Reply to 'Generic Medicines as a way to Improve Access and Affordability: A Proposed Framework for Pakistan'
Correspondence Address :
I read with great interest, the article titled, â€˜Generic medicines as a way to improve access and affordability: A proposed framework for Pakistanâ€™ by Jamshed and coworkers (Journal of Clinical and Diagnostic Research 2009; 3:1596-1600.). The authors have highlighted the broad definition of generics in their article. In a previous article, I and my colleague, Mr. Thapa, had highlighted the fact that many â€˜brandsâ€™ marketed in South Asia may be considered as generics and only a few manufacturers in South Asia manufacture generics in the classic sense of the term (1). An expansion of the definition may thus be useful in a South Asian context.
A problem we had raised in the article (1), was the issue of the quality of medicines. South Asia has a major problem of counterfeit medicines. Another problem is the ambiguous pricing of medicines. A study had shown significant variation in the cost of medicines available in the Nepalese market (2). Ten individual drugs and three drug groups showed more than 50% variation. Many essential drugs which provide a low margin to the manufacturer had only a single manufacturer. On the other hand, there were many manufacturers for medicines with a high margin, like vitamins and tonics. In a free market economy, it is natural for manufacturers to concentrate on drugs which give them a high profit margin. A study was also carried out on the pricing of topical dermatological products (3). Twenty-five drugs showed more than 75% variation in prices. Nepalese brands were generally cheaper than their Indian counterparts, but there were exceptions. Among the therapeutic categories, maximum variation was observed among topical antiseptics, topical antivirals and corticosteroids (3). A study on drug prices in Malaysia had found a significant variation in the cost of innovator brands and generics (4). Costs were higher in private sector retail pharmacies and dispensing doctor clinics as compared to that in the government sector. The manufacturing selling price was high for innovator brands as compared to generics in all sectors (4). A wide variation in medicine prices was also found in an Indian study (5).
At the KIST Medical College, Imadol, Lalitpur, the Medicine and Therapeutics Committee (MTC) has restricted the number of brands available in the hospital pharmacy. For each generic, a maximum of four brands, two Nepalese and two foreign, are stocked (5).The criteria for selection, are the registration of the brand with the Department of Drug Administration and the National Drug Regulatory Authority, the possession of the Good Manufacturing Practice certification by the company and the cost. However, recently, certain clinicians were not completely happy with the selection of brands and wanted particular brands to be stocked in the pharmacy. They claimed that the brands that they were proposing were of superior quality and gave better results based on their â€˜clinical experienceâ€™. An issue to be considered is that, ultimately clinicians are the ones treating the patients and the patient outcome is ultimately their responsibility. This has to be reconciled with the need for objective drug selection and the rational use of medicines.
The number of drug testing laboratories in developing countries is few and the results of tests are not widely disseminated. There is a lack of information on the prices and the quality of different medicines. Manufacturers often claim that their medicine which is priced higher is of superior quality and that one always has to pay more for a superior quality product. However, lack of independent objective information to back this claim, remains a problem. The cost benefit analysis of different brands has not been carried out. Considering the proliferation of brands and the wide variation in costs, I think that we have to concentrate on developing modalities for such studies. The authors of the article have mentioned about doubt being cast in Pakistan on the quality of generic drugs. The same is true in other South Asian countries and innovator companies promote their products as superior. Consumer magazines often do a head to head comparison of costs and features of various consumer goods like televisions, refrigerators and cars. Though medicines differ in certain respects from these goods, head to head comparisons of various brands of the same generic may be required.
Thus, a wider availability of information on drug prices, on the pharmacokinetic and pharmacodynamic equivalence of various brands and studies on the analysis of cost effectiveness of various brands of medicines are the need of the hour in South Asia. Provision and wider dissemination of this information may help in making more rational decisions.
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