By Saif Rasul Khan, Government Law College, Mumbai.
In this era of online shopping, one can buy medicines with a click of the mouse from the comfort of their home without going to a pharmacy. This trend of online sale of drugs is making life easier for people and can provide tremendous benefit to the consumers, including lower prices through increased competition, easier availability of drugs, ease of comparative shopping among many sites etc. Nonetheless, the concerns and pitfalls regarding the same cannot be overlooked.
The rise in cases of illegal sale of drugs has compelled the drug quality regulator to work on framing necessary guidelines and mechanisms to monitor such sales. The central regulator is consulting numerous international drug regulatory authorities such as the US Food and Drug Administration (FDA) and the European Medicines Agency. The agency is examining their models to understand how quality and standards of medicines sold through e-commerce portals are monitored in these countries. The apprehensions relate to the quality, efficacy, and standards of the medicines sold online. However, the prime concern is monitoring the medicines, which are made available online because many drugs can be misused of not traded through prescription. There are medicines, which if consumed unregulated, may lead to serious health consequences.
The Indian Pharmacist Association (IPA) reiterated this concern. The Association wrote to the Drugs Controller General of India (DCGI) opposing online pharmacies in India. The DCGI had appointed industry body FICCI as the nodal agency to consolidate and frame guidelines for online sales of medicines through e-commerce channels. In the said letter, the IPA raised certain issues regarding the proposal of setting up online pharmacies. The principal concern being that online pharmacies are in contravention of the Drugs and Cosmetics Act, which states that ‘drugs should be dispensed by registered pharmacists’. Further concerns relate to the following:
- As per Section 42 of Pharmacy Act, “Only Pharmacist can dispense medicine on the prescription of a doctor.” Whoever contravenes this provision is punishable with imprisonment.
- There are insufficient numbers of Drug Inspectors in Drug Control Department and it will not be easy to monitor each online pharmacy.
- As per Schedule P of Drugs and Cosmetic Act, no medicine should be stored at a temperature exceeding 30 degree. Storing medicine above the prescribed temperature make medicines ineffective.
- In the absence of a registered pharmacist, at online pharmacy, wrong medicine may be dispatched to patient and it may cost the life of patients.
- There is strong possibility that fake, misbranded, adulterated, counterfeit medicine will be sold through online pharmacies.
- There will be a deficit of 5% to 12.5% value added tax to the government and that there will be evasion of taxes by online pharmacies.
Many cases highlight how such online sale of drugs can be a reason for major health issues and distress. The Maharashtra Food and Drug Administration (FDA) issued an order prohibiting Nagpur based wholesaler Kale Impex for illegally selling addictives, anti depressants and anti hypertensive drugs to overseas clients in contravention of the Section 18 C of the Drugs and Cosmetics Act. According to officials, FDA has seized and issued orders for drugs worth over Rs. 2 crore from 28 locations in three months from Nagpur, Mumbai and Pune alone. In another case in Telangana, the Telangana State Drugs Control Administration (TSDCA) performed a chain of raids on online pharmacies, which had launched a ‘customer-friendly’ service, packaging heavy discounts on medicines with door deliveries. Post the raids, the TSDCA ordered the online retailers to discontinue the online sale of drugs under various provisions of Drugs and Cosmetics Act, 1940. The officers emphasized that there is an imminent need to develop specific regulations for such online sale of drugs. Under the Drugs and Cosmetics Act, it is obligatory for medical shops to provide drugs only under the direction of a registered pharmacist, against a written prescription of a registered medical practitioner. “When online retailing of other goods began, everybody had the same question on safety. Will the goods delivered will be safe? At the moment, the government does not recognise online retailing, but we hope things will change. Ultimately, consumers will benefit because they can order medicines from their homes,” said MedPlus Health Services CEO Madhukar Gangadi. Further, in another case against the online retail company Snapdeal, the Maharashtra’s Food and Drug Administration (FDA) filed an FIR against the CEO Kunal Bahl and the company’s directors for selling prescription drugs on the e-commerce. The online portal was allegedly selling sildenafil citrate tablets (Viagra), a drug that registered urologists, psychiatrists, endocrinologists and dermatologists are authorised to prescribe. In addition, the marketplace was also selling OTC emergency contraceptives.
The problems associated with online sale are not limited to India. In other countries, the same issues have cropped up. United States (US) is struggling with the issue of fake online pharmacies. In an advisory to US citizens, US FDA has publicized the sites that operate legally and offer the convenience, privacy, and safeguards for purchasing medicines. They also have highlighted the many rogue websites that offer dangerous drugs that are perilous to health. These rogue sites often sell unapproved drugs, drugs that contain the wrong active ingredient, drugs that may contain too much or too little of the active ingredient, or drugs that contain dangerous ingredients. In the UK, the regulators have seized more than £15 million of counterfeit and unlicensed medicines and devices. The haul is believed to be one of the biggest recorded to date and includes enormous quantities of illegally supplied and potentially harmful slimming pills, erectile dysfunction tablets, anemia pills and narcolepsy tablets. The MHRA said the raids saw almost 6.2 million doses of falsified, counterfeit and unlicensed medicines seized. Interpol’s executive director of police services Tim Morris said: “More and more people are using the internet to purchase everyday items, and criminals are taking advantage of this trend to deceive customers into buying fake and even dangerous medicines and medical products online, with no concern to the health risks this poses.” In China, ordering illegal drugs is as effortless as typing on a keyboard. The e-commerce portal Qinjiayuan sells air-conditioners, trampolines and a banned hallucinogen known as spice, which set off a devastating spike in US emergency room visits in April. In a country that has perfected the art of Internet censorship, the open online drug market is just the most blatant example of what international law enforcement officials say is China’s reluctance to take action as it has emerged as a major player in the global supply chain for synthetic drugs.
Thus, there is no denying the fact that the online sale of drugs would benefit consumers, nevertheless there is need to control and legalize such sale to ensure that there should be sale of only legitimate drugs, which are fit for human consumption. The concerned authorities must ensure that there should not be any error in maintaining the quality and standard of drugs as these pertain to matters of life and death.