World Patient Safety Day is observed today every year. The theme this year is ‘Engaging patients for patient safety’, along with the slogan, ‘Elevate the voice of patients.’ But what relevance do these words carry without proper understanding, communication and transparency?
A pilot study published in the Journal of Patient Safety and Risk Management in 2022 had concluded that while awareness about patient safety among urban Indian patients was high, there was lack of awareness about the ways of dealing with patient safety issues. Academic exercises only touch the surface of the problem of patient safety. We need to look upstream to examine what factors influence the doctor-patient relationship at the downstream.
There have been a couple of policy changes and one proposal which call for debate. All three concern patient safety.
The latest was the gazette notification of Aug 2 by the National Medical Commission that laid down guidelines for registered medical practitioners. The new code of conduct — it has been stalled for the moment — directs practitioners to prescribe generic drugs only, else face suspension of license for 30 days. This ostensibly appears to be in favour of the patients. Generic drugs are 30%-80% cheaper than branded ones. Cutting medical expenses seems logical. But India’s poor drug regulations raise serious concerns regarding drug safety and efficacy and, consequently, patient safety. There are numerous instances of the poor quality of our drugs. News has been pouring in from around the world on the deadly impact of Indian-made cough syrups and eye-drops.
The Indian Medical Association was quick to respond to this. In a statement, it expressed its reservations and concerns on drug safety, stating that less than 0.1% of the drugs manufactured in India are tested for quality and that the NMC guidelines should be deferred until the government can assure the quality of all the drugs released into the market since patient care and safety are non-negotiable. The book, The Truth Pill, by Dinesh Thakur and Prashant Reddy, devoted an entire chapter on the shortcomings of quality control of generic drugs in India. It is an essential read for all stakeholders, including patients, lest they get swayed by demagogy endangering their health.
The second policy change was the jan vishwas bill that was passed in the Lok Sabha in July. An amendment of Section 27 (d) of the Drugs and Cosmetic Act, 1940 proposed in the bill makes a provision for “compounding” some offences — the payment of a fine would replace imprisonment. Experts like Dinesh Thakur and the parliamentarian, Asaduddin Owaisi, raised objections with the bill which allows the pharmaceutical industry to get away with the supplying of medicine while paying very little attention to patients’ safety. Patient protection needs to be streamlined processes both upstream and downstream: while thorough testing and clinical trials are needed in the upstream to ensure drug safety, companies need to be penalised for any lapses in the quality of drugs that they supply.
The third issue concerning patient safety is a letter submitted collectively by around half-a-dozen civil society groups to the health ministry asking for the revision of the Biosimilar Guidelines of 2016 to waive both animal substandard studies and comparative efficacy trials for the approval of biosimilars. It is claimed that this will bring down the prices of these drugs and facilitate better access. It makes no mention of patient safety.
Biosimilars are biological products approved by regulatory agencies based on demonstration of similarity in quality, safety and efficacy with reference biologics. They require stringent comparative evaluations to ensure that they are safe and efficacious. They are increasingly being used to treat cancers and autoimmune diseases. A paper published in the Indian Journal of Medical Research in 2020 had forewarned against the potential for compromise on safety issues.
Further relaxation of clinical trials for biosimilars is a dangerous step that will put a question mark on the quality assurance and the efficacy of these drugs. Biosimilars not only need testing during the manufacturing process but also intra-batch testing to ensure consistency in quality control. The absence of proper quality checks in a country with a poorly-functioning pharmacovigilance system to monitor long-term adverse effects will be hazardous to patient safety.
Each of these three issues highlighted here brings to light the tilting of regulations in the pharmaceutical sector towards the interests of the industry. Little heed is being paid to the end user — the patient. While bringing down prices of medicine and facilitating accessibility is important, should it come at the cost of patients’ lives? Waiving clinical trials in the upstream to bring down prices of biosimilars or mandating prescription of Indian-made generic drugs, which are already creating waves across countries for the fatalities arising post their use, in the downstream pave the way for accessibility of drugs whose quality cannot be vouched for. Significantly, their availability puts indirect pressure on physicians to prescribe them. If the above-mentioned policy changes continue to be implemented, the market will be flooded with low-quality drugs and biosimilars, leaving doctors with very few quality alternatives.
These developments, all of which appear to be driven by the interests of the pharmaceutical industry and political expediencies in the name of bringing prices down and accessibility, will further strain the fragile doctor-patient relationship. After all, patients entrust doctors with the responsibility of their lives, taking prescribed medicines with unquestionable faith.
This calls for an urgent restrategising of the Indian pharma regulatory framework to train the spotlight back on the quality of drugs, bringing back patient safety to the core of the discussion. There must be greater consultation among patients, families, civil society, doctors, parliamentarians and policy-makers because human lives are at stake.
Amitav Banerjee, MD, is a professor in a medical college in Pune
