CHENNAI: Online E-pharma companies want the government to provide more clarity on the regulatory framework that will allow state and central authorities and doctors to seek consumer information, as well as ease the guidelines on data localisation.
The health ministry had on August 28 published the draft guidelines for e-pharma companies, giving stakeholders 45 days to make suggestions. Founders of e-pharma firms have welcomed the proposals in the draft, but requested clarity on the circumstances under which they would be answerable to the Central Drugs Standard Control Organisation or state food and drug administrations. They are also looking to get granular details on data-sharing protocols.
“While the intent is that the government will seek data if there’s a requirement of investigation, I think we would like details on under what circumstances and for what use (the data will be required), because we don’t want a situation where the government is seeking data for non-specific purposes,” said Prashant Tandon, cofounder of 1mg.
Adding that they have no concern in making the data available, Bengaluru-based startup Myra’s cofounder and CEO Faizan Aziz said it would be important to have a due process in place to iron out ambiguities on the rights of companies and consumers. “Without the process, companies and consumers won’t know where their rights lie,” he said.
Dhaval Shah, cofounder of PharmEasy, said the companies would also want to know how a doctor could get the necessary privilege to view the medical records of a consumer and how that consumer could approve that doctor access to such data hosted on the e-pharma platform.
The current ‘data localisation’ aspect detailed in the draft would also require further definitions, online players said. The draft states that “The e-pharmacy portal shall be established in India through which they are conducting the business of e-pharmacy and shall keep the data generated localised…”
Aziz of Myra said in the current form, this particular guideline would hinder companies from sharing critical information with drug manufacturers outside of India. “Suppose the manufacturer would like to understand what percentage of his products are damaged or are being returned and where he ranks against competitors, we would not be able to tell him that or what the industry average is. We cannot tell him that it maybe because the packaging (of the product) isn’t strong enough, etc.”
Makers of over-the-counter drugs and supplements are currently allowed to supply from outside of India, while all other drug manufacturers are required to be stationed within the country.
There are others like Pradeep Dadha, CEO of Chennai-based Netmeds, who feel despite various aspects of the draft guidelines being contemplated and debated upon now, “the bigger picture of data security would be determined by the Digital Information Security in Healthcare Act (DISHA) and the privacy Act”.
According to Tushar Kumar, CEO of Medlife International, a system like in the US of providing a “verified” seal to certain online pharmacies on the government’s health portals would be welcome, to prevent the proliferation of fly-by-night operators.