Drug License In Chennai

Any business in India must have the proper licences in order to operate. A drug licence is a valid government authorization to operate a business that sells medications and cosmetics. Each state requires a different licence if the business activity takes place in two or more states, and must obtain a separate licence if sold at more than one site. This is because drug licences are region- and location-specific. The drug licence covers both the production and selling of drugs. This article examines the steps involved in acquiring a Tamil Nadu drug licence in great depth.

In comparison to the global pharmaceutical industry's predicted growth of 5% from 2015 to 2020, the Indian pharmaceutical industry is expected to increase by nearly 16% annually. The Indian pharmaceutical industry has enormous potential, which provides opportunities for entrepreneurs and start-ups engaged in the pharmaceutical industry. According to the 1940 Pharmaceuticals and Cosmetics Act, a drug licence is required for any pharmaceutical businesses operating in India that deal with drugs, medications, and cosmetics. To lawfully conduct business in the pharmaceutical industry, including the sale of Ayurvedic and Unani medicines, one must get a drug licence.

   

Types Of Drug License

• Manufacturing License : A company that manufactures homoeopathic and allopathic medicines is granted a manufacturing licence.
• Sale License : Depending on the sort of activity the company engages in, the sale licence includes two subcategories.
  
  

  1. Drug Wholesale License : In order to wholesale drugs, the applicant must register as a member of the wholesale category if his company is a drug wholesaler.
  
  2. Drug Sale License : The applicant must register under the Drug Sale licence application only if he intends to sell drugs through a retail store, dispensary, hospital, etc.

• Loan License : A loan licence is given to the applicant who plans to manufacture their medications in accordance with the Drugs and Cosmetic Act utilising the machinery, personnel, equipment, etc. of another registered manufacturer.
• Import License : If the applicant intends to bring drugs into India from any other country, he or she must apply for an import licence with CDSCO in order to secure the required licences to sell the pharmaceuticals in India.

 

Document Required for Drug Sales License

When requesting a drug licence, the Food and Drug Association of India has made the submission of specific documentation necessary. The list of required documents is provided below.

• Affidavit attested by Public Notary :

1. Of Proprietor, if the applicant firm is proprietorship firm.
2. If the business is a partnership, then all of the partners
3. of the individual who has been properly approved by the Private Limited Company's Board of Directors.

• If a partnership firm, a copy of the partnership deed
• Address verification for the applicant or authorized proprietor (copy of voter I.D., driving license)
• Affidavit of the responsible party for regular operations and for any violations of drug-related laws.
• Pharmacist-related documents:



1. Affidavit duly attested by Public Notary
2. copies of certificates attesting to one's education (Attested)
3. A certified copy of the U.P. Pharmacy Council's registration certificate and its renewal.
4. Per licencing application, two photos.
5. Address validation
6. Letters of appointment and joining

• Documents related to qualified person (for Wholesale licence) :



1. copies of educational credentials that have been attested
2. affidavit's experience certification
3. Two images for each licencing application
4. letter of appointment and, if applicable, letter of joining
5. The planned premises' floor plan in three copies.


• Documentary evidence of the proposed location's ownership or renting status



1. A photocopy of the lease, if the space is rented.
2. A certified copy of the landlord's ownership proof of the rented space

• Two pictures of the owner, partners, or authorised person
• certified copy of a refrigerator's purchase receipt

 

Process Of Drug License

• Login credentials : Registering the applicant on the drug licensing portal is the initial step in registering for a drug licence. After the applicant registers on the portal, login information is sent to the registered email address or mobile number.
• Registration of pharmacist and competent person : Once the user has access to the portal's login information. He or she must update the information on qualified individuals and registered pharmacists.
• Application filling : Post registering pharmacist and competent person, the applicant needs to submit all the requisite details and upload necessary documents. Once completed, the application is given to the department along with the required payments.
• Inspection : After an online application is submitted, a drug inspector visits the location to authenticate the location and check the originality of any documents. The Drug Inspector delivers the inspection report to DLA following the inspection, and it is on the basis of this report that the final license is issued.

   

FAQ

 

What is form 20B and 21B for drug licence?

The forms used to submit applications for a drug wholesaler licence to the relevant department are 20B and 21B.

The drug licence file submitted online or offline.

The drug licence application must be submitted online for all major states in India, along with a self-attested copy of each required document and the required costs.

What is minimum land requirement for applying drug licence?

Having a minimum space of 15 square metres for a wholesale licence and 10 square metres for a drug sale licence is one of the crucial requirements for getting a drug licence. The ceiling height must comply with the 2005 National Building Code of India. The applicant must also provide a layout plan of the property showing all of the space's dimensions.

Who is eligible for technical person?

A licensed pharmacist in the relevant state who is registered and has a current registration number may serve as a technical representative for the business requesting a drug licence. The pharmacist is unable to work for two companies at once, though.

Who is DLA and DI?

The Drug Licensing Authority is DLA, while the Drug Inspector is DI. The applicant's location is physically inspected by the drug inspector, who then provides the drug licence authority with the inspection report, on the basis of which the final licence is issued.