DGCI Held Fresh Talks With E-Pharmacy Stakeholders on Draft Rules       

DGCI held a discussion last week with stakeholders on the draft rules to regulate e-pharmacies. Online pharmacy platforms such as Tata 1mg, PharmEasy, Netmed, and Practo attended this meeting. 

The Drug Controller General of India (DGCI) held discussions with e-pharmacy stakeholders recently. This came on the back of the Delhi High Court's request to share information on the draft drug regulations.  

The meeting was attended by representatives from the All India Organisation of Chemists and Druggists (AIOCD), the Pharmacy Council of India, and online pharmacy platforms such as Tata 1mg, PharmEasy, Netmed, and Practo.'¯ '¯ 

The HC had permitted six weeks to the Centre to inform it regarding the discussions with pharmacy stakeholders while hearing petitions seeking a ban on '˜illegal' sales of drugs online. The court scheduled the next hearing on August 28.'¯ 

The rules propose several regulations for e-pharmacies, including the requirement for a licence, the need to have a physical presence, and the prohibition on selling drugs without a valid prescription.  

India's online pharmacies expressed their concerns and opposed the rules, saying they would stifle competition and make it difficult for small chemists to operate. 

About 20 such e-pharmacy platforms received show-cause notices from the DCGI in February. The notice pertains to allegations of rules and regulations under the Drug and Cosmetic Act violations.'¯ 

The health ministry also published a draft notification 2018 that prohibited the sale of medications from unregistered e-pharmacies. It banned online pharmacies from selling tranquilisers, psychotropic drugs, and narcotics. But the rules published in 2018 could never be finalised.'¯ 

In March 2023, the department-related parliamentary committee on commerce encouraged the Ministry of Health and Family Welfare to announce the draft e-pharmacy rules.'¯ 

It is said that 'œit was '˜appalled' that rules had not been finalised till now.' 

Due to the lack of regulation, retail pharmacist organisations have been criticising the sale of drugs through e-pharmacies. During the two-hour deliberation on Thursday, the AIOCD drew attention to the Drugs Act's lack of provisions for granting licences to online pharmacies. 

Further, the AIOCD appealed to the government to set aside the 2018 draft guidelines and take enforcement action against the e-pharmacies. 

Last year, the government released the New Drugs, Medical Devices and Cosmetic Bill 2022 draft. The Bill aimed to include online pharmacies in its remit.  

According to Section 41(2) of this draft bill, e-pharmacies must obtain a licence to continue operating as usual. The proposed law makes recommendations for additional regulation of online pharmacies. If the Bill is passed, online pharmacies would also be prohibited from selling medical devices without a licence. 

It seems that the government is taking steps to regulate the growing e-pharmacy market in India. The draft rules are a step in the right direction, but they must be finalised and implemented carefully to protect consumers.