role in the development of medicines. They are used to treat various illnesses and diseases, and are carefully regulated to ensure that they do not cause harm to the human body. The correct number of drugs must be used in order to create effective medicines, without causing any negative side effects.

The government is regulating medicines manufacturing by imposing strict and stringent laws and regulations which are to be followed by distributors and manufacturers of drugs and medicines in India in order to protect consumers’ health.

Types of online Drug Licenses Issued in India – There are different types of licenses issued, depending on the nature of a business.

Manufacturing Drug License – All manufacturers of allopathic, cosmetics, ayurvedic products or any other medications or drugs as specified under the Drugs and Cosmetics Act 1940 need to obtain a state license from the particular state government where their unit is situated.

Import Drug License – All dealers importing substances for the manufacture of drugs or involved in the business of importing drugs in India must obtain a license.

Online Wholesale Drug License – Wholesalers doing the business of pharmaceuticals shall obtain wholesale drug license from the central drugs standard control organization. Wholesale drug license specifies certain minimum requirement on the person applying for this license such as: Minimum 1-year experience in drug dealing and Degree and diploma in pharmacy

Indian Regulatory Authorities for Pharmaceutical products.

The drug regulatory authorities grant and renew licenses to sell or manufacture drugs and cosmetics and to operate blood banks. They issue free sale certificates, good manufacturing certificates, and export registration documents for export registration, if required. The business may also need a no conviction certificate, performance certificate, and a market standing certificate granted by the regulatory authorities to participate in government tenders. There are various regulatory authorities to regulate the business of drugs and cosmetics to ensure their safety and efficacy.

License issued by State Drug Controlling Authority are:

• Allopathic Drugs Licence
• Cosmetic manufacturing licence
• Veterinary Medicines licence

Drug license issued by State Drug Controlling Authority with an approval by the Central License Approving Authority

• Blood Products like Vaccines, Sera and Parenteral,
• Blood components &
• Blood Banks

License issued by Department of Ayush Ministry

• Ayurvedic Medicines
• Homeopathic Drugs
• Herbal Products for Medicinal Use
• Siddha Medicines
• Herbal Products for Cosmetic Use
• Unani Medicines

Online license issued by Central Drugs Standard Control Organization (CDSCO)

• Import of Drug and medical devices
• Clinical trial (test Licence)
• Import of Cosmetics

License issued online by Food Safety and Standards Authority of India (FSSAI) for Proprietary food like Herbal Powder and Churn where no Medicinal Use is claimed

Eligibility & Qualifications of Pharmacists / Competent Persons

To start a pharmaceutical business, you must have a qualified and registered pharmacist on staff. The first step is to check the basic eligibility requirements for the position. The qualifications for a Competent Person for Retail and Wholesale Drug License are as follows:

For deal in drug on retail basis – B Pharma, D Pharma Degree holder and Registration with State Pharmacy Council

For deal in drug on whole sales basis – B Pharma/ D Pharma Degree holder Registered with State Pharmacy Council or an undergraduate having four years’ experience of dealing in drugs or A graduate with one year of experience of dealing in drugs.

Are you considering starting a pharmaceutical business?

Are you looking to enter the drug business? If so, it’s important to be aware of the regulatory requirements. Here is a step-by-step process for starting a drug company:

• Understand the laws and regulations that apply to the manufacture, distribution, and sale of drugs in your country. Make sure you are in compliance with all applicable laws.
• Develop a business plan. This should include a market analysis, financial projections, and a marketing strategy.
• Obtain the necessary licenses and permits. In most countries, you will need to obtain a license to manufacture drugs.
• Find a reliable source of raw materials.

Online process for drug license

Documentation- A successful licensing process requires accurate documentation. The list of documents necessary for a Wholesale/Retail sale drug license varies depending on the applicant’s type and business activity.   Having the correct documentation from the start makes the process much simpler and more likely to result in a successful outcome.

Application filing for User ID & Password – In order to apply, the applicant must first register for a user ID and password. Once generated, this information will be sent to the applicant’s registered email address. With this user ID and password, the applicant can then proceed with their application.

Application filing – The applicant is seeking a Drug license from the appropriate state authority. Different forms are required for each type of license, and there is no provision for a central certificate/license covering all states. The applicant must file separate applications for each store.

Inspector visit and inspection of premises – A drug license is only granted after a drug inspector visits the premises and verifies the information in the application. They also take measurements of the premises and check to see if it is in a commercial or mixed-use area.

Issue of license online – After reviewing the documents and verifying the details, the Drug Control department will issue a Drug License. The license is valid for five years and can be renewed before expiry of that.