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Ramesh Shankar
Wednesday, July 27, 2022, 08:00 Hrs  [IST]

The inordinate delay in finalizing the norms to regulate online sale of drugs in the country is a matter of grave concern as counterfeit drugs are reportedly entering the supply chain, jeopardizing the public health. Even though the offline pharmacy traders in the country have all along been expressing grave concern over the possible sale of counterfeit drugs through online pharmacies and have been urging the Centre to stop operation of e-pharmacies in the interest of public health, the Union Health Ministry conveniently chose to be lethargic on this grave issue. But, in what should now be an eye opener to the Ministry, which has been in self-imposed slumber for the last several years on this serious public health issue, fake drugs worth crores of rupees have recently been seized from online pharmacy dealers in raids conducted by Special Task Force in Uttarakhand. Earlier in 2019, similar raids in Rajasthan also led to seizure of counterfeit drugs worth crores of rupees which were also meant for online sale. The major reason for this kind of situation is that the country presently does not have a regulatory mechanism for online sale of drugs and the laws governing the brick-and-mortar pharmacy business are applicable to the e-pharmacies as well. The D&C Act does not distinguish between conventional and online sale of drugs. As per Section 18(c) of D&C Act, 1940 to be read with Rule 65, only a licensed retailer is entitled for the sale of drugs and that too on the basis of prescription of a doctor only. Rule 65 stipulates sale of drugs under the supervision of a registered pharmacist which also involves signing of the bill and stamping of the prescription by the pharmacist and the doctor. But, according to reports, as the existing laws are vague on the issue, there are rampant sale of prescription drugs by the e-pharmacies in contravention to the prevailing laws of the country. In the absence of clear-cut provisions in the D&C Act regarding the sale of drugs through e-pharmacies, utter confusion prevails in the country's pharmaceutical market, which has resulted in the verbal duel between the offline and online pharmacy associations.

In the backdrop of the grave situation, a new set of rules for online pharmacy has become very crucial as the nation’s e-pharmacy market is now brimming with activity with the entry of billionaires like Jeff Bezos and Mukesh Ambani in the fledgling sector. Of course, the scope for e-commerce in the pharmaceutical sector is immense and if properly regulated, online pharmacies in India could prove beneficial to various stakeholders. However, there is a serious need for framing the laws within India, as the online pharmacy laws in India are still in nascent stage and there are no dedicated online pharmacy laws in India. In the absence of regulatory guidelines, there is always a threat and possibility for supplying illegal or unethical medicines or outdated, substituted, or counterfeit medications to the person, who ordered the drug, instead of the real medication. Other concerns due to the lack of dedicated laws include potential lack of confidentiality, improper packaging, and intake of harmful drug interactions among several other issues. In the absence of exclusive and stringent laws, there is always the possibility of misuse of online platforms for distribution of illegal or unethical medicines or outdated, substituted, or counterfeit medications. In view of the potential harm it can cause to the public health, stringent regulation is the need of the hour. The recent seizure of fake drugs worth crores of rupees by Special Task Force in Uttarakhand might be the proverbial tip of the iceberg. The government should shed its lethargic attitude on this grave issue and immediately release the final regulation on e-pharmacies. Otherwise it will take a huge toll on the public health in the country.


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