Drugs License Application Registration and Certificate

Drugs License Application Registration and Certificate

Drugs License Application

Why Choose Us

MetaCorp encourages and empowers change in all we do. Every single day, we challenge ourselves to bring our absolute best to clients, to the public, and to one another. We set ourselves apart through our affection and pride, our expertise and eagerness, our inclusive culture, and our focus on developing the leaders of tomorrow. If you’re looking for the best consultant to help you with registration for a drug license certificate, a drug license online application, document registration,  forms, and compliance, contact Metacorp for the best assistance in the whole process of obtaining a medicine manufacturing license. We invest in our people and innovation to create an environment in which people are proud to associate with and work with MetaCorp to apply for medical store licenses and CDSCO manufacturing licenses. 

  • We add value to your business to develop your strategic goals. Our team of dedicated professionals ensures that the requirements of our clients are fulfilled with solutions that result in the best possible outcomes.
  • We are known to be consistent and ensure that there is no communication gap between our clients and that our team will provide the best solutions, no matter whom you speak with from our team.
  • We ensure that the business solutions offered to our clients are of the highest quality while maintaining the global standards of our quality Drugs License Application Registration
     services. Our customer business model ensures that our client's needs are always prioritised.

  • India is the source of 60,000 generic drug brands across 60 therapeutic categories and manufactures more than 500 different Active Pharmaceutical Ingredients (APIs). The API industry is ranked third largest in the world contributing 57% of APIs to prequalified list of the WHO.
  • To ensure the good health of a country, Drugs are needed. The Government has laid down strict laws because Drugs are totally different from other commodities. The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) of India under the Director-General of Health Services, Ministry of Health and Family Welfare, Government of India. Under the Drugs and Cosmetics Act, 1945, given the regulations governing the manufacture & sale of drugs and Rules framed thereunder.


  1. License for Manufacturing of Drugs
  2. License for Wholesale of Drugs
  3. License for Retail of Drugs
  4. Loan license Manufacturing in Pharma
  5. Medical Store License
  6. Pharmaceuticals Manufacturing License

  1. The sale of Allopathic drugs by retail other than those specified in Schedule C, C(1) and X.
  2. The sale of restricted Allopathic drugs by retail other than those specified in schedule C, C (1) and X.
  3. Wholesale of Allopathic drugs other than those specified in Schedule C, C (1) and X.
  4. The sale of Homoeopathic medicines by retail.
  5. The sale of Homoeopathic Medicines by wholesale.
  6. Retail sale of Allopathic drugs specified in Schedule C & C.
  7. Wholesale of Allopathic drugs specified in Schedule C & C.
  8. Retail sale of restricted Allopathic drugs specified in Schedule C 
  9. Retail sale of drugs specified in Schedule  X. 
  10. Wholesale of drugs Specified in Schedule X.

  • Applicant Company details
  • Key Plan and Site Plan in Blue Print
  • Rent Agreement/Property papers
  • Affidavit of Non-Conviction
  • List of Equipment and Machineries Provided for Manufacturing.
  • List of Equipment Provided for Testing.
  • List of Technical Staff for manufacturing along with following documents
    • Certificates of Education Qualification,
    • Experience Certificate
    • biodata on Proforma
    • Appointment Letter
    • Three photographs.
  • An affidavit from the employer and/or Technical Staff for full time working with the firm
  • List of Formulations to be permitted along with product information separately for each drug and affidavit about owner/user of the trade name applied for.
  • Consent of Approved Testing Laboratory for Sophisticated Testing.

  • KYC of Authorised Person
  • Site Plan and key Plan
  • MOA and AOA/Partnership deed
  • Affidavit regarding Non-Conviction
  • For Retail sale Registered Pharmacist
      1. Proof of qualification
      2. Registration of Pharma Council
      3. Appointment Letter and Bio-Data
  • For Wholesale License Competent person
      1. Proof of Qualification
      2. Experience Certificate
      3. Appointment Letter and Bio Data
  • Rent Agreement/Property Paper


Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicine. The Act that governs the end-to-end process for medicine manufacturing license in India is the Drugs and Cosmetics Act, of 1940. 

