Professional Documents
Culture Documents
REQUIREMENTS
I. OVERVIEW
While the e-commerce business comes under the domain of the Information
Technology Act, 2000, the legislations governing the sale of drugs in India
comes within the ambit of the Drugs and Cosmetics Act, 1940, The Drugs and
Cosmetic Rules, 1945, The Pharmacist Act 1948, The Indian Medical Act,
1956. However, the legislations mentioned neither permits nor prohibits online
sale of medicines in India.
Further, vide Circular2 dated 30th December 2015, the Joint Drugs Controller
clarified that The Drugs and Cosmetic Rules, 1945 don’t distinguish between
the conventional and over the internet sale/distribution of drugs. However, the
provisions of the aforementioned rules have to be complied in both cases.
Therefore, the existing legal framework governing the sale of drugs and
medicines through the retail stores are also applicable for the legal governance
of e-pharmacies.
1
http://egazette.nic.in/WriteReadData/2018/189043.pdf
2
Circular No 7-5/2015/Misc/e-governance/091 available at
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?
num_id=NjA5
II. EXISTING FRAMEWORK
The Drugs and Cosmetics Act, 1940 regulates the import, manufacture,
distribution and sale of drugs and cosmetics in India. Chapter IV of the Act
deals with the manufacture, sale and distribution of drugs and cosmetics. Part
VI of The Drugs and Cosmetic Rules, 1945 governs the ‘Sale of drugs other
than Homoeopathic Medicines’ and Part VI-A governs the ‘sale of
Homeopathic Medicines’. The rules broadly describes the different types of
licenses issued by the licensing authorities, conditions to be satisfied before a
license is granted, duration of licenses and also provides for cancellation and
suspension of licenses under certain circumstances.
Further, Guidelines3 For Grant of Licences for Sale of Drugs Under Drugs &
Cosmetics Act, 1940 and Rules thereunder provides in detail the ‘Types of
Licences issued by the Department for sale of Drugs’ as well as documents
required for issue of the above license which is given hereunder:
A. Different types of licence required for the sale of drugs (the required
number of application form for a particular licence is mentioned in the
bracket) are given hereunder:-
Licence on Form 20 is issued for the sale of Allopathic drugs by retail
other than those specified in Schedule C, C(1) and X. (Form-19)
Licence on Form 20-A is issued for the sale of restricted Allopathic
drugs by retail other than those specified in schedule C, C(1) and X.
(Form-19A)
Licence on Form 20-B is issued for wholesale of Allopathic drugs other
than those specified in Sch C, C(1) and X. (Form-19)
3
http://drugscontrol.delhigovt.nic.in/wps/wcm/connect/doit_drug/DoIT_Drug/Home/Procedures+For+Obtaini
ng+Licences/
Licence on form 20-C is issued for sale of Homoeopathic medicines by
retail. (Form-19B)
Licence on Form 20-D is issued for sale of Homoeopathic Medicines by
wholesale.(Form -19B)
Licence on Form 21 is issued for retail sale of Allopathic drugs specified
in Sch C & C(1).(Form-19)
Licence on Form 21-B is issued for wholesale of Allopathic drugs
specified in Sch C & C(1). (Form-19)
Licence on form 21-A is issued for retail sale of restricted Allopathic
drugs specified in Schedule C (I). (Form-19A)
Licence on Form 20-F is issued for retail sale of drugs specified in Sch.
'X'. (Form-19-C).
Licence on Form 20-G is issued for wholesale of drugs Specified in Sch.
'X'. (Form-19-C)
On 28th August, 2018 the Ministry of Health and Family Welfare vide
notification published in the Official Gazette, issued the draft rules whereby it
proposed to insert Part VI-B namely ‘Sale of drugs by E-Pharmacy’ in The
4
http://egazette.nic.in/WriteReadData/2018/189043.pdf
Drugs and Cosmetic Rules, 1945. The said notification further invited the
suggestions and objections from various stakeholders. However, till date the
said draft rules have not been notified in its final form in the Official Gazzete.
Important rules under the said draft rules are discussed hereunder in detail:
Rule 67N provides that the central licensing authority after scrutinising
the information and documents furnished by the applicant and after
being satisfied that the provisions of Part VI-B are complied with, shall
grant registration to the applicant. If not, it shall reject the application
within a period of thirty days, and record the reasons in writing for
doing so. The applicant so aggrieved can file an appeal to the Central
Govt. within forty-five days from the date of receipt of such rejection.
