• Is online pharmacy legal?

We are starting an online pharmacy in Mangalore, KA. We are already into this project but are facing a few legal hurdles where the Local Drug Controller, has no idea about the numerous Online Pharmacy Apps running legally in India. We are aware that there are no laws regulating this area, but we seek your advice on how to proceed further. So can you please state the legality of these online pharmacies & if legal how do we go about procuring the license?
Asked 4 years ago in Civil Law

3 answers received in 30 minutes.

Lawyers are available now to answer your questions.

16 Answers

no separate licence is required for online sale of medicines as on date . according to the Indian law, prescription drugs can only be issued on seeing the prescription of doctor by the retailer in presence of its chemist.

2) Also the bill the retailer gives the patient should have the license no. and name of the doctor. to add to it, the drug supplied should not be in excess of the quantity mentioned by the doctor.

3) These issues actually make it difficult to run an online pharmacy.

4) if you want to sell online you will need scanned copy of prescription signed by doctor

5) you need registration under copyright act of your online website

6) you will have to mention terms and conditions for use of services

7) the users agree to accept responsibility for all activities that occur under Your Account or Password. your online website shall not be liable for any loss or damage, which may take place if the user fails to protect his/her account details or password.

8) get the terms and conditions for using your website be drafted by a local lawyer

Ajay Sethi
Advocate, Mumbai
87894 Answers
6207 Consultations

5.0 on 5.0

There are no rules governing online pharmacy in India. But you need to follows rules and regulations of The Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945 as these regulates online pharmacy indirectly.

Also you need to mention terms and conditions which needs to be agreed by users thereupon you need to ask them to upload prescription. You can serve as medium between stores and consumers, your app being platform for same.

Swarnarka Chowdhury
Advocate, Mysore
1878 Answers
5 Consultations

5.0 on 5.0

Dear Sir,

You just register on "Karnataka Start-up policy".and ge authoritative information on your proposed business, which government sponsored.

http://startup.karnataka.gov.in/cif/

=====================================================================================

Go to FAQs of above site. Even you do not wish to have finance, it better to start your business through the above authority so that it will treated as 100% legalized business.

===================================================================================

1WHAT IS KARNATAKA STARTUP CELL?

Karnataka Startup Cell has been set up under the Dept. of IT, BT

The cell shall act as a single connect for handholding upcoming startups and providing information regarding:

Govt. Policy and Incentives.

Facilitation in setting up business.

Getting statutory clearances.

Connect with related Govt. departments for product validation, clearances, mentorship etc.

2WHY SHOULD I REGISTER WITH THE KARNATAKA STARTUP CELL?

3HOW DO I REGISTER WITH THE KARNATAKA STARTUP CELL?

4AM I A STARTUP ACCORDING TO KARNATAKA STARTUP POLICY?

5HOW DOES ONE DIFFERENTIATE A TECH- STARTUP?

6WHAT ARE THE INCENTIVES UNDER THE KARNATAKA STARTUP POLICY?

7WHAT DOES SELF CERTIFICATION COVER?

8WHAT DO VAT/ CST/ ST BENEFITS COVER ?

9WHAT DO REIMBURSEMENTS FOR PATENT SPENDS COVER ?

10WHAT DO REIMBURSEMENTS OF MARKETING SPENDS COVER ?

11WILL I BE ELIGIBLE FOR INCENTIVES IF I AM NOT INCUBATED?

12WHAT ARE THE INCUBATORS THAT ARE AVAILABLE AT SUBSIDISED COST?

13HOW DO I GET FUNDS FOR MY STARTUP?

Kishan Dutt Kalaskar
Advocate, Bangalore
6050 Answers
381 Consultations

4.8 on 5.0

on the drug licence you may sell the drugs online as well and you need to disclose the sale in your GST Return in the form for online sale disclosure

Vimlesh Prasad Mishra
Advocate, Lucknow
6848 Answers
23 Consultations

4.9 on 5.0

You need to take normal pharmacy licence. Online app promotion doesn't have separate set of regulations. You need to draft proper disclaimer Clause in the agreement.

Prashant Nayak
Advocate, Mumbai
27224 Answers
88 Consultations

4.4 on 5.0

The Drugs and Cosmetics Act, 1940 and it’s given provisions, have set rules on the offer of Schedule H and Schedule X drugs, which can be sold with a legitimate prescription only.

Legality Of Online Pharmacy

The essential contention about the legitimacy and viability of the online pharmacy has been with respect to the sale of prescription drugs. Numerous e-drug stores have received a strategy where the customers are required to upload a virtual copy of their e-prescription or prescription This virtual remedy is then confirmed by the online drug store and appropriately the medications are given to the clients. Such a prescription can be utilized just once to buy the endorsed medicine and can’t be re-utilized.

