INTRODUCTION
The Indian Pharmaceuticals market is the third-largest in terms of volume and thirteenth in size. India is the largest supplier of generic medicines in the world with Indian components accounting for 20% of total exports. India enjoys an important position in the global pharmaceutical industry. The country also has a large pool of scientists and engineers who have the power to direct the industry to an equal level. Currently, more than 80% of the antiretroviral drugs used worldwide to fight AIDS are provided by the Indian Pharmacy Industry.
An online pharmacy sells orders online and gives patients the opportunity to talk to a pharmacist online or over the phone rather than visiting a physical store. With up to 50% of people failing to take their medication as prescribed, business owners are trying to mobilize the industry by offering a variety of access to information or medical advice.
ONLINE PHARMACY OR E-PHARMACY
The process of opening an online pharmacy in India is almost the same as opening a pharmacy in India. However, there are rules that have to be followed in both cases while they put more stress on online pharmacy law in India:
• No Sales Without a prescription
• No Sale of Schedule X Medicines
• Final packing with distraction cover under the watchful eye of a registered pharmacist
• Valid bill for every sale
• Prepare Medicines in a Government-directed manner.
IIPA is working with the Central Government to revise the regulations by linking the Aadhaar number to directives to strengthen online pharmacy law in India. The first step is to set up an online pharmacy under Online Pharmacy Law in India to purchase domain and hosting. Then combine the e-commerce portal with it. You can later verify the inclusion of payment options including cash on delivery and other prior transactions.
LEGAL PROCEDURES FOR SETTING UP OF ONLINE PHARMACY
Recently, people have switched to Online Pharmacy as it is the easiest way to buy medicine. By using online pharmacies customers can buy even the most unusual medicines with great ease and privacy. Loads of online pharmacies are common in India but they are also required to comply with certain legal procedures before operating.
LICENSE REQUIRED
• Retail Drug License
• GST number
• Retail Drug License:
The drug license is issued by the District Drug Control Officer who provides the drug license in accordance with the guidelines issued by the State Drug Control Officer. You need to visit a regional drug control office where you apply for a drug license number. The process of using a drug license offline or offline as per state policy will apply.
• GST Number:
GST is required by the firm to have an annual turnover of more than 40 lakhs but in the event of online sales, GST may be compelled to all firms/individuals with annual revenue. After obtaining a drug license and GST number, you need to set up Internet availability. An online presence can be set up by creating a website/e-commerce app at a pharmacy or creating a merchant account on existing online pharmacy websites/applications. To complete the next step, you can start selling medicines and drugs online.
SETTING UP AN ONLNE PHARMACY
Anyone can set up an online drug store only if they are registered with a licensed traditional medicine store or if they partner with a licensed retailer to place online orders.
Green Zone: According to Indian law, the following practices are legal in online pharmacies:
• With the exception of imported drugs, all other drugs require a prescription.
• The contact details of the online pharmacy must belong to the state where they obtained the drug license.
• A licensed drug store must verify and verify the drugs delivered.
Grey Zone: These practices are not legally recognized in Indian law.
• Transmission of drugs from one state to another.
• Offer to take money before delivery of medicines.
Red Zone: These practices are illegal according to Indian Law:
• Sale of Schedule H and Schedule X medicines without a prescription.
• Selling drugs for minors.
• Sale of drugs not approved by the State Drug Control Organization.
• Exporting drugs without a permit from the drug department in the appropriate country.
REGISTRATION OF ONLINE PHARMACY
1. From effect from the commencement of part VIB of these rules, no person shall distribute or sell, stock up, display or donate drugs through the e-pharmacy portal unless it is registered under regulation 67N.
2. The owner of the pharmacy registration will accept the sales orders via the e-pharmacy portal.
3. The online pharmacy registration holder shall arrange or supply the drugs, as directed by the customer, within the period specified by the registrar of the pharmacy at the time of ordering by the e-pharmacy portal.
4. The registrar of an online pharmacy shall have a customer support center and to resolve the grievances of all stakeholders which will operate for a minimum of twelve hours seven days a week:
Provided that a customer support center will have a registered pharmacist in the area to answer customer inquiries via such customer calls.
APPLICATION FOR REGISTRATION OF ONLINE PHARMACY
• Anyone intending to run an online pharmacy business will apply for registration with the Central Licensing Authority on Form 18AA through the Central Government portal.
• The information provided above will be supported by a duly affidavit from the applicant
• Any application for the registration of an e-pharmacy pharmacy made in Form 18AA with the Central Licensing Authority shall be accompanied by a fee of fifty thousand rupees and the details and documents as set out in Form 18AA.
CONDITIONS OF REGISTRATION OF ONLINE PHARMACY
• An online pharmacy registration holder shall comply with the provisions of IT Act, 2000 (21 of 2000) and rules made there-under.
• Patient information will be kept confidential and will not be disclosed to anyone other than the Central Government or the State Government concerned, as the case may be.
• The supply of any drug shall be made against a cash or credit memo generated through the e-pharmacy portal and such memo shall be maintained by the online registration holder as a record which shall contain the following particulars:
the name, address, and sales license number of the licensee who is dispensing the drugs mentioned in prescription uploaded on the e-pharmacy portal;
the serial number and date of the cash/ credit memo; and
the name of the drug, quantity, batch number or bulk number, expiration date, and manufacturer name;
the name and address of the pharmacy registration holder by Registration Number and the signature / digital signature of the Registrar in charge.
• The owner of the pharmacy registration shall notify the Central Licensing Authority in writing should there be a change in the constitution of the firm operating under the registry. In the event of any change in the firm's constitution, the current registration will be deemed to be valid for a period of three months from the date of the change unless, in the meantime, new registration is taken from the Licensing Authority on behalf of the company and the changed constitution.
• The registrar of an online pharmacy may not perform e-pharmacy in respect of drugs covered under Narcotic and psychotropic categories as provided in the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), tranquilizers and drugs as defined in Schedule X for Drugs and Cosmetics Laws, 1945.
• The e-pharmacy will address the following details in its part of the pharmacy, -
registration issued in Form 21AA;
the constitution of the firm including the details of the Directors, partners, or persons owned by E-pharmacy;
the official logo of the e-pharmacy website, if any
details of the service provider;
reinstating a drug policy already issued;
the name of the registered pharmacist, and Regd. No, and the name of the Pharmacy Council where the pharmacist is registered, who confirms the drug before transferring it for drug withdrawal;
pharmacy contact details including telephone number, mobile phone number, email, address;
the procedure for lodging grievances etc on the e-pharmacy portal and grievance redressal procedures.
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