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Putting the bite into our laws

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The recent faulty hip implant episode proves that our laws have not evolved as fast as medical technology

With the recently released draft guidelines for e-pharmacies, policy makers have a good opportunity to shed light on all the grey areas in the pharma supply chain and create a more transparent ecosystem. There seems to be the will to do this, but will policy makers find a way to plug all the loop holes? Or will it be yet another case of ‘all bark and no bite’?

Unfortunately, the recent faulty hip implant episode proves that our laws have not evolved as fast as medical technology. A substantial number of patients who had undergone ASR hip implants made by DePuy International, a subsidiary of Johnson & Johnson (J&J), had to go in for revision surgeries when the implants started releasing metal ions into the surrounding tissues due to wear and tear as part of normal usage. Besides the physical distress and mounting medical bills of revision surgeries, they had to fight for their legal rights for fair compensation.

Even today, J&J is reportedly still trying to track down more than half of the patients in India who underwent ASR hip implants. While public outcry has forced action and compensation, though not of the magnitude awarded to similar cases in the US, we as a country need to introspect on our own shortcomings as well.

Our pharmacovigilance system definitely can be stronger. Secondly, the Drugs and Cosmetics Rules, 1945, does not expressly provide for compensation. The good news is that perhaps regulators are being doubly cautious now. This is possibly why the National Coordination Centre – Materiovigilance Programme of India (NCC-MvPI) has extended the last date for sending suggestions/comments on the Draft Guidance Document for Medical Devices by almost a month from September 1 to September 25. Hopefully, compensation guidelines and redressal mechanisms are included in the revised draft for medical devices.

Policy makers and implementers thus need to incorporate these lessons into the draft rules for e-pharmacies which were released on August 28 and will be open for suggestions and comments for the next 45 days. The days ahead are likely see the noise on this issue escalate on both sides of the fence.

It is easy to understand why the stakes are so high. According to the India Brand Equity Foundation (IBEF) website, medicine spending in India is expected to increase at 9-12 per cent CAGR between 2018-22 to $26-30 billion. Increasing consumer spending, rapid urbanisation, and raising healthcare insurance are some of the factors driving this trend.

Online pharmacies may currently have a relatively small slice of this pie, but it is only set to increase, fuelled by funding from PE and VCs. Just five of the larger e-pharmacies, from a cohort of 250 plus e-pharmacies, reportedly received funding to the tune of ` 1700 crores in the past five years.

The turf war between the traditional brick and mortar pharmacies and e-pharmacies has thus been resurrected with a vengeance. The All India Organization of Chemists & Druggists (AIOCD) has called for all of its members to wear black ribbons on their shirts for a week, from September 20- 27, to protest against the online sale of medicines/ e- pharmacies. A note from AIOCD’s National President JS Shinde says that the protest will culminate with an all India chemists’ bandh on September 28.

The AIOCD campaign includes sending memoranda to the Prime Minister, all Members of Parliament, Ministers, Central Ministers, and other government officials stating their major concerns over the online sale of medicines as well as hold press conferences to get their message out in the media. More of concern is the stated intent to hold protests at the taluka and district level.

On the face of it, online pharmacies seem to be a logical next step to online grocery shopping, especially with the push towards a Digital India, online payments etc. But for patients and their caregivers, buying medicines is not the same as a monthly/weekly stock up of household items. A consumer can make out when she receives stale produce but she will have to be made aware that checking the expiry dates of medicines, even if they are substantially discounted by the e-pharmacy, could mean the difference between life and death. So also, she needs to be educated about fake e-pharmacy sites as well as lookalike counterfeit medicines. At the other end, e-pharmacy staff need to be trained to spot fake prescriptions and raise the red flag for potential abuse.

There have been concerns that the rules for e-pharmacies might be lighter than for traditional pharmacies. For example, several other provisions of Rule 65 of Drugs & Cosmetics Rules 1945 reportedly do not find mention in the draft rules for e-pharmacies. Industry observers like Raj Kumar Singla, former State Drugs Controller, Food & Drug Administration, Haryana, emphasise that there should be a ‘level playing field’ for the chemist (who has a retail drug licence as per Form 20 & 21) and the e-pharmacy. Also, the draft is silent on the jurisdiction of e-pharmacies, as unlike physical pharmacies, they are not bound by district, state or event country boundaries.

It is better to have some rules rather than none and all, and the draft rules are a good solid step in this direction. But policy makers need to address the finer nuances before the rules are finalised and put into action. Else we will have another tragic situation of toothless laws proving inadequate to protect patients’ interest.

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