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Generic Medical Devices: Can They Breach the Branded Wall?


Multinational companies such as J&J, GE, and Siemens have dominated the medical devices industry thanks to product innovation and lack of competition from cheaper alternatives from generic manufacturers. Though local competition has emerged in some of the larger markets such China, most domestic companies remain small-sized, focusing on less complex Class I and Class II type medical devices, such as orthopedic accessories, catheters, wound solutions, and inhalers.

Most emerging countries rely heavily on imported devices such as stents, pace-makers, artificial joints, biologics, etc., as there are very limited alternatives available in their domestic markets. For instance, India imports about 80% of the required medical devices. This is where generic devices come into play.

Generic medical devices are copies of those branded devices that are not patent-protected. While the quality of such medical devices is at par with branded products, the price can be up to 50% lower. So far, only a few generic products, such as asthma inhaler (1995) and Pulse-Oximeter (2003), have caught market attention. The recent addition being a range of orthopedic products, including plates, rods, and screws by Emerge, a company started by former employees of Swiss-based Synthes (now acquired by J&J).

Currently, the market for generic devices is predominantly US-driven, where regulations do not differentiate between a branded device and its ‘substantially equivalent’ design. It is expected that more generic devices may enter the market as branded devices go off-patent. Other branded devices, which are similar in function and not manufactured through proprietary process, may also face generic competition.

Generic Medical Devices

Generic devices may be the answer to various governments’ aim of minimizing healthcare cost without compromising on quality. However, the market for generic devices is still fragmented and geographically constrained vis-à-vis branded ones. Much would depend upon the ability of generic manufacturers in containing costs (to remain competitive) and in breaking the hold of established players over sales and distribution channels.

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Essential Drugs in India – Is It All About Affordability?

For a pharmaceutical company, establishing a balance between production cost, profitability and affordability of the drug for consumers is a delicate matter, with natural temptation to push the aspect of affordability to the back seat in search for profit maximization. Large pharmaceutical corporations have often been criticized for not undertaking sufficient efforts to promote availability and affordability of essential medicines, especially in poor and developing countries. It seems that this criticism is slowly yielding positive results – several drugmakers, led by giants such as GlaxoSmithKline and Johnson & Johnson, are intensifying their initiatives oriented at ensuring the availability and affordability of their drugs in less affluent markets. These efforts are mirrored in the “Access to Medicine Index”, published in 2012 by Access to Medicine Foundation, that clearly indicates drugmakers’ response to rising social pressure to provide affordable drugs.

The drugmakers’ initiatives span a range of actions – differential and reduced pricing, technology transfers under license agreements, as well as donations. For instance Gilead, a US-based biopharmaceutical company, provides waiver of royalty payments to licensed manufacturing partners of its HIV medicines. Since 2011, it has also operated a five-year single-drug donation program, which involves donation of 450,000 vials of AmBisome (amphotericin B liposomal), for the treatment of visceral leishmaniasis in developing countries, including in India. Another example is Merck India, which has been selling its anti-diabetic drug, Januvia, at one-fifth of the US price since 2008.

But pharma companies are not alone in their efforts. Indian government has introduced a policy aimed at increasing the availability of essential drugs at affordable prices. In 2011, the government proposed to increase the number of drugs remaining under the purview of the National Pharmaceuticals Pricing Policy 2011 to 348, up from initial 74. This policy has been amended in 2012 to include 652 commonly-used drugs under 27 therapeutic areas. Introduction of this policy is expected to result in a price drop of 10% or more for about two-thirds of essential drugs available in the Indian market.

While these combined corporate and government efforts are likely to boost access to inexpensive essential drugs, Indian government actions might, ironically, have an adverse impact on the industry. Several pharmaceutical corporations operating in the Indian market are already averse to these new government policies, citing erosion in both top and bottom line results. There are at least two more negative repercussions potentially arriving from the government’s actions:

  • In a scenario, where the provision of price-capped drugs becomes unprofitable for the drugmaker, the pharmaceutical company may decide to discontinue the availability of these medicines in the Indian market. This took place prior to the introduction of the National Pharmaceuticals Pricing Policy 2011, when 27 of the 74 drugs under price control were discontinued. Such a scenario would render these price control efforts counter-productive, to say the least.

  • At the same time, quite possibly, small domestic generic drug manufacturers are likely to be tempted to raise the prices of their low-cost drugs closer to the designated price-cap level, which in their case would mean an increase in the average price of drugs. This would, without a doubt, negatively impact consumers, particularly in smaller tier II and tier III cities across the country.

Increasing social pressure to provide affordable drugs is forcing both corporations and governments to introduce efforts to control drug prices. While these price control measures are necessary to make essential drugs affordable to the Indian public, these efforts may backfire in the long run. Possible drug discontinuation and average price hikes ultimately point towards corporations placing profit maximization over consumer needs.