DRAFT GUIDELINES FOR E-PHARMACY:
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 accessibility 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.
“Any person who intends to conduct 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 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 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 record.
After the rules are finalised, 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 per cent discounts, thus benefiting the patients.
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.
However, sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs have been prohibited through these portals.
The premises from where the e-pharmacy business is conducted shall be inspected, every two years, by a team of officers authorised by the Central Licensing Authority, with or without the experts in the relevant field or the officers authorised by the concerned State Licensing Authority.
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 centres.
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.
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.
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION:
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration of the United States and the Medicines and Healthcare products Regulatory Agency of the United Kingdom.
Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.
Drug Controller General of India under the gamut of Central Drugs Standard Control Organization is responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India.
The current DCGI is Dr. S. Eswara Reddy