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Ergo Update

08-Apr-2020

Introduction

On 26 March 2020, the Ministry of Health and Family Welfare (Health Ministry) legalised the doorstep delivery of certain drugs which are ordinarily sold by way of prescription only (Notification). These include Schedule H drugs, except narcotics, psychotropics and controlled substances, as defined in the Narcotic Drugs and Psychotropic Substances Act, 1985; Schedule H1 drugs, under the Drugs and Cosmetics Rules, 1945 (Drug Rules); and Schedule X drugs, under the Drugs Rules. While the last mile delivery of drugs has been a commonly prevalent practice, this Notification is unique in being the first instance of this concept being expressly recognised under Indian pharmaceutical law.

Persons permitted to undertake the last mile delivery of drugs: Licensees who are holders of a license in Form-20 or Form-21 under the Drug Rules have been authorised to deliver the abovementioned drugs.

Persons who can avail these doorstep delivery services: The Notification prescribes that the drugs will be supplied at the doorstep of the ‘consumers’. The coverage of the Notification is narrow and limited to patients, not covering B2B delivery of drugs to hospitals, dispensaries, or medical, educational or research institutes.

Mandatory conditions to be satisfied:

Ø   

Prescription:

 

§    

Doorstep delivery of all Schedule H drugs must be based on a prescription provided to the licensed seller either physically or through e-mail;

 

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In case of chronic diseases, the requirement of the prescription shall be dispensed only if it is presented to the licensee within 30 days of its issuance; and

 

§    

In acute cases, the prescription shall be dispensed only if it is presented to licensee within 7 days of its issuance.

Ø   

Licensees’ registered email IDs: Licensees are required to submit the e-mail ID for registration with the licensing authority if prescriptions are to be received through e-mail.

Ø   

Geographical restrictions on the doorstep delivery of drugs: Licensees can supply drugs at the doorstep of the patients located within the same revenue district where the licensee is located.

Ø   

Licensee to maintain records of such transactions: Licensees are required to send the bill / cash memo for such transactions over e-mail. Further, records of such transactions are to be maintained by the licensee.

Comment

Last-mile delivery of medicines is as much a boon for patients, who are unable to step out and purchase the drugs (especially in times of COVID19), as it is for the e-pharmacies or online marketplaces engaged in the sale of such drugs. As opposed to the previously unregulated regime of companies and individuals indulging in doorstep drug delivery as a matter of industry practice, this Notification has regulated the sale of drugs allowing only Form-20 or Form-21 license holders to do last mile delivery of drugs upon satisfaction of the prescribed conditions.

That said, there is still scope for misuse of this provision and clarity on the enforceability remains to be assessed. While specifying the validity period of the prescriptions (30 days for chronic diseases and 7 days for acute cases) is a welcome step, the Notification does not address the reuse of the same prescriptions in the abovementioned periods. Issues such as disallowing inter-state or even inter-district delivery of drugs constitute logistical challenges which this Notification poses. Moreover, since the Notification does not legitimise e-pharmacies, further steps must be considered from a B2B perspective. To aid the process, the ambit of delivery of drugs should be widened to include hospitals and other pharmacies to cater to the re-stocking demands of license holders.

Going one step beyond the draft rules issued by the Health Ministry in August 2018, as a draft amendment to the Drugs Rules (Draft E-Pharmacy Rules), the Notification allows for prescriptions to be shared electronically – without touching upon data privacy concerns. Given that health related data is proposed to be classified as sensitive data in the Personal Data Protection Bill, 2019, certain other checks may need to be introduced to prevent misuse of such data i.e. the prescriptions provided for obtaining medicines at our doorsteps.

We note that this Notification is a small, yet much required step, in the right direction. However, it still warrants more clarity from a legal as well as a logistical standpoint. Once the Draft E-Pharmacy Rules are notified, the Notification will need to be read in tandem and conflicting positions will need to be harmonised by the Legislators.

-       Sanchit Agarwal (Principal Associate) and Akarshita Dhawan (Associate)

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