The rule also provides that if the deficiencies in the application are
rectifiable, the licensing authority shall inform the applicant who shall
further rectify them within a reasonable period.
It is important to point out here that in the draft rules proposed drugs
specified in Schedule X of the Drugs and Cosmetics Rules,1945 are
prohibited to be sold by the e-pharmacies. However, as per the current
regime, the same is allowed as the rules at present does not distinguish
between the offline and online mode of selling of drugs and cosmetics.
1. 1mg:
Inception: 2014
Founders: Prashant Tandon, Vikas Chauhan, Gaurav Agarwal
Based in: Gurugram
Parent Company/Vision: The venture was launched by the name
‘Health kart Plus’ as a part of the Health kart family which
focuses on health and nutrition.
e-Pharmacy Model: Market place-based model
2. CareOnGo:
Inception: 2015
Founders: Ritu Singh, Aditya Kandoi and Yogesh Agarwal
Based in: Delhi
Parent Company/Vision: ZotikDelhi a sister concern of
CareOnGo, is India's first and largest e-distributor of medicines
and general wellness products. It aims to be a is a one-stop
destination for one's pharmacy procurement needs.
e-Pharmacy Model: Inventory based model
3. Medlife:
Inception: 2014
Founders: Tushar Kumar and Prashant Singh
Based in: Bengaluru
Parent Company/Vision: Tushar Kumar, son of Prabhat Narain
Singh, one of the founders of Alkem Laboratories
e-Pharmacy Model: Inventory based model
Delivery Time: 24-48 hours. Express delivery (2 hours) has
recently been started.
Medlife supplies medicines Pan India. The most popular cities from
which it receives orders are Bengaluru, Mumbai, Kolkata, Delhi,
Chennai, Hyderabad, Pune, Ahmedabad, Indore, Allahabad, Durgapur,
Faridabad, Agra, Kanpur, Ghaziabad, Gurugram, Gwalior, Howrah,
Rajkot, Jabalpur, Jaipur, Bhopal, Kharagpur, Lucknow, Noida, Surat,
Vadodara, Thane and Varanasi. Patients can take consultation
appointments for doctors in Bengaluru. It also offers e-consultation,
laboratory services, app-based healthcare-related services, private label
generics and ayurvedic brand to become an integrated healthcare service
provider with a pan-India presence. Medlife has also expanded by
adopting the franchise model.
4. Myra:
Inception: 2015
Founders: Faizan Aziz and Aniruddh Coontoor
Based in: Bengaluru
Parent Company/Vision: The founders wish to make medicines
accessible at the time of need and also ensuring quick and timely
delivery.
e-Pharmacy Model: Inventory based model
Delivery Time: 1 hour
5. Netmeds:
Inception: 2012
Founders: Pradeep Dadha and Bruce Schwack
Based in: Chennai
Parent Company/Vision: In 1914, the Dadha family ventured into
pharmaceutical retailing business and entered into drug
manufacturing in 1972. The manufacturing unit, Tamil Nadu
Dadha Pharmaceuticals, was later merged with Sun Pharma in
1996. The Group sells drugs in wholesale in Kerala and retail in
Tamil Nadu. It has now ventured to the online model.
e-Pharmacy Model: Inventory based model
6. PharmEasy:
Inception: 2015
Founders: Dharmil Sheth and Dhaval Shah
Based in: Mumbai
Parent Company/Vision: The company was started with a vision
to deliver genuine medicines at affordable rates by optimizing the
supply chain and logistics.
e-Pharmacy Model: Market place-based model
PharmEasy supplies medicines all over India to more than 1000 cities
and towns covering 22000+ pin codes all over India. Popular cities are
Mumbai, Delhi, Kolkata, Pune, Bengaluru, Jaipur, Thane and
Ahmedabad. Diagnostic Test services are available in Mumbai including
Thane, Navi Mumbai, Kalyan and Dombivali, Delhi with Noida,
Gurgaon, Faridabad & Ghaziabad, Chennai, Pune, Ahmedabad and
Gandhi Nagar, Surat, Vadodara, Lucknow, Kolkata, Hyderabad,
Bengaluru and Jaipur. PharmEasy has medicine reminders, medicine
refills (subscription), digital prescription records, free E-Doctor-
Consultation, sample collection from home for laboratory tests and easy
return policy. It has tied up with laboratories like Apple diagnostics,
iGenetic Diagnostics, Oncquest Diagnostics, SRL Diagnostics, Dr.
Avinash Phadke labs, SRL Diagnostics and Suburban Diagnostics.