New Delhi: Online pharmacies in India face a tough challenge from the government, which plans to bring a bill that could ban or restrict their operations, despite their pleas in response to notices issued by the Drugs Controller General of India (DCGI) earlier this year.
The latest version of the draft Drugs, Medical Devices and Cosmetics Bill, 2023, a copy of which is with ThePrint, has a provision that allows the government to regulate, restrict or ban online sale or distribution of any drug by notification. The Bill is likely to be presented to the Union Cabinet before being tabled in Parliament in the ongoing monsoon session.
This provision is a departure from the previous draft, which was released for public feedback last year and proposed permitting operations of e-pharmacies. “No person shall himself or by any other person, or his behalf sell, or stock or exhibit or offer for sale, or distribute, any drug by online mode except in such manner as may be prescribed,” it read.
In a notice to online drug sellers, including Amazon and Flipkart Health, in February, the DCGI had stated that selling, stocking, exhibiting or offering for sale or distribution of drugs through online, internet or other electronic platforms, including various mobile applications, without a licence, could affect the quality of drugs and pose a risk to public health due to potential misuse of drugs through self-medication or indiscriminate use of the drugs.
Clarifying that no licence was issued to any company for the online sale of drugs, DCGI sought responses from the companies within two days of issuance of the notice, stating that failure to reply may result in immediate action.
Sources in the Central Drugs Standard Control Organisation (CDSCO) and the Union health ministry told ThePrint that the companies complied with the deadline and that no action had been taken against them so far, mainly because the central government was planning to curb their operations through a provision in the revised draft bill.
“Given the major problem areas, the government feels that online sale of drugs should stop and will bring in a notification to stop their operations,” said a senior official in the Union health ministry who did not wish to be named.
The All India Organisation of Chemists and Druggists (AIOCD), which represents about 12.5 lakh pharmacists in India, has also been opposing what they call ‘illegal business practices and predatory prices’ of e-pharmacies. “We want the government to take action against the online pharmacies soon,” said Rajeev Singhal, AIOCD general secretary.
According to Dr R. V. Asokan, a senior Indian Medical Association (IMA) member, the medical community is concerned that drug cartels may use doctors to reauthorise the prescriptions for patients they have never seen. “Doctors might end up being used in this malpractice, and also while there would be no guarantee of the quality and safety of the drugs, adverse effects may go unmonitored,” he told ThePrint.
Industry estimates suggest that the market size of e-pharmacies in India was $30 billion in 2022 and growing at a compound annual growth rate of nearly 40 percent. Over the last year, the sector attracted big investments from global investors, such as Tiger Global Management, Sequoia Capital, Temasek and Prosus, besides industrial groups such as Reliance Industries and Tata Group who have invested in companies like Netmeds and 1mg.
ThePrint reached Prashant Tandon, chief executive of TATA 1mg, Pradeep Dadha, founder of Netmeds and Siddharth Shah, CEO of PharmEasy, over the phone and via text messages to inquire what they plan to do if the government persists with its plan to ban or curb their operations, but did not get any response.
Email queries sent to Amazon and Flipkart Health+ also remained unanswered.
ThePrint also reached Union Health Secretary Rajesh Bhushan and DCGI Rajeev Singh Raghuvanshi over the phone but was told that they were not available for comment.
This report will be updated if and when a response is received.
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Restrictive drugs & self-medication
Online pharmacies may offer convenience with no queues, no rush, easy ordering, 24/7 availability and doorstep delivery of medicines via courier.
But according to government officials, this convenience comes at a cost. “We have received several representations that online drug sellers sell prescription medicines indiscriminately, which is completely illegal,” said a second health ministry official who did not wish to be named.
In 2019, a white paper on online pharmacies in India, published by the Indian Medical Association (IMA) — the largest network of doctors in the country — pointed out that the online availability of prescription drugs was a violation of provisions of various laws like the Pharmacy Act 1868 and the Drugs and Cosmetics Act, 1940.
For example, the Drugs and Cosmetics Act, 1940, has clear guidelines on the sale of Schedule H and Schedule X drugs, which are ‘restrictive drugs’ and can be sold only on the prescription of a registered medication practitioner, said the paper. But they are sold indiscriminately in online pharmacies in violation of the guidelines, the paper added.
Schedule X drugs include narcotics and psychotropic substances and chances of drug abuse and addiction are higher with these drugs, while they also require meticulous storage and dispensing records, the paper explained.
In the case of these drugs, a dual prescription is needed, one copy of which is to be retained by the licensed pharmacist for two years, but there may not be a way to verify it in the case of online pharmacies, the IMA paper underlined.
Schedule H1 (a part of Schedule H), which contains some habit-forming drugs, apart from various antibiotics, mandates a licensed pharmacist to maintain a separate register for sale of drugs with details of the patient, doctor and name of drug(s), besides quantity. These records are to be kept for three years and are open to inspection by regulatory authorities.
“Online pharmacies, however, will promote drug abuse, drug misuse, self-medication etc.,” the IMA white paper noted, adding that any medication taken without the supervision of doctors “may be dangerous and even potentially life-threatening”.
According to a Delhi-based public health specialist, online sale of drugs may also be leading to rampant misuse and overuse of anti-microbial agents leading to anti-microbial resistance. “There are also concerns of polypharmacy (simultaneous use of multiple medicines for the same condition) leading to pill burden and peddling of unnecessary supplements through bundle offers and discounts,” he told ThePrint.
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‘Formalising long-pending rules’
Highlighting the purported issues with the online sale of drugs, Singhal claimed that all sorts of malpractices, such as the sale of prescription drugs without proper prescription or record keeping, are carried out by online pharmacies. He added that these companies have been relying on a 2020 home ministry order — that allowed doorstep delivery of medicine within a revenue district — which is yet to be withdrawn.
The AIOCD has also received support from the Laghu Udyog Bharti, a Rashtriya Swayamsevak Sangh-backed body that represents nearly 300 small and medium-scale industries, and has been demanding a ban on e-pharmacies, said Rajesh Gupta who heads its pharma committee, adding that the issues raised by the AIOCD may be valid.
Meanwhile, industry sources revealed that NATHEALTH — an industry body of private healthcare providers and players and the Federation of Indian Chambers of Commerce and Industry (FICCI) which also counts several online pharmacies as its members — had sought a meeting with the government in March this year.
Reminding the government that it had in 2018 initiated preparing draft rules to regulate the functioning of online pharmacies, NATHEALTH had said that the “enabling regulation remains an area that requires much-needed attention”.
“Our intent here is to address any concerns that impact the sector, as well as offer our support in formalising and adopting the long-pending rules of e-pharmacies,” the network wrote in a letter to the government, a copy of which was seen by ThePrint.
According to government sources, the Union health ministry, however, did not invite FICCI or NATHEALTH for a meeting in this regard.
NATHEALTH declined to comment on the issue, but an industry source said that companies are now awaiting the government’s final decision in this regard.
(Edited by Richa Mishra)
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