Advisory Services for Drugs Manufacturing & Import

What is a Drugs Manufacturer / Importer Registration

As per the Drugs and Cosmetics Act of 1940, every business entity or an individual, engaged in the pharmaceutical manufacturing, import or sale, is required to get a Drugs License for Manufacturing, Wholesale, Retail or import of drugs. 
As a result of the enforcement and execution of the above Act, the Drugs Control Department / FDA / Controller of Drugs, was created by combining all the Laws pertaining to drugs and cosmetics. A business entity engaged in the manufacturing of drugs is required to get a Drugs Manufacturing Certificate, while the businesses selling Drugs must get a Drugs Sale Permission.

The Salient Features of the Drugs and Cosmetics Act,1940

• Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any Government. But the permission to manufacture and sell drugs and medicines has to be granted after a due diligence.  
• Therefore the Governments have stringent rules for granting Registrations for the manufacturing and selling of drugs and medicines.
• This Act governs the end-to-end process for medicine manufacturing registration in India 
• Section 3(b) of the Drugs and Cosmetics Act, of 1940 defines “drug” to include all medicines and devices for the use of human beings or animals internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings, including preparations applied on the human body for the purpose of repelling insects like mosquitoes; it also includes all substances that can be used for the destruction of insects and all components of a drug – like empty gelatin capsules. The definition was amended in 1964, to include Ayurvedic and Unani Drugs. 
• The purpose of the Drugs Business Registration is to grant permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics. No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a Drugs Business Registration in India.
• The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, enable the Government to regulate and monitor the quality of drugs sold in India. The Government exercises control over drugs from the raw material stage during manufacturing, sale, and distribution, till it is sold to a patient or consumer by a pharmacist in a retail pharmacy, hospital or dispensary.
• The Government also exercises control in the aspects related to the import and export of medicines, sale of drugs to minors, consumption of schedule H & X drugs, etc., which requires thorough monitoring and cautious execution. The drug controlling authority under the Drugs and Cosmetics Act,1940, also grants the Contract manufacturing of pharma Registration

Drug Controlling Authority or Regulatory Authority

The Drug Controlling Athority, known as the Drugs Controller, specified under the Drugs and Cosmetics Act, is responsible for issuing different drugs licences. The drug controlling authorities (licensing authorities) are as follows:

• State Drugs Standard Control Organisation (SDSCO) – Issues Registrations for the sales, distribution, and manufacture of drugs regulated by the state authorities.
• Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving and issuing Registrations for newly made drugs and clinical trials of drugs. It also controls the quality of the imported drugs and coordinates with the SDSCO.
• State Drug Controlling Authority with approval by the Central License Approving Authority – Issues Approvals for establishing blood banks and their components and products like Vaccines, Sera, etc.
• Department of Ayush – Issues Permissions for Ayurvedic, Unani, Siddha, homoeopathic and herbal products for cosmetic and medical use.

Types of Drugs Business Registrations

Looking at the definition of “drug”, the pharmaceutical business in India requires the following types of Registrations:

• Parmaceuticals Manufacturing Business– Registration issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
• PharmaSale Business – Registration issued for the sale of drugs. It has the following bifurcations: 
  1. Wholesale Registration – A drug wholesaler must obtain a wholesale Drug Registration. Wholesale means the sale of the drug to a person/retailer to further sell it.
  2. Retail Registration – A retail Registration is required for the retail sale of drugs. A retail sale means the sale of drugs or cosmetics for the consumption of the end consumer. Retailers can sell it to a dispensary, hospital, educational, medical, or research institute. Retailers engaged in pharmaceuticals, cosmetics, stand-alone pharmacists, ayurvedic shops, etc need this Registration.
• Loan Registration – A Registration issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another Registered Entity
• Import Registration – A Registration is issued to any dealer importing the products for the manufacturing of drugs or is engaged in the business of importing drugs in India.
• Multi-Drug Registration – New drugs Business Registration issued to businesses that own pharmacies in multiple states with the same name.

Requirements for Obtaining a Drugs Registration in India

• Pharmacist/Competent Individual: The pharmacist must be qualified in the case of a retail business. In the case of a wholesale business, the individual must be a graduate with 1-year experience or an undergraduate with 4 years of experience for getting a Wholesale Drug Registration in India.
• Technical Staff: The retail pharmacy staff must be experienced with in-depth knowledge. The staff of the wholesale pharmacy must be a graduate with a minimum of 1-year experience or an undergraduate having four years of experience.
• Space Requirement: The other important requirement is space, that is the area of the pharmacy/unit. For both wholesale and retail Registrations, the area of the pharmacy/unit should be 15 square meters. In the case of a retail and medical shop, it should be 10 square meters. The clear height of the premises of the sale shall be as per the guidelines laid down under the National Building Code of India, 2005.
• Storage Facility: The other important requirement is a storage facility since some drugs must be stored in low temperatures, refrigerators and air conditioners are a must.

 

1.  Manufacturer Registration Benefits
Legal operation prevents penalties and enables production of drugs under strict quality standards like GMP. It builds consumer confidence by proving authenticity, safety, and efficacy, while allowing access to government schemes and smoother regulatory approvals. Proper monitoring enhances business credibility and protects public health from substandard products.

2.  Government Tenders
Most government health departments and large institutional buyers (like hospitals) require a valid manufacturing or wholesale license as a prerequisite for bidding.

3. Legal and Regulatory Protection
Legitimacy: It grants the legal right to manufacture, stock, and sell medicines, shielding the business from lawsuits, raids, and heavy penalties under acts like the Drugs and Cosmetics Act.

4.  Market Access
It allows manufacturers and sellers to legally supply medicines to pharmacies, hospitals, clinics, and distributors across the market.
 

1.  Appointment of Qualified Technical Staff
For manufacturing or wholesale drug licenses, a qualified technical person or registered pharmacist may be required to supervise operations and ensure compliance with regulatory standards.

2. ONDLS Portal Online Application
The applicant is required to first generate a login ID & password on the ONDLS portals. The application is to be submitted online.

3.  Technical Scrutiny
The department reviews your Site Master File (SMF), equipment lists, and SOPs.

4.  Wholesale/Retail Sales License Process
Prepare documents like premises proof, pharmacist qualification, and affidavit; register on State portal (e.g., UP Drugs Control) and fill Form 19 (wholesale), 20B/21B (allopathic wholesale), or 20/21 (retail). Upload/submit with fees, allow Drug Inspector site visit for storage/infrastructure check, and get license in 30-60 days post-verification. For Ghaziabad, submit hard copies within 15 days of online registration.

5. Joint Inspection
A team of inspectors from the State and sometimes the Central authority/CDSCO conducts a rigorous physical audit of the manufacturing site
 

• PAN Card & Adhar Card of the proprietor/partners/directors
• Registered Rent Agreement or Sale Deed
• Electricity Bill
• Machinery & Lab List
• Manufacturing process
• Refrigeration equipment details
• Layout Plan / Site Plan of the premises
• Qualification Certificates of Pharmacist or Technical Person
• GST Registration 
• SPCB CTO, for manufacturer registration

• SPCB CTE for Drugs Manufacturing 
• SPCB CTO for Drugs Manufacturing
• STP / ETP Diagram, if water is used in processing
• FDA Drugs Manufacturing / Wholesale License