USTR Report on Online
pharmacies - polity
NEWS: Nearly all of the 35,000 online pharmacies worldwide are
operating illegally, according to the US Trade Representative’s annual report’s
annual report on “notorious markets.”
WHAT’S IN THE NEWS?
- Risks to Consumers:
- These illegal
pharmacies pose significant health risks by selling ineffective,
substandard, or dangerous drugs.
- Many operate without
valid licenses and offer medicines without requiring prescriptions or
including proper safety warnings.
- Their websites are
designed to mimic legitimate e-commerce platforms, often with false
claims of approval by the US Food and Drug Administration (FDA).
- Survey Findings:
- A survey conducted by
the Alliance for Safe Online Pharmacies’ Global Foundation found that
nearly 25% of Americans who used online pharmacies encountered
substandard, counterfeit, or harmful medicines.
- Federal Cases of Concern:
- A network involving
individuals from the US, the Dominican Republic, and India was found
selling counterfeit prescription pills containing deadly synthetic
opioids.
- The pills, disguised
as legitimate prescription drugs, led to at least nine deaths from
narcotics poisoning between August 2023 and June 2024, as per federal
prosecutors.
- Manufacturing Concerns:
- Many of these
counterfeit medicines are produced in unsanitary conditions and may
contain harmful ingredients, adding further risks to consumers.
Global Concerns About Counterfeit and Pirated Products
- Countries Highlighted:
- The report flagged 19
countries for issues related to counterfeit or pirated products.
- It specifically called
out online retailers, many of which are based in China and other parts of
Asia, for engaging in the sale of counterfeit products or illegal
activities.
- Counterfeit Medicines and Imported Ingredients:
- The report highlighted
the dangers of counterfeit medicines, which could include inert
ingredients, allergens, or dangerous chemicals.
- Imported ingredients,
such as fentanyl from China, were flagged as contributing to the issue.
Progress in Combating Counterfeits and Piracy in USA
- Major Enforcement Successes:
·
A coordinated effort among US authorities, industry groups,
and local police resulted in the shutdown of Fmovies, a Vietnam-based piracy
ring, and other related piracy sites in mid-2024.
·
Fmovies, once the world’s largest pirated movies site, had
recorded over 6.7 billion visits between January 2023 and June 2024.
·
In another Vietnam-linked case, operators of the pirate TV
platform BestBuyIPTV were convicted, ordered to pay fines, and had their
property confiscated.
·
Additional crackdowns were reported in Brazil, the UK, and
Kuwait, targeting sellers of counterfeit goods such as designer purses,
clothing, and footwear.
- Challenges Persist:
·
Despite enforcement, cyberlockers, which store and share
pirated movies and other content, continue to thwart efforts to curb piracy.
·
Some internet service providers (ISPs), referred to as
“bulletproof” ISPs, offer platforms that provide users with leeway to host or
access piracy-related sites. One such ISP, Avito, a Russian-based advertising
platform, was flagged for allowing counterfeit product advertisements.
Regulation of
E-Pharmacies in India:
- No Statutory Backing:
- The Drugs and Cosmetics Act,
1940 regulates
the import, manufacturing and distribution of drugs in India.
- However, there is no statutory definition of
“e-pharmacy” either
under the Drugs and Cosmetics
Act, 1940 or
the Pharmacy
Act, 1948.
- However, the electronic sale of
physician-prescribed drugs from online drug store sites is
expressed under
the IT Act, 2000.
- The Draft e-pharmacy rules were
floated by the Ministry of Health in 2018.
- Multiple court orders, including those
from Bombay,
Madras, Delhi, and Patna High Court, have called for regulating
e-pharmacies.
- The 172nd Parliamentary
Standing Committee report released in June 2022, deemed it "appalling" that
e-pharmacy rules had not been notified.
Laws that apply to online pharmacies in India:
- Drugs and Cosmetics Act, 1940: This act applies
to the online sale of drugs.
- Drugs and Cosmetic Rules, 1945: These rules
apply to the online sale of drugs.
- Pharmacy Act, 1948: This act applies to the distribution of
drugs.
- Information Technology Act, 2000: This act governs
some legal issues related to online dealings.
Other regulations
- The Drugs Controller General of India (DCGI) can ban the online sale
of medicines.
- Pharmacies must be registered with the CDSCO, the central drugs
regulator.
- Pharmacies must have permits from state regulators for sales and
distribution.
- A prescription from a registered medical practitioner is required
for the sale of drugs online.
- Only a registered pharmacist can distribute drugs
The
growth of e-pharmacy in India:
- The growth of e-pharmacy in India has been significant in recent years and is expected to
grow at a robust growth rate of 21.28% compound annual growth rate during 2021-2027.
- The main factors driving this growth include increasing internet and
smartphone penetration, rising healthcare costs, and a growing demand for convenience and accessibility.
- The acute need for doorstep delivery of drugs was felt
during Covid-19. Nearly 8.8 million households used home delivery services
during the lockdown.
- E-pharmacies call themselves
facilitators of doorstep delivery and claim tie-ups with retail chemists for vending
medicines.
Conclusion
The USTR’s report highlights the widespread global
challenges associated with counterfeit goods, piracy, and illegal online
pharmacies. It acknowledges progress in enforcement efforts through
collaborations between authorities and industries but emphasizes that
significant challenges remain, particularly with the proliferation of
counterfeit products, unsanitary drug production, and the persistence of
piracy-enabling technologies and platforms.
Source:
https://www.business-standard.com/world-news/us-notorious-markets-report-warns-of-risks-from-online-pharmacies-125010900734_1.html