India looks to counter the epidemic of fake drugs through regulation of online pharmacies

• The Union Health Ministry of India has published draft rules for the sale of drugs by online pharmacies in the country.
• The draft proposes regulation of the ₹30 billion e-pharmacy market and the privacy of user data held with them.
  
• The registration and accountability of these firms is crucial to countering the phenomenon of fake medicines in India.

India has been fighting a losing battle against counterfeit drugs. The phenomenon is not only present at hospitals and offline chemists, but also when buying from online pharmacies. In an attempt to handle at least one side of the problem, the Union Health Ministry published the ‘Draft Rules on Sale of Drugs by E-Pharmacy’.

The sunshine segment currently consists of around 282 e-pharmacies in India. The big names include Pharmeasy, Myrameds and Netmeds. And, while pharmaceutical sector has an upward trajectory overall, the subset of e-pharmacies is showing a growth rate in the double-digits. According to the Drug Controller General of India, the online pharmaceutical business is currently worth ₹30 billion.

With the aim of regulating online pharmaceutical portals in India, the policy focuses on 2 key paradigms - accountability and consumers.

Accountability

In the most basic of requirements, the draft regulations state that no person or entity will distribute or sell, stock, exhibit or offer the sale of drugs through e-pharmacy portal until registered with the Central Drugs Standard Control Organisation (CDSCO).

In order to register with country’s apex drug regular, individuals will have to file Form 18AA with the Central Licensing Authority along with a deposit of Rs 50,000 asserting that the registration holder will comply with the IT Act, 2000.

This registration is essentially a 3-year license to operate an e-pharmacy. After that period, the companies will have to apply for a renewal. And no matter how many renewal cycles occur, the base of operations of any e-pharmacy will be inspected every 2 years by the Central Licensing Authority.

After addressing the supply side of the business, the draft lays out regulations for the incoming demand as well. Whenever a consumer purchases a drug, the pharmacy must file a cash or credit memo through the pharmacy’s online portal. These memos serve as records for the pharmacy in case of problems down the road.

And, no matter what the case, the sale of tranquillisers, psychotropic drugs, narcotics and habit forming drugs is prohibited with no exceptions.

The ribbon on the package is if any e-pharmacy violates these regulations and requirements, it will lead to the suspension of their license and possible cancellation as well.

Consumers

The degree of privacy may be up for contention because, while patient details are to be kept confidential from other people or companies, government requests are an exception. Similar to the point on contingency that most people have with the draft bill of data protection, this draft also allows for data sharing if the state or central government come calling.

Even the delivery of drugs is held accountable. When placing an order, patients will be able to specify the exact time when they’d like their medical delivery, and the e-pharmacy must adhere to that time line.

In addition, online pharmacies are required to set up 24/7 call centers as a customer helpline to address grievances and doubts.

These regulations, though not holistic, do implement some of the basic measures that should ideally be in place. As per the World Health Organisation (WHO), one is every 10 medical product in countries like India either substandard or fake altogether.

The real danger doesn’t lie in their ineffectiveness but unintended adverse effects or allergies resulting in further illness or even death.