Safety concerns over e-pharma put Centre in a spot
April 30, 2023

Why in news?

  • The Central Health Ministry is not willing to allow e-pharmacy platforms to operate without regulation and oversight.
  • It believes that such a move would be too risky and could pose a significant threat to public health and safety.

What’s in today’s article?

  • E-pharmacy in India
  • News Summary

What is E-pharmacy?

  • E-pharmacy, also known as online pharmacy or internet pharmacy, is a digital platform that allows customers to purchase medicines and other health-related products over the internet.
  • E-pharmacies are a form of e-commerce, where customers can browse through a wide range of medicines, medical devices, and health supplements and order them from the comfort of their own home.

What is the size of e-pharmacy Market in India?

  • In 2021, the market for online pharmacies was worth ₹25.50 billion.
  • It is anticipated to expand at a compound annual growth rate (CAGR) of 22.20% from 2022 to 2027 when it is expected to reach ₹89.47 billion.

What is the Legislative Framework for e-Pharmacies in India?

  • As of now, no exact rules are in place for E-drug stores in India, and this is a significant inhibitor to the online drug store market in India.
  • At present, E-pharmacies in India follow the Drugs and Cosmetics Act 1940, the Drugs and Cosmetics Rules 1945, the Pharmacy Act 1948 and the Indian Medical Act 1956.
  • However, the electronic sale of physician-prescribed drugs from online drug store sites is expressed under the IT Act, 2000.
  • E-pharmacies are managed by state drug controllers and approvals for E-pharmacies should be given by the Drug Controller General of India (DCGI).
  • The MoH&FW in 2018 came out with draft rules to control the online offer of medications and availability of genuine drugs from certifiable online sites.
  • But, after being sent to a group of ministers, the proposal was immediately put on hold.
  • Since then, multiple court orders and the 172nd Parliamentary Standing Committee report have called for regulating e-pharmacies.
  • An administrative structure to oversee/regulate the e-pharmacy sector is necessary when antimicrobial resistance (AMR), criminal and risky movement of drugs, is on the rise.

News Summary: Safety concerns over e-pharma put Centre in a spot

Why there is need for regulation and oversight of e-pharma in India?

  • Consumer safety
    • There are concerns over the distribution of illegal or unethical medicines, or outdated, substituted, or counterfeit medications.
  • Other issues
    • Unlimited accessibility to medicines through e-pharmacy, sale of sub-standard, habit-forming medicines [like sedatives, mood-altering drugs], profiling of patients and buyers, and illegal data collection are the main concerns.
    • Drug abuse, misuse, self-medication, access to children etc. are problems that the e-pharma industry is currently facing.
    • Besides, there is no place or system to evaluate adverse drug reactions.
    • Also, there is no clarity on drug storage conditions and no system of immediate recall in case of drugs.
  • There is a general notion that vigilance must win over the perceived convenience and economics of the e-pharma market.