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Parliamentary panel on commerce asks health ministry to notify E-Pharmacy Rules

Gireesh Babu, New Delhi
Monday, March 27, 2023, 08:00 Hrs  [IST]

The Department Related Parliamentary Standing Committee on Commerce has once again asked the ministry of health and family welfare (MoHFW) to notify the E-Pharmacy Rules and formulate comprehensive guidelines with regard to the online pharmacy and health platforms.

The Committee, headed by the Member of Parliament Dr Abhishek Manu Singhvi, in its 167th report on the actions taken by the government on its previous report on ‘Promotion and Regulation of e-commerce in India’, observed that online sale of medicines has not been regulated despite objections and concerns raised by stakeholders.

“The Committee further notes that no decisions have been taken on the recommendations made by the Group of Ministers (GoM). The Committee opines that delay in such crucial policy matter is not conducive to the fast paced digital market,” it said.

“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,” added the Committee report.

The recommendation comes at a time when the nation’s drug regulator has tightened the implementation of the existing rules and regulations related to the sales of drugs, which could have a negative impact on the online drug sales. The draft of new Drugs, Medical Devices and Cosmetics Bill, 2022, has proposed regulations in place for regulating and monitoring the online pharmacy sector.

The MoHFW has earlier informed the Committee 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, and a few recommendations were agreed to.

The Prime Minister’s Office vide communication dated September 20, .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 Ministry informed the Committee.

The Ministry in August, 2018, published a draft gazette notification for amendment of Drugs and Cosmetics Rules, 1945 to regulate the online sale of medicines through e-platform in the country. The draft rules published on August 28, 2018 contain provisions for registration of e-pharmacy, periodic inspection of e-pharmacy, monitoring of the online pharmacies, among others.

However, the Chemists and Druggists Associations, especially the largest trade organisation in pharmacy business, the All India Organisation of Chemists and Druggists (AIOCD), opposed the proposed rules stating that around eight lakh chemists would be out priced and shall go out of business. It was also representative that the concept paper is not in accordance to Foreign Direct Investment policy since it prohibits business to consumer sale models.

The chemists are presently not allowed to home deliver drugs while this is being permitted for online pharmacies, and 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. The chemists association represented against permitting habit forming drugs, anti-tubercular drugs and higher antibiotics through online pharmacies. They also alleged that the data with respect to patients is prone to misuse since it will be available online to e-pharmacy holders.

In response to a question in the Lok Sabha on March 17, 2023, related to the online sale of medicines, Dr Mansukh Mandaviya, minister of health and family welfare said that there are several cases pending in various High Courts on online sale of drugs and the Central Drugs Standard Control Organisation (CDSCO) has forwarded the order of High Court of Delhi, which injuncted the online pharmacies from online sale of medicines without licence, to all state and Union territory drugs controllers on May 8, 2019, November 28, 2019 and February 3, 2023. Further, show cause notices were issued by CDSCO to various firms engaged in online sale of drugs on February 8 and 9, 2023.

The Minister did not specifically answer the questions on whether the government is planning to completely ban online sale of medicines, and whether the Government has finalised the guidelines for sale and distribution of drugs through e-pharmacies. The Minister also did not refer to the provisions in the draft Bill, regarding the online pharmacies.

However, the Minister said that the CDSCO has informed that no specific report has been received regarding creation of their own health data by e-pharmacies on their portal.


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