 "House panel wants e-pharmacy rules in place asap, MoHFW to act soon")
A decision on regulating online pharmacies is likely to be taken soon. A Parliamentary panel has now asked the Ministry of Health to finalise the draft e-pharmacy rules and implement them without any further delay. It has also expressed concerns over the possible misuse of such avenues of sales and distribution of medicines in the absence of regulations.
The Union Health Ministry is likely to take up the matter soon, sources said.
Meanwhile, e-pharmacies are open to working with the Ministry and regulators for any alignment required. “I think it is good if the draft rules are published and there is clarity. The parliamentary report seems very much in favour of the rules being published at the earliest,” said an industry player who did not wish to be quoted.
“We would be happy to work with the ministry and regulators, should they need any industry alignment or views on any aspects,” said the person who is also the co-founder of an online pharmacy.
The Department Related Parliamentary Standing Committee on Commerce said in its report that ‘undue’ delay in adopting a definitive regulatory framework results in uncertainty, which is not ‘conducive’ for fast-paced digital markets. The committee, headed by Abhishek Manu Singhvi, recommended in its report that the health ministry formulate comprehensive guidelines in consultation with stakeholders.
The health ministry is considering the matter and has also initiated discussions with other ministries in this regard, said a government source, who added that the concerns primarily are surrounding data privacy rules.
Three groups of Assistant Secretaries, one each in the Ministry of Electronics and Information Technology, Department of Pharmaceuticals and Ministry of Health and Family welfare were constituted to study the draft rules and submit their reports.
Also Read
“Recommendations of Assistant Secretaries received from the respective Departments were considered by the Ministry of Health and Family Welfare, and a few recommendations were agreed to. The Prime Minister’s Office vide communication dated 20.09.2019 constituted a Group of Ministers (GoM) to further examine the details of the proposal to notify e-pharmacy rules and make suitable recommendations. The recommendations of the GoM are under consideration of the Government,” the report said.
Sources indicate that the Centre is concerned around the data privacy issues as online pharmacies have patients’ medicine use and even diagnostic test data. This data which is collected by online pharmacies can be eventually misused. Moreover, offline retailers have protested that online pharmacies go for predatory pricing to attract consumers, which, in turn, is detrimental for the small retail chemist shop. There are more than 800,000 chemist shops in the country.
“Stakeholders especially Chemists and Druggists Associations opposed the proposed e-pharmacy rules stating that approximately 800,000 chemists would be out priced and shall go out of business…. The chemists are presently not allowed to home deliver drugs while this is being permitted for online pharmacies,” the Parliamentary committee report stated.
The chemists represented that online pharmacies should only be permitted to sell medicines on the basis of e-prescription to avoid multiple dispensing of same medicines and also said that online pharmacies should not be allowed to sell habit forming drugs, anti-tubercular drugs and higher antibiotics.
On the issue of data privacy, online pharmacy industry sources say that those are easy to comply with.
The report has further noted that the finalisation and enactment of the Personal Data Protection Bill, 2019 is crucial as this will provide the guiding principles for formulation of rules regarding the ownership and storage, use and access and cross border movement of data.
Parliamentary panel asks MoHFW to finalise the draft e-pharmacy rules and implement them
Three groups of Assistant Secretaries--one each in MeitY, DoP and MoHFW--were set up to study the draft rules and submit their reports
MoHFW has published a draft gazette notification in Aug 2018 for amendment to Drugs and Cosmetics Rules, 1945
Draft rules published on August 28, 2018 contain provisions for registration of e-pharmacy
Online pharmacies say willing to work with govt and regulators
Offline chemists want online pharmacies barred from selling habit-forming drugs