E Pharmacy Regulation

IN NEWS:

• The Central Drugs Standard Control Organization (CDSCO) sent out notices to 20 online pharmacies to explain why action should not be taken against them for sale and distribution in contravention of the law.

E PHARMACY:

• A web-based pharmacy is an online system that provides a platform for customers to purchase medicinal drugs and E-services online.
• Some of the known e-pharmacies include 1MG, Netmeds, BookMEDS, mChemist, PharmEasy, and Savemymeds.

GROWTH DRIVERS:

• Technological developments:
  • Increased adoption of smartphones, UPI-based payments, cheaper internet connectivity etc. has reduced the cost of building digital products and improved access to markets.
• Changing lifestyle and disease progression:
  • Incidence of noncommunicable diseases such as diabetes and hypertension has grown dramatically due to changing lifestyle habits, thereby generating a demand for a lifelong supply of medication.  
• Favourable government policies:
  • Central and State governments have come up with several IT-enabled initiatives to improve the accessibility, affordability and quality of healthcare in India, such as national health portal and national Health Stack. This has improved public trust on digital healthcare facilities.
• Support from insurance sector:
  • Medical insurance penetration in India is increasing and many insurers are progressively elevating the clients to purchase drugs through E-pharmacy gateways.
• Booming market:
  • Development in the Indian financial industry has increased medical spending, thereby providing an attractive market for drug manufacturers and pharmacies.
• Pandemic outbreak:
  • E-pharmacies have shown great resilience toward the pandemic by providing essential healthcare services to people during trying times. Hence, many offline customers have permanently shifted to e-pharmacies.

EXISTING REGULATIONS:

• Currently, there is no concrete regulatory framework for E-pharmacy companies in India.
• They are largely regulated through the Drugs and Cosmetics Act, 1940, Pharmacy Act, 1948 and Information Technology (IT) Act, 2000.
• In 2016, the Federation of Indian Chambers of Commerce & Industry came up with a Self-Regulation Code for e-pharmacies.
• In 2018, government came up with a set of draft regulations to govern e-pharmacies. But no significant progress has been made in finalizing it.

CHALLENGES:

• Ambiguity with existing legislations:
  • The absence of clear rules has led to confusions. For instance, the Delhi and Madras High Courts took divergent positions on online sale of drugs: the former prohibiting the same, and the latter allowing the same till the government brought into effect its rules on e-pharmacies.
  • Some of the e-pharmacies, like PharmEasy and 1mg, are aggregators. They take orders, pick the medicines from licensed offline pharmacies and drop them to the customers. These pharmacies argue that this does not require a license because there is no direct selling involved.
• Inter-state trade:
  • Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities. But the rules concerning interstate sale of drugs are not well established, posing a challenge to E-pharmacies that are spread all across India.
• Data privacy:
  • In the absence of a data regulation regime, users have limited control over how their health data is collected, processed, who has access to it etc.
  • A data breach in an online pharmacy can compromise the confidentiality of a person’s personal information.
• Potential misuse of drugs:
  • With E-pharmacy, there is a possibility that one prescription can be uploaded several times on the website portal, and this can lead to incidents of self-medication and drug abuse.
  • Also, there is no regulation on the sale of drugs to minors. This increases the vulnerability of children to habit-forming drugs.
• Regulating the sale of ‘restrictive drugs’:
  • Schedule H and X drugs can be purchased only with a prescription. However, it is difficult to trace the authenticity of the prescription when it is uploaded on the websites for online purchase of drugs.
• Quality of drugs:
  • Some medicines have to be stored at certain conditions, like cool temperatures. However, without proper regulation, assuring such facilities in online pharmacies is challenging.
  • For instance, refrigerated units are often not used in the delivery of medicines to customer’s doorstep. This may affect the quality of drugs due to high temperature and humidity.
• Hesitancy among investors:
  • The lack of definite rules has profoundly affected the overall market growth of the E-pharmacy sectors in India and has kept many large investors at bay.

WAY FORWARD:

• The Government should work on a robust policy and provide clear-cut laws to regulate the e-commerce space in pharmaceuticals, starting with the draft e-pharmacy rules of 2018.
• Through efforts like the startup mission, government could encourage more entrepreneurs to enter the sector and add to the general development of the online pharma business market in India.
• Instead of competition, the collaboration of the offline and online pharmacies needs to be promoted.
• Government could mandate barcoding for the online mode of drug distribution to promote transparency and accuracy in data management systems.
• India needs to finalise and implement the data protection legislation.

PRACTICE QUESTION:

Q. Critically analyse the role of online pharmacies in improving the pharmaceutical service delivery in India?