The Narendra Modi-led NDA government is set to take charge for its second 5-year term, a report in IE has indicated that the country's health services industry may have to soon gear up for some regulatory changes such as more price control on medicines to make it cheaper for patients.
Patients, doctors and pharmacists, pay attention! Gear up for some significant changes in the healthcare sector anytime soon. The changes may include cheaper medicines, a proposal whereby patients can claim compensation for death caused by faulty medical devices and a significant boost to e-pharmacies in the country.
Now that the Narendra Modi-led NDA government is set to take charge for its second 5-year term, a report in IE has indicated that the country’s health services industry may have to soon gear up for some regulatory changes such as more price control on medicines to make it cheaper for patients.
Separately, there may be a proposal to amend the 2017 Medical Devices Rules to allow patients to seek compensation in case of death or any adverse reactions due to a faulty medical device. According to the IE report, this had been brought up during a meeting of the Drugs Technical Advisory Board in November 2018. Currently, there is no provision to facilitate compensation for such scenario.
In February 2019, the National Pharmaceuticals Pricing Authority, which is the country’s drug pricing watchdog, had capped trade margins of 42 cancer medicines at 30 per cent. The move was expected to drop the maximum retail prices of more than 100 brands by up to 85 per cent and also provide over Rs 100 crore in savings for patients suffering from cancer.
The current expectation is that this move may feature on the re-elected NDA government’s 100-day agenda. Note that there has been no official communication regarding the same.
Another area of focus may pertain to the implementation of the health ministry’s regulations for online pharmacy players. As you already know, this has been in the works since 2016 but had to be put on hold close to the Lok Sabha elections.
As per industry estimates, it is said that online pharmacies account for around 1 per cent of India’s over 1 lakh crore medicines retail industry. The move to recognise and regulate e-pharmacies in India has faced strong opposition from brick-and-mortar chemists across the country over the last three years. Whether the strong opposition and mass protests by chemists played a role in the delay of the draft remains unclear.
In December 2018, the Delhi High Court stayed the online sale of medicines by e-pharmacies, citing that it is not permitted as per the Drugs and Cosmetics Act, 1940 and the Pharmacy Act, 1948.
The petitioner also listed out several health hazards such as how children can be victims of wrong medication, substandard medicines can be sold online, over use of prescription medicines and consumption of such medicines without understanding a patient’s medical history, among other issues.
Notably, there is no specific statute or law to regulate and govern the e-pharmacy business in the country.
Another report in Down To Earth refers to how India has over 850,000 independent pharmacy retail stores that cater to fulfill only 60 per cent of the country’s total domestic demand and with online pharmacies contributing a mere one per cent.
This points to the business potential in the e-pharmacy space, assuming that all processes can be streamlined with a comprehensive approach.
India is not alone when it comes to tackling issues pertaining to e-pharmacy.
Last month, UK’s pharma regulatory watchdog, General Pharmaceutical Council (GPC), raised concerns over people buying drugs online. The GPC announced new rules to safeguard consumers from the dangers of buying drugs from online pharmacies and to put in place some regulatory measures to restrict access to additive opiate drugs.
The new rules prescribed by the GPC also impose upon online pharmacies certain mandatory obligations such as:
1. Carrying out identity checks of people buying medicines online from their website.
2. Pharmacy websites cautioned to not allow patients to choose prescription-only and its quantity before a medical consultation has taken place.
3. The online pharma staff should have the competency to identify and filter out requests for medicines that are inappropriate and identify when multiple orders are made to a single address.
Also, opioids like codeine are highly addictive and requires careful monitoring in terms of usage.
Last summer, the death of Jennifer Ann Lacey in south London triggered public debate on legal loopholes in the UK pertaining to e-pharmacies. The coroner Fiona Wilcox concluded that she had killed herself after a drug overdose, consuming 210 tablets, half of which she had bought online.
The disturbing legal loophole points to the fact that doctors in Europe can prescribe medicines without access to the patient’s medical history, records and without even consulting or seeking information from a patient’s GP in the UK. In Lacey’s case, the doctor who prescribed the tablets had neither met her nor known her medical history as he practiced from Czech republic!
Other countries are also facing the heat.
A recent report states that 16 out of 28 European Union member states softened their stance on pharmacists’ monopoly over drug distribution. However, countries such as Belgium, Spain and Luxembourg have restrictive legislations where drugs, be it prescription-based or over-the-counter, can be sold only in brick-and-mortar pharmacies by qualified pharmacists.
With the NDA government set to address a host of issues related to the pricing of drugs and the regulation of e-pharmacies in the country, a cautious approach may require a comprehensive legal draft that takes into account every possible stakeholder conflict scenario including those related to emerging networks, data sharing and tech-connectivity services that are a part of the offerings of healthcare providers online.
For disabled persons, senior citizens and working professionals in India, e-pharmacies can offer considerable relief as they can order medicines from the comfort of their homes and workplaces.
Additional regulatory safeguards will need to be taken into account so as to ensure that children and teenagers are not able to find a way to get into these platforms and order medicines online.
Cheaper medicines, e-pharmacies and compensation for death caused by faulty medical devices can be effective triggers to build a robust healthcare ecosystem in India. To scale up and keep it a sustainable model of healthcare requires an effective regulatory backing, and that has to come right from the top, namely, good governance.