How to Get Drug License in Bangalore India

Posted on: 2019-10-14 06:21:16

As per the Drugs and Cosmetics Act, 1940; if you wish to manufacture or sale Ayurvedic, cosmetic, and allopathic drugs or products you would need a manufacturing or sales license. It is the State Licensing Authority that issues the various licenses in this regard and monitors them as well.

To get drug license in Bangalore for retail or wholesale, the applicant/ entity has to apply with the specific authority along with proper documentation and process ensure to obtain the license certificate.

The most prominent ones among these are Drugs Sales License and Drugs Manufacturing License for Ayurvedic, Allopathic and Cosmetics. These offices also perform a number of other functions such as inspecting the sales premises and the drug manufacturing units on a regular basis. They also implement the Food & Drug Act in order to make sure that there is no malpractice in this regard.

It obviously goes without saying that the biggest part of this work has to be done by these offices which issue the manufacturers’ licenses as per the provisions of the Drugs Act.

What other licenses does the state authority issue?

Karnataka State Licensing Authority that also issues the manufacturing licenses for the following entities:

  • Blood banks
  • Blood components
  • Blood products
  • Large volume parenterals
  • Large volume sera
  • Vaccines

However, in these cases the approval of the Central Licensing Authority is necessary as well. In this case we are referring to the Drugs Controller General India, whose headquartered is situated at New Delhi.

In such cases the Central Drugs Standard Control Organization and the State Drug Control carry out joint inspection of the premises where the manufacturing work will be done.

Licenses need to acquire for pharmaceutical products in Indian market

The Drug and Cosmetic Act makes it mandatory for you to receive a number of licenses so that you are able to manufacture Ayurvedic, Allopathic and Cosmetic products in India. They tend to vary.

However, a brief idea in this case can be had as well. License on Form 32 is issued for manufacturing, selling, and distributing cosmetic products. For this you would have to sign Form 31. When you get License on Form 32A you can take loans for making, selling, and distributing cosmetic products.

If you wish to start a lab where the manufacturers of cosmetics and drugs can get their raw materials and final products tested before selling and distributing them you would need the License on Form 37.

For this you would have to fill up and submit Form 36. In fact, this same process needs to be followed in order to renew this approval.

What are the requirements in these cases?

As you would know already, you would receive your drug manufacturing license from the state licensing authority. As a maker you would need to make sure your production is being overseen and done by technical staff members who are qualified to do such work in the first place. It is very important that at least one of your technical staff members has the following qualifications:

  • Diploma in pharmacy that has been approved by the Pharmacy Council of India as per the Pharmacy Act, 1948; or
  • She or he should have passed the intermediate examination with chemistry being one of the subjects or any other examination that is deemed to be an equal of the same by the licensing authority; or
  • He/ she has to be registered under the Pharmacy Act, 1948

What are the documents required for drug license?

If you want a cosmetic license that allows you to make and sell such products in India you would need to produce the following documents:

  • Application forms
  • A certified copy of the proof of constitution in your form
  • Challan of fee deposited
  • Affidavit of non-conviction of proprietor, partners, or directors of the company as per the Drug Act 1940
  • Declaration form
  • Certified copy of Registration Certificate of the local pharmacy council or Experience Certificate of the Registered Pharmacist or competent person along with qualification certificates
  • Blueprint of key plan
  • Bio-data form
  • Blueprint of site plan
  • Affidavit of registered pharmacist or competent person with respect to fulltime working of the firm – this should be attested duly by a notary
  • Basis of possession of premises
  • Appointment letter of registered pharmacist or competent person in charge if in case she or he is employed by the firm
  • Proof of ownership of premises if it not rented

Drug license application process

Here’s the steps need to be followed to get the drug license:

  1. Preparation of documentation
  2. Submission of application
  3. Inspector visiting the premises
  4. Scrutiny and inspection
  5. Issue or grant of license

In order to get the approval of drug license from the regulatory bodies it is rather important to follow what constitutes good manufacturing processes. Depending on the kind of products that you wish to manufacture or sale – such as drugs, cosmetics, and herbal products – you would have to file a separate application form with the issuing authority. You also need to file the application in its prescribed format.

After this a Senior Inspector, under instructions from the State Licensing Authority, would visit your business premises and submit a report on the basis of what she or he has seen.

After this the report would be received by the higher authorities and they would scrutinize the same. It is on the basis of this scrutiny that your application would either be accepted or rejected.

If your application is accepted, then you’ll get a license certificate. Else you’ve to neatly follow the mentioned rules and regulations of drug license process advised by the authorities.

Once you get the drug license, you can apply for more items to be endorsed in your license. A similar process would be followed in that case as well. If you wish to get approval as a testing laboratory where the manufacturers would carry out their analyses and tests you would be subjected to a joint inspection by drug inspectors from both the state and the central bodies.

As may be expected in a process that is as detailed as these you would have to fill up a number of forms and submit them in order to get the license.

How our experts can help you in this regard?

These days, you can find there are number of companies in such regards, but BusinessWindo is different from them. We have people who are skilled and trained in doing such work in the first place. And our professionals are also highly experienced in this regard – today we have been here as we’ve done that a number of occasions and you can be sure that we would be able to help you fulfill your dream of obtaining drug license in India as well.