How to Buy the Rights to a Pharmaceutical Drug

Last Updated at: Dec 21, 2020
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Pharmaceutical Drug
COVID-19 vaccines have been developed by big pharma companies in developed countries. India and South Africa have proposed intellectual property rights waiver at WTO to make vaccines easily available to poor countries as well. WTO’s TRIPS Council will decide on this on 10th December, 2020. 

 

The patent right is one of the important rights in the pharmaceutical drugs business. It is like an agreement between the inventor and the government. The government gives protection to the product or service for a particular period. The pharmaceutical drug analysis is done by medical experts. In India, the drug industry is a very profitable business. It is also the third-largest on the earth. Every company maintains its pharmaceutical drugs list. These types of companies are around 15,000 in India and they employ more than 5 lakh people. 

Drug license

Drug Licensing is a procedure through which corporations receive approval to do business with drugs. These permissions is by the government after the completion of the requirement process. In general, there are 2 kinds of licenses for pharmaceutical drugs. They are wholesale licenses and retail licenses for the distribution of drugs. 

Eligibility to Earn a Drug License

So, below are some of the conditions and requirements to get a pharmaceutical drug license. 

Experienced Pharmacist

Unlike other industries, pharmaceutical drug companies need specialist and skilled employees. The drugs and medicines require a competent expert or professional. Because pharmaceutical drug analysis will be done by a specifically skilled pharmacist. The pharmacist should know the pharmaceutical drug’s list. At least one pharmacist must work in the company in case of a retail license. But for a wholesale drug license, a graduate needs to have at least 1 year of experience. If he/she is an undergraduate then they must have at least four years of experience. 

Region of Shop

To begin a pharmacy, one should meet the conditions and requirements. For inaugurating a drugstore business, the minimum coverage area should be 10 square meters. In the case of the wholesale drugstore then the minimum carpet area should be 15 square meters. The pharmaceutical drugs list should be kept safely with reasonable temperature requirements. 

Storage of Drugs

Every medicine and drug should be stocked in a place that meets requirements. Further, they are cool temperature, neat, safeguarded, and open ventilation places. Because few types of medicines and vaccines need a cold storage facility. Also for pharmaceutical drug analysis, a neat storage facility is required. Additionally, the store needs to have a refrigerator and air conditioner with an immediate inverter or generator backup. 

Inspection

Before giving the license, the specific jurisdiction drug inspector visits the pharmacy and its premises. He/she will examine and verify the prerequisites. The inspection also includes checking the pharmacy as if it is good for pharmaceutical drug analysis or not. Sometimes the owner and the employees of the store might have to give an interview to the inspector. This is to test the awareness and knowledge about pharmaceutical drugs

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Documents

Below is the list of documents that are mandatory while applying for the license of pharmaceutical drugs.  

  • Pan Card and Photographs 
  • Incorporation Certificate 
  • Affidavit from directors 
  • The premises format and site plan 
  • Memorandum of Association, LLP Agreement
  • ID and Address Proof of the pharmacist and Directors
  • Bio-data, experience certificate, and Appointment Letter of the Pharmacist
  • Documents of Shareholders/Directors 
  • If the pharmacy place will have rent, then water or electricity or rent agreement or NOC letter 

Procedure for Acquiring Rights for Pharmaceutical Drugs

Step 1

The most crucial point is organizing the required documents. The application must obtain and analyze all the essential papers for getting a pharmaceutical drug license. Also, you must meet an experienced architect and call for a ground strategy from them. 

Step 2

The applicant can fill the application online. Now, the applicant needs to upload the crucial documents. At last, he/she needs to pay the application fee using online payment methods. 

Step 3

The official councils will check the samples of the documents and examine them. If the application didn’t meet the conditions, then the officials will reject it. 

Step 4

If the application is perfect, then the officials will send it for inspection. 

Step 5

The particular area’s inspection team will reach the pharmacy. They will evaluate every document and the premises of the store. 

Step 6

If everything is clear then the inspector will give a green light. After that, a subjective interview will be done by the inspection team on the owner and the staff.

Step 7

After the completion of the inspection, the data will include valid verification and approval. The official body will distribute the license for the pharmacy. 

Conclusion

The pharmaceutical drug industry is one of the most successful and productive businesses everywhere. Because medicines are essential for everyday life. Starting from a minor headache to deadly tumours, there is a drug for almost everything. But acquiring the rights to a pharmaceutical drugs business is quite a long and complicated process. Connect with us and we’ll get you sorted. 

 

Senior Executive - Content in Vakilsearch