How to Buy the Rights to a Pharmaceutical Drug in India?

Last Updated at: May 06, 2020
226
How to buy the rights to a pharmaceutical drug in India_

The Pharmaceutical Drug in India is a large and successful business, being the third-largest in the world. There are over 5 lakh people employed by this sector, working in more than 15,000 companies all over the country. Many of these companies sell generic drugs at lower prices. Generic medicines are those which function like drugs from large brands but at lower costs. Most generic drug manufacturing requires reverse engineering and substitution with more affordable compounds. Therefore, in most cases, companies have to buy the rights for these drugs from other companies. So, how does the process of drug licensing work in India, and why is it necessary? Here’s a look at everything you need to know regarding how to buy or get licenses for drugs in India.

  1. What is Drug Licensing?

  2. Why do you need a Drug License?

  3. Eligibility to Obtain a Drug License

  4. Documents Required For Obtaining Rights for Pharmaceutical Drug

  5. Process for Obtaining Rights for Pharmaceutical Drug

What is Drug Licensing?

Drug Licensing is the process by which pharmaceutical companies get permission to deal with drugs. The consent to analyze, research, and recreate drugs must be given by the Indian government. Most drug licenses are of two kinds – Retail License and Wholesale License for drug distribution. Depending on what business your company does, and what qualifications and infrastructure you possess, the license will vary. All drug distribution and sale in India require the concerned company to have a legal drug license.

Why do you need a Drug License?

Drug license is necessary permission granted by an overseeing authority that functions under the Drugs and Cosmetic Act, 1940. Such a permit is required to carry out a business related to drugs, medicines, and cosmetics in India. Therefore, no one can begin a company that deals with the manufacture and sales of medicines and cosmetics unless they have a license to do so. The Drugs and Cosmetics Act, 1940, covers all drugs and cosmetics, including allopathic, ayurvedic, homeopathic, and even Unani drugs. Such an Act and the laws that come under it were formulated to ensure the quality of medicines. Therefore, the pharmaceutical company tasked with creating and distributing drugs in India must maintain a minimum quality. If anyone consuming the drug suffers harm due to bad condition or negligence from the side of the manufacturer or seller, it can result in serious legal repercussions.

Start Your Pharmacy Business

Eligibility to Obtain a Drug License

For a pharmaceutical company to receive a registered Drug License in India, they must employ specialists to handle the medicines. Here’s a look at the requirements needed to get a license in India.

  1. Competent Pharmacist

Since the drugs need a competent handler or specialist, drug licenses are only given out if the company has qualified pharmacists with them. In case you want a retail license, you must have at least one pharmacist working under you. In case you wish to have wholesale permission, you must have as an employee a graduate with at least 1 year worth of experience or an undergraduate with four years of experience.

  1. Area of Shop

If you wish to open a pharmacy in India, the shop must have a carpet area of at least 10 square meters. If you want to obtain a wholesale license, then the minimum space is 15 square meters. Also, the shop area and premises must have proper ventilation. 

  1. Storage of Drugs

All medicines must be stored in a clean, cool, sheltered, and well-ventilated space. Since certain kinds of drugs, vaccines, in particular, require very cold storage, the shop must have facilities that permit all this. To get a license, a pharmacy must have an air conditioner and refrigerator with proper inverter backing.

  1. Inspection

Before granting a drug license, the premise will be visited by the drug inspector who has jurisdiction over that area. The inspector has to verify that all the conditions required are met, and in case it isn’t, the owner will have to make provisions for the same. Furthermore, the inspector will take measurements of the shop to check whether it meets area specifications. Also, the inspector might interview both the owner and the pharmacist employed to gauge their competence.

Documents Required For Obtaining Rights for Pharmaceutical Drugs

  1. Certificate of Incorporation 
  2. Memorandum of Association/ Articles of Association/ Partnership Deed/ LLP Agreement
  3. Pan Card 
  4. Canceled Cheque
  5. Photographs
  6. ID and Address Proof of all the Directors
  7. Affidavit from Directors
  8. Bio-data of the Specialist/Pharmacist
  9. Appointment Letter of the Specialist/Pharmacist
  10. Qualification and Experience Certificate of the Specialist/Pharmacist
  11. ID and Address proof of the Specialist/Pharmacist
  12. Documents of Shareholders/Directors
  13. Registered Sale Deed / Conveyance Deed 
  14. If on rent, then Electricity Bill / Water Bill/ Registered Rent Agreement and NOC from owner
  15. If located in a village – Khasra Khatauni documents 
  16. Layout and Site Plan of the premises attested by an architect approved by the municipality

Process for Obtaining Rights for Pharmaceutical Drugs

  1. The most essential step in obtaining rights for the pharmaceutical drug in India is preparing the documentation required. This requires the concerned parties to collect and verify all the necessary documents to get a drug license. Further, they must approach a registered architect and request a floor plan from them. 
  2. Once all the documents are ready, the applicant can file for a drug license online. The party must upload the required documents after filling the application form. After uploading, they may pay the government fee online.
  3. The concerned authorities will go through the scanned copies of all the documents and verify them. In case they find something lacking, they will reject the application. In such cases, you will have to reapply after attaching all the required documents.
  4. Once they are happy with the application, they will mark it for inspection.
  5. A concerned drug inspector under whose jurisdiction your shop falls will pay a visit to your establishment. They will then verify all the documents and check your premises to see if it falls under the eligibility criteria.
  6. Once the inspector has cleared the application after verifying everything, a personal interview may be taken by the same inspector.
  7. After that, all the information will have correct verification and approval, the concern body will issue a Drug License.

