Access to low-cost generics at the cost of quality and safety has been a decade-long argument; it falls flat when we compare them with efficacy and safety of brands
By Bejon Kumar Misra
The government, in its efforts to cut down on out-of-pocket expenditure and make affordable healthcare a reality, is relying on a generics-only model. The push for generics witnessed a boom under Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana, a scheme that is economically non-discriminatory. But if ensuring universal health coverage by making medication affordable is the goal, superior-quality drugs are a prerequisite. While the government advocates for a generics-only model, forming policies without empirical evidence can have devastating effects on patients.
India ranks third in the global pharma market (10% in global sales) but the domestic scenario is worrisome. In 2016, a study on the Spurious and Not of Standard Quality (NSQ) medicines in the supply chain in India comprising of more than 47,000 samples collected scientifically, revealed that more than 10% samples were declared NSQ in the supply chain, of medicines procured by government agencies, compared to the all-India average of 4%. The world’s largest ever study was reported by the government of India and based on a model designed by the Indian Statistical Institute. Medicine procurement and distribution should be driven by global best standards, not lowest price—in the Indian market, generics hold a whopping 75% share. It makes one wonder if the ‘generics-only model’ is a panacea to India’s disease burden. Not only does a low-quality drug delay a patient’s recovery, but also attacks immune system, inviting associated comorbidities. Are we ready to face these risks involved in using substandard drugs?
When developing branded generic, companies follow bio-equivalence (same efficacy) and bio-availability (same active ingredient), filling gaps left open by generics—quality, regulatory mechanisms, infrastructure etc. The March 2017 edition of CDSCO’s surveillance report shows a range of commonly consumed generic drugs fall short of standard quality-control criteria. Branded generics, on the other hand, follow regulatory mechanisms like US FDA and WHO Good Manufacturing Practices, which make them more reliable than generic counterparts.
In 2017, five drugs were recalled from Jan Aushadhi stores over quality lapses. Another six drugs were rolled back in the first four months of 2018. Most of India’s generic drugs manufacturers do not follow US FDA guidelines for domestic distribution. India has more than 67,000 drug formulations but the quality control mechanism of all the Central Drugs Testing Laboratories can ascertain the quality of only 15,753 drugs annually.
This major quality snag explains the 2014 Chhattisgarh tragedy—15 deaths, 70 critical and 20 were put on mechanical ventilation. All these women were administered substandard drugs used in sterilisation camps. Many court proceedings later, the verdict declared drug manufacturing companies responsible for producing substandard versions.
The government’s push for the generics-only model by introducing Jan Aushadhi stores nationwide has bolstered the hold of generics in India. But if we wish to develop unwavering trust in generics, first we need case studies to rely on. The examples above clearly state a different story.
Come 2020, the NCD burden will be responsible for 73% of deaths and 60% of disease burden in India. A low-quality drug delays recovery time, weakens the immune system by a longer duration of dosages, and invites comorbidities. Substandard medicines may promise affordable healthcare in the present, but in the future results could be catastrophic. Relying on generics alone can be counter-productive in the mission to make India disease-free.
Brands are created after years of research, extensive spend on R&D and are priced for perfection. Since generics do not involve repetition of extensive clinical trials over the years, their manufacturing cost is less, and so are their prices. Are you willing to trade affordability for quality and safety?