The law in regards to e-pharmacies is loaded with ambiguities, and accordingly has been translated in an accompanying way and partitioned into three categories:

Green Zone

In this zone fall the prescriptions which must be sold -out by a registered pharmacy having a drug specialist (pharmacist) on its payroll.

The orders of the offer must be taken from areas where the retail permit is legitimate and registered. For instance, if the permit for retail is legitimate just in Karnataka, at that point orders might only be engaged for Karnataka.

Grey Zone

Each state has a state drug department that issue licenses for the sale of the medical drug just in that specific state.

There is uncertainty with respect to the sale of medications between various states, in light of the fact that there exist no provisions for an inter- state permit available for sale of medicinal drugs.

There is additionally some uncertainty in connection with the collection of cash before the conveyance of medicines. This raises the question to the legitimacy of the payment through credit/charge card choice given on the sites, where one can make the payment before the conveyance of the prescriptions ordered.

Red Zone

Sale of physician recommended drugs without a prescription from a specialist is prohibited.

Sale of medications at a cost higher than the value given as the maximum retail price (MRP) is an offense.

The legitimacy and lawfulness of e-prescriptions fall into a gray area of the law and accordingly, acknowledgment of these prescriptions by e-drug stores for providing drugs against such prescription has been under the scanner.

Section 4 of the Information Technology(IT) Act manages “Legitimate acknowledgment of electronic records” and Section 5 of the IT Act accommodates “Lawful acknowledgment of electronic signature”. sec 5 likewise gives the three essentials for legitimate acknowledgment is that there ought to be a law that requires data, matter or report should be signed by a man, in place of such signature, an electronic signature is affixed and such an electronic sign ought to be appended in a way recommended by the central government. Run 65 of The Drugs and Cosmetic Rules, 1945 provided that “a prescription ought to be in writing and signed by the individual giving it with his typical sign and be dated by him”.This perusing of sections 4 and 5 of the IT Act alongside Rule 65 of the Drugs and Cosmetics Rules fulfill the lawfulness and legitimacy of an e-prescription, that is to be composed and signed electronically.

The position of law on the legitimacy of e-prescription has been settled by the currently enacted Pharmacy Practice Regulations, 2015. Sec 2(j)(3) of the Regulations give the meaning of a prescription as a “written and electronic bearing from a Registered Medical Practitioner or other appropriately license experts to a pharmacist to compound and apportion a particular sort and nature of arrangement or prefabricated medication to a patient”. This definition clarifies that e-prescription is substantial and legitimately recognizable.

Subsequently, it can be inferred that doctors can prescribe medication to their folks through an electronic remedy also, yet the issue remains regardless of whether the present Indian laws consider these e-prescriptions to be utilized for purchasing prescriptions online too or just to buy from a physical pharmacy.

In India, the sale of professionally prescribed medications is controlled by laws detailed under “the Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, and Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954”. Every one of these Acts is pre-colonial and in this way couldn’t have expected the online offering of pharmaceutical items through e-pharmacies. Subsequently, these laws are quiet on the issue of e-drug stores and don’t have any laws to direct online selling of professionally prescribed medications. Since the Indian laws are silent on the working and controlling of online drug stores, numerous online pharmacy sites have taken the directions given under the Drugs and Cosmetics Act for running physical pharmacy as being appropriate to online drug stores too, building them to be lawful in essence.

So you have to follow the guidelines of a.drug store keeping in view the information technology act.

Shubham Jhajharia
Advocate, Ahmedabad
25516 Answers
179 Consultations

5.0 on 5.0

Apply for retail pharmacy licence and then sell medicines online

Ajay Sethi
Advocate, Mumbai
87894 Answers
6207 Consultations

5.0 on 5.0

You can not sell without the licence

Vimlesh Prasad Mishra
Advocate, Lucknow
6848 Answers
23 Consultations

4.9 on 5.0

1) Legal Status of Online Pharmacy in India

The Drugs and Cosmetics Act, 1940 and it’s given provisions, have set rules on the offer of Schedule H and Schedule X drugs, which can be sold with a legitimate prescription only. Along these lines, in India, where online drug store is taking control over, the administration’s laws have kept up; ensuring no unlawful medication utilization is practiced online. Ayurveda and nutraceuticals likewise have laws that regulate and govern their use.

2) Formalities to be made when opening an online pharmacy

A) As expressed over, specific laws are to be followed while opening an online drug store and these rules are very stringent.

B) The sum total of what laws have been settled and any online drug store must agree to every one of the standards and directions, nonetheless, there are numerous escape clauses that these drug stores are using for their benefit and illicit medications have been on the ascent.

C) In light of its inconceivability, medical laws can’t be extensive henceforth causing the flow of illicit medications and pharmaceuticals.

