Millennium Post

A patently obvious fact

Given that generic medicines are just as safe and effective as branded medicines while still being more cost-effective, it is prudent to promote the same for wider healthcare access

The annual pharmaceutical sales turnover in any state including Telangana touches thousands and thousands of crores of rupees. According to Doctors, the annual expenditure on branded medicines incurred by a diabetic patient and hypertension patient roughly touches around Rs 10,000 and Rs 7,500 respectively. Similarly, a patient treated for serious infection may incur anywhere between Rs 6,000 to Rs 10,000 for a minimum of ten days. This is a definite burden on patients belonging to the lower middle class, middle class and even the upper-middle-class, whose incomes cannot keep up with these expenses. The only way out is to shift from buying branded medicines to generic medicines.

Available data says that the family level disease burden is quite alarming. In every state on an average, every family has one case of diabetes or hypertension and sometimes both. In every two families, at least one case of cardiovascular disease is present. In every five families, at least one case of mineral and/or vitamin deficiency is found. In every three families, one illness episode of a serious nature per year occurs. Lifestyle diseases like diabetes, hypertension, cardiovascular diseases like ischemic, atherosclerosis and dyslipidemia are very common. Drugs have thus become a part of the average person's life.

Every drug has three names namely, chemical (For example N-Acetyl Para Amino Phenol), generic (Paracetamol) and brand name (Crocin). The generic name is most important of all. It is the official pharmacological name of the active ingredient — chemical or biological -— in the medicine that produces the curative effect. The brand name is chosen by the manufacturer, usually on the basis that it can be recognised, pronounced and remembered by health professionals and members of the public.

The generic name medicines also contain inactive ingredients, which are used to formulate the active ingredient into a tablet, liquid, cream or other preparation. Medicines containing the same active ingredient but made by different manufacturers may vary in appearance. There may be small differences between them, such as colour, the amount of time taken for a tablet to be absorbed into the bloodstream, etc. These differences are rarely significant which is why generic and branded medicines are almost interchangeable.

When a pharmaceutical company develops a new drug formulation, it is put through a series of clinical trials to gain approval for marketing from the concerned regulatory agency constituted for this purpose by the government. If the clinical trial results show the new drug to be safe and effective for the condition in question, the regulatory agency approves the drug and gives it a license.

The pharmaceutical company can then market the generic medicine under a brand name with exclusive rights to market for a certain period, say, about 10 to 12 years. This is known as a patent and allows the drug company to recoup the costs of research and development of the new medicine before other drug companies are allowed to produce it as well. Other drug companies are likely to be able to produce and sell the medicine at a cheaper rate because the research and development for the same has already been done. However, they must market it under a different brand name or under its generic name.

A generic drug must contain the same active ingredients as the original formulation. Both generic and branded drugs have the same active ingredient. The strength, dosage norms, route of administration, absorption and curative effect of both products would be similar. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs are no longer are protected by patents. Companies incur fewer costs in creating generic drugs and are therefore able to maintain profitability at a lower price.

There is however a huge difference in the price. A branded drug is priced high because advertisement and other promotion expenses are unreasonably high. There is no relationship between the cost of raw materials and the final price.

A generic drug from reputed companies costs a fraction of the branded ones. Generic drugs are subject to the same regulations of the government as branded drugs in matters of the production process, quality and safety profile. There is, therefore, wisdom in picking such generic drugs against their branded counterparts. Medication becomes cheaper but the treatment quality is not compromised.

The low price does not mean low quality since the various drug control authorities require generic drugs to be as safe and effective as brand-name drugs. To ensure this, the same checks and monitoring on the production processes are followed. These are produced by highly reputed companies. Generic drugs work as fast and as effectively as the original brand-name products. The side effects are also the same as in case of branded ones and most people make the brand to generic transition smoothly.

Indian Medical Council regulations prescribe that every physician should prescribe drugs with generic names legibly and preferably in capital letters and he or she shall ensure that there is a rational prescription and use of the drug. The MCI or the appropriate state medical councils have been empowered to take disciplinary action against a doctor for violation of the provision of the aforementioned regulations.

The Ministry of Health and Family Welfare has taken various regulatory measures to promote and ensure the quality of generic medicines. Generic drugs should have been in the limelight given that PM Modi had announced that the Government will make it compulsory for doctors to prescribe generic drugs. Unfortunately, the scenario is not that bright and not at all on the expected lines.

For instance, in the whole of Telangana, there are just about 100 generic medical shops spread over 23 districts, including seven in twin cities which are known as Jeevandhara or Janaushadhi Medical Shops. The situation is nearly the same in other states as well. They are not in proportion to and commensurate to the requirements of the people.

The writer is the Chief Public Relations Officer to the Chief Minister of Telangana. Views expressed are personal

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