India: Regulatory Guidelines For E-Pharmacy Start-Ups

An ePharmacy is an online pharmacy, Internet pharmacy or mail-order pharmacy that operates over the Internet and sends the orders to customers through the mail or shipping companies. In India ePharmacy sector is in its growing stage, whereas in US and Europe it is fully functional and regularized. In recent years ePharmacy startups in India has been rising at a steady pace, with focus to deliver affordable medicines to anyone who needs it, and to supply the medicines in remote areas where physical drug stores are not present. Moreover, the present ePharmacy stores not only sell medicines but also offer other facilities like - list of diagnostic (pathological/radiological) test bookings, online consultation to the Physician, and consumer education through value added information/ educational leaflets/articles on their websites.

However, it's been observed that the offline/physical pharmacy community has been opposing the ePharmacy business model, and a nationwide strike against the e-pharmacies was performed under the leadership of All India Organization of Chemists & Druggists (AIOCD). According to the retail chemist shop owners as cited in Indian express "verification of drug quality in online retail is difficult and the sale of psychotropic substances will also increase online". In response to this, the Indian Internet Pharmacy Association (IIPA) a self-regulatory body for e-Pharma portals said that, the e-pharmacies will enable transparent drug dispensing mechanism and give high accountability as the entire procedure will be tracked.

Apart from this, the present drug regulation in India resides under Drugs and Cosmetics Act, 1940, Drugs and Cosmetics Rules, 1945, Pharmacy Act, 1948, Indian Medical Act, 1956 and Code of Ethics Regulations, 2002, Information Technology (IT) Act, 2000 etc..The powers of regulation have been distributed between the centre and the state governments. Central Government is responsible for licensing of drug imports and the state governments are responsible for the manufacture, sale and distribution of drugs. Every state has its own Drugs Control Administration1.

However, the Drugs and Cosmetics Act, 1940 does not differentiate between medicines sold online or offline; there is no solid regulation/policy available to regulate ePharmacy operation in India. Therefore, the health ministry and Central Drug Standard control Organization (CDSCO) have been working together on ePharmacy regulation policy, which is expected to streamline the online sales of medicine. Despite this the present developments of entrepreneurial ventures in ePharmacy Sector has already established the ePharmacy success story for a greater cause. In this view, the IIPA in the absence of ePharmacy policy by the government announced a voluntary "Code of Conduct", as this Code complies with existing Drug and Cosmetic Act, 1940 suggests that-

  • The e-pharmacies will only process scheduled medicines (Schedule H, H1) against a valid physical or scanned copy of the prescription. They will not process schedule X and other habit forming medicines.
  • The e-pharmacies will only dispense medicines through licensed pharmacies and will deliver medicines "safely and with appropriate instructions", according to the code.

Online medicine sellers will also partner with the government to recall medicines, raise awareness on the Jan Aushadhi scheme and also compile adverse events of medicines for the National Centre for Pharmacovigilance2.

Moreover, The Draft Pharmaceutical Policy of 2017 also encourages ePharmacies, and seeks to take on the powerful distribution lobby by allowing e-pharmacies, which will cut down channel costs3.

The Central Drugs Standard Control Organization (CDSCO) and ePharmacy

The Drugs Consultative Committee (DCC) of CDSCO is a statutory body constituted under Section 7 of the Drugs and Cosmetics Act, 1940. The DCC is authorized to maintain the uniformity of Drug and Cosmetic Act, 1940 throughout the country. In regards ePharmacy, the DCC on 11 Aug 2015 constituted a sub-committee of seven members headed by Mr. Harshdeep Kamble, Commissioner, FDA, Maharashtra, to examine the issue of sale of drugs on the internet in the light of practices being followed in the developed countries where such provisions are available for e-pharmacies, while taking care the risks and concerns related to such sales.

Meanwhile, On 30 December 2015, The CDSCO notified that selling of drugs through internet is not permitted as it violates the provisions of the Drugs & Cosmetics Act, 1940 and the Rules, 1945,4 and the status stands same at present as reported in the minutes of 50th DCC meeting held on 5th November, 2016.

