The Central Drugs Standard Control Organisation (CDSCO), which regulates pharmaceuticals and medical devices in India, and the Ministry of Health and Family Welfare are currently working towards framing a policy for regulating online pharmacies, according to this Livemint report. Apparently, the government wants to set up an electronic platform, which will be the focal point for monitoring all sales via online pharmacies. The report also mentions that drugs will be categorised into five separate brackets:
- Medicines with limited risk of abuse
- Medicines with greater risk of abuse
- Over-the-counter drugs
- Prescription drugs
- Antibiotics and anti-bacterial drugs
- Narcotics and psychotropic drugs
Earlier this year, the Ministry of Health and Family Welfare had begun a public consultation regarding an electronic platform for regulating the sale of medicines in India. A revenue model had also been proposed for this portal: a small transaction fee of not more than 1% of total cost of medicines, subject to a ceiling of Rs 200 per prescription, to be paid online by pharmacies/ e-pharmacies/ wholesale /retail distributions, etc.”, as well as a “small amount of registration fee and renewal fee for manufacturers/ pharmacies/hospitals/ clinical establishments, etc.” More on this here. This development happened almost two years after the the Indian Pharmacist Association (IPA) wrote to the Drugs Controller General of India (DCGI) opposing online pharmacies in India.
With this in mind let’s look at how the United States regulates online pharmacies and what India can learn from it.
To begin with, note that in the United States pharmacies (online or offline) are licensed at the state level, and there is no licensing procedure at the federal level. So, there are minor differences in licensing rules among the various states.
Online pharmacies are allowed to operate in the country, with the following restrictions:
- According to the Food and Drug Administration (FDA) rules, importing prescription drugs is illegal in the US. Hence, all online pharmacies need to be physically located in the country. There are a certain exceptions in regards to importing of prescription drugs for personal usage. More on that here.
- As mentioned above, all Internet-based pharmacies need to be licensed at the state-level. Note that if an online pharmacy wants to deliver to a particular state, then it needs a license from that state. However, it doesn’t need to be physically located in that state.
- Online pharmacies are not allowed to sell prescription drugs to customers without a prescription from a doctor, based on an in-person patient-doctor consultation and not just an online consultation. The only exception is the state of Utah where this is allowed, provided the pharmacy, the doctor and the customer are all based in Utah.
The FDA also runs the BeSafeRx campaign that raises awareness regarding the dangers of buying prescription drugs online. It provides information about risks of buying from a fake online pharmacy, how to identify a fake online pharmacy, and finding a safe online pharmacy. More on this here and here.
National Association of Boards of Pharmacy
The National Association of Boards of Pharmacy (NABP) runs the Verified Internet Pharmacy Practice Sites (VIPPS) program, which provides accreditation to pharmacies that sell prescription drugs via the Internet.
How does the accreditation process work?
- Online pharmacies submit an application, required documentation, and specified fees to NABP
- NABP reviews policies, procedures, and websites to ensure adherence to VIPPS criteria and standards
- NABP verifies the pharmacy’s license status
- NABP performs an on-site survey
VIPPS sets the criteria and standards that online pharmacies need to meet to receive the accreditation. Some of the key criteria and standards include:
- Maintain and enforce policies and procedures that assure the integrity, legitimacy, and authenticity of the Prescription Drug Order and seek to prevent Prescription Drug Orders from being submitted, honored, and filled by multiple pharmacies. Maintain and enforce policies and procedures that assure that prescription medications are not prescribed or dispensed based upon telephonic, electronic, or online medical consultations without there being a pre-existing patient-prescriber relationship that has included an in-person physical examination.
- Maintain and enforce policies and procedures ensuring reasonable verification of the identity of the patient, prescriber, and, if appropriate, caregiver, in accordance with applicable state law;
- Obtain and maintain in a readily accessible format, patient medication profiles and other related data in a manner that facilitates consultation with the prescriber, when applicable, and counseling of the patient or caregiver;
- Conduct a prospective drug use review (DUR) prior to the dispensing of a medication or device in accordance with applicable state law; and
- Maintain and enforce policies and procedures to assure patient confidentiality and the protection of patient identity and patient-specific information from inappropriate or non-essential access, use, or distribution while such information is being transmitted via the internet and while the pharmacy possesses such information.
- Comply with all applicable federal and state laws regarding the sale of Over-the-Counter Products identified as precursors to the manufacture or compounding of illegal drugs.
Check out the complete list of criteria and standards here.
