Trending Legal Aspects of E-Pharmacy in India

Trending Legal Aspects of E-Pharmacy in India
02 July 2019

Trending Legal Aspects of E-Pharmacy in India

Introdution

E-pharmacy means the business of distribution or sale, stock, exhibit or offer for sale of drugs through the web portal or any other electronic mode. With digitally improvising India this sector is also evolving in the e-commerce business and dealing of patients and consumers is evolving on a faster and 24/7 basis.


In India, the “Digital India” concept is adopted by almost all types of industries so why should this be left behind? There was a lack of regulatory rules for the legal formation and working of e-pharma until June 10th, 2019, when a draft by the “Union Health Ministry” by notification in the Official Gazette of India got published for amendment of Drugs and Cosmetics Rules, 1945 by inserting part ‘VIB’ after rule 67H and before part VII by the title “SALE OF DRUGS BY E-PHARMACY”.
Since 2000, the number of internet users has been increasing day by day. Due to the technology, the pharmacies are easily accessible to the common man over the internet. The increasing number of netizens, long term illness patients, increasing chronic disease, and some of the listed factor fueling the gear up of e-pharmacies have been the cause. Within-country like India, the population of youngsters are really effective by the use of the internet over mobile phones, tablets, and computers. Reliance Jio scheme will surely add more smartphone and internet users in India.

The increasing users of e-pharmacy are enjoying some perks like time-saving, money-saving, 24/7 access, transparency, convenience, etc. Expectations of better and quicker services from e-pharmacies and at the same time, no compromise with the quality and safety of drugs are witnessed.

Where the pros are noticed, one should not neglect the cons like prescription medicines are ordered without any valid prescription. No check on the genuineness of the orders due to the absence of qualified pharmacists, improper record keeping and audit is also the major areas of concern. It causes illegal international trade of drugs. They are shipped across the border without any proper prescription or permission from the concerned authorities. A cheaper version of drugs is highly targeted in this process.

Legislations and Regulations in India

Before understanding the legislation of e-pharmacy we should throw some light on the legislation of Drugs in India. Where the central government is responsible for licensing of drugs import in India and the state governments are responsible for the manufacture, sale, and distribution of drugs. Regulatory control by central govt. is exercised by New Delhi based Central Drugs Control Organisation headed by the Drugs Controller General India. State authorities’ exercises regulatory control over drugs by state-based Drugs Control Administration headed by the State Drugs Controllers. Every state has its own Drugs Control Administration.

The governing Acts of Drugs in India are Drugs and Cosmetics Act, Drugs and Cosmetics Act, 1940; Drugs and Cosmetics Rules, 1945; Pharmacy Act, 1948; Indian Medical Act, 1956 and Code of Ethics Regulations, 2002, etc.

There are no specific laws concerning E.pharmacy, only the Information Technology Act, 2000 governs all issues and activities related to the Internet. There is a lack of accurately and unambiguously stated laws and clear-cut guidelines to regulate, control, and monitor e-pharmacies.

Key takeaways from the draft policy

Section 67I talks about definitions of ‘e-pharmacy’, ‘e-pharmacy portal’, ‘ Central Licensing Unit’, ‘Prescription’ and ‘sale by way of e-pharmacy’.
Section 67J talks about ‘Registration of e-pharmacy’ which prevents any person from distributing or selling, exhibiting or offering of sale of drugs through e-pharmacy portal unless registered under rule 67N.

Retail sale of orders should be received and entertained through the e-pharmacy portal only.

The registered portal owner shall provide the drugs as per the order received and in the committed time by him at the time of receiving the order.

Facility for customer support and grievance redressal of all stakeholders which shall run not less than twelve hours for all seven days 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.

Section 67K talks about Disclosure of Information which states that the registered portal owner shall not disclose any information of order received either by way of prescription or by any other way to any other person.

Registered portal owner is bound to share this information if asked by central or state govt. Or when required for the purpose of public health.

E-pharmacy portal shall be established in India and their data should remain localized. Provided, that in no case the data produced or reflected through e-pharmacy portal shall be stored or sent, by whatever means, outside India.

Section 67L talks about the application for registration of e-pharmacy. The owner shall apply for the grant of registration to the Central Licensing Authority in Form 18AA through the online portal of the Central Government.
Section 67M talks about the condition for registration of e-pharmacy at govt. Portal
Section 67N talks about Grant of registration of e-pharmacy
Section 67O talks about Periodic Inspection of e-pharmacy. It shall be inspected, every two years, by a team of officers authorized by the Central Licensing Authority
Section 67P talks about Procedure for distribution or sale of drugs through e-Pharmacy
Section 67Q talks about the Validity of registration of e-pharmacy which is for a period of three years from the date of its issue
Section 67R talks about Renewal of Registration of e-pharmacy- E-pharmacy registration holder of e-pharmacy shall make an application in Form 18AA along with the fee of fifty thousand rupees and the documents as specified in Form 18AA: Provided that if the application for renewal of registration is made before its expiry or if the application is made within three months of its expiry, the registration shall continue to be in force until orders are passed on the application. The registration shall be deemed to have expired if an application for its renewal is not made within six months after its expiry.
Section 67S talks about Prohibition of advertisement of drugs through e-pharmacy
Section 67T talks about Suspension or cancellation of registration
Section 67U talks about. Complaint Redressal mechanism
Section 67V talks about Monitoring of e-pharmacy
Section 67W talks about Mode of payment of a fee.