Recently, there was a huge debate going-on both at the state and center level regarding online sales of the medicine. E-Pharmacy a recent entrant in the e-commerce arena is receiving huge support from Central Government and investors. As per Ken Market Research's report12, the total revenue generated by the online sales of healthcare products in India was INR 5,075.9 million in FY 2015 up from INR 771.0 million in FY 2012 at a CAGR of 87.4 during the period FY2012-FY2015. Though online pharmacy sector has shown tremendous growth in the economy and helped the public by providing them online portals where they can compare the price of the drugs, it has also increased the number of fraud cases in online sale of the prescription drugs.
Despite attaining a benchmark in the field of e-commerce, the sector is lacking in regulatory guidelines. The Drug & Cosmetic Act, 1940, governs the pharmacies in India. Since the law was written before the computer era, there are no laws related to internet and e-commerce. The Information Technology Act, 2000 (IT Act), governs all activities and issues related to the internet. But there is a lack of accurate and crystal clear laws and guidelines when it comes to e-pharmacies regulation. There is a need of stringent regulatory guidelines to be incorporated in current Drug & Cosmetic Act, 1940 (Act), to ensure efficient and legitimate running of e-pharmacies. Despite numerous oppositions from various physical Pharmacy associations over possibilities of misuse/fraudulence in online sales of medicines, the Central Drugs Standard Control Organization (CDSCO) on 28.08.2018, came up with draft rules on 'SALE OF DRUGS BY E-PHARMACY' with an aim to regulate e-pharmacy business and sales, storage and distribution therein across India under the Drugs and Cosmetics Rules, 1945 (Rules).
Ban on online sales
Recently Delhi High Court ordered13 ban of the online medicines, which ban will continue till new laws are framed in this entity.
The bench comprising Chief Justice Rajendra Menon and Justice V K Rao said that "once the rules come into play, Online Pharmacies can start selling the medicines". The application for the impleadment was filed in a PIL by Zaheer Ahmed seeking a ban on "illegal" sale of drugs and medicines online. The main complaints in the PIL include14:
- Medicines worth lakhs was being sold online every day without much regulation and posing a huge risk to patients as well as doctors.
- Online sale of medicines is not permitted under the Act, and the Pharmacy Act
- The Drug Controller General of India, in 2015, had clearly directed all state drug controllers to protect the interest of public health by restraining such sale online.
- By allowing unchecked online sales, the government has failed in its responsibility to protect public health and fulfill its obligation.
- Drugs are different from common items; and their misuse and abuse can have serious consequences for public health.
- Internet is used by a large number of children, minors and also uneducated people in rural areas. They can become victims of wrong medication.
- Online pharmacies are working without drug licenses and are also indulging in selling psychotropic substances.
As per the petition filed - Online pharmacies are operating without a drug license and cannot be regulated in the present regime. Unregulated and unlicensed sale of medicines will increase risk of spurious, misbranded and sub-standard drugs being sold.
Conclusion
Delhi High Court ban on the sale of the online medicine will certainly give a direction to the authorities where they will need to come up with some stringent regulatory guidelines and fast-track the implementation process. This will not only regulate the online sale of medicine but will also help the e-pharma sector to have transparency with the drug authorities and abide with the regulatory guidelines for public safety.
Footnotes
13. http://delhihighcourt.nic.in/dhcqrydisp_O.asp?pn=299654&yr=2018
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