The sub-committee had invited suggestions /views on online pharmacy regulation, further received suggestions/views regarding the same from various stakeholders, medical and Pharma associations, regulatory agencies, trade organizations & companies etc. It also received around 368 representations from individuals and other organizations, As few of these suggestions are highlighted below-

Associations Suggestions/views regarding ePharmacy
Indian Internet Pharmacy Association (IIPA) The association gave a detailed presentation on advantages of online mode of sale and also advocated that the market place and electronic platforms are in line with the provisions of the Information Technology Act, 2000 and Pharmacy Practice Regulation 2015. They also reiterated that the sale of medicines does not violate prevailing provisions of the Act.
Federation of Indian Chambers of Commerce & Industry (FICCI) FICCI gave a detailed presentation on advantages of this mode of sale and also advocated that the market place and electronic platforms are in line with the provisions of the Information Technology Act, 2000 and Pharmacy Practice Regulation 2015. They also reiterated that the sale of medicines through online mode do not violate prevailing provisions of the Act.
Indian Pharmaceutical Alliance (IPA) The changes in the present statute shall be made to ensure that online pharmacy players shall deliver against every order and should not be selective. It should be mandatory to cater and deliver to the remote and rural areas of the country. They said that this mode of sale will increase the accessibility of the medicines in general.
Organization of Pharmaceutical Producers of India (OPPI) Although online pharmacy have some advantages such as medicines being available at reduced cost, reduced inventory but cautioned on entry of counterfeit and spurious medicines. The system should ensure the traceability of the medicines.
Indian Medical Association (IMA) The sale of medicines over internet will further contribute this menace. IMA is not in favor of encouraging this mode of making availability of medicines. The prescriptions on the electronic platforms should be verifiable.
Consumer Online Foundation, New Delhi The foundation has submitted the copy of written representation and points for consideration. While accepting the online pharmacy that the technology advancements are inevitable, but it has to be taken with caution and with certain safeguards.
P h a r m a c y Council of India (PCI) The Pharmacy Practice Regulations have been made by Pharmacy Council of India, with approval of the Central Government, as powers conferred under Section 10 and 18 of the Pharmacy Act, 1948. While dispensing the medicines whether online or offline, the provisions under these regulations have to be considered.
All India organization of Chemist and Druggist Association (AIOCDA) The association out rightly opposed the concept of online sale of medicine. The concerns raised by the associations on online sale with a detailed power point and written presentation:
All India Drug Control Officer's Confederation (AIDCOC) This activity should be covered under the Drugs and Cosmetics Act, 1940 and rules 1945 with specific amendments to it.

The sub-committee after going through the suggestions, and considering the international practices followed in some of the major countries and also keeping the existing provisions of the Drugs and Cosmetics Act, 1940 and Rules, 1945 made there under, Narcotic Drugs and Psychotropic Substances (NDPS) Act, 1985, Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954, Drug Price Control Order (DPCO), 2013, IT Act, 2000 etc. made 22 points recommendation in its report: as some of them are suggesting-

EPharmacy may be permitted under strict monitoring and vigilance with effective law enforcement and period inspections. It also suggests some geographical restrictions for supply of drugs will be required for effective administrative control on online sale such as drug recalls and Pharmacovigilance.

In order to regulate online pharmacies, a National Portal will be created, which will be the nodal platform for transacting and monitoring online sale of drugs. Whereas the e-pharmacy service providers need to be registered with Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Rules, 1945. No unregistered entity shall be permitted to undertake online sale of medicines.

However the Sub-committee also suggested amendments in the Drugs and Cosmetics Rules, 19455.

Conclusion :

In 50th meeting of DCC, the committee accepted the report of the Sub-committee that the report should be forwarded to the Govt. for consideration and further action6.

At Present, the leading ePharmacy players such as- 1mg, Netmeds, mChemist, Myra, Medlife, PharmaEasy Medidart as many as 140 startups are currently operating in the online pharmacy market. There is an immediate need to have effective regulatory mechanism as the delay in process is not beneficial for the e-pharmacy service providers and consumers as well.

Footnotes

1. https://www.omicsonline.org/open-access/epharmacies-regulation-in-india-bringing-new-dimensions-to-pharmasector-2167-7689-1000175.pdf

2. http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/until-government-releases-rules-e-pharmacies-to-self-regulate-iipa/articleshow/55555554.cms

3. http://app.investmentguruindia.com/Mobile/ResearchArticles/2017/August/Pharma_Sector_Update_170817.pdf

4. http://www.cdsco.nic.in/writereaddata/Online-Sale-dec-2015.pdf

5. http://www.cdsco.ni.in/writereaddata/Sub-Committee%20Report%20on%20e-pharmacy.pdf

6. http://cdsco.nic.in/writereaddata/ddc50report.pdf

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