Parliamentary Panel "Appalled" with pending E-Pharmacy Rules, asks Health Ministry to finalise and implement Draft without delay
New Delhi: Taking cognisance of the fact that draft e-pharmacy rules have not been finalised yet, the department-related Parliamentary Committee on Commerce has urged the Union Health Ministry to ensure that the rules are finalised and implemented without further delay.
Mentioning that it was appalled to note that the E-Pharmacy Rules are pending till date, the Parliamentary panel observed that undue delay in adopting a definitive regulatory framework results in uncertainty.
The panel stated in its report, "The Committee is appalled to observe that the Draft E-Pharmacy Rules have not been finalised till date. The Committee reiterates that undue delay in adopting a definitive regulatory framework results in uncertainty which is not conducive for the fast pace digital markets. The Committee, therefore, recommends the Draft E-Pharmacy Rules are finalised and implemented without further delay."
The Committee, headed by Congress leader Abhishek Manu Singhvi, tabled its 176th report on ‘Promotion and Regulation of E-Commerce in India' and presented to the Parliament on March 24, 2023.
It was observed by the panel, "The Committee, while appreciating the rise of e-commerce in the pharmacy and health sector, expresses concern at the possible misuse of such avenues for distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications amid the absence of regulations. Stringent regulation of the e-health and e-pharmacy sector is essential in view of the potential harm it can cause to health of end user in case of misuse."
Therefore, suggesting that a comprehensive guideline for e-pharmacy and e-health platforms is necessary, the report further stated, "The Committee, therefore, recommends that a comprehensive guideline that encompasses the due diligence measures to be undertaken by the e-pharmacy/e-health platforms, mandatory registration with the appropriate authority for sale of drugs, assigning responsibility on such platforms for the sale of genuine drugs, regulating the sale of controlled drugs, etc., should be formulated in consultation with the stakeholders."
The Panel took note of the fact that the Prime Minister’s Office on 20.09.2019 had 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.
However, in this regard, the Parliamentary panel pointed out that online sale of medicines has not been regulated despite objections and concerns raised by the stakeholders. Further, the panel noted that no decisions have been taken on the recommendations made by Group of Ministers (GoM).
"The Committee opines that delay in such crucial policy matter is not conducive to the fast paced digital market. The Committee, therefore, reiterates its recommendation and urges the Ministry of Health and Family Welfare to notify E-Pharmacy Rules and formulate comprehensive guidelines with regard to e-pharmacy/e-health platforms," stated the report.
In its report, the panel also referred to the actions taken by the Union Ministry of Health and Family Welfare (MoHFW) in this respect. The panel noted that the Ministry published a draft Gazette notification on August 28, 2018 for amendment to the Drugs and Cosmetics Rules, 1945 and to regulate the online sale of medicines through e-platform in the country.
The draft rules published on 28.08.2018 contain provisions for registration of e-pharmacy, periodic inspection of e-pharmacy, prohibition of sale of certain categories of drugs through e-pharmacy, monitoring of e-pharmacy, etc. A large number of comments were received which were compiled and examined.
Apart from this, the Ministry further informed the panel that 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. 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.
Besides, referring to the Draft Competition (Amendment) Bill, the panel mentioned in its report, "The Committee further recommends that necessary provisions should be incorporated in the amendment bill to empower and enable the Competition Commission of India (CCI) as well as the Digital and Markets and Data Unit (DDMU) to effectively regulate the fast paced digital market taking into account the present day realities."