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 drug license 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 drug license in India. The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from the raw material stage during manufacture, 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 the drug to a minor, 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 grants the third party manufacturing pharma license.

About Us: 

MetaCorp is a renowned group of individual professionals that has established itself as a market leader in guiding corporate houses and entrepreneurs. We specialise in various fields such as Legal, Tax, Audit, Product Certifications and all other services rendered by professionals independently. We assist entrepreneurs and start-ups in providing consultations for Drug License Certificate. We have a tailor-made solution in the best interests of your business, and we provide a guaranteed and satisfactory service. We are a globally recognised individual consultancy firm backed by avant-garde AI tech and Automation, known for its customer-centric, customised and peerless services to its clients worldwide. Our team comprises seasoned Lawyers, CAs, Cost Accountants, CSs and CPAs operating from our offices worldwide.


About Drugs License

Drug Controlling Authority or Regulatory Authority

The drug controlling authority as known as the drugs controller specified under the Drugs and Cosmetic Act is responsible for issuing different drug licences. The drug controlling authorities (licensing authorities) are as follows:

  • State Drugs Standard Control Organisation (SDSCO) – Issues licenses for the sales, distribution, and manufacture of drugs regulated by the state authorities.
  • Central Drugs Standard Control Organisation (CDSCO) – Responsible for approving and issuing licenses 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 licenses for establishing blood banks and their components and products like Vaccines, Sera, etc.
  • Department of Ayush – Issues licenses for Ayurvedic, Unani, Siddha, homoeopathic and herbal products for cosmetic and medical use.

Essential Documents For Obtaining a Drug License Application

The documents essential for obtaining a medical Store license and apply for FDA License are:

  • 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.
  • Proof of availability of storage space such as cold storage, refrigerator, etc.
  • Copy of challan as proof of depositing fee.
  • Site plan and key plan of the premises.
  • Copy of Board resolution permitting obtaining of a license.
  • Affidavit regarding non-conviction of proprietor/partner/director and the firm.
  • The affidavit from the registered pharmacist/competent person.
  • Cover letter with name and designation of the applicant
  • Declaration form in a prescribed format
  • ID proof of partner/director/proprietor.
  • Documents related to premises– Copy of ownership documents of property or rental agreement and NOC (No Objection Certificate) from the owner of the rented premises as the case may be.
  • Applicant’s qualification certificate.
  • For a pharmacist at a retail sale:
    • Proof of qualification
    • Registration of local pharmacy council
    • Appointment letter
  • For a pharmacist at a wholesale sale:
    • Proof of qualification
    • Experience certificate
    • Appointment letter

Types of Drug Licenses

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

  • Parmaceuticals Manufacturing license– License issued to a business that manufactures drugs inclusive of allopathic/homoeopathy medicines.
  • Sale License – License issued for the sale of drugs. It has the following bifurcations: 
    1. Wholesale License – A drug wholesaler must obtain a wholesale Drug license. Wholesale means the sale of the drug to a person/retailer to further sell it.
    2. Retail License – A retail license 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 license.
  • Loan License – A license issued to a business that does not own the manufacturing unit but uses the manufacturing facilities of another licensee.
  • Import License – A license 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 License – New drug License issued to businesses that own pharmacies in multiple states with the same name.

Requirements for Obtaining a Drug License 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 Obtain a Wholesale Drug License 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 licenses, 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.

How We Do It


A customer may leave his/her contact number on the Contact Us form in our website, visit our office or call us on the IVR number given on the website

Dedicated Manager
Dedicated Manager

Once the new customer is logged in, a dedicated manager is allotted to provide a personalized service to our esteemed patrons.

Application Submission
Application Submission

Once the required documents are provided to us, we complete the documentation in no time and apply online/offline to the particular Authority.

Regular Update
Regular Update

At each stage and during the application processing, till the end to end delivery, we keep our clients posted on a regular basis.

Service Delivery
Service Delivery

It is our constant endeavor that our esteemed patrons do not have to wait for the final service delivery and with minimum cost.

Our Clients

Cafe VSB
Two Shef
Shahid Enterprises
Malabar Coco
Iqbal And Sons
Fruits Of Earth
Dr Lal Chandani


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