It was widely reported on Wednesday that the country’s drug regulator put a halt to the online sale of drugs. This was based on a letter sent by the Directorate General of Health Services under the Central Drugs Standard Control Organisation (CDSCO) to all states and union territories. The letter told states to take “necessary action” to comply with a Delhi High Court order from 2018 in the matter.
The court order had barred the online sale of medicines without a licence and directed the government to prohibit the same till further instruction. This Delhi HC order was based on an interim order passed by the Madras High Court, which had barred the online sale of drugs without a licence and asked a competent authority to stall sales. This stay, however, was later vacated by the Madras High Court in January 2019.
However, many of the major players in the e-pharmacy space aren’t too perturbed by the CDSCO letter. They say that none of them stock the drugs themselves but get it from a pharmacist on the receipt of a prescription.
‘Order doesn’t affect us’
Pradeep Dadha, the founder and CEO of Netmeds.com, says, “The interim stay will be in place until the Union government notifies statutory rules for online trade of medicines. Since then, we have been operating in a fully compliant manner. We only work with licensed pharmacy partners and we are committed to adhering to all the guidelines and standards that have been defined for our sector.”
While the argument is that there is no regulation for e-pharmacies, companies reason that they are intermediaries, and fall under the IT Act of 2000 and the Drugs and Cosmetics Act. There is no separate licence for the sector yet -- the government has put out a draft of the Drugs and Cosmetics Rules to amend the law to include e-pharmacies. These draft e-pharmacy rules are currently being reviewed by a group of ministers led by Defence Minister Rajnath Singh.
Dr Varun Gupta, the Vice President of Medical and Regulatory Affairs at 1mg Technologies, said that the order does not affect them. “In our case, 100% of sales happen through pharmacies having a valid license given by the state Food and Drug Administration (FDA) and under the supervision of registered pharmacists. This order does not affect us.”
The same was echoed by Dharmil Sheth, the co-founder of PharmEasy, who said that it’s business as usual for the company.
“The order is good because any sale happening without a valid licence should definitely be blocked. 100% of all our sales happen through a licensed pharmacist. The pharmacists have a valid licence given by the state FDA, and the sale takes place under the supervision of a pharmacist,” he says.
No rules governing e-pharmacy sector
Presently, there are no rules in place for the sector. In September, the government, in an affidavit submitted to Delhi High Court, said it is in the process of finalising the draft rules for regulating e-pharmacies after going through representations of all stakeholders.
The health ministry in its earlier draft had allowed online sale of drugs barring narcotics and psychotropic drugs, by a licensed online medical store. Currently, online pharmacies are operating in the country without a drug licence as there are no rules framed for the sector. A health ministry official told news agency PTI that around 50 such pharmacies currently operate in India.
"The changes were being made following consultation with the stakeholders after the retail pharmacists expressed concern over their business going to loss with online medical stores getting official recognition. According to them, online pharmacies will offer huge discounts and provide customers with the option of plethora of brands of drugs because of which more and more people will opt for them," an official said.
Some of the main players in the e-pharmacy space back the government’s move to block unlicensed providers. They added that each of their own businesses is auditable, and every transaction can be tracked with a prescription and an invoice.
Due to the back and forth in the matter of e-pharmacies, those in the e-pharmacy space say that the easy of doing business needs to improve.
Earlier this week, Digital Health Platforms, a group of entrepreneurs in the digital health space, at a press conference in New Delhi urged the government to release the rules governing e-pharmacies without any further delay.
“These continued long policy/procedural issues are continuing to cause issues around ease of doing business in this space and a simple and clear regulatory pathway is a prerequisite for innovation to thrive in this important sector,” said Prashant Tandon told Economic Times.
Matter in court
In the PIL that was filed in the Delhi High Court, the petitioner was a Dr Zaheer Ahmed who said that the online illegal sale of medicines would lead to a drug epidemic, drug abuse, and misuse of habit-forming and addictive drugs. Dr Zaheer also moved a contempt plea in April against online providers, contending that e-pharmacies continue to "blatantly" violate the high court’s direction, and the Union government was not doing anything to stop it. Following this, the court issued notices to the Centre and some e-pharmacies.
E-pharmacies told the court in July that they are an intermediary where they only deliver the medications, likening themselves to food-delivery app, Swiggy.
After the Delhi High Court gave its order to bar the online sale of medicines in 2018, e-pharmacies moved applications before the Delhi High Court for the same to be vacated. The matter is now sub-judice.
With PTI inputs