Ganesh Kadam
Advocate, Pune
12335 Answers
191 Consultations

4.9 on 5.0

Hello ,

No you don't need any licence to run an online pharmacy as there is no specific law which deals with it .But i would like to suggest you for your safe guard to have a qualified pharmacist in your team and it would be better if your brand is registered and has its retail outlets with necessary license . This would be your protection for long term .

Hope this helps .

Swarupananda Neogi
Advocate, Kolkata
2941 Answers
6 Consultations

4.7 on 5.0

The law governing and regulating Payment Gateways in India is the Payment and Settlement Systems Act of 2007 which sets out the objective of ensuring that all the payment and settlement systems operating in the country are safe, properly secured, sound, efficient, accessible and authorized.

As per the Payment and Settlement Act, 2007 (“Act”), Payment Gateways service provider will fall under the definition of ‘system provider’ which means a person who operates an authorized payment system. The Act, under its Section 5(1) mandates authorization by RBI for commencing or carrying on a payment system. An authorization from RBI for this purpose shall— (a) specify the date on which it takes effect; (b) specify the conditions subject to which the authorization shall be in force; (c) state the payment of fees, if any, to be paid for the authorization to be in force

So to set up such gateway there is special provision of law to be complied with . Only the payment to be paid is to be ensured. The gateway can be any registered company having license to run a business.

The work frame that you have suggested is within the legal parameters and hence it can be allowed to set up without further hassles.

Devajyoti Barman
Advocate, Kolkata
22515 Answers
402 Consultations

5.0 on 5.0

Dear Sir,

Yes, it is wise, it is as good as retail pharmacy and you must possess license. The only difference is instead of personal retailing you are providing online on satisfactory productions prescriptions by the registered medical practitioners. Very good service. When the following agencies are selling online then how your business become illegal try to convince the Drug Controller.

To be more informative you may visit the existing websites and peruse their terms and conditions

https://mednear.com/

https://m.medlife.com/

https://www.practo.com/order/

https://www.netmeds.com/

https://www.apollopharmacy.in/ordermedicine/medicine/ordermedicine

Kishan Dutt Kalaskar
Advocate, Bangalore
6050 Answers
381 Consultations

4.8 on 5.0

Online pharmacies laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. The Information Technology Act 2000 governs some of the legal issues pertaining to online dealings but it is silent on the aspect of online pharmacy.

Anilesh Tewari
Advocate, New Delhi
17940 Answers
377 Consultations

5.0 on 5.0

Therefore I would advise you to have a pharmacy license before starting the online services for delivery of the medicines

Always get the prescription uploaded

Anilesh Tewari
Advocate, New Delhi
17940 Answers
377 Consultations

5.0 on 5.0

The Drugs and Cosmetics Act, 1940 and it’s given provisions, have set rules on the offer of Schedule H and Schedule X drugs, which can be sold with a legitimate prescription only. Along these lines, in India, where online drug store is taking control over, the administration’s laws have kept up; ensuring no unlawful medication utilization is practiced online. Ayurveda and nutraceuticals likewise have laws that regulate and govern their use.

The essential contention about the legitimacy and viability of the online pharmacy has been with respect to the sale of prescription drugs. Numerous e-drug stores have received a strategy where the customers are required to upload a virtual copy of their e-prescription or prescription This virtual remedy is then confirmed by the online drug store and appropriately the medications are given to the clients. Such a prescription can be utilized just once to buy the endorsed medicine and can’t be re-utilized.

T Kalaiselvan
Advocate, Vellore
78048 Answers
1543 Consultations

5.0 on 5.0

We have already drafted terms & Conditions where the prescriptions should be uploaded by the consumer and the same will be saved with us. There will also be an in house pharmacist to validate the prescriptions and dispense the drugs. So, do you propose that we must apply for the normal retail pharmacy license, and work online with it? Because the local drug controller thinks its illegal to have an online pharmacy.

The local drug controller may not be aware of the latest law on online pharmacy.

Sale of physician recommended drugs without a prescription from a specialist is prohibited.

Sale of medications at a cost higher than the value given as the maximum retail price (MRP) is an offense.

The legitimacy and lawfulness of e-prescriptions fall into a gray area of the law and accordingly, acknowledgment of these prescriptions by e-drug stores for providing drugs against such prescription has been under the scanner.

The position of law on the legitimacy of e-prescription has been settled by the currently enacted Pharmacy Practice Regulations, 2015. Sec 2(j)(3) of the Regulations give the meaning of a prescription as a “written and electronic bearing from a Registered Medical Practitioner or other appropriately license experts to a pharmacist to compound and apportion a particular sort and nature of arrangement or prefabricated medication to a patient”. This definition clarifies that e-prescription is substantial and legitimately recognizable.

T Kalaiselvan
Advocate, Vellore
78048 Answers
1543 Consultations

5.0 on 5.0

Ask a Lawyer

Get legal answers from lawyers in 1 hour. It's quick, easy, and anonymous!
  Ask a lawyer