Saturday, July 2, 2011

Branded or Generic Drug: Vanam Jwala Narasimha Rao

Branded or Generic Drug

ESMEDS Initiative to open

Generic Medical Stores

Vanam Jwala Narasimha Rao

In Andhra Pradesh, the current annual pharmaceutical sales turnover touches over Rs.6, 000 Crores. Roughly, the cost of basic medicines required for a diabetic patient is around Rs.20/- per day which works out to Rs. 7, 000 + per year. Similarly a Hypertension patient on an average needs to spend around Rs. 15 per day and Rs. 5, 500 per year. A patient treated for “serious infection” incurs Rs.600/- to Rs.1, 000/- per day and it would be anywhere between Rs. 6, 000 to Rs. 10, 000 for a minimum of ten days. This is a definite burden on the patient and particularly whose incomes are low. The sufferers are the lower middle class, middle class and even the upper middle class population. The only way out for this is, shift from buying Branded Medicines to Generic Medicines. Towards this direction ESMEDS initiated sale of Generic Medicines in Hyderabad to reduce the cost on buying medicines.


Essential Medical Services (ESMEDS) is a not-for-profit organization engaged in health care delivery at affordable prices for over three decades. It has now obtained permission to start on an experimental basis an exclusive retail medical shop situated in the Rajbhavan Lane, to sell Generic Medicines. They have also taken up an active campaign known as “Wise Medication”- a high quality medication at low cost. Very soon this has caught the attention of several patients, who regularly use medicines for long and chronic ailments like Diabetes and High Blood Pressure. In fact, two years ago, the then Visakhapatnam Collector Syamala Rao in consultation with an officer of Drug control authority there, Udaya Bhaskar, facilitated an NGO to start five medical shops in different places in Visakhapatnam to sell Generic Drugs to prescription holders at very low prices.


An analysis of ESMEDS reveals that, the present day family level disease burden is quite alarming. In our state on an average every family has one case of Diabetes or Hypertension (High B.P) 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 serious nature per year occurs. Drugs have thus become a part of average person’s life. Due to dietary indiscretion, lack of exercise, high levels of stress, consumption of tobacco and alcohol, there has been continual rise of incidence of what is known as the “Life style diseases” like Diabetes, Hypertension, Cardiovascular Diseases like Ischaemic, Atherosclerosis and Dyslipidemia in the state and the country. Unlike for episodic illnesses like fevers, diarrhea, respiratory infections and injuries, life style diseases (Chronic diseases) require Medication for years together, lifelong in many cases, to keep the disease under control. Like food and water drugs have become daily necessity.


Every Drug has three names - 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 recognized, pronounced and remembered by health professionals and members of the public.


The generic name Medicines also contains 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 color, the amount of time taken for a tablet to be absorbed into the bloodstream. 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 in order 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. The company then has exclusive rights to market the medicine for a certain period of time, usually 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 has already been done. Once a patent expires, other drug companies then have the right to manufacture and market the generic drug. 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. Many standard and reputed pharmaceutical companies manufacture both Branded and Generic versions of the same medicine. Both have same active ingredient. The Strength, dosage norms, route of administration, absorption and curative effect of both products would be similar. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. One reason for the relatively low price of generic medicines is that competition increases among producers when drugs 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. Branded drug is priced high because advertisement and other promotion expenses are unreasonably high. A Branded drug incurs 30% to 80% of the MRP on promoting medicine through Medical representatives, doctors, retailers, etc. There is absolutely no relationship between cost of raw materials and the final price. Incentives to doctors or trade are several times that of actual cost of bare medicine in the final price. A Generic drug from reputed companies costs a fraction of branded one. Generic drugs are subject to same regulations of the governments as for branded drugs in matters of production process, Quality and safety profile. Generic drugs are labeled with the name of the manufacturer or with a non proprietary. Wisdom lies in picking such Generic drugs as against their branded counterparts. Medication becomes cheaper but the treatment quality is not compromised. When generic products become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms.


Pharmacists are obliged by law to dispense whatever the doctor has written on the prescription. If the doctor has prescribed a medicine by its brand name, the pharmacist must dispense that brand. If a medicine has been prescribed by its generic name, the pharmacist can dispense whatever version of the generic medicine available with them, because each version will have the same therapeutic effect, regardless of whether one manufacturer makes the tablets with a different shape or color.

There are few apprehensions which in fact are far from reality. Low price does not mean low quality since Drug Control Authority requires that generic drugs be as safe and effective as brand-name drugs and to ensure this. Same checks and monitoring on production process are followed. It is not true that only small or substandard firms produce them. 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 same as in case of branded one and most people make the brand to generic transition smoothly.

If there is a mechanism to source quality generics from standard firms, directly from the companies and the depots and made available to people the cost of medicines can be brought down significantly. When this is done, the burden on budget eases, medication compliance raises as well as ensures better cure and better Health of people.

ESMEDS has set out on this endeavor and also is trying its best to sensitize the Doctors Community to prescribe Generic Medicines and hopes that they will understand the need and extend their support. End

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