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Drug Registration

 What is a drug license?

Drug License in India is issued by the concerned State Authority to the manufacturers, retailers, wholesalers, distributors and people involved in the business of pharmaceuticals or carrying out the business activities related to the pharmaceutical industry. 

It is mandatory to obtain a license to do business in Drugs in India. The rules and regulations for it are given in Drugs and Cosmetics Act, 1940 (hereinafter “the Act”) which is applicable to the whole of India.

The Act contains all the laws and provisions related to drugs and cosmetics and further established the Drugs Control Department.

It is to be noted that in the year 1964 after amendments Ayurvedic and Unani drugs were included in the Act. To understand the types of licenses required one should consult the experts and then act further on.  

What are the kinds of Drug licenses?

There are different kinds of Drug licenses required by an entity and they are as follows:

  1. Drug license for manufacturers  
  2. Drug license for importers
  3. Loan Drug License in India 
  4. Multi License for Drugs
  5. Sale Drug License in India

 

Drugs License in case of Retailing & Wholesaling in Indian Market

If an entrepreneur is operating in more than two states, then it has to obtain a drug license of every state where the business is operating. Drug license is location specific. In case drugs are sold or stocked for sale at more than one place, an application shall be made, and license shall be issued, in respect of each such place except migrant vendors.

 

Compliances after you obtain Drug License

Once the license is granted to the business, all such License must ensure that all the conditions in the drug license are compiled at all the time during the course of the business. Every person involved in the business of pharmaceuticals must maintain all the records /registers /form in the manner specified by the licensing authorities and they shall be kept informed for all the changes in the business activities.

What is the procedure to obtain a Drug License?

The process of drug registration is given as under: 

  • First step is to fill the form and get it duly signed
  • Second step is to prepare the list of documents, form and the applicable fees, 
  • Application to CDSCO has to be made for provisioning of an online portal for making drugs license application.
  • The application form along with the documents has to be uploaded on CDSCO provided portal.
  • After, the required documents are submitted to the authority, then an inspector will visit the location and verify the validity of the documents.
  • After the above-mentioned steps are duly complied with, the concerned authority shall issue the drug license.

 

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What are the essential documents required for registration?

The essential documents required for registration are as follows:

  • Photograph of the owner
  • Identity proof of owner
  • Address proof of owner
  • Proof of depositing the application fees
  • Application form, filled and signed
  • A copy (self-attested) of the registered plant layout
  • Utility bill as the certified office proof, in case of owned land
  • Rent agreement, if applicable
  • No-objection Certificate from the landlord
  • Educational background, experience letter of the registered pharmacist
  • Invoice of Refrigerator for business purpose
  • Invoice of the purchase of Air-Conditioner

In case of partnership firm, the following additional documents are required,

  • Partnership deed
  • Complete list of partners

Other documents required in case of Private and Public Limited Company

  • Certificate of Incorporation
  • Memorandum of Association
  • Article of Association (AOA)
  • Appointment of the concerned and authorized person who will be responsible for daily operations.
  • A copy of the board resolution regarding the authorized person who will be responsible for the day-to-day operations.

Additional documents required in case of a pharmacist

  • Copy for the diploma in pharmacy
  • Registration Certificate from The Pharmacy Council
  • Experience Letter, if any
  • Affidavit of pharmacist
  • Details of the educational certificate of a competent person 

 

Below mentioned documents are required for obtaining import license

  • Cover Letter
  • Form-8/8A duly Signed & Stamped by applicant
  • Form 9 (Undertaking given by Manufacturer or on behalf of manufacturer)
  • Notarized copy of Wholesale Licence or Manufacturing Licence
  • Labels
  • Copy of valid Registration Certificate (RC) on Form 41 duly attested by the Indian Agent or Importer
  • Copy of permission under rule 122A (Application for permission to import new drug) in case of New Drug in the name of importer.

How much time does it take to obtain drug registration?

One can apply for license directly with the government, but the process is time taken and tedious. The department shall take around 45-60 working days to completely review the application and grant the drug registration certificate. If done with the help of experts like ELT Consultants, things may be done swiftly.

Do I need the help of legal and technical experts?

It is important to take help of the experts as the process is complicated and time consuming for the common people. An expert like ELT consultants can make the process easier, smoother and faster. Our team of experts are very well aware of the process to obtain a drug license.  

What is the validity of drug registration? What are the renewal provisions of the registration?

The drug registration is valid upto three years from the date of the issue and shall be renewed under the Drugs and Cosmetics Act, 1945. After the license expires it is important to re-register to continue the business operations. Whereas, re-registration is no such term in the Drugs and Cosmetics Act, 1940 and Rules 1945. One should apply for re-registration certificate shall be made within nine months before the expiry of the existing certificate.

 

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