Customers can simply check the NABP website for a list of accredited online pharmacies or alternatively they can check the safe.pharmacy website. NABP also provides a list of Not Recommended Sites. In fact, “NABP has reviewed over 11,500 online drug outlets [in the US] and found that 96% appear to be operating in conflict with pharmacy laws and practice standards.”
Along with its global coalition of pharmacy community stakeholders, the Association also sought to keep the domain out of the hands of a third party that may turn a blind eye to illegal activities. In today’s digital environment, .pharmacy is the way to turn the tide against sophisticated criminals who build authentic-looking sites and can easily duplicate verification logos to trick unsuspecting consumers into thinking they are visiting a legitimate online pharmacy… As with all NABP programs, vetting for .pharmacy applicants is thorough and requires those seeking approval to prove that they are operating safely, legitimately, and in accordance with program standards. And once NABP has granted approval, the Association continues to monitor registered sites to be sure that they adhere to program standards and operate legitimately.
The Centre for Safe Internet Pharmacies
The Centre for Safe Internet Pharmacies (CSIP) is a non-profit organisation started by a group of Internet-based service providers and tech companies, including Amaerican Express, dotHealth (registry operator of the .health domain), Facebook, Google, MasterCard, Microsoft, PayPal, UPS and Yahoo. Together they represent “each point in the online advertising and purchase/delivery cycle, including domain name registries, registrars, shipping companies, payment processors, and advertising service providers.”
CSIP, its member organizations and partners in the industry provide consumers and medical professionals with ways to verify online pharmacies, to report illegal online pharmacies or counterfeit pharmaceutical products, and to become educated about these issues. CSIP also collaborates with global law enforcement in support of efforts to end the threat of illegal online pharmacies.
What can India learn from the US?
Even though India doesn’t yet have a policy for regulating online pharmacies, it already has the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, which provides guidelines for how prescription drugs are to be sold in the country, including specific rules for how these drugs are labeled and bar coded. Then there is the Pharmacy Practice Regulations, 2015, which provides a clear definition of what a prescription means:
(2) (j) “Prescription” means a written or electronic direction from a Registered Medical Practitioner or other properly licensed practitioners such as Dentist, Veterinarian, etc. to a Pharmacist to compound and dispense a specific type and quantity of preparation or prefabricated drug to a patient.
- The primary stumbling block for the government of India and CDSCO, while framing a regulatory guideline for online pharmacies, will be regulation of online marketplace that sell pharmaceutical products. To be fair the issue of intermediary liability in case of the marketplace model hasn’t been resolved across all verticals, and not just online pharmacies. Should the marketplace bear the onus of ensuring that the customer has the required prescription, or the offline pharmacy that supplies the medicine?
- One of the tricky parts of the US policy is the requirement for all online pharmacies to have a physical presence as well. On paper this sounds perfect, because it increases the credibility of an online pharmacy. However, at the current stage a number of smaller online pharmacies in India might not have the funds available to set up an offline presence as well. Plus, offline chemists who have been consistently protesting online sale of drugs are unlikely to be pacified by this. However, certain tough measures are required because as online purchases of medicines become popular fake online pharmacies will crop up without fail.
- Then there is the question of licensing. Even though health is a state subject in India (the centre also has a say), the draft guidelines should make it simpler for online pharmacies to register for a license once and operate across the country.
- Once purchasing prescription drugs online becomes an accepted and popular alternative in India, the issue of patient information privacy and security will come to the fore. By now the government of India must be well aware of the pitfalls in this regards through its UIDAI-Aadhaar experience, and hence should include stringent guidelines for the same at the initial stage itself.
- Online pharmacies and other tech companies should learn from how the CSIP operates, and form a similar body in India, through which it can not only educate potential customers, but also help the government and law enforcement agencies in weeding out any and all unscrupulous players in this space. Note that last year, a number of online pharmacies had come together to form the Indian Internet Pharmacy Association (IIPA) to demand a level-playing field. The members included Bookmeds, mChemist, Medidart, Medlife, Medstar, Netmeds, Pharmeasy, Zigy.com (PM Health & Life Care), SaveOnMedicals, Savemymeds and 1mg.
- It is also important to educate people about safe practices of buying pharmaceutical products online. Similar to the US, a list of approved/accredited online pharmacies needs to be created.
- The .pharmacy domain is a great idea to ensure that the online pharmacy is genuine. India could jump on board or create a separate domain specifically for online pharmacies in India. In case of online marketplace, they could be required to set up a separate vertical with for example the .pharmacy domain to sell pharmaceutical products.