Is A License Compulsory For Starting Pharma Business In India?

Thinking of starting your own pharmaceutical business? While your business plan might be right on track, it is important to fulfill an important legal requirement before you jump into the pharma companies.

Did you know? No individual or enterprise can start as well as carry on a pharmaceutical business or pharma franchise dealing in medicines like antispasmodic tablets, cosmetics or drugs without obtaining a license for the same in India. This is governed by the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rules 1945 which monitor the licensing and quality of pharmaceutical products sold in India.

Pharma businesses that aspire to deal with manufacture of drugs inclusive of homeopathy, allopathic, ayurvedic cosmetics are required to obtain a drug manufacturing license while PCD pharma franchise company dealing in bulk sale of medications must obtain a wholesale drug license.

Moreover, possessing a license also governs the supply and distribution chain of pharma companies and pharma franchise companies. Patients, who are the consumers and end users of medicines purchase pharma products from retail chemists who stock these products from distributors. Distributors obtain their medicines from stockists who get their products from c&f agents (clearing and forwarding agents). These c&f agents obtain their stock from the pharma company. This distribution channel of a pharmaceutical business is legal and recognized only through the possession of a valid license.

There are retail as well as distribution license for carrying out a pharmaceutical business, which can enable you to:

• Distribute prescribed drugs and medicines
• Carry out API and Surgical business
• Indulge in PCD pharma franchise business
• Supply herbal, ayurvedic products as well as medical devices
• Online and institutional supply for pharmaceutical products

When you enter the pharmaceutical business arena you are conferred with an important responsibility and a little mistake on your part might result in fatal outcomes. Hence, pharma businesses are required to follow an array of legal procedures, licensing being the foremost.

Let’s take a look at the advantages of a 

drug license for pharma business:

1. With medical and health related issues on the rise in recent time it has become important for the government to take stringent steps governing the pharma enterprises and exercise control over the same. Possessing a license helps a pharma business stay out of the scope of suspicion of carrying out illegal or illicit business.
2. Enterprises working in the pharma business can expand their retail business owing to the presence of a valid license as required by concerned authorities.

In order to possess a pharma license it is important you know the following :

1. An area specification the requirement of which is 10 square meters if you wish to start a medical shop or pharmacy.
2. Your medical store must be equipped with an appropriate storage facility of a refrigerator and air conditioner along with labeling specifications for vaccines which require controlled temperature storage.
3. Prior to the permit of a drug license, the drug inspector exercising jurisdiction of the area visits the place where a retail drug license is required to verify the particulars of the application.
4. You must have a qualified medical technical staff to cater to the needs of the patients and healthcare faculties you wish to associate your business with.

As for wholesale business, the sale of drugs must be made in the presence of a registered pharmacist or a competent person with graduation and 1 year experience in dealing with pharmaceutical drugs. While in the case of retail business, the sale of drugs must be made in the presence of a registered pharmacist approved by the department who must be present during all working hours of sale of medicines.

Now, let’s take a look at the documents required to obtain a retail drug license:

• A cover letter with the application, duly signed, comprising all information like applicant’s name and designation;
• An application form in the Act’s prescribed format;
• Affidavit pertaining to non-conviction of the proprietor, the partners, or the directors under the Drug and Cosmetics Act, 1940
• Blueprint of the proposed premises
• Declaration form in the prescribed format of the Act
• Proof of business constitution plus its registration certificate
• Affidavit of the registered chemist or an equally competent who works there the entire time

We’ll leave you with the most important steps toward starting your own pharmaceutical business in India:

• Company Registration
• Obtaining drug license number via drug licensing
• Generating a GST number and getting your trademark registered

We at Bioversal Remedies understand the importance of healthcare and aspire to serve our customers with the best pharmaceutical products and accurate information.