The Government’s well-intentioned decision to promote generic medicines will backfire unless it addresses concerns about the poor quality of such drugs
Health is one of the most important components of human development and lays the foundation stone for any country to grow and excel upon. Prime Minister Narendra Modi also emphasised the importance of health in his party's election manifesto. His Government is taking giant steps to improve access to healthcare in the form of reduced prices for essential drugs, increased human resources through medical colleges and better infrastructure through investment in hospitals and equipment. A revised and better health policy is also on the anvil, and affordable healthcare has been promised to all through the National Health Assurance Mission.
Recently, the Government has also sent a circular to the All India Institute of Medical Sciences, instructing doctors, consultants and residents to prescribe drugs by their generic names. This circular does not come as a surprise as it is part of the Government’s policy to make healthcare affordable and accessible to the masses. The biggest thrust in this regard has been on universal insurance and also universal access to medicines through the promotion of generic drugs whose prices are being lowered. But will this really translate into universal healthcare for the massesIJ
India is the third largest manufacturer of generic drugs worldwide. It exports medicines to more than 200 countries. Its generics are recognised worldwide and they have a large market even in the US and other developed countries. These demands of these markets, in turn, have made it compulsory for domestic producers to invest in factories and production units that meet international protocols for good manufacturing and laboratory practice.
However, concerns of quality, efficacy and safety have been raised regarding generic drugs produced for domestic consumption within India. This is largely because the Indian market is not well regulated. Thereby, spurious, sub-standard and low quality drugs are allowed into the system. Combined with poor prescription practices, over-the-counter medicines, and an un-supervised healthcare delivery mechanism, especially in rural and semi-urban areas, prescribing generic drugs in India seems like a recipe for disaster.
Under these circumstances, it is difficult to support the prescription of generic medicines. Physicians outside the public system will continue to prescribe branded versions. Those forced to prescribe generics will find it difficult to choose the best option, in the absence of a system that facilitates transparent and robust procurement mechanisms. Recent incidents of large quantities of spurious drugs being discovered in a State-run hospital, and the findings of the Food and Drug Administration pointing to poor manufacturing practices, further strengthen the belief that India is still not ready for generics. Patients, therefore, will continue to be at risk for both low quality generic drugs as well as expensive branded drugs.
Compulsory price cuts will also discourage companies from investing in innovation for better quality, low priced alternatives. As of now, increased scrutiny from the FDA is already prompting local drug makers to invest in better factories and better trained personnel. As companies devote resources toward compliance with US regulations, they also become more sensitive about their profit margins.
Ultimately, a combination of the US-style scrutiny and price caps at home can lead the pharmaceutical industry to look elsewhere for business. Further, investment into research for generics hasn't been upped by the Government and innovation is still not an accepted vocabulary within publicly-funded research circles. Is the Government then missing the woods for the trees in its hurry to bring in populist measures like low cost genericsIJ
(The author is the CEO and co-founder of DakshamA Health and Education, an organisation that is dedicated to working for access to health, patient education and advocacy.)