Crocin or Paracetamol: What Should the Doctor Prescribe?

An interesting research piece in this week’s EPW by ChatterjeeKensuke Kubo, and Viswanath Pingali.

Apparently the doctor prescription is likely to change. Till date, doctors give us some branded medicine which is likely to change to a generic formula:

Recently, a news item in The Economic Times, a key business newspaper in India, stated that the Government of India (GOI) is planning to pass legislation where the doctors would have to write prescriptions for the generic name of the drug, and not for the brand name of the drug (Singh 2011). The health ministry of GOI has already mandated that all doctors working in all central government hospitals and clinics should write the generic name along with the brand name. As per the current practice, if, for example, a doctor wants to prescribe paracetamol, he would write his preferred brand of paracetamol, like Crocin, Dolo, etc, along with the associated strength on the prescription. However, if the new legislation were to be enacted, all doctors, including those working in state government and private sector hospitals and clinics, would be required to write only “paracetamol” along with the associated strength on the prescription, and not the brand name.

What are the pros and cons of such a change in the regulatory regime? This question is relevant not just to India, but to any country, where even generic medicines are sold through brand names (referred to as branded generics). In China too, for example, the doctors write prescriptions using the brand name of the medicine, and not the generic name. An article inThe New York Times reported that, due to this practice, branded drugs have significant presence even after the loss of patent status, and subsequent onset of significant competition from generic manufacturers (Japsen 2012). Therefore, the debate on such legislation becomes pertinent in all emerging economies as they attempt to balance keeping the prices of medicines under check, with other issues like the quality of manufacturing.

Such stuff is barely discussed by the media with most time spent watching markets. Things like these should be debated extensively in society..

Anyways what are the pros? Well it gives the customer a choice of a generic brand which is likely to be less expensive. The negative is it could lead the medicine industry to get into all kinds of practices:

However beneficial this policy change may sound – especially in terms of more affordable essential medicines – some important issues need to be taken into cognisance before implementing it. A prerequisite for mandated generic name prescriptions is that, for a given molecule, quality is identical across all companies that manufacture it. While the regulatory authorities have mandated that all pharmaceutical companies have to necessarily comply with the “good manufacturing practice” (GMP) prescribed by the World Health Organisation (WHO) from 2005 onwards, it is not clear as to what extent these are rigorously enforced. If, as expected, quality and cost of manufacturing are positively related, then a policy mandating generic name prescriptions may cause lower-quality products to gain market share at the expense of higher-quality ones.

This problem is exacerbated as mandatory generic prescriptions force manufacturers to shift their attention from doctors to pharmacies. Pharmacists have a financial incentive to fill prescriptions with products that give them the highest margins, and not necessarily those with the lowest prices or highest perceived quality. If this is so, unless quality regulations are strictly enforced, companies with lower costs (presumably, lower quality) are likely to provide greater margins to the pharmacists. In this context, it is also important to note that the retail pharmacy segment in India is highly unionised and powerful. Therefore, the scope for such perverse incentives (of promoting the products of those drug companies that offer greater margins) would indeed be present.

Another issue this change in regulation is likely to bring forward is the generic pharmaceutical companies’ incentives to differentiate themselves from the competition. Mandated generic name prescriptions could lead to the proliferation of “pharmaceutical combos” – combinations of two or more molecules already approved into a single drug. While in some cases, these combos yield significantly better health outcomes (through better patient compliance) or cost advantages, in other cases, they are used by the companies to differentiate themselves from their competitors.

Conversations with some doctors suggest that the benefits of some of the new combos are indeed questionable. As the events in 2012 revealed, the regulatory mechanism of how new combos are approved is not clear, and as such, some of these products should be viewed with caution. If the introduction of generic name-based prescriptions drives manufacturers to artificially differentiate their products through combos, then the net effect on health outcomes may well be negative.

An additional caveat to this regulation pertains to biological drugs like insulin. The approval process of biosimilars (generic versions of the biological drugs, also called follow-on biologics) is not yet clear. These drugs are scientifically complex, and are sensitive to manufacturing processes. In fact, unlike small molecule drugs, establishment of bioequivalence2 with the innovator drug in case of these biological drugs is not straightforward (Wang and Chow 2012). Therefore, the quality issues we have discussed above become pertinent in this case as well.

Interesting stuff..

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