 

 

 

0

How to Buy the Rights to a Pharmaceutical Drug in India?

226

The Pharmaceutical Drug in India is a large and successful business, being the third-largest in the world. There are over 5 lakh people employed by this sector, working in more than 15,000 companies all over the country. Many of these companies sell generic drugs at lower prices. Generic medicines are those which function like drugs from large brands but at lower costs. Most generic drug manufacturing requires reverse engineering and substitution with more affordable compounds. Therefore, in most cases, companies have to buy the rights for these drugs from other companies. So, how does the process of drug licensing work in India, and why is it necessary? Here’s a look at everything you need to know regarding how to buy or get licenses for drugs in India.

  1. What is Drug Licensing?

  2. Why do you need a Drug License?

  3. Eligibility to Obtain a Drug License

  4. Documents Required For Obtaining Rights for Pharmaceutical Drug

  5. Process for Obtaining Rights for Pharmaceutical Drug

What is Drug Licensing?

Drug Licensing is the process by which pharmaceutical companies get permission to deal with drugs. The consent to analyze, research, and recreate drugs must be given by the Indian government. Most drug licenses are of two kinds – Retail License and Wholesale License for drug distribution. Depending on what business your company does, and what qualifications and infrastructure you possess, the license will vary. All drug distribution and sale in India require the concerned company to have a legal drug license.

Why do you need a Drug License?

Drug license is necessary permission granted by an overseeing authority that functions under the Drugs and Cosmetic Act, 1940. Such a permit is required to carry out a business related to drugs, medicines, and cosmetics in India. Therefore, no one can begin a company that deals with the manufacture and sales of medicines and cosmetics unless they have a license to do so. The Drugs and Cosmetics Act, 1940, covers all drugs and cosmetics, including allopathic, ayurvedic, homeopathic, and even Unani drugs. Such an Act and the laws that come under it were formulated to ensure the quality of medicines. Therefore, the pharmaceutical company tasked with creating and distributing drugs in India must maintain a minimum quality. If anyone consuming the drug suffers harm due to bad condition or negligence from the side of the manufacturer or seller, it can result in serious legal repercussions.

Start Your Pharmacy Business

Eligibility to Obtain a Drug License

For a pharmaceutical company to receive a registered Drug License in India, they must employ specialists to handle the medicines. Here’s a look at the requirements needed to get a license in India.

  1. Competent Pharmacist

Since the drugs need a competent handler or specialist, drug licenses are only given out if the company has qualified pharmacists with them. In case you want a retail license, you must have at least one pharmacist working under you. In case you wish to have wholesale permission, you must have as an employee a graduate with at least 1 year worth of experience or an undergraduate with four years of experience.

  1. Area of Shop

If you wish to open a pharmacy in India, the shop must have a carpet area of at least 10 square meters. If you want to obtain a wholesale license, then the minimum space is 15 square meters. Also, the shop area and premises must have proper ventilation. 

  1. Storage of Drugs

All medicines must be stored in a clean, cool, sheltered, and well-ventilated space. Since certain kinds of drugs, vaccines, in particular, require very cold storage, the shop must have facilities that permit all this. To get a license, a pharmacy must have an air conditioner and refrigerator with proper inverter backing.

  1. Inspection

Before granting a drug license, the premise will be visited by the drug inspector who has jurisdiction over that area. The inspector has to verify that all the conditions required are met, and in case it isn’t, the owner will have to make provisions for the same. Furthermore, the inspector will take measurements of the shop to check whether it meets area specifications. Also, the inspector might interview both the owner and the pharmacist employed to gauge their competence.

Documents Required For Obtaining Rights for Pharmaceutical Drugs

  1. Certificate of Incorporation 
  2. Memorandum of Association/ Articles of Association/ Partnership Deed/ LLP Agreement
  3. Pan Card 
  4. Canceled Cheque
  5. Photographs
  6. ID and Address Proof of all the Directors
  7. Affidavit from Directors
  8. Bio-data of the Specialist/Pharmacist
  9. Appointment Letter of the Specialist/Pharmacist
  10. Qualification and Experience Certificate of the Specialist/Pharmacist
  11. ID and Address proof of the Specialist/Pharmacist
  12. Documents of Shareholders/Directors
  13. Registered Sale Deed / Conveyance Deed 
  14. If on rent, then Electricity Bill / Water Bill/ Registered Rent Agreement and NOC from owner
  15. If located in a village – Khasra Khatauni documents 
  16. Layout and Site Plan of the premises attested by an architect approved by the municipality

Process for Obtaining Rights for Pharmaceutical Drugs

  1. The most essential step in obtaining rights for the pharmaceutical drug in India is preparing the documentation required. This requires the concerned parties to collect and verify all the necessary documents to get a drug license. Further, they must approach a registered architect and request a floor plan from them. 
  2. Once all the documents are ready, the applicant can file for a drug license online. The party must upload the required documents after filling the application form. After uploading, they may pay the government fee online.
  3. The concerned authorities will go through the scanned copies of all the documents and verify them. In case they find something lacking, they will reject the application. In such cases, you will have to reapply after attaching all the required documents.
  4. Once they are happy with the application, they will mark it for inspection.
  5. A concerned drug inspector under whose jurisdiction your shop falls will pay a visit to your establishment. They will then verify all the documents and check your premises to see if it falls under the eligibility criteria.
  6. Once the inspector has cleared the application after verifying everything, a personal interview may be taken by the same inspector.
  7. After that, all the information will have correct verification and approval, the concern body will issue a Drug License.

 

 

 

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