Health Ministry draft rules on sale of drugs by e-pharmacy- Details
E-pharmacies will have to be backed by a physical facility that will provide customer support and which shall run not less than twelve hours for all seven days of a week.
New Delhi: The Union Health Ministry has come out with draft rules on sale of drugs by e-pharmacies with an aim to regulate online sale of medicines across India and provide patients access to genuine drugs from authentic online portals.
The draft rules on "sale of drugs by e-pharmacy" state that no person will distribute or sell, stock, exhibit or offer for sale of drugs through e-pharmacy portal unless registered.
The rules call for a physical facility to provide customer support to the online customers for the pharmacy. According to the draft rule,
the e-pharmacy registration holder shall have a facility for customer support and grievance redressal of all stakeholders which shall run not less than twelve hours for all seven days of a week. Provided, that the facility for customer support shall have registered pharmacist in place to answer the queries of customers through such customer helpline.
"Any person who intends to conduct the business of e-pharmacy shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government," the draft notification said.
The draft notification says the application of registration of e-pharmacy will have to be accompanied by a sum of Rs 50,000 while asserting that an e-pharmacy registration holder will have to comply with provisions of Information Technology Act, 2000 (21 of 2000).
"The details of the patient shall be kept confidential and shall not be disclosed to any person 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 memos shall be maintained by the e-pharmacy registration holder as a record which shall contain the following particulars: -
- name, address and sale licence number of the licencee who is dispensing the drugs mentioned in prescription uploaded on the e-pharmacy portal;
- serial number and date of the cash/credit memo; and
- the name of the drug, quantity, batch number or lot number, date of expiry and name of the manufacturer;
- name and address of e-pharmacy registration holder with Registration Number along with signature/ digital signature of Registered Pharmacist-in-charge.
Elaborating on the main highlights of the draft, the Drugs Controller General of India Eswara Reddy said rules have been proposed to ensure accessibility and availability of drugs to the people across India.
"After the rules are finalized, people will be able to get genuine drugs through these online pharmacies. These pharmacies will be purchasing directly from the drug manufacturer so they will also be able to give 20-30 percent discounts, thus benefiting the patients," Reddy stated.
He pointed out that under the rules it has been proposed that those who want to do online pharmacy will have to register with the Central Drugs Standard Control Organization (CDSCO), the country's apex drug regulator and central licensing authority.
"Now those who want to operate e-pharmacies, only need to take one licence in any state. They can sell drugs all over the country even if they have one licence," Reddy said.
However, the sale of tranquillisers, psychotropic drugs, narcotics and habit-forming drugs have been prohibited through these portals.
As per new draft rules, "The e-pharmacy registration holder shall not carry out e-pharmacy with respect to the drugs covered under the categories of the Narcotic and psychotropic as referred to in the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985), tranquilizers and the drugs as specified in the Schedule X of Drugs and Cosmetics Rules, 1945."
"The premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorized by the Central Licensing Authority, with or without the experts in the relevant field or the officers authorized by the concerned State Licensing Authority," the draft rules
Reddy said it would binding on the e-pharmacies to deliver the drugs in the specific time that will be told to the patient during the time of purchase while the e-portals are mandatorily required to have 24/7 call centers.
The registration issued to any person for e-pharmacy will remain valid for a period a three years from the date of its issuance and a renewal of registration will have to be done in case it wants to continue.
"No e-pharmacy shall advertise any drug on radio or television or internet or print or any other media for any purpose," the draft said, adding that there are provisions of suspension and cancellation of registration of the e-portal if the latter contravenes any provision of the Drugs and Cosmetics Act, 1940.
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