GUEST COLUMN

A case for branded generics

Improvements on existing drugs contribute to the quality of health care

Dr Sundeep Mishra Dr Sundeep Mishra

Making a mark in the global market, India is the largest provider of generic drugs globally. Today, the Indian pharmaceutical sector industry supplies over 50 per cent of the global demand for various vaccines, and 40 per cent of the generic demand in the US. While India’s generic drug manufacturing industry constitutes 10 per cent of the volume of the global pharma industry, it only forms 1.4 per cent of its value. This means that the pharma sector will have to do more than just manufacturing copies.

For a long time now, in emerging economies, branded generics have been associated with trustworthy quality at a low cost. Incremental innovations can raise the benchmark for quality treatments—faster delivery methods, smarter dosage combinations, and newer indications or digital solutions that improve patient adherence. Incremental innovation is one area where pharma firms are making their mark through branded generics.

Applying science to make small improvements to make patients’ lives better. I strongly believe that the advantages of incremental improvements on already existing drugs have contributed to overall improvement in the quality of health care worldwide.

A Bain & Company report on trillion-dollar growth trend projections for 2020 noted that $5 trillion of incremental growth would be based on 'soft innovations' this decade. These are innovations that offer people better or more niche products that meet their needs and change basic habits over time. After all, what does a patient want—medicines that are easier to take and offer a better experience.

THE INDIAN CONTEXT

Currently, these innovations are largely offered by branded generics. As our current patent regime does not encourage or support the patenting of incremental innovations, interest in micro-innovation is marginal. There is only a fraction of amount of sales spent on innovations, and even public expenditure on research is just 0.7 per cent of the GDP in the last two decades. The pharma companies in India must tread the path towards incremental innovation so that the special patient needs are satisfied via trustworthy branded generics, which deal with problems specific to our country. And, this includes the cost of disease and medication to ensure that patients have everything they need. The government and the industry need to work in tandem in future, and that demands high levels of investment and technology.

WHY INCREMENTAL INNOVATION MATTERS

Incremental innovation is capable of changing the way a disease is treated. An example can be non-compliance due to huge pill burden; herein, a pharmaco-dynamically and pharmaco-kinetically compatible combination can reduce pill burden as well as the cost. Likewise, a sustained /modified release dispensation can provide a round-the-clock smooth drug levels and also reduce pill burden.

Incremental innovations will tailor drugs according to India’s need: for instance, the use of microspheres in vaccines or salt forms of pyrroloquinoline and benzoquinoline is the way ahead to maintain stability under high humidity. Some innovations can also improve drug stability in the hot Indian environment where maintaining a cold chain might be difficult. Furthermore, chiral pure drugs or some other innovations may reduce toxicity and side-effects and improve the effectiveness of drugs.

The world’s fastest growing economy should strive for innovative solutions that matter. For the patients' good, we cannot lose sight of the value provided by branded generics through incremental innovations. It is time that the research-based branded generic companies are supported through a positive business ecosystem and globally harmonised regulatory mechanisms, and are given the recognition they deserve without looking at the upfront cost alone but also the long term cost of patient care and effective treatment.

Dr Mishra is professor, department of cardiology, AIIMS, Delhi.

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