 "medicine, online pharmacy pharmacy")
The recent Madras High Court’s (HC’s) ruling in favour of the online pharmacy players will usher in the required validation and certainty to their business model, said industry players.
They are now awaiting discussions with the central government on the regulatory framework.
The Madras HC has reportedly set aside an earlier order by a single judge Bench asking them to stop engaging in the digital trade of medicines.
“There was a bit of uncertainty before, but with the draft rules being released, and now the favourable Madras HC order, the industry has received the validation it needed. It is unlikely that e-pharmacies will be barred from functioning,” said a senior executive of an online pharmacy.
The next step, industry executives say, is for the central government to put in place a proper regulatory framework for the sector to be monitored.
“This is going to give a lot of confidence to e-pharmacy companies to operate smoothly,” said a top e-commerce executive.
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“However these firms are still operating in grey areas. What is required is a comprehensive e-pharmacy policy. E-pharmacies have to follow different laws in bits and pieces. Also, there is pressure from offline pharmacists, which have been having legal battles with the online companies. However, what is required is co-opt model, where e-pharma companies work with offline stores and deliver the medicines to the customers,” said the executive.
However, the government has yet to approach e-pharmacies for industry feedback.
“The government has not yet sought industry feedback from us on forming a proper framework. We are waiting for the government to take the lead on the discussions. We want to work with the government on this and are supportive of the decision to roll out proper regulations, which will give legitimacy to the industry,” said one of the executives quoted above.
A single-judge bench of the Madras High Court, in December 2018, had ruled that e-pharmacies were bound to discontinue their online business in “drugs and cosmetics” until the central government came out with a proper regulatory framework for the digital trade of medicines. Online pharmacies had, at the time, appealed the order.
During the same year, the Ministry of Health and Family Welfare had issued a draft notification with guidelines for e-pharmacy players. Based on these rules, a broader regulatory framework is in the works.
The case was reportedly set aside by a division bench on Tuesday. However, the full order is yet to be released.
Industry watchers have cautioned on the immediate need for regulations in the space.
“There is a need for a dedicated legal framework for e-pharmacies in India, as they are not covered under the IT Act. Appropriate due diligence parameters for e-pharmacies need to be specifically formulated and drafted by the government so stakeholders have more clarity,” said Supreme Court advocate and cyberlaw expert Pavan Duggal.
According to Alpana Srivastava, partner at law firm Desai & Diwanji, who is heading the Pune office, the central government had sought more time to frame policy on online sale of medicines in March this year, stating that the subject of the online sale of drugs is complex and a modification in the manner of the sale of drugs would have far-reaching consequences.
“The government has submitted that the new policy framework will involve changes in many other Acts and rules apart from the Drugs and Cosmetics Act, Pharmacy Act, Pharmacy Practice Regulations, Indian Medical Act, Code of Ethics Regulations, and the Drugs and Magic Remedies (Objectionable Advertisement) Act,” said Srivastava.
Meanwhile, online pharmacies have continued their operations unabated.
“Courts have ruled to maintain the status quo. So, our operations will continue as they have been. We have been following the draft rules that were released by the government in 2018, which required us to get a license. The retailers we work with are also licensed,” the executive quoted above said.
With the favourable court ruling, executives say they do not foresee challenges ahead, regardless of whether these regulations come into effect.
An e-commerce executive said: “E-pharmacies are still operating in grey areas… they require a comprehensive policy. There is also some pressure from offline pharmacists”
Pavan Duggal, Supreme Court advocate and cyberlaw expert, said: “Appropriate due diligence parameters for e-pharmacies need to be specifically formulated and drafted by the government so stakeholders have more clarity”
Alpana Srivastava, Partner at law firm Desai & Diwanji, said: “The government has submitted that the new policy framework will involve changes in many other Acts and rules apart from the Drugs and Cosmetics Act, Pharmacy Act, Pharmacy Practice Regulations, Indian Medical Act, Code of Ethics Regulations and the Drugs and Magic Remedies (Objectionable Advertisement) Act”
