Regulating the Generic Drugs Market: Eliminating the difference between Branded and Unbranded Generics
[By Mansi Subramaniam & Sanigdh Budhia] The authors are students at the Gujarat National Law University. Introduction The Indian Pharmaceutical Industry has been transformed greatly in the past few years with the incoming of various companies and brands. It is one of the largest markets in the world, both in terms of volume and value. One of the unique features of the Indian Pharmaceutical Industry is the existence of ‘Branded Generics’. Generics are low-cost, functionally undifferentiated products with identical active components to the patented drugs whereas ‘Branded Generics’ are generic medications sold under a brand name. Branded Generics enjoy an edge over Unbranded Generics even though the chemical composition of both of them are the same because of their brand value, as well as certain anti-competitive practices. This creates a unique problem for the Indian Regulatory Authority for fair competition in the market, i.e., the Competition Commission of India (“CCI”). The latest study of the CCI on the Indian Pharmaceutical Industry highlights the existence of this problem in India and gives recommendations for the same. This article analyses the said problem and gives recommendations to ensure fair competition in the market in the presence of Branded Generics. Branded Generics Market Quandary India is the biggest supplier of generics globally. India’s pharmaceutical business is dominated by generics, which account for 97 per cent of the country’s drug consumption in terms of value. Around 10 per cent of these medications are unbranded generics. Branded Generics account for the rest of 87 per cent of all the drugs prescribed. Even though unbranded generics and branded generics are homogenous in nature, there is a significant price differentiation between the two. The price difference between them ranges from 1 to 200 per cent, making Branded Generics very expensive for the population at large. The companies selling Branded Generics increase their market share by selling in large volumes and by adopting certain uncompetitive practices. Since these branded generics are priced higher, they earn a huge profit, resulting in them becoming a market leader in the pharmaceutical sector. These market leaders often determine the prices in the market. Causes of high-priced Generic Drugs The prevalence of branded generics is one of the main causes of highly-priced generic drugs. Branded generic drugs are priced higher owing to the high trade margins maintained by the drug manufacturers. Higher trade margins are offered to traders by these companies to prioritize or only stock their drugs in trade and retail stores over other manufacturers. The general public perception that branded generic drugs are of higher quality in comparison to unbranded generics, is a major reason why the former is preferred, despite the latter being a cheaper option. The CCI study reveals that the market is usually dominated by the highest-priced brand. However, these findings are contradictory to an ideal competitive market. Ironically, studies have even shown that there exists no difference in quality and efficacy between branded and unbranded generics drugs. The demand for branded generics is further spurred by arrangements between drug companies and hospitals/medical practitioners. Patients are prescribed specific branded drugs, despite the availability of lower-cost options. Private hospitals often have a compulsory tying of consumables (patients are mandated to purchase drugs from the hospital itself), thus leading them to purchase specific brands irrespective of the cost. This issue is further exacerbated by information asymmetry in the market and the fact that consumers are generally unaware of lower-priced options. Proposed Recommendations The CCI in its study has recommended that in order to assuage the concerns about the quality of drugs in the minds of people, the quality of drugs should be maintained at a pre-determined standard. It has recommended the implementation of existing quality standards and periodic and scientific testing of drugs. When all the drugs are obligated to satisfy the same specifications and regulations, it is entirely incorrect to presume that a more expensive brand is of higher quality than a less expensive brand or unbranded generics. Even branded generics can fail the quality test if companies do not comply with existing standards. Thus, Branded Generics cannot justify their higher prices based on quality perceptions. Reducing Doctor- Pharmaceutical company nexus In order to ensure fair competition among all types of generics in the market, the doctor-pharma company nexus should be restrained. The government should mandate the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and actively implement it. The UCPMP is India’s version of the US’ Physicians Payment of Sunshine Act (Sunshine Act). Sunshine Act has resulted in fines of millions of dollars for some pharmaceutical corporations. However, in India, the implementation of UCPMP remains voluntary till date. The UCPMP restricts pharmaceutical companies from giving any kind of financial or pecuniary benefits to doctors and their family members, wholesalers, retailers, etc. The pharmaceutical companies often employ such incentivization tactics to persuade doctors to prescribe their high-priced brands over others (and in some cases, doctors have asked for incentives in exchange for prescriptions). Implementing UCPMP mandatorily will curb such practices. The Essential Commodities (Control of Unethical Practices in the Marketing of Drugs) Order, 2017 (“CUPMD Order”) was released by the government in 2018 and was proposed to be passed as a law under the Essential Commodities Act, 1955. The order noted that doctors are often lured to recommend a particular drug in exchange for incentives. This order outlawed such transactions and proposed the creation of a new authority known as the Ethics Compliance Officer, who would be in charge of investigating any alleged violation of the CUPMD Order. This order needs to be converted into a law and implemented effectively. In 2017, the government proposed to bring in a law ensuring that doctors prescribegeneric drugs only. The Medical Council of India has already recommended the same. However, this law was never enacted. The government should actively take steps to enact and implement the said law in order to ensure that doctors do not favour one company over another. Price Control Mechanism for Generic Medicines The Government needs to revisit








