Rocky Road to E-Pharmacy Regulations
New Delhi: With the Centre proceeding towards formation of rules and regulations to regulate the online sale of medicines across the country, something that was being demanded by chemist bodies for a long time now, the last leg of this journey is turning to be quite a rocky ride.While the two major stakeholders, namely the online chemist operators and on the other hand the chemist and...
New Delhi: With the Centre proceeding towards formation of rules and regulations to regulate the online sale of medicines across the country, something that was being demanded by chemist bodies for a long time now, the last leg of this journey is turning to be quite a rocky ride.
While the two major stakeholders, namely the online chemist operators and on the other hand the chemist and pharmacist association are leaving no stones unturned to get an audience from the Government, there is mounting pressure from the Courts on the Government to come out fast with the required regulations.
The proposed New Drugs, Medical Devices and Cosmetics Bill, 2022, brought e-pharmacies under its ambit and mandates online pharmacies to have a licence to continue operating as usual. Online pharmacies would also not be permitted to sell medical devices without a licence, if the bill is passed into law.
The problems of E-pharmacies kicked off in early February, when the Drug Controller General of India (DCGI) pulled up at least twenty companies including Tata-1mg, Flipkart, Apollo, PharmEasy, Amazon and Reliance Netmeds and issued show-cause notices over online sale of drugs citing violation of norms as they were found to be selling schedule H, H1 and X without a valid licence.
The development came in the backdrop of the All India Organisation of Chemists and Druggists (AIOCD), an association of over 12 lakh pharmacists, threatening to launch a country-wide agitation if the government didn’t act.
Medical Dialogues team had earlier reported that a delegation of AIOCD held a meeting with Dr V K Paul, Member, Niti Aayog seeking to take action against e-pharmacies for predatory pricing and allegedly aiming to drive out small pharmacies of the market to create a monopolistic situation, in the longer run.
Also Read: Take Action Against E-Pharmacies For Providing Predatory Pricing: AIOCD Tells Niti Ayog
The government has been working on proposing a draft legislation to regulate the sale of online drugs since a while now. In 2018, the health ministry had released a draft notification regulating e-pharmacies that barred the selling of medicines without registration. However, the rules could never be finalized.
Taking note of the fact that draft e-pharmacy rules have not been finalised yet, in March this year, the department-related Parliamentary Committee on Commerce 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.
Amidst the loggerhead between chemists and e-pharmacy players, the Center has been seeking the opinion of other government departments on the revised draft of the New Drugs, Medical Devices and Cosmetics Bill.
The proposed regulation seeks to include a clause that empowers the government to “regulate, restrict or prohibit” any sale, stocking or distribution of any drug by online mode, by issuing a notification. The draft regulations were being circulated for internal consultations and expected to replace the earlier legislative framework, which was released to the public in July 2022 for stakeholder comments, the sources had told ET.
Stand of E-pharmacies
Meanwhile, more than a dozen online pharmacies are seeking an audience with health ministry officials to explain their standpoint, reports The Economic Times.
Likely to take a hit, PharmEasy parent API Holdings recently wrote a letter to Union Health Minister Mansukh Madaviya seeking his intervention in the matter.
"We seek your support towards the quick notification of the draft e-pharmacy rules and the New Drugs, Medical Devices and Cosmetics Bill 2022 to remove any uncertainty and to harmonise all the existing regulations under which the e-pharmacy is already compliant," the letter said.
Putting its stance forward, the online drug platform, in the letter further said, “Multiple e-pharmacy players have received show cause notice from DCGI accusing them of violation of the provisions of Drug and Cosmetic Act and rules. Since the said Act is not applicable to e-pharmacies the question of violation of provisions is moot.”
Some of the e-pharmacies had earlier told the high court that they do not require a licence for online sale of drugs and prescription medicines as they do not sell them and instead they are only delivering the medications akin to food delivery app Swiggy.
Stand of Chemists- What AIOCD says
The All India Organisation of Chemists and Druggists (AIOCD), a powerful body representing approximately 12.40 lakh chemists and distributors in India, has written to the cabinet secretary urging him to intervene and ban online pharmacies stating that they are violating norms and putting people’s lives at risk.
Citing the Delhi High Court order of 2018, which issued an injunction to e-pharmacies from the online sale of medicines without a license and directed that such sales were prohibited until further order, the letter said that “they continue to operate despite court orders."
AIOCD also said that though the Union Health Minister took the initiative and issued show cause notices to these illegal e-pharmacies by the DCGI, no action has been taken against them since the issuance of the notices.
“The issue of online sale of drugs was under the consideration of the government,” the letter said, adding that this submission by the CDSCO clearly indicates that there is no licence for the online sale of drugs. “Therefore, in accordance with the orders of the Hon’ble High Court of Delhi, online sales of medicines should be immediately ceased,” the letter added.
However, a recent status report on e-pharmacies submitted by the CDSCO on the orders of the Delhi High Court reveals that there are no provisions in the Drugs & Cosmetics Act, 1940 and Rules 1945 that restrict the shipping, mailing, or door delivery of prescribed medicines.
“This submission contradicts the earlier affidavit filed in the Hon’ble High Court of Delhi and raises concerns about the well-being of our citizens. We remain hopeful and have faith in our elected government and senior bureaucrats that they will uphold the laws of the land and protect public health,” they added.
The appeal sent to cabinet secretary by the chemist body has been summarized as below:
Currently no provision under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945 for online pharmacies
No licence for the online sale of drugs, says CDSCO
In February, Centre pulled up 20 companies by issuing them with a show-cause notice for selling medicines online
In 2018, Delhi HC issued injunction to e-pharmacies from online sale of medicines without licence.
Pressure from the Court
In a recent development, the Delhi High Court has granted six weeks' time to the Centre to inform it about the outcome of consultations and deliberations with stakeholders on draft rules to regulate e-pharmacies.
"The Union of India is granted six weeks' time to inform the outcome of the consultations and deliberations and also to inform the final stand taken by the Union of India in the matter. List on August 28, 2023. It is made clear that the pendency of the present matters will not come in the way of the Union of India in taking action against the persons who are violating the interim order dated December 12, 2018," the bench comprising Honorable Chief Justice Satish Chandra Sharma and Honorable Justice Subramonium Prasad said.
PTI reports that the latest status report filed by the Centre stated that the draft notification is pending consultations and deliberations and the Central Drugs Standard Control Organisation (CDSCO) is contemplating to hold fresh stakeholder consultations with various associations or affected parties.
The status report was filed on petitions seeking a ban on "illegal" sale of drugs online.
The court's decision was made in response to a case filed by Dr Ahmed Zaheer against the central government, where Dr Ahmed Zaheer sought the court's intervention to halt the sale of medicines through e-pharmacies.
Supporting this stance, the South Delhi Chemists and Distributors Association, also being a petitioner in the case, where the ministry's August 2018 notification was challenged, has called upon the Central Drugs Standard Control Organization (CDSCO) and all State Drug Control Authorities to take immediate action against illegal e-pharmacies.
The Association further said the draft rules are being pushed through in serious violation of the law, ignoring the health hazards caused due to sale of medicines online without proper regulations.
The Court had earlier sought responses of the Centre, Delhi government, CDSCO and the Pharmacy Council of India to the petition.
The matter has been listed for further hearing on August 28